Researchers affiliated with the SATURN study have reported that maintenance therapy with Tarceva® (erlotinib) improves overall survival (OS) in patients with advanced non–small cell lung cancer (NSCLC) who have no evidence of disease progression after four cycles of platinum-based induction therapy. The details of this randomized trial were presented at the Joint ECCO 15 – 34th ESMO Multidisciplinary Congress in Berlin, September 20-24, 2009.[1]
Tarceva is an epidermal growth factor receptor (EGFR) inhibitor. EGFRs are small proteins that are found on the surface of all cells. EGFR binds exclusively to small proteins circulating in the blood called growth factors. The binding action between EGFR and growth factors stimulates biological processes within the cell to promote growth of a cell in a strictly controlled manner. However, in many cancer cells, EGFR is either abundantly over-expressed or the EGFR biological processes that normally stimulate cell growth are constantly active, leading to the uncontrolled and excessive growth of the cancer cell.
Researchers affiliated with the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) have previously reported that Tarceva improves the quality of life of patients with NSCLC who have failed two or three chemotherapy regimens. This study led to the approval by the U.S. Food and Drug Administration of Tarceva for use in patients with NSCLC. Subsequent studies have shown that the response rate to Tarceva is determined by EGFR mutation status.
At ASCO 2009 researchers affiliated with the SATURN study reported that maintenance therapy with Tarceva improved progression-free survival (PFS) in patients with NSCLC who had no evidence of disease progression after four cycles of platinum-based induction therapy. The data on OS is now mature enough to present.
The SATURN study included 889 patients who were randomly allocated to receive Tarceva or a placebo after induction therapy. Disease control rate was 41% for the Tarceva group and 27% for the control group. Tarceva was described as well tolerated. Patients with EGFR mutations had a 31% improvement in PFS.
The current analysis focused on OS with the following results:
- Tarceva maintenance was associated with a 19% improvement in OS for all patients in an intent-to-treat analysis.
- Tarceva maintenance was associated with a 23% improvement in OS for patients with adenocarcinoma.
- Tarceva maintenance was associated with a 14% improvement in OS for patients with squamous cell carcinoma.
- Tarceva maintenance was associated with a 17% improvement in OS in the EGFR mutation + group.
- Tarceva maintenance was associated with a 23% improvement in OS in the EGFR wild-type group.
Seventy percent of patients in this study received a diversity of post-study therapies. Eleven percent of patients in the Tarceva maintenance group received subsequent targeted agents compared with 21% in the control group.
Comments: An OS benefit was obtained for maintenance Tarceva despite a variety of treatments after progression in the control group. These authors also noted that the OS benefit “was not driven by EGFR mutation-positive subgroup, with a significant improvement in OS observed in the EFGR wild-type group.”
Reference:
[1] Cappuzzo F, Coudert B, Wierzbicki R, et al. Overall survival analysses from the SATURN phase III placebo-controlled study of erlotinib as first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC). European Journal of Cancer Supplements, Vol. 7, NO 3, September 2009, page 12, abstract 22LBA.
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