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Adjuvant Radiotherapy Improves Local Control in High-risk Melanoma Patients (11/12/2009) Researchers affiliated with the Intergroup Randomized Trial (TROG 01.01/ANZMTG 01.02) have reported that adjuvant radiotherapy (RT) improves regional control for patients with high-risk melanoma without a statistically significant effect on survival. The details of this study were presented at the 2009 meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO).
PLX4032, an Oncogenic BRAF-selective Inhibitor, Is Active in Advanced Melanoma (9/30/2009) Researchers involved in a U.S.-Australian Phase I study have reported significant activity for PLX4032 in the treatment of patients with advanced melanoma. The details of this study were presented as a late-breaking abstract at the Joint ECCO 15-34th ESMO Multidisciplinary Congress in Berlin, September 20-24, 2009.
Sutent® Has Antitumor Activity in Patients with Advanced Melanoma (9/24/2009) Researchers from Belgium have reported that Sutent® (sunitinib) benefits one-third of patients with advanced malignant melanoma who have previously failed dacarbazine-based chemotherapy. The details of this Phase II study were presented at the Joint ECCO 15 – 34th ESMO Multidisciplinary Congress in Berlin, September 20-24, 2009.
Full-body Skin Examination Detects Early Skin Melanomas (9/11/2009) Researchers affiliated with North Florida Dermatology Associates have reported that more the half of all melanomas detected in their clinic were not found in patients presenting complaint and were earlier stage than those diagnosed following patients specific complaints. The details of this study appeared in the August 2009 issue of Archives of Dermatology.
Adjuvant Radiation Therapy May Improve Outcomes of Melanoma (9/4/2009) Researchers from the M. D. Anderson Cancer Center have reported that adjuvant radiation therapy (RT) improves local control of melanoma following therapeutic lymph node dissection for lymph node-metastatic disease and may improve disease-specific survival. The details of this retrospective study were published early online in Cancer on August 21, 2009.
Tanning Beds Classified as “Carcinogenic to Humans” (8/12/2009) The International Agency for Research on Cancer (IARC) now classifies tanning beds and other UV-emitting tanning devices as Group 1 carcinogens, meaning that there is sufficient evidence to conclude that these devices cause cancer in humans. Use of tanning beds has been linked with an increased risk of melanoma, the most deadly type of skin cancer.
Adjuvant Peginterferon Associated with Decreased Quality of Life in Patients with Stage III Melanoma (7/29/2009) Researchers affiliated with the European Organisation for Research and Treatment of Cancer Melanoma Group have reported that adjuvant pegylated interferon alfa-2b (peginterferon, Pegasys®, PEGintron®) improves relapse-free survival in patients with Stage III melanoma but has significant side effects that interfere with quality of life (QOL). The details of this study appeared in the June 20, 2009 issue of the Journal of Clinical Oncology.
Experimental Vaccine Improves Melanoma Outcomes (6/9/2009) Patients with advanced melanoma experienced higher response rates and longer survival without cancer progression when treated with an experimental anticancer vaccine in addition to standard therapy. These were the preliminary findings from a Phase III clinical trial presented at the 2009 annual meeting of the American Society of Clinical Oncology (ASCO).
Nexavar® Fails to Improve Melanoma Survival (5/18/2009) Among patients with Stage III or Stage IV melanoma that cannot be surgically removed, treatment with a combination of Nexavar® (sorafenib) and chemotherapy did not result in better survival than treatment with chemotherapy alone. The results of this Phase III clinical trial were made available in a press release from Onyx Pharmaceuticals.
Mobile Phone Use Not Linked with Melanoma of the Eye (2/4/2009) Researchers from Germany have reported that mobile phone use does not increase the risk of uveal melanoma. The details of this study appeared in the January 21, 2009 issue of the Journal of the National Cancer Institute.
Paraplatin®, Taxol®, and Avastin® Effective Palliation for Metastatic Melanoma (2/2/2009) Researchers affiliated with the North Central Treatment Group Study NO47A reported that the combination of Paraplatin® (carboplatin), Taxol® (paclitaxel), and Avastin® (bevacizumab) provides effective palliation in patients with metastatic melanoma. The details of this Phase II study were published in the January 1, 2009 issue of Cancer.
Chemo-immunotherapy Not Better Than Chemotherapy Alone for Metastatic Melanoma (11/17/2008) Researchers affiliated with Eastern Cooperative Oncology Group trial 3695 have reported that the addition of interleukin-2 and Interferon-alfa to a regimen of cisplatin, vinblastine, and dacarbazine did not improve survival of patients with metastatic melanoma. The details of this study appeared in an early online publication in the Journal of Clinical Oncology on November 10, 2008.
Adoptive Cell Transfer Following a Myeloablative TBI Regimen Promising for Metastatic Melanoma (11/13/2008) Researchers from the National Cancer Institute have reported a response rate of 72% following 12 Gy of total body irradiation (TBI) and infusion of autologous tumor infiltrating lymphocytes (TIL) and autologous stem cells in patients with metastatic melanoma. The details of this study appeared in the November 10, 2008 issue of the Journal of Clinical Oncology.
Mediterranean Diet May Protect Against Cutaneous Melanoma (9/29/2008) Researchers from Italy have reported that the Mediterranean diet may protect persons from cutaneous melanoma. The details of this study appeared in an early online publication in the International Journal of Epidemiology on June 11, 2008.
Dacarbazine plus Pegylated Interferon for Metastatic Melanoma (9/9/2008) Researchers from Germany have reported that the combination of dacarbazine (DTIC) and pegylated interferon alfa 2a (INF) was well tolerated with a response rate of 24% in the treatment of metastatic melanoma. The details of this study appeared in the September 15, 2008 issue of Cancer.
Radiofrequency Ablation Effective for Lung Tumors (7/22/2008) Researchers involved in a multicenter international trial have reported that the use of radiofrequency ablation for the treatment of lung cancer or pulmonary metastases provides an effective and safe therapeutic option for selected patients. These results were recently published in the July 7, 2008 issue of Lancet Oncology.
Melanoma Rates Increasing in Young Women (7/15/2008) Researchers from the National Cancer Institute have reported that rates of melanoma continue to increase among young women in the United States. These results appeared in an early online publication in the Journal of Investigative Dermatology on July 10, 2008.
Adjuvant Pegylated Interferon Improves Disease-free Survival in Patients with Stage III Melanoma (7/14/2008) Researchers affiliated with the European Organization for Research and Treatment of Cancer (EORTC) have reported that adjuvant pegylated interferon alfa-2b increases recurrence-free survival in patients with Stage III melanoma. The details of this report appeared in the July 12, 2008 issue of The Lancet.
Primed Autologous CD4+ T Cells Produces Complete Remission in a Patient with Metastatic Melanoma (6/23/2008) Researchers from the Fred Hutchinson Cancer Research Center have reported that a patient with metastatic melanoma responded completely to infusion of autologous CD4+ T cells with specificity for the melanoma-associated antigen NY-ESO-1. The details of this case report were published in the June 19, 2008 issue of the New England Journal of Medicine.
Nexavar® May Have Significant Activity in Advanced Melanoma (5/7/2008) Researchers associated with a multicenter U.S. Phase II clinical trial have reported that the addition of Nexavar® (sorafenib) improves progression-free survival (PFS) in patients with advanced melanoma receiving dacarbazine. The details of this study appeared in the May 1, 2008 issue of the Journal of Clinical Oncology.
Tanning Beds Pose Skin Cancer Risks (4/30/2008) Researchers from Mount Sinai School of Medicine in New York have reported that “there is absolutely no justification for indoor tanning,” citing the associated risk of skin cancer and the availability of vitamin D from sources other than UV exposure. These results were presented at the 2008 annual meeting of the American Academy of Dermatology.
Gleevec® May Be Effective for KIT-Mutated Melanoma (4/29/2008) Researchers from the Dana Farber Cancer Center have reported that Gleevec® (imatinib) may be a promising therapy for patients with KIT-mutated melanoma. The results of treatment with one patient were published in the April 20, 2008 issue of the Journal of Clinical Oncology.
Elesclomol Granted Orphan Drug Status (3/4/2008) Elesclomol (formerly STA-4783), an investigative agent being jointly developed by Glaxo-Smith Kline and Synta Pharmaceuticals, Corp., has been granted orphan drug status by the United States Food and Drug Administration (FDA) for the treatment of metastatic melanoma.
Patients with Endometriosis and Fibroma at Increased Risk for Melanoma (11/6/2007) Researchers from France have reported that women who have a history of endometriosis or uterine fibromas have a higher rate of melanoma than women without such history. The details of this study were published in the October 22, 2006 issue of the Archives of Internal Medicine.
Platinol®, Gemzar® and Theosulfan is Palliative for Relapsed Melanoma (11/5/2007) Researchers from Germany have reported that the combination of Platinol (cisplatin), Gemzar (gemcitabine) and theosulfan (dihydroxybusulfan) has significant palliative effects in patients with stage IV melanoma who have failed 1-3 lines of therapy. The details of this study appeared in an early on-line advanced publication in the British Journal of Cancer on October 30, 2007.
ALS-357 Granted Orphan Drug Status for Metastatic Melanoma (9/20/2007) The United States Food and Drug Administration (FDA) has granted Advanced Life Sciences Holdings, Inc. orphan drug designation for their agent ALS-351 in the treatment of metastatic melanoma.
Antioxidant Supplements Linked to Increased Rates of Skin Cancer in Women (8/27/2007) Researchers from France have reported that antioxidants consumed in supplement form appear to be associated with an increase in the rate of skin cancer among women but not men. The details of this study appeared in the August, 2007 issue of the Journal of Nutrition.
Addition of Gliadel® Wafer to Surgery and Radiation Effective for Brain Metastasis (6/27/2007) Researchers involved in a multicenter trial have reported that the addition of Gliadel® Wafer (carmustine polymer wafer) to surgery plus external beam radiotherapy is a safe and effective regimen for patients with single brain metastasis. The details of this study appeared in the June 15, 2007 issue of Clinical Cancer Research.
Marathon Runners May Be at Increased Risk of Skin Cancer Including Melanoma (11/22/2006) Researchers from Austria have reported that marathon runners have an increased risk of developing malignant melanoma and non-melanoma skin cancer.
Little Evidence Statins or Fibrates Protect Against Melanoma (11/10/2006) Researchers from the University of Colorado have reported that the use of statins or fibrates does not decrease the risk of melanoma.
Addition of Genasense® to DTIC-Dome® Improves Outcomes in Metastatic Melanoma Patients With Normal LDH (10/10/2006) Results from a multi-national phase III trial indicate that addition of the Genasense® (oblimersen) to DTIC-Dome (dacarbazine) provides a significant survival benefit in patients with metastatic stage III or IV melanoma compared to DTIC alone. However, this benefit was only demonstrated in patients with normal LDH levels.
Genetically Engineered Lymphocytes May Have Activity in Melanoma (9/5/2006) Researchers from the National Cancer Institute have reported the successful transfer of genetically engineered lymphocytes with responses in 2 of 17 patients with advanced melanoma.
Temodar® and Peg-Intron® Active in Metastatic Melanoma (7/27/2006) Researchers from Memorial Sloan-Kettering Cancer Center have reported that the combination of Temodar (temozolomide) and Peg-Intron (pegylated interferon-alfa 2b) has significant anti-tumor effects and is well tolerated in patients with metastatic melanoma.
Combination of Volociximab (M200) and DTIC Well Tolerated in Treatment of Metastatic Melanoma (6/7/2006) According to the results of a phase II clinical trial presented at the 2006 annual meeting of the American Society of Clinical Oncology, volociximab (M200) in combination with DTIC is well tolerated in the treatment of metastatic melanoma.
Metastatic Melanoma Responds to Taxol® and Paraplatin® (2/16/2006) Researchers from the Mayo Clinic have reported that 45% of patients with metastatic melanoma that has failed first line chemotherapy appear to benefit from the combination of Taxol (paclitaxel) and Paraplatin (cisplatin).
Addition of Genasense® to Dacarbazine Improves Outcomes in Metastatic Melanoma Patients with Normal LDH (11/16/2005) Results from a multi-national phase III trial indicate that addition of the Genasense® (oblimersen) to dacarbazine (DTIC) provides a significant survival benefit in patients with metastatic stage III or IV melanoma compared to dacarbazine alone.
Abraxane™ Shows Significant Activity for the Treatment of Metastatic Melanoma (11/11/2005) Researchers from the University of Arizona have reported that Abraxane (albumin-bound paclitaxel) has significant activity for the treatment of patients with metastatic melanoma.
Pegylated Arginine Deiminase Promising for Metastatic Melanoma and Hepatocellular Carcinoma (10/26/2005) An Italian/American phase I/II trial has evaluated pegylated arginine deiminase (ADI-SS PEG) for the treatment of metastatic melanoma and concluded that this is a promising agent that needs further testing. A previous study has shown activity of ADI-SS PEG in hepatocellular carcinoma (HCC).
Oncophage® Improves Survival in Metastatic Melanoma (10/17/2005) According to results from a recent phase III clinical trial, the vaccine Oncophage (vitespen, formerly HSPCC-96) improves survival by over 50% in some patients with metastatic melanoma.
Adjuvant Interferon Alfa May Not Improve Survival in Patients with Stage IIb-III Melanoma. (9/30/2005) Researchers affiliated with the European Organization for Research and Treatment of Cancer (EORTC) have reported that intermediate doses of interferon alfa may not improve overall survival of patients with stage IIb-III melanoma.
Researchers Suggest Over Diagnosis as the Cause of Increase in Melanoma Incidence (8/10/2005) Researchers affiliated with VA Outcomes Group have reported that the increase in incidence of melanoma over the past decade is due to an increased number of biopsies with more patients being diagnosed with localized disease. They also report that there has not been an increase in deaths from melanoma.
Vaccine Promising in Metastatic Melanoma (3/11/2005) According to results presented at the 58th annual Cancer Symposium of the Society of Surgical Oncology, March 3-5, 2005, the vaccine MDX-010 in addition to interleukin-2 (Il-2, Proleukin®) provides significant responses in patients with metastatic melanoma. MDX-010 is now in phase III testing in patients with melanoma.
Surgical Resection of Brain Metastasis in Primary Motor Cortex Feasible (3/1/2005) Researchers from the Cleveland Clinic, Vanderbilt University and the National Institutes of Health recently reported that complete surgical resection of brain metastasis within the motor cortex of the brain is an effective and feasible practice in patients with cancer. These results were reported in the February 20, 2005 edition of the Journal of Clinical Oncology.
Increased Dosage of Vitamin A More Effective in Preventing Sun Damage (4/22/2004) Researchers from the University of Arizona and the MD Anderson Cancer Center have reported that vitamin A doses of 50,000 and 75,000 IU/day for 1 year proved safe and equally or more effective than 25,000 IU/day dose and can be recommended for future skin cancer chemoprevention studies. The details of this study appeared in the March 2004 issue of
Clinical Cancer Research.
Autologous Vaccine May Be Effective in Stage III Melanoma (3/9/2004) Researchers from Thomas Jefferson University have reported that an autologous tumor cell vaccine may prolong survival in patients with stage III melanoma. The study was published in the February 1, 2004 issue of the
Journal of Clinical Oncology.
Proleukin® Improves Responses to Autologous Melanoma Vaccine (2/24/2004) Researchers from Israel have reported that responses to an autologous melanoma vaccine were increased with the administration of systemic Proleukin® (interleukin-2, IL-2). This report appeared in February 23, 2004 issue of the
British Journal of Cancer.
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The Role of Sunscreen in Increasing or Decreasing Risk of Melanoma Still Uncertain (12/29/2003) Researchers from the University of Iowa have reported that no association was seen between melanoma and sunscreen use. They stated that it may take decades to detect a protective association between melanoma and use of the newer formulations of sunscreens. The results of this meta-analysis were reported in the December 16, 2003 issue of the
Annals of Internal Medicine.
Intralesional IL-2 Effective Treatment for Accessible Soft-Tissue Melanoma (11/14/2003) Researchers from Germany have reported a high response rate in soft-tissue melanomas treated with intralesional injection of interleukin-2 (IL-2). The details of this report were published in the November 3, 2003 issue of the
British Journal of Cancer.
Vaccinations and Childhood Infections Lower the Risk of Melanoma (11/13/2003) Researchers affiliated with the European Organization for Research and Treatment of Cancer (EORTC) have reported that vaccination with BCG and vaccinia significantly lowers the risk of developing melanoma in adulthood. These findings were published in the November 2003 issue of the
European Journal of Cancer.
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Sun Burn and Tanning Salons During Adolescence and Young Adulthood Confirmed as Risk Factors for Melanoma in Women (10/15/2003) A large prospective study in Norway has identified factors associated with an increased incidence of melanoma. These authors reported that the following factors were associated with an increased incidence of melanoma: increasing body surface area, increased number of nevi on the legs, light hair color, increasing number of sunburns per year at a young age, and use of a tanning salon one or two times per month. They suggest that Adolescence and early adulthood appear to be among the most sensitive age periods for the effects of sunburn and solarium use on melanoma. The results of these analyses appeared in the October 15, 2003 issue of the
Journal of the National Cancer Institute.
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GM-CSF Secreting Melanoma Vaccine Produces Promising Results (9/2/2003) In the September issue of the
Journal of Clinical Oncology, researchers from the Dana Farber Cancer Center reported that vaccinating with irradiated, autologous melanoma cells engineered to secrete GM-CSF by adenoviral-mediated gene transfer augments anti-tumor immunity in patients with metastatic melanoma.
Further Evidence for Activity of Temozolomide and Thalidomide for Treatment of Melanoma (9/2/2003) Researchers from the Sloan Kettering Cancer Center have reported promising activity of the combination of temozolomide and thalidomide for the treatment of patients with metastatic melanoma. The results of this phase II clinical trial were reported in the September 1, 2003 issue of the
Journal of Clinical Oncology.
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Temozolomide and Thalidomide: An Active Palliative Regimen for Metastatic Melanoma (7/7/2003) Researchers from England have concluded that a regimen of temozolomide provides the least toxic palliation for persons with metastatic melanoma. They reported these findings in the July 2003 issue of the
Journal of Clinical Oncology.
Sunscreen Application Decreases Incidence of Solar (Actinic) Keratoses (5/15/2003) Australian researchers have reported that daily application of sunscreen reduces the incidence of solar (actinic) keratoses by 24%. They reported their findings in the May 2003 issue of the
Archives of Dermatology.
Melanoma Vaccine, Melacine®, Unlikely to be Approved by FDA Without Further Studies (5/2/2003) In conference titled
Development of Therapeutic Cancer Vaccines, Dr. Martin A Cheever, of the Corixa corporation announced that although their melanoma vaccine Melacine® appears to have significant activity in patients with melanoma who have HLA types A2 and/or C3, the FDA will require a new study which will take 8-10 years to complete before they approve the commercial use of Melacine® in the US. Melacine® is already approved in Canada. Corixa has not yet decided whether or not to perform this study.
Oncophage®, A Cancer Vaccine, On Fast Track for FDA Approval (4/29/2003) At a meeting on Development of Therapeutic Cancer Vaccines held in Los Angeles April 27-29, 2003 Antigenics Inc announced that Oncophage® was the first patient specific cancer vaccine to be given US Food and Drug Administration (FDA) fast track approval. Canada has approved this vaccine for melanoma called Melacine for use in patients with metastatic melanoma. At the present time, no cancer vaccine is approved by the FDA.
Outpatient Chemoimmunotherapy Regimen for Metastatic Melanoma (3/27/2003) Researchers in Holland have reported a new regimen for treatment of patients with metastatic melanoma which consists of combined oral temozolamide, subcutaneous low-dose IL-2, and IFN alpha. Their results appear in the April 24 2003 issue of the
British Journal of Cancer.
Adjuvant Radiation Therapy Prevents Local but Not Distant Recurrences of Melanoma of the Head and Neck (3/21/2003) Excellent disease-free survival was reported in patients with stage I-III head and neck melanomas who were treated with adjuvant radiation therapy. These results were reported by researchers from the MD Anderson Cancer Center and appeared in the March 15, 2003 issue of
Cancer.
Adjuvant Immunotherapy May Be of Benefit for Resected Stage III-IV Melanoma (3/18/2003) In the January 2003 issue of the
Journal of Immunotherapy, Italian researchers reported on the feasibility and possible therapeutic advantage of adoptive immunotherapy in patients with resected stage III-IV melanoma. adoptive immunotherapy where tumor infiltrating lymphocytes (TIL) are collected, expanded in vitro and returned to the patient with simultaneous administration of
Proleukin®.
Public Education Improves Early Diagnosis of Melanoma (2/20/2003) Early diagnosis is crucial for the success of treating skin melanomas. Stage I melanomas are restricted to the outer layer of the epidermis and/or the upper part of the inner layer of dermis but have not spread to lymph nodes. Disease-free survival following surgery approaches 90%. Stage II melanomas are 1.5 millimeters to 4 millimeters thick and have spread to the lower part of the dermis, but have not spread into the tissue below the dermis or into nearby lymph nodes. Approximately 50% of stage II melanomas will recur following surgery. Stage III melanomas are larger than 4 millimeters and/or invade the subcutaneous tissue. Stage III melanomas can be any size with spread to regional lymph nodes. The recurrence rate following surgery alone for stage III melanoma is greater than 60%.
The Vaccine, Canvaxin, Prolongs Survival of Patients with Resected Metastatic Melanoma (12/5/2002) Over the past two decades, there have been many attempts to treat melanoma with vaccines. The primary reason for these efforts is the belief than immune mechanisms control the spread of melanoma. For example, melanoma is one of the few cancers with a small but significant incidence of spontaneous remissions. Furthermore, a significant fraction of patients with metastatic melanoma are cured by surgery suggesting that residual cancer cells are eradicated by the bodys immune system. In most vaccine trials to date, improved outcomes have occurred entirely or predominantly in those patients who demonstrate a cellular or antibody response to the vaccine. Most vaccines have utilized killed autologous or allogeneic melanoma cells as immunogens. This has complicated vaccine trials as it is difficult to prepare large batches of consistent vaccine from this approach.
Study of Airline Pilots Fails to Show Marked Increase in Cancer From Cosmic Radiation (9/13/2002) Low-energy ionizing radiation has been shown to cause double-stranded DNA deletions and induce genomic instability in human chromosomes. So far, data on this matter has been inconclusive, except for the documentation of an increased incidence of melanoma and other skin cancers in pilots and flight attendants. However, it has never been clear if the increased cancer incidence was due to cosmic radiation and not to sun exposure due to the lifestyle of these individuals when compared to the general population. Scandinavian researchers (Denmark, Finland, Iceland, Norway and Sweden) assessed the incidence of cancer in 10,032 male airline pilots with a median follow-up of 17 years. Results indicated that airline pilots had a substantial increase in melanoma, other skin cancers and prostate cancer but could not directly attribute these increases to cosmic radiation. This study was published in the September 14, 2002 issue of the
British Medical Journal.
FDA Grants Orphan Drug Status to Oncophage® Vaccine for Metastatic Melanoma (8/2/2002) The Food and Drug Administration (FDA) recently granted Oncophage® (HSPC-96) orphan drug status for metastatic melanoma. Orphan drug status is given to drugs that target an illness affecting 200,000 or fewer people in the U.S. Financial incentives, such as tax breaks, specific regulatory fee waivers, available funding for clinical trials and marketing exclusivity for 7 years if the product is approved are granted in order to aid in the development of the product.
Delayed Hypersensitivity Reaction Predicts Response to Melanoma Vaccine (6/4/2002) A wide variety of vaccines made from autologous or allogeneic melanoma cells have been evaluated for the treatment of melanoma but no vaccine has emerged as consistently effective and none are commercially available. Researchers in Israel have recently reported that the outcome of patients with melanoma treated with their vaccine depends on the degree of immunization as measured by delayed hypersensitivity reaction to autologous melanoma cells. They reported their findings in a recent issue of the
British Journal of Cancer.
Temozolomide and Thalidomide is an Active Treatment Regimen for Metastatic Melanoma (6/4/2002) Metastatic melanoma is an incurable disease and there have been great efforts to improve outcomes by developing new chemotherapy regimens, vaccines and immunotherapy including interleukin-2 (IL-2) and interferon-alfa (IFN). However, until recently, the standard treatment was with dacarbazine (DTIC)-based regimens. Recently, DTIC has been replaced by temozolomide, which is a congener of DTIC that can be given orally. DTIC and temozolomide as single agents produce response rates in 10% to 20% of patients lasting approximately 5-6 months, with less than 5% of the responses being complete. Adding other chemotherapeutic agents to DTIC or temozolomide has not clearly improved responses or survivals. The addition of IL-2 and/or IFN to DTIC or temozolomide increases the response rate, but has not clearly improved survival.
The Addition of Alfa Interferon and Interleukin-2 Adds to the Palliative Effects of Chemotherapy in Patients with Metastatic Melanoma (5/7/2002) According to results published in the
Journal of Clinical Oncology, a recent randomized trial conducted by the M.D. Anderson Cancer Center suggests that the addition of cytokines to chemotherapy improves times to cancer progression, but does not improve the cure rate for patients with advanced melanoma.
Histamine Dihydrochloride Improves Survival of Interleukin-2 Treatment of Patients with Metastatic Melanoma (2/12/2002) A multicenter international trial has concluded that the addition of dihydrochloride improves survival of some patients with metastatic melanoma treated with IL-2. Reactive oxidative species (ROS) produced by phagocytic cells have been ascribed a role in the localized suppression of lymphocyte function within malignant tumors. Histamine has been shown to inhibit ROSformation and possibly synergize with cytokines to permit activation of natural killer cells and T cells. This study was designed to determine whether the addition of histamine to a subcutaneous (SC) regimen of interleukin-2 (IL-2) would improve the survival of metastatic melanoma patients. They performed a randomized trial involving 305 patients with advanced melanoma. Patients were randomized to IL-2 (9 MIU/m2 bid SC on days 1 to 2 of weeks 1 and 3, and 2 MIU/m2 bid SC on days 1 to 5 of weeks 2 and 4) with or without histamine (1.0 mg bid SC days 1 to 5, weeks 1 to 4). Combined treatment with histamine plus IL-2 significantly improved overall survival in patients with liver metastasis (P = .004) and showed a trend for improved survival in the entire population (P = .125). Further examination of the survival data according to the modified AJCC staging system demonstrates that those patients with M1b (lung alone) median survival was improved from 463 days to 565 days for patients treated in the histamine plus IL-2 group (P = .071), and for the patients classified M1c (visceral disease plus allpatients with LDH upper limit of normal), median survival was improved from 140 days to 280 days for the histamine plus IL-2 group (P = .026). The observed survival advantage for the combination treatment was obtained in an outpatient setting and without negatively impacting the patients quality of life (manuscript in preparation). Grade 3 and 4 adverse events were comparable in the two arms. These Investigators concluded that the use of histamine as an adjunct to IL-2 is safe, well tolerated, and associated with a statistically significant prolongation of survival compared with IL-2 alone in metastatic melanoma patients with liver involvement. Further trials to confirm and understand the role of histamine in this combination treatment are underway.
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