A Randomized Phase II Trial Assessing in Advanced Non-small Cell Lung Cancer Patients with Stable Disease after Two Courses of Cisplatin-Gemcitabine an Early Modification of Chemotherapy Doublet with Paclitaxel-Gemcitabine Versus Continuation of Cisplatin-Gemcitabine Chemotherapy (GFPC 03-01 Study)

摘要: Background There is no consensus on the optimal treatment for patients with advanced non-small cell lung cancer and stable disease after cisplatin-based chemotherapy. The objective of trial was to evaluate a switch different dual-agent Methods Patients stage IV two cycles cisplatin (P) gemcitabine (G) (P day1 (d 1 ): 75 mg/m 2 , G: 1250 d 8 every 3 weeks) were randomized receive either further PG (arm A) or paclitaxel (100 15 ) plus (1250 4 B). Results Two-hundred-twenty-eight enrolled between October 2003 August 2006. After PG, 98 (43%) had disease; 87 randomized: 45 arm A 42 B. response rates 15.6% (6.5–29.4) 21.4% (10.3–36.8) in arms Overall survival randomization 9.6 months (7.0–13.8) 9.3 (7.4–13.3) Adverse events similar hematological non toxicities. Conclusions Sequential first-line chemotherapy these feasible difference rates. These results do not warrant phase III trial.