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Patterns of Use of Erythropoiesis-stimulating Agents in Medicare Population Reported (11/19/2009) Researchers from Columbia Medical Center have reported that by 2002, 45.9% of Medicare recipients with common cancers were treated with erythropoiesis-stimulating agents (ESAs) such a Procrit® (epoetin alfa) and Aranesp® (darbepoietin). The details of this study appeared in an early online publication in the Journal of the National Cancer Institute on November 10, 2009.
Denosumab Delays Skeletal-related Events in Cancer Patients with Bone Metastases (9/22/2009) Researchers involved in a multicenter Phase III study have reported that denosumab is at least as effective as Zometa® (zoledronic acid) in delaying skeletal-related events (SREs) in cancer patients with bone metastases. The details of this study were presented at the ECCO 14- ESMO 34 Congress in Berlin on September 20 as a late-breaking abstract.
Denosumab Shows Bone Benefits in Two Pivotal Studies (8/11/2009) Denosumab increases bone mineral density (BMD) and reduces the risk of vertebral fractures in women with postmenopausal osteoporosis as well as men treated with androgen deprivation therapy for non-metastatic prostate cancer, according to the results of two pivotal studies published in the New England Journal of Medicine.
Denosumab Effective in Patients with Bone Metastases (8/10/2009) Among patients with bone metastases from cancers other than breast cancer or prostate cancer, the investigational drug denosumab was as effective as Zometa® (zoledronic acid) at reducing the risk of bone complications such as fracture. The results of this Phase III clinical trial were made available in a press release from Amgen.
Denosumab More Effective than Zometa® in Patients with Bone Metastases (7/10/2009) A press release from Amgen has reported that denosumab was more effective than Zometa® (zoledronic acid) for the prevention of bone complications in women with metastatic bone disease from breast cancer. These results were obtained in a large Phase III clinical trial comparing denosumab to Zometa for prevention of bone complications.
Ginger Supplements Reduce Chemotherapy-induced Nausea (5/20/2009) Researchers from the University of Rochester-affiliated Community Clinical Oncology Program (CCOP) have reported that use of ginger supplements in combination with conventional antinausea drugs reduces chemotherapy-induced nausea to a greater extent than antinausea drugs alone. The details of this study will be presented at the 2009 annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando Florida, May 29-June.
Rezonic™ Enhances Effects of Zofran® and Dexamethasone for Prevention of Chemotherapy-induced Nausea and Vomiting (5/15/2009) Researchers involved in an international randomized study have reported that cancer patients receiving Rezonic™ (casopitant) in addition to Zofran® (ondansetron) and dexamethasone have better control of chemotherapy-induced nausea and vomiting (CINV) than patients receiving only Zofran and dexamethasone. The details of this study appeared in an early online publication on May 11, 2009 in Lancet Oncology.
Fentanyl Buccal Tablets Effective for Control of Pain in Opioid-tolerant Patients with Chronic Cancer Pain (5/14/2009) Researchers from the University of Utah have reported that fentanyl buccal tablets (FBT) (Fentora®) were effective and had a favorable safety profile for the management of patients with persistent cancer pain who had breakthrough pain on opioids. The details of this study appeared in an early online publication in Cancer on April 16, 2009.
Acupressure Wristbands Relieve Nausea from Radiation Therapy (4/16/2009) Researchers from the University of Rochester have reported that acupressure wristbands can reduce nausea among cancer patients receiving radiation therapy. The details of this study appeared in an early online publication in the Journal of Pain and Symptom Management on March 28, 2009.
Denosumab Benefits Patients with Bone Metastases Who Have Received Bisphosphonates (4/6/2009) Researchers from France have reported that patients with bone metastases who are treated with denosumab have a greater reduction in urinary N-telopeptide and fewer skeletal-related events than patients continuing to receive bisphosphonates. The details of this study appeared in the April 1, 2009 issue of the Journal of Clinical Oncology.
Aloxi® Superior to Kytril® for Delayed Nausea and Vomiting Due to Chemotherapy (2/24/2009) Researchers from Japan have reported that the combination of Aloxi® (palonosetron) and dexamethasone was as effective as Kytril® (granisetron) and dexamethasone for prevention of acute chemotherapy-induced nausea and vomiting (CINC) but was superior for prevention of delayed CINC. The details of this study appeared in the February 2009 issue of Lancet Oncology.
Erythropoiesis-stimulating Agents Increase Mortality in Cancer Patients (12/11/2008) Researchers affiliated with the EPO IPD Meta-Analysis Collaborative Group have reported that erythropoiesis-stimulatin agents (ESAs), such as Epogen® (epoetin alfa) and darbebpoetin (Aranesp®), increase on-study mortality by 17% and decease overall survival by 6% compared with control patients. The details of this study were presented at the annual meeting of the American Society Hematology on December 6, 2008 in San Francisco.
Age of Blood Used for Transfusions May Affect Incidence of Infection (10/30/2008) Researchers affiliated with Cooper University Hospital in Camden NJ have reported that transfused blood stored longer than 29 days was associated with an increased risk of infection compared to blood stored for a shorter period of time. The details of this study were presented at the annual meeting of the American College of Chest Physicians, which was held October 25-28 in Philadelphia.
Kepivance® Reduces Mucositis Associated with High-dose Methotrexate (9/10/2008) Researchers from Germany have reported that Kepivance® (palifermin, keratinocyte growth factor) reduces the incidence and severity of oral mucositis associated with high-dose methotrexate. The details of this study were reported in the September issue of the Annals of Oncology.
Aranesp® Improves Quality of Life in Anemic Patients Not Receiving Chemotherapy (9/8/2008) Researchers affiliated with South Carolina Oncology Associates have reported that the administration of Aranesp® (darbepoetin) to patients with cancer-related anemia not receiving chemotherapy or radiatiotherapy improves quality-of-life parameters. The details of this study appeared in the October issue of Supportive Cancer Therapy.
Intravenous Iron Improves Response to Aranesp® (4/4/2008) Two randomized clinical trials published in the April 1, 2008 issue of the Journal of Clinical Oncology demonstrated that the administration of intravenous iron and Aranesp® (darbepoetin) improved hemoglobin response compared with Aranesp alone in patients with chemotherapy-related anemia.
Chlorhexidine or Oral Cooling Decrease Chemotherapy-induced Mucositis (3/31/2008) Researchers from Denmark have reported that chlorhexidine mouth washes or oral cooling decreases the incidence and severity of oral mucositis associated with 5 FU and leucovorin-based chemotherapy for gastrointestinal cancer. The details of this randomized study appeared in an early online publication in Cancer on February 15, 2008.
Neulasta® on First Day of Chemotherapy May Be More Convenient for Gynecologic Cancers (3/18/2008) Researchers from the University of Alabama have reported that the administration of Neulasta® (pegfilgrastim) on the first day of chemotherapy among women with gynecologic cancers may be as effective as and more convenient than second-day administration. These results were recently reported at the 2008 annual Society of Gynecologic Oncologists meeting.
Venous Thromboembolism and Mortality Increased by Erythropoietin Use in Cancer Patients (2/28/2008) Researchers from more than 20 U.S. medical centers have reported that erythropoiesis stimulating agents (ESAs) Epogen® (epoetin alfa) and darbebpoetin (Aranesp®) administered to patients with cancer-related anemia is associated with a 57% increase in the incidence of venous-thromboembolism (VTE) and a 10% increase in mortality from all causes. The details of this study were published in the February 27, 2008 issue of the Journal of the American Medical Association.
Nplate® (Romiplostim) Set for ODAC Review (2/8/2008)
Long-Term Use of Eltrombopag for Chronic Idiopathic Thrombocytopenic Purpura (ITP) Reported (12/27/2007) Researchers affiliated with an international study have reported that long-term use of eltrombopag is safe and effective for the treatment of chronic idiopathic thrombocytopenic purpura (ITP). This study was presented at the 2007 meeting of the American Society of Hematology (ASH) in Atlanta, Georgia, December 10-11, 2007.
Erythropoiesis-Stimulating Agents do not Affect Long-Term Survival of Gleevec® Treated Patients with Chronic Myeloid Leukemia (12/13/2007) Researchers from the MD Anderson Cancer Center have reported that the use of erythropoiesis agents (ESA) such as epoetin alfa (Epogen®, Procrit®) and darbepoetin alfa (Aranesp®) do not affect survival of patients with chronic myeloid leukemia (CML) treated with Gleevec (imatinib). The details of this study were presented at the 2007 meeting of the American Society of Hematology, December 8-10, in Atlanta Georgia.
Romiplostim (AMG531) Effective in Chronic Immune Thrombocytopenic Purpura (12/12/2007) Researchers have reported that romiplostim (AMG531) is an effective agent for the treatment of chronic immune thrombocytopenic purpura (ITP). The results of several clinical trials involving romiplostim were presented at the 2007 meeting of the American Society of Hematology, December 8-10 in Atlanta Georgia.
ASH/ASCO Updates Clinical Practice Guidelines for Epoetin Alfa and Darbepoetin Alfa (11/12/2007) Researchers from several U.S. medical centers have updated the clinical practice guidelines for the erythropoiesis-stimulating agents (ESAs) epoetin alfa (Epogen®, Procrit®) and darbepoetin alfa (Aranesp®). These guidelines have been approved by the American Society of Hematology (ASH) and the American Society of Clinical Oncology (ASCO) and were published as an early on-line publication in Blood on October 23, 2007.
Amgen Revises Labeling on Erythropoietin-stimulating Agents (11/8/2007) Amgen, in collaboration with the United States Food and Drug Administration (FDA) and Johnson and Johnson Pharmaceutical Research & Development, has updated package inserts for Aranesp® (darbepoetin alfa) and Epogen®/Procrit® (epoetin alfa).
Epoetin Alfa Has No Effect on Survival or Relapse in Patients with Head and Neck Cancer (11/6/2007) Researchers affiliated with RTOG 99-03 study have reported that the administration of radiotherapy with or without recombinant erythropoietin alfa did not affect survival or relapse of anemic patients with head and neck cancer. The details of this study were published in the November 15, 2007 issue of the International Journal of Radiation Oncology * Biology * Physics.
Neulasta® Facilitates Chemotherapy Administration and Reduces Febrile Neutropenic Hospitalizations (9/28/2007) Researchers involved in an international randomized trial have reported that the prophylactic administration of Neulasta (pegfilgrastim) is associated with improved chemotherapy delivery, reduces febrile neutropenia (FN) and decreases hospitalization compared to current practice of neutropenia management. The details of this study were presented at the European CanCer Organization (ECCO) 14th European Cancer Conference meeting in Barcelona, Spain.
Aranesp® for Chemotherapy Induced Anemia has no Adverse Effect on Survival or Relapse (9/27/2007) Researchers affiliated with six randomized controlled trials of Aranesp® (darbepoetin alfa) versus placebo for treatment of chemotherapy induced anemia (CIA) in patients with non-myeloid malignancies have reported that Aranesp decreases transfusion requirements and improves hemoglobin responses without an adverse effect on disease progression or survival. The details of this analysis were presented at the 14th European Cancer Conference in Barcelona.
Prophylactic Colony-Stimulating Factors have No Effect on Mortality but Decrease Infections (9/25/2007) Researchers from Canada have reported that the use of prophylactic hematopoietic colony-stimulating factors (CSFs) decrease febrile neutropenia and infection but have no impact on survival. The details of this meta-analysis were reported in the September 18, 2007 issue of the Annals of Internal Medicine.
Aranesp® Has No Adverse Effect on Survival or Progression-free Survival when Used to Treat Chemotherapy-induced Anemia in SCLC (9/17/2007) Researchers involved in Amgen’s Aranesp pharmacovigilance program (the 145 Study) have reported that Aranesp (darbepoetin alfa) has no adverse effect on the outcomes of patients with extensive stage small cell lung cancer (SCLC) receiving platinum-based chemotherapy. The details of this randomized Phase III study were reported at the 2007 World Conference on Lung Cancer.
Congress Asks Centers for Medicare and Medicaid Services to Reconsider Guidelines for Use of Erythropoiesis Stimulating Agents (9/7/2007) On September 4, 2007 the senate passed a “Sense of the Senate” non-binding resolution asking the Centers for Medicare and Medicade Services (CMS) to reconsider its highly restrictive National Coverage Determination (NCD) for erythropoiesis stimulating agents (ESAs). The details of this document are available on the Community Oncology Alliance web site.
Celebrex® May Improve Cachexia in Patients with Cancer of the Head, Neck and Gastrointestinal Tract (8/14/2007) Researchers from the University of North Carolina have reported that treatment of patients with cancer cachexia with Celebrex (celecoxib) resulted in weight gain, increased body mass index (BMI) and improved quality of life (QOL) measurements. The details of this study were published early on-line on July 5, 2007 in Head and Neck.
Neulasta® Decreases Neutropenia in Patients with Colorectal Cancer Receiving Every 2 Week Chemotherapy (8/8/2007) Researchers involved in a multi-center US randomized Phase II trial have reported that Neulasta® (pegfilgrastim) was effective in preventing grade 3-4 neutropenia in patients with locally advanced or metastatic colorectal cancer receiving one of three chemotherapy regimens. The details of this study were presented at the 9th World Congress on Gastrointestinal Cancer in Barcelona, June 28- July 1.
Prophylactic G-CSF Reduces Febrile Neutropenia and Early Infectious Deaths (7/24/2007) Researchers from the University of Rochester, the University of Washington and Duke University have concluded that the prophylactic use of granulocyte-colony stimulating factor (G-CSF) reduces febrile neutropenia and early deaths due to infections in adult patients receiving chemotherapy. The details of this study appeared in the July 10, 2007 issue of the Journal of Clinical Oncology.
G-CSF May Improve Outcomes of Patients with Severe Aplastic Anemia Treated with ATG and Cyclosporine (7/12/2007) Researchers from Japan have reported that G-CSF (filgrastim, Kirin-Sankyo or lenograstim, Chugai) may improve outcomes of patients with aplastic anemia treated with ATG (anti-thymocyte globulin) and cyclosporine. The details of this study were published on-line in Blood on May 25, 2007.
Every-2 Week Aranesp® Effective for Anemia of Cancer (7/6/2007) Researchers involved in a multi-center trial have reported that every-2-week Aranesp (darbepoetin alfa) significantly improves hemoglobin levels and decreases transfusion requirements in patients with anemia of cancer. The details of this study appeared in the June, 2007 issue of the Oncologist. The preliminary results of this study were also presented at the Multinational Association of Supportive Care in Cancer (MASCC) symposium in Geneva, Switzerland in June of 2005 (see related news).
Risk of Bisphosphonate Induced Osteonecrosis of the Jaw Defined (7/6/2007) Researchers from the University of Texas at Galveston have reported that osteonecrosis of the jaw increases 9 fold with more than 21 infusions of bisphosphonates. The details of this study appeared in the July 4, 2007 issue of the Journal of the National Cancer Institute.
Reduced Schedule of Zometa® May Decrease the Incidence of Osteonecrosis of the Jaw (6/29/2007) Researchers from Italy have reported that monthly treatment with Zometa (zoledronic acid) followed by treatment every 3 months can reduce the incidence of osteonecrosis of the jaw compared to continued monthly dosing in patients with multiple myeloma. The details of this study appeared in the July, 2007 issue of Leukemia.
Intravenous Iron Improves Clinical Outcomes of Aranesp® Treatment of Chemotherapy-Induced Anemia (6/20/2007) Researchers involved in a multicenter study have reported that iron supplementation improves the response of patients with chemotherapy-induced anemia to Aranesp (darbepoetin). The details of this study were presented at the 2007 meeting of the American Society of Clinical Oncology.
Dose- Dense Adjuvant Chemotherapy Supported by Epoetin Alfa for Breast Cancer not Associated with Increased Relapses (6/18/2007) Researchers affiliated with CALGB have reported that the dose-dense adjuvant regimen ETC (epirubicin, paclitaxel, cyclophosphamide) supported by epoetin alfa (Epogen®, Procrit®) significantly reduces the number of red blood cell infusions, prevents anemia and does not increase relapses or effect overall survival. The details of this study were presented at the 2007 meeting of the American Society of Clinical Oncology in June.
Ginseng May Improve Cancer-Related Fatigue (6/14/2007) Researchers affiliated with the North Central Cancer Treatment Group, N03CA trial have reported that American Ginseng Doses of 1000-2000 mg/day may be effective in alleviating cancer-related fatigue. The details of this randomized trial were presented at the 2007 meeting of the American Society of Clinical Oncology in June.
AMG 531 Maybe Effective in Treating Thrombocytopenia in Patients with MDS (6/11/2007) Researchers affiliated with The AMG 531 in Myelodysplastic Syndrome Study Group have reported that AMG 531 can reduce bleeding and transfusion events in patients with myelodysplastic syndromes (MDS). The details of this study were presented at the 2007 meeting of the American Society of Clinical Oncology in June.
No Risk of Cancer from Blood Transfusions (5/21/2007) Researchers from Sweden and Denmark have concluded that blood transfusions from individuals who develop cancer within 5 years of donation do not cause cancer in the recipients. The details of this study appeared in the May 19, 2007 issue of The Lancet.
Aranesp® and Epoetin Alfa Do Not Increase Blood Clots in Ovarian Cancer (5/2/2007) Researchers from the University of North Carolina have reported that use of Aranesp® (darbepoetin alfa) or epoetin alfa (Procrit® or Epogen®) does not appear to increase the risk of developing medical complications due to blood clots in patients with ovarian cancer who have chemotherapy-induced anemia. The details of this study appeared in the May 2007 issue of Gynecologic Oncology.
Intermittent Androgen Suppression Therapy Confirmed Effective for Prostate Cancer (4/27/2007) Researchers from Canada have reported that intermittent androgen suppression (IAS) is a good treatment option for men with prostate cancer. The details of this study appeared in an early online publication in the International Journal of Radiation Oncology* Biology* Physics on March 20, 2007.
Progressive Increase in Osteoporosis with Long-Term Androgen Deprivation (4/20/2007) Researchers from Barcelona, Spain, have reported that the prevalence of osteoporosis is high before treatment and progressively increases with long-term androgen deprivation therapy (ADT). The details of this study appeared in the March 2007 issue of Urology.
ASH Publishes Comments on Medicare and Medicaid Coverage of Erythropoiesis Stimulating Factors. (4/19/2007) On April 12, 2007 the American Society of Hematology (ASH) issued comments to the Centers for Medicare and Medicaid Services on coverage for erythropoiesis stimulating agents (ISA’s) including Procrit®, Epogen® and Aranesp® for patients other than end stage renal disease. The details of these comments can be accessed on ASH's website at www.hematology.org.
IV Iron Decreases Epoetin Dose Requirements and Improves Hemoglobin Responses (4/13/2007) Researchers from Sweden have reported that the addition of intravenous (IV) iron improves hemoglobin responses and decreased epoetin beta (NeoRecornan®) dose requirements in patients with lymphproliferative malignancies. The details of this study appeared in the April 2007 issue of Leukemia.
Epoetin Alfa May Decrease Survival in Anemic Patients with NSCLC (3/26/2007) Researchers affiliated with the Ontario Oncology Group have reported that anemic patients with non-small cell lung cancer (NSCLC) randomly allocated to receive epoetin alfa (Eprex®, Procrit®) for disease-related anemia had a shorter median survival than patients receiving a placebo. The details of this study appeared in the March 20, 2007 issue of the Journal of Clinical Oncology.
New Guidelines on the Use of Procrit® and Ananesp® Released by the FDA (3/13/2007) The Food and Drug Administration (FDA) has released new guidelines on the use of epoetin alfa (Procrit®) and darbepoetin alfa (Ananesp®).
Aranesp® Every 2 or 3 Weeks Confirmed as Effective as Weekly Schedule (3/12/2007) Researchers involved in a multi-center trial have reported that Aranesp (darbepoetin alfa) administered every 2 or 3 weeks is as effective as a weekly schedule for correction of chemotherapy induced anemia. The details of this interim analysis were reported at the 2007 Gastrointestinal Cancer Symposium sponsored by the American Society of Clinical Oncology.
Aromasin® Compromises Bone Health in Breast Cancer Patients (1/31/2007) Researchers associated with the Intergroup Extemestane Study (IES) have reported that women with breast cancer who switch from Nolvadex® (tamoxifen) to Aromasin (exemestane) have an increased risk of bone fractures. However, it was also noted that overall survival is improved with Aromasin.
Zometa® Prevents Bone Loss in Premenopausal Breast Cancer Patients (1/17/2007) Researchers affiliated with the Austrian Breast and Colorectal Cancer Study Group have reported that Zometa (zoledronic acid) prevented bone loss in premenopausal patients receiving adjuvant endocrine therapy for hormone-responsive breast cancer.
Kepivance® May Decrease Oral Mucositis Following High-Dose Chemotherapy (1/8/2007) There were several clinical studies presented at the 2006 meeting of the American Society of Hematology in December which suggest that Kepivance (palifermin) is effective in decreasing the incidence, severity and duration of severe oral mucositis in patients with hematologic diseases receiving high-dose Alkeran® (melphalan) (200 mg/m2) or high-dose BEAM (carmustine, etoposide, cytarabine and melphalan) followed by autologous stem cell infusion.
Kepivance® Decreases Oral Mucositis in Patients with Metastatic Colorectal Cancer. (11/27/2006) The results of a randomized multicenter trial demonstate that Kepivance (palifermin, keritinocyte growth factor) given before chemotherapy reduces the incidence of severe oral mucositis in patients receiving 5-FU/leucovorin for metastatic colorectal cancer.
Kepivance® Reduces Mucositis After Allogeneic Stem Cell Transplantation Without Impact on Acute GVHD (11/9/2006) Researchers from the University of Minnesota and Michigan have reported that the administration of Kepivance (palifermin, keritinocyte growth factor) before and after allogeneic stem cell transplantation reduces the incidence and mean severity of mucositis in patients receiving a total body irradiation (TBI) conditioning regimen.
Ferritin Levels Used to Determine Need for Colonoscopy in Anemic Men (11/7/2006) Researchers from the University of Minnesota have suggested that anemic men with ferritin levels below 100 ng/mL should undergo colonoscopy to rule out colon cancer.
Patients with Breast Cancer Bone Metastasis Failing Bonefos® or Aredia® Benefit From Zometa® (10/31/2006) Researchers from Canada have reported Zometa® (zoledronic acid) can improve pain control in patients with breast cancer who have worsening of bone metastases during bisphosphonate therapy with Aredia® (pamidronate) or Bonefos® (clodronate).
Daily Low Power Laser Therapy May Prevent Oral Mucositis in Stem Cell Transplant Patients (10/25/2006) Researchers from Brazil have reported that low power laser therapy (LPLT) reduces the incidence of grade 2-4 oral mucositis by 60% following autologous or allogeneic stem cell transplantation.
Early Procrit® Improves Quality of Life in Patients With Mild Anemia (10/23/2006) Researchers conducting a multicenter U.S. trial have concluded that treating early mild anemia with Procrit® (epoetin alfa) during chemotherapy for hematologic malignancies improves hemoglobin (Hb) responses, quality of life (QOL) measurements and patient productivity.
Prevention and Management of Bisphosphonate Toxicities Reviewed (8/15/2006) Researchers from the H. Lee Moffitt Cancer Center and Loyola University have published suggestions for the management of adverse effects associated with intravenous bisphosphonate therapy.
Zometa® May Prevent Bone Loss Associated With Androgen Suppression for Prostate Cancer (8/9/2006) Researchers from Oregon Health and Science University, the University of Chicago and Pennsylvania State University College of Medicine have reported that Zometa (zoledronic acid) may prevent bone loss associated with androgen deprivation treatment (ADT) for prostate cancer without metastases when started during the first year of therapy.
L-Glutamine Effective in Prevention of Oral Mucositis After Chemoradiotherapy for Head and Neck Cancer (8/6/2006) Researchers from Argentina have reported that the intravenous administration of L-alanyl-L-glutamine was effective in reducing the incidence and severity of oral mucositis following chemotherapy for head and neck cancer.
Weekly Procrit® Benefits Children Receiving Myelosuppressive Therapy (8/2/2006) A multicenter trial has reported that weekly Procrit (epoetin alfa) improved hemoglobin levels, decreased transfusion requirements and improved quality of life (QOL) in children with cancer receiving myelosuppressive chemotherapy.
ASCO Guidelines for Use of White Blood Cell Growth Factors Published (7/19/2006) The American Society of Clinical Oncology (ASCO) has published the 2006 update of recommendations for the use of white blood cell growth factors such as Neupogen® (filgrastim) or Neulasta® (pegfilgrastim) for prevention of neutropenia. These updated recommendations were published in the July 1, 2006, issue of the Journal of Clinical Oncology.
Aranesp® Plus IV Iron May Benefit Patients with Chemotherapy-Induced Anemia (6/12/2006) According to interim results from a phase IIIb trial presented at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO), the combination of Aranesp® (darbepoetin alfa) and intravenous (IV) iron may increase the proportion of patients with chemotherapy-induced anemia who reach target hemoglobin levels.
Additional Evidence that Aranesp® Effective for Treating Anemia Associated with Low-Risk MDS (6/9/2006) According to interim phase II results presented at the 42nd annual meeting of the American Society of Clinical Oncology, Aranesp® (darbepoetin alfa) administered every three weeks produced a major erythroid response in 59% of patients with low-risk myelodysplastic syndrome (MDS) who had not previously received an erythropoiesis-stimulating agent.
Low Incidence of Neutropenic Complications Among Patients Treated with Neulasta® in Community Setting (6/6/2006) According to the final results of a large prospective study presented at the 2006 annual meeting of the American Society of Clinical Oncology, providing Neulasta® (pegfilgrastim) to patients undergoing myelosuppressive chemotherapy results in a low occurrence of neutropenic complications and a low occurrence of chemotherapy dose or schedule alterations related to neutropenia.
Zometa® Reduces Cancer Progression Over Clondronate® (6/6/2006) The bisphosphonate Zometa (zoledronic acid) significantly reduces the progression of disease in subgroups of patients compared to Clodronate (pamidronate) in women with breast cancer that has metastasized to the bone. Results from this retrospective analysis including data from a phase III clinical trial comparing Zometa to Clodronate were presented at the 42nd annual meeting of the American Society of Clinical Oncology.
Meta-Analysis Defines Benefits and Risks of Erythropoietins (6/2/2006) A large meta-analysis review of previously published clinical trials has concluded that use of Procrit® (epoetin) or Aranesp® (darbepoetin alfa) to treat anemia in cancer patients reduces the need for blood transfusions but may increase the risk of blood clots.
Oral Cryotherapy Prevents Mucositis From High-Dose Alkeran® (6/1/2006) Researchers from the Fred Hutchinson Cancer Research Center have reported that 6 hours of exposure to oral ice chips significantly decreased the incidence of grade 3-4 oral mucositis in patients receiving 200 mg/m2 of Alkeran® (melphalan).
Every-Two-Weeks Aranesp® Comparable to Weekly Procrit® (5/23/2006) Researchers affiliated with the 20030125 Study Group Trial have reported that every two week Aranesp (darbepoetin alfa) is as effective as Procrit (epoetin alfa) for the treatment of chemotherapy-related anemia in patients with non-myeloid malignancies.
Kepivance™ Improves Patient-Assessed Oral Mucositis Following Autologous Stem Cell Transplantation (4/21/2006) Patients receiving Kepivance in this study reported significant improvement in the daily functioning activities of swallowing, drinking, eating, talking and sleeping compared to the control group. This study further documents the effectiveness of Kepivance in preventing oral mucositis in the stem cell transplant setting.
Epoetin Alfa Effective in Correcting Anemia in Platinum-Treated Ovarian Cancer (4/7/2006) Researchers from Greece have reported that epoetin alfa (EPO) improves hemoglobin levels, reduces transfusion requirements and improves quality of life (QOL) of women with ovarian cancer receiving platinum-based chemotherapy.
Epoetin Alfa Improves Quality of Life in Patients Receiving Platinum Based Chemotherapy (3/10/2006) Researchers from the Netherlands have reported that patients receiving epoetin alfa (Epo) to correct anemia have statistically significant improvement in quality of life parameters.
Velafermin May Decrease Oral Mucositis after Autologous Transplantation (3/2/2006) A multi-center phase II trial of the fibroblast growth factor, velafermin (CG53135), suggests that a very specific dose of this agent may decrease the severity and duration of oral mucositis associated with autologous stem cell transplantation.
Every-Three-Week Aranesp® Effective Treatment of Chemotherapy-Induced Anemia (3/1/2006) European researchers have reported that patients with chemotherapy-induced anemia can be treated safely and effectively with Aranesp (darbepoetin) administered every three weeks.
Canadian Study Suggests Procrit® Should Be Started Early to Prevent Transfusions (1/31/2006) Researchers from several Canadian Medical Centers have published data that suggests starting Epoetin at hemoglobin levels greater than 10 g/dl could reduce the number of blood transfusions.
Anti-Androgen Therapy for Prostate Cancer Increases Risk of Fractures (1/19/2006) Researchers from Massachusetts General Hospital have reported that the use of gonadotropin-releasing hormone (GnRH) agonist therapy increases the risk of fractures in men with prostate cancer.
Chemotherapy-Induced Anemia Impairs Mental and Physical Function of the Elderly (1/18/2006) Researchers from Rome have reported that chemotherapy-related anemia has a significant impact on mental and functional abilities of the elderly.
Computer Modeling Suggests Cost-Effectiveness of Once Weekly Aranesp® to Prevent Chemotherapy Induced Anemia in Lung Cancer Patients (1/13/2006) Researchers from France have performed a Markov analysis, which concluded that weekly Aranesp (darbepoetin) was cost-effective for prevention of anemia in patients with lung cancer receiving chemotherapy.
Patients with Breast Cancer Bone Metastasis Failing Clodronate or Pamidronate Benefit From Zometa® (12/16/2005) Researchers from Toronto, Canada, recently reported that the administration of Zometa (zoledronic acid) significantly improved pain control in women with progressive bone metastasis from breast cancer who had progression while receiving clodronate or pamidronate.
Risk Factors for Osteonecrosis of the Jaw from Bisphosphonates Defined (12/2/2005) Researchers from Greece have reported that the use of bisphosphonates is associated with the development of osteonecrosis of the jaw with the most important risk factor being the time of exposure. The details of this report appeared in the December 1, 2005, issue of the Journal of Clinical Oncology.
Risk of Pelvic Fractures in Women Greater Following Radiation Therapy (12/1/2005) Researchers from the University of Minnesota and the University of North Carolina have reported that women who have received radiation therapy to the pelvis for cancers of the cervix, rectum, or anus are at an increased risk for pelvic fractures compared to women with these types of cancer who did not undergo pelvic radiation.
Anemia in Lung Cancer Patients Often Undertreated (11/30/2005) Researchers affiliated with the European Cancer Anaemia Survey (ECAS) have reported that approximately 50% of patients with lung cancer with anemia received appropriate treatment.
Neulasta® and Aranesp® Provide Effective Hematopoietic Support for Dose-Dense Chemotherapy (11/21/2005) Researchers from the Dana Farber Cancer Centerhave reported that the prophylactic administration of pegfilgrastim (Neulasta) and darbepoetin alfa (Aranesp) was effective and safe for prevention of febrile neutropenia and anemia in women receiving adjuvant dose-dense chemotherapy for the adjuvant treatment of localized breast cancer.
Prophylactic G-CSFs May Reduce Infection-Related Mortality (11/11/2005) Researchers from the University of Rochester have reported that the use of prophylactic granulocyte-colony stimulating factor (G-CSF) may reduce the risk of infection-related mortality in cancer patients.
Neupogen® Plus Antibiotics Decrease Febrile Neutropenia in Small Cell Lung Cancer (11/8/2005) Researchers from the Netherlands have reported that the addition of Neupogen (granulocyte-colony stimulating factor) to prophylactic antibiotics decreases febrile neutropenia in patients with small cell lung cancer (SCLC) undergoing intensive sequential chemotherapy.
Aranesp® Does Not Increase Relapses in Patients with Lung Cancer or Lymphoproliferative Malignancies (10/19/2005) Researchers from Belgium have reported that treatment of chemotherapy-induced anemia with Aranesp® (darbepoetin alfa) does not increase relapses in patients with lung cancer or lymphoproliferative malignancies.
Levaquin® Prevents Bacterial Infection in Neutropenic Cancer Patients (9/9/2005) Two randomized studies were published in the September 8, 2005, issue of the New England Journal of Medicine suggesting benefit from prophylactic Levaquin (levofloxacin) administration in patients with chemotherapy-induced neutropenia.
Neutropenia During Chemotherapy Associated with Improved Survival of NSCLC (8/10/2005) Researchers from Italy have reported that patients with advanced non-small cell lung cancer (NSCLC) who receive chemotherapy have a better survival if they develop neutropenia compared to patients who do not develop neutropenia. These authors suggest that neutropenia is a surrogate marker for optimal dosing of chemotherapy.
Recommendations for Improving Quality of Cancer Pain Management Published (8/3/2005) Members of the American Pain Society (APS) have published the first update of Quality Improvement Guidelines for the Treatment of Acute Pain and Cancer Pain to improve quality of care since 1995.
Risk of Neutropenia Highest During the First Cycle of Chemotherapy (7/28/2005) Researchers from the United States have reported that an initial episode of severe neutropenia or febrile neutropenia is most likely to occur during the first cycle of chemotherapy.
Decompressive Surgery and Radiation Therapy Optimal for Metastatic Spinal Cord Compression. (7/25/2005) Researchers concucting a multicenter trial at the University of Kentucky have determined that patients with non-hematologic metastatic tumors causing spinal cord compression have better outcomes with immediate surgery followed by radiation therapy than those who receive radiation alone.
Frozen Glove May Help Prevent Skin and Nail Damage From Taxotere® (7/19/2005) Researchers from France have reported that a 90 minute cold treatment of the hands can prevent Taxotere (docetaxel) nail and finger toxicities.
Aranesp® Effective for Anemia of Cancer (7/12/2005) According to results presented at the recent Multinational Association of Supportive Care in Cancer (MASCC) symposium, Aranesp (darbepoetin alfa) appears to be an effective treatment for anemia of cancer.
Updated Meta-Analysis Shows Prophylactic G-CSFs Significantly Reduces the Risk of Infection-Related Mortality (7/7/2005) Researchers from the United States have reported that prophylactic recombinant human granulocyte colony-stimulating factors (G-CSFs) not only reduce the risk of febrile neutropenia across a wide variety of malignancies, chemotherapy regimens, and risk factors, but also significantly reduce the risk of infection-related mortality.[1]
Significant Decline in Patient-Reported Quality of Life with the Onset of Severe Neutropenia (7/7/2005) Researchers from the United States have reported results of a clinical trial that indicate patients who experience grade 3-4 neutropenia report greater symptom distress than those with grade 2-3 and experience significant impairment in quality of life.
Single Dose Radiotherapy Effective Palliation for Bone Metastasis (6/20/2005) Researchers affiliated with the Radiation Therapy Oncology Group (RTOG) have reported that a short course of radiotherapy for palliation of painful bone metastases is as effective as a long course.
Every Three-Week Dosing of Aranesp® As Effective as Weekly Dosing for Management of Chemotherapy-Induced Anemia (5/17/2005) Researchers from Europe recently reported that administration of Aranesp® (darbepoetin alfa) once every three weeks appears just as effective as weekly administration of Aranesp in the management of anemia in patients undergoing multicycle chemotherapy. These results were presented at the 2005 annual meeting of the American Society of Clinical Oncolgoy (ASCO).
Anemia Effectively Treated with Procrit® in Cancer Patients Receiving Chemotherapy (5/13/2005) Researchers associated with the National Central Cancer Treatment Group (NCCTG) have reported the results of a randomized multi-center trial which confirmed that weekly treatment with Procrit® (epoetin alfa) improves hemoglobin levels, reduces the need for blood transfusions and improves quality of life in cancer patients with chemotherapy-induced anemia.
Hospitalization of Neutropenic Patients Has High Costs (5/3/2005) Researchers from the Sutter Cancer Center in Sacramento have reported that hospitalization for complications of neutropenia affect over 60,000 U.S. patients per year with a mortality rate of 6.8% and a cost per hospitalization of $13,372.
Cryoablation Effective for Reducing Pain Associated with Bone Metastasis (4/8/2005) According to results presented at the 30th annual meeting of the Society of Interventional Radiation (SIR), cryoablation appears to provide effective pain relief for patients with bone metastasis.
Anemia Correlated with Poor Response to Chemo-Radiotherapy for Head and Neck Cancer (3/21/2005) Researchers from Duke University have reported that anemic patients with advanced head and neck cancers treated with radiation therapy have poorer outcomes than comparable patients without anemia. The details of this retrospective analysis were reported in the March 15, 2005 issue of the International Journal of Radiation Oncology Biology Physics.
Neulasta® Prevents Febrile Neutropenia in Breast Cancer Patients (2/24/2005) A multi-center international trial has determined that first and subsequent cycle use of Neulasta® (pegfilgrastim) with a moderately myelosuppressive chemotherapy regimen significantly reduced febrile neutropenia, febrile neutropenia-related hospitalizations, and IV anti-infective use. The details of this report appeared in the February 20, 2005 issue of the Journal of Clinical Oncology. This data was also presented at the 2004 San Antonio Breast Cancer Symposium.
Aranesp® Effective in Low-Intermediate Risk MDS (2/16/2005) Researchers from Italy have reported that Aranesp® (darbepoetin alfa) improves anemia in patients with myelodysplastic syndromes. The details of this report appeared in the January 2005 issue of the British Journal of Hematology.
Prevention of Anemia with Aranesp® Effective in Neoadjuvant Therapy for Breast Cancer (1/27/2005) According to results recently presented at the 27th San Antonio Breast Cancer Symposium (SABCS), Aranesp® (darbepoetin alfa) can be highly effective in preventing chemotherapy-induced anemia in patients undergoing neoadjuvant chemotherapy for breast cancer.
Androgen Deprivation for Prostate Cancer Increases Bone Fractures (1/19/2005) Researchers from the University of Texas at Galveston have reported that men receiving androgen deprivation and surviving at least 5 years after diagnosis had a fracture rate of 19.4% compared to 12.6% for comparable men not receiving such therapy.
Aranesp® Improves Quality of Life in Patients with Breast Cancer (1/12/2005) According to results recently presented at the 27th annual San Antonio Breast Cancer Symposium (SABCS), Aranesp® significantly improves the quality of life in breast cancer patients with chemotherapy-induced anemia.
Aranesp® Produces Similar Outcomes with Greater Comfort and Convenience than Epoetin Alfa in Women with Anemia and Breast Cancer (12/29/2004) According to results presented at the 27th annual San Antonio Breast Cancer Symposium (SABCS), Aranesp® (darbepoetin alfa) is at least as effective as epoetin alfa (Procrit®) but requires significantly less dosing for the treatment of chemotherapy-induced anemia in breast cancer patients.
A Single Dose of Neulasta® is as Effective as 16 Doses of Neupogen® in Remission Induction of AML (12/28/2004) According to results recently presented at the 46th annual meeting of the American Society of Hematology (ASH), Neulasta® (pegfilgrastim) appears at least as effective as Neupogen® (filgrastim) in the treatment of chemotherapy-induced neutropenia in patients with acute myeloid leukemia (AML). One injection of Neulasta® was comparable to 16 injections of Neupogen® in this group of patients.
The FDA Approves keratinocyte growth factor (Palifermin, Kepivance™) for Prevention of Mucositis in Patients Receiving High-Dose Chemotherapy (12/16/2004) On December 15, 2004 the U.S. Food and Drug Administration approved the use of keratinocyte growth factor (palifermin, Kepivance™) for the treatment of patients undergoing high-dose chemoradiotherapy for hematologic malignancies. The details of the pivotal study leading to approval were published in the December 16, 2004 issue of the New England Journal of Medicine.
Aranesp® As Effective as Procrit® with Less Frequent Dosing (12/7/2004) According to results recently published in the online edition of The Oncologist, further evidence indicates that Aranesp® (darbepoetin alfa) is at least as effective as Procrit® (epoetin alfa) in preventing anemia and blood transfusions in patients undergoing treatment for cancer. The number of injections of Aranesp® is reduced by half compared to Procrit®, as Aranesp® is only necessary once every two weeks, while Procrit® is required every week.
Zometa® Reduces Skeletal Complications Compared to Placebo (11/9/2004) In the first trial comparing Zometa® (zoledronic acid) to placebo (inactive substitute), Zometa® produced a significant clinical benefit in patients with bone metastases from breast cancer. These results were presented by Japanese researchers at the 29th Congress of the European Society of Medical Oncology (ESMO) held in Vienna Austria, October 29-November 2, 2004.
Meta-Analysis Confirms Quality of Life Improvement with Epoetin Alfa (10/14/2004) A meta-analysis, sponsored by Johnson and Johnson, concluded that “epoetin alfa significantly improved QOL for patients with cancer, irrespective of chemotherapy use. Specifically, epoetin alfa significantly improved QOL using scales that focus on cancer and anemia.” The details of this report appeared in the October 15, 2004 issue of Cancer.
Meta-Analysis Suggests that Prophylactic Colony-Stimulating Factors Decrease Febrile Neutropenia in Children with Cancer (8/25/2004) Researchers from the U.S. and Canada performed a meta-analysis of 16 randomized controlled trials of colony stimulating factors (CSFs) in children with cancer. They concluded from these analyses that CSFs reduced the rate of febrile neutropenia by 20%, reduced documented infections by 22%, reduced amphotericin B use by 50%, and decreased hospitalization duration by approximately 2 days, but had no effect on infection-related mortality. The details of this study were reported in the August 15, 2004 issue of the Journal of Clinical Oncology.
Acetaminophen Improves Narcotic Pain Control in Cancer Patients (8/25/2004) Researchers from Australia have reported that the use of acetaminophen for patients with advanced cancer receiving opioids decreases pain and improves well-being. This placebo-controlled study appeared in the August 15 issue of the Journal of Clinical Oncology.
Long-Term Zometa™ Prevents Skeletal Complications in Men with Prostate Cancer (6/4/2004) Researchers affiliated with the Zolendronic Acid Prostate Study Group have presented a 24 month follow-up of a clinical trial which randomly allocated men with bone metastases from prostate cancer to receive Zometa™ or placebo.
Procrit® Corrects Anemia in CML Patients Treated with Gleevec® (5/25/2004) Researchers from MD Anderson Cancer Center have reported that anemia in patients with chronic myeloid leukemia (CML) receiving imatinib mesylate (Gleevec®) therapy was corrected by the administration of erythropoietin (Procrit®). The details of this report appeared in the June 1, 2004 issue of Cancer.
Physicians and Nurses Underestimate the Incidence of Delayed Chemotherapy-Induced Nausea and Vomiting (5/13/2004) Researchers from 14 medical practices in Denmark, France, Italy, Germany, the UK, and the US have reported that physicians and nurses underestimate the incidence of delayed, chemotherapy-induced nausea and vomiting. This prospective study was supported by Merck and Company and was published in the May 15, 2004 issue of
Cancer.
Intravenous Iron Enhances Response to Procrit® (4/13/2004) A multicenter randomized trial has shown that cancer patients with anemia who are receiving intravenous iron have an enhanced response to weekly Procrit®. The results of this study were reported in the April 1, 2004 issue of the
Journal of Clinical Oncology.
Single Dose Neulasta® Effective for Mobilization of Peripheral Blood Stem Cells (4/7/2004) Researchers from Dresden have reported that a single 6 mg injection of Neulasta® (pegfilgrastim) was as effective as multiple days of granulocyte-colony stimulating factor filgrastim (Neupogen®) for the mobilization of peripheral blood stem cells in patients undergoing autologous transplantation. The results of this study were presented at the 30th annual meeting of the European Group for Bone Marrow Transplantation in Barcelona on March 2004.
Aloxi® Injection Incorporated into NCCN® antiemetic guidelines (3/30/2004) MGI PHARMA, INC. announced today that Aloxi (palonosetron hydrochloride) injection has been incorporated into the 2004 National Comprehensive Cancer Network® (NCCN®) antiemetic guidelines for prevention of chemotherapy-induced nausea and vomiting (CINV) following moderately and highly emetogenic chemotherapy. The 2004 guidelines will be made available on the NCCN Web site in the coming weeks.
Aloxi® Approved for Acute and Delayed Nausea and Vomiting (3/8/2004) On July 25, 2003, the Food and Drug Association approved Aloxi® (palonosetron), for the prevention of:
Fixed Dose of Aranesp® is as Effective as Weight Based Dosing (2/10/2004) Researchers affiliated with the Darbepoetin Alfa 20010102 Study Group have reported that a fixed dose of Aranesp® is as effective as a dosage schedule based on weight. The results of this trial appeared in the February 14, 2004 issue of
Cancer.
1
Palifermin Improves Quality of Life and Decreases Resource Use (12/12/2003) Results of a phase III study reported at ASCO 2003 demonstrated that palifermin, a keratinocyte growth factor, significantly reduces the incidence and duration of severe mucositis in patients undergoing peripheral blood stem cell transplants.
1 At ASH 2003, researchers reported resource use and quality of life analysis of this study. Results indicate that palifermin significantly reduced days of hospitalization, analgesic use, and incidence of parenteral feeding. Evaluation of patient reported quality of life factors indicate that palifermin produced a clinically meaningful reduction in mouth and throat soreness and improvements in daily activities as well as physical and functional well-being.
Aprepitant (Emend®) Decreases Nausea and Vomiting Due to Cisplatin-Based Chemotherapy (11/24/2003) Two randomized clinical trials published in the November 15, 2003 issue of the
Journal of Clinical Oncology demonstrated that the addition of Emend® to a standard anti-emetic regimen of ondansetron (Zofran®) and dexamethasone significantly reduced the incidence of cisplatin-induced nausea and vomiting.
1,2 These two randomized clinical trials were the basis for FDA approval of Emend®.
National Comprehensive Cancer Network Update on Anemia Includes Use of Aranesp® (11/5/2003) The National Comprehensive Cancer Networks (NCCN) updated clinical guidelines for the treatment and management of anemia, related to cancer and cancer therapy, recommend the use of Aranesp® (darbepoetin) or Procrit® (epoetin alfa).
8 Gy in One Fraction Equivalent to 30 Gy in 10 Fractions for Palliation of Bone Metastasis (10/23/2003) Researchers affiliated with the Radiation Treatment Oncology Group (RTOG) have reported preliminary data suggesting equivalency of palliation of painful bone metastasis with 8 Gy of radiation in a single fraction compared to the standard approach of 30 Gy in 10 fractions. If confirmed with longer follow-up this could represent significant cost savings as well as being more convenient for patients. The results of this randomized trial were presented at the 45th annual meeting of the American Society for Therapeutic Radiology and Oncology on October 20, 2003 in Salt Lake City.
Oral and Gastrointestinal Chemotherapy Induced Mucositis Causes Significant Clinical Problems and Increases the Costs of Treatment (9/24/2003) Researchers from the MD Anderson Cancer Center have reported that 37% of patients with solid tumors or lymphomas develop oral and GI mucositis which leads to increased hospitalization and increased costs. Methods to decrease the incidence and severity of mucositis would have major clinical and economic benefits. These results were published in the October 2003 issue of
Cancer.(1)
A Single Dose of Neulasta" is Equivalent to 11 Daily Injections of Neupogen® (3/4/2003) Pegylation is a technique that allows for the slow delivery of biologic agents, cutting down the need for daily dosing. It has been used successfully to develop
Aranesp®, which is a long-acting form of recombinant human erythropoietin. Aranesp® can be given at weekly or longer intervals. The same technology has been used to develop
Neulasta® (pegfilgrasim), a long-acting form of recombinant granulocyte colony stimulating factor (G-CSF, Neupogen®). A multi-center randomized trial compared daily
Neupogen® to once per cycle injection of Neulasta in patients with non-Hodgkins Lymphoma (NHL) undergoing chemotherapy.
1
The results of this trial were published in the February 1, 2002 issue of the
Journal of Clinical Oncology.
Prophylactic Antibiotics Prevent Neutropenic Fever but Drug Resistance May be Emerging (2/28/2003) For over 10 years, antibiotics have been routinely administered to prevent infections during periods of neutropenia following the administration of chemotherapy. The most commonly used antibiotic is ciprofloxacin either alone or in combination. The choice of this antibiotic over the past decade is due to good oral absorption and a broad spectrum of activity. There have, however, been many recent reports of drug resistance and few studies have documented the cost-effectiveness of this approach. In the February 2003 issue of the
Annals of Oncology, researchers affiliated with the European Organization for the Treatment and Research of Cancer (EORTC) reported on the combination of ciprofloxacin and roxithromycin, which is an antibiotic related to erythromycin.
1
Roxithromycin is used to prevent gram- positive infections, is active against crypotosporidiosis and is used frequently in Europe for patients with HIV infection.
Increased Doses of Aranesp® for Four Weeks Hasten Recovery From Chemotherapy-Induced Anemia (2/27/2003)
Aranesp® is a long-acting form of erythropoietin (rHuEPO) which was approved in July of 2002 by the U.S. Food and Drug Administration for the treatment of anemia in patients with cancer receiving chemotherapy. The usual schedule for erythropoietin is one to three times per week, whereas Aranesp® can be given on a weekly schedule. However, optimal dose and schedule of Aranesp® is still under investigation. Aranesp® is usually given at a dose of 4.5 µg/kg per week. Researchers from UCLA School of Medicine, Hematology-Oncology Associates of Jacksonville, Pacific Coast Hematology Oncology Medical Group and Amgen Inc. have reported that the administration of high loading doses of Aranesp® may hasten recovery from chemotherapy-induced anemia. They published the results of their trial in the March issue of
Cancer.
Long-Term Study Confirms Benefit of Cyclosporine in Immunosuppressive Regimen Treatment of Aplastic Anemia (2/11/2003) Aplastic anemia is a life-threatening disease which is best treated in younger individuals by allogeneic stem cell transplantation. However, the majority of patients with this disease are older or do not have a suitable stem cell source available for transplantation. The most common treatment regimen for patients with aplastic anemia who are not transplanted consists of anti-thymocyte globulin (ATG), prednisolone and cyclosporine. This combination has been associated with a higher response rate than for patients getting ATG or cyclosporine alone. However, patients who cross over after one of these agents can have a response to the alternate drug. Thus, the main question is whether combined use up front is better than sequential administration. In a report in the February 1, 2003 issue of
Blood, German researchers have confirmed the higher response rate of ATG, prednisone and cyclosporine compared to ATG and prednisone but found no survival difference.
Long-Acting Single Dose Pegylated Filgrastim Found Effective in Randomized Trial (12/26/2002) Pegylation is a technique that allows for the slow delivery of biologic agents, cutting down the need for daily dosing. It has been used successfully to develop Aranesp® which is a long-acting form of recombinant human erythropoietin. Aranesp® can be given at weekly or longer intervals. The same technology has been used to develop a long-acting form of recombinant granulocyte colony stimulating factor (G-CSF). Researchers in Germany performed a randomized controlled trial to compare pegylated filgrastim (pegfilgrastim,
Neulasta) to
Neupogen®. They reported their results of this trial in the January 2003 issue of the
Annals of Oncology.
Randomized Trial in Women with Breast Cancer Confirms Effectiveness of Erythropoietin (epoetin alfa) (11/5/2002) Recombinant erythropoietin (epoetin alfa) is used to treat anemia in cancer patients. Procrit® is the usual form of epoetin alfa, but more recently Aranesp®, a longer acting formulation, has been approved for use by the FDA. All clinicians recognize that anemia can produce significant morbidity, but there is controversy over how and when to use epoetin alfa to correct anemia. Epoetin alfa is usually prescribed for patients with chemotherapy-associated anemia who have a hemoglobin (Hgb) below 10 g/dL. For patients with Hgb levels between 12 g/dL and 10 g/dL there may be clinical situations where epoetin alfa is indicated. For patients not responding to initial treatment, dose escalation for 6-8 weeks is usually recommended. When the hemoglobin reaches 12 g/dL the dose of epoetin alfa is usually titrated. Although these are general guidelines, randomized trials continue to be performed in order to determine the optimal way to administer epoetin alfa and to document effectiveness in a variety of treatment situations. At the 27th annual meeting of the European Society of Clinical Oncology, Italian researchers reported results of a randomized trial conducted in women with breast cancer.
Intraspinal Implantable Drug System Effective in Controlling Pain Due to Metastatic Cancer (10/1/2002) The management of pain is an important component for the treatment of most patients with metastatic cancer. It is estimated that 5-15% of patients with metastatic cancer have pain that is refractory to oral and i.v. narcotics. Intraspinal implantable drug delivery systems (IDDSs) deliver small doses of morphine directly to the spinal fluid, theoretically requiring smaller doses of narcotics. Although this system is known to be effective, there have been no randomized controlled trials. Researchers in the U.S. and Europe affiliated with the Implantable Drug Delivery Systems Study Group have determined that IDDSs are better than conventional pain management techniques. They reported these results in the October 2002 issue of the
Journal of Clinical Oncology.
ASH and ASCO Publish Guidelines for Use of Epoetin In Patients with Cancer (9/19/2002) Recombinant erythropoietin (epoetin) is used to treat anemia in cancer patients. Procrit® is the usual form of epoetin, but more recently AranespÔ, a longer acting formulation, has been approved for use by the FDA. All clinicians recognize that anemia can produce significant morbidity, but there is controversy over how and when to use epoetin to correct anemia. One of the concerns is the expense of the drug, especially if overused. The American Society of Clinical Oncology and the American Society of Hematology have published an evidence-based clinical practice guideline for the use of epoetin in patients with cancer. This guideline appeared in the September 18, 2002 issue of
Blood.
Aranesp Reduces Blood Transfusions in Patients with Lung Cancer Receiving Chemotherapy (8/21/2002) Patients with lung and other cancers receiving chemotherapy may develop anemia, which is corrected by blood transfusions. The main symptomatic side effect of anemia is fatigue. Some patients receiving chemotherapy have low levels of endogenous erythropoietin, although the cause of anemia is multifactorial and significantly includes chemotherapy suppression of blood production. Human recombinant erythropoietin (rHuEPO) can enhance red blood cell production in patients receiving chemotherapy and theoretically avoid blood transfusions despite continued myelosuppression. Darbepoetin alfa (Aranesp") is a new erythropoiesis-stimulating protein that has a longer half-life than rHuEPO and can be administered less frequently.
Quality of Life in Cancer Patients Better when Hemoglobin Levels Are Maintained Between 11-13 g/dL with Procrit® (8/6/2002) Anemia in cancer patients leads to physical, mental and social dysfunction, which interferes with quality of life. Randomized controlled trials have shown that Procrit® increases the level of hemoglobin in most patients with cancer, improves the quality of life and decreases the amount of blood that is transfused. However, the optimal level of hemoglobin required for relatively normal function of cancer patients is not clear. Many physicians try to maintain cancer patients at a hemoglobin level 10 g/dL. Researchers from several U.S. medical centers published a report in the August 1 issue of the journal
Cancer, which suggests that 10 g/dL may be too low a level for the palliation of patients with cancer. They analyzed in detail previously published studies involving 4,382 anemic cancer patients.
ARANESP Approved for Anemia Associated with Chemotherapy (7/24/2002) ARANESP has recently been approved by the Food and Drug Administration (FDA) for the treatment of anemia associated with chemotherapy. ARANESP had already been approved by the FDA for the treatment of anemia due to chronic renal failure.
Autologous Cryopreserved Platelets Now A Practical Alternative for Platelet Transfusion Support (6/27/2002) Most chemotherapeutic agents are myelosuppressive, causing neutropenia and thrombocytopenia, especially when used in moderate to high doses. The advent of platelet transfusions in the mid-1960s led to a marked decrease in bleeding complications from chemotherapy induced thrombocytopenia. Originally, platelets were collected from single units of whole blood donated to blood banks and pooled in units of 6 to 8 for transfusion purposes. However, in order to reduce the risks of alloimmunization and occult disease, transmission platelets were subsequently collected from single volunteer or family member donors. Collection of platelets from a single donor is accomplished by an apheresis technique where platelets are extracted and red blood cells and plasma are returned to the donor. At the present time, over 60% of all platelets administered by blood banks in the U.S. are from single donors. In some areas, this percentage is even higher. Single donors can also be selected to be compatible with the recipient in many instances where immunization is present. Immunization occurs from transfusions of red blood cells or platelets, but many women will be immunized by pregnancy and do not respond to fresh platelets from allogeneic donors when administered for the first time. The ability to cryopreserve platelets has been available for a decade or more but the methodology requires a cryopreservative, dimethylsulfoxide (DMSO), which can be toxic to patients and must be removed before administration and patients with normal platelet levels yield inadequate numbers of platelets.
Ethyol® May Prevent Granulocytopenia in Children Being Treated for Osteosarcoma (5/22/2002) According to results recently published in the
Journal of Pediatric Hematology-Oncology, Ethyol® (amifostine) decreases the incidence of granulocytopenia in patients undergoing treatment for osteogenic sarcoma.
Component of Red Wine Has Potential Anti-cancer Properties (5/20/2002) According to results recently published in the
British Journal of Cancer, the cancer preventive agent resveratrol metabolizes into the anti-leukemic agent piceatannol, which may provide a novel explanation for the cancer preventive properties of resveratrol.
Adenosine Triphosphate Improves Nutritional Status of Advanced NSCLC Patients (3/14/2002) According to a study recently published in the
Journal of Clinical Oncology, adenosine 5-triphosphate (ATP) appears to improve energy intake and reduce muscle wasting associated with advanced non-small cell lung cancer patients.
Intravenous Zometa® Improves Bone Mineral Bone Density in Postmenopausal Women (2/28/2002) Osteoporosis affects millions of postmenopausal women in the United States. Vertebral and hip fractures associated with osteoporosis are common features of aging in American women. The current preventative measures include: adequate calcium intake (at least 1200 mg daily for postmenopausal women) and adequate vitamin D intake (400 to 800 IU daily) and regular weight-bearing exercise, as well as avoidance of smoking and excessive alcohol consumption.
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