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)

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 the trial was to evaluate a switch to a different dual-agent chemotherapy. Methods: Patients with stage IV non-small cell lung cancer and stable disease after two cycles of cisplatin (P) and gemcitabine (G) (P day1 (d₁): 75 mg/m², G: 1250 mg/m² d₁ and d₈ every 3 weeks) were randomized to receive either two further cycles of PG (arm A) or paclitaxel (100 mg/m2 d₁, d₈, d₁₅) plus gemcitabine (1250 mg/m ² d₁ and d₈, every 4 weeks) (arm B). Results: Two-hundred-twenty-eight patients were enrolled between October 2003 and August 2006. After two cycles of PG, 98 patients (43%) had stable disease; 87 were randomized: 45 to arm A and 42 to arm B. The objective response rates were 15.6% (6.5-29.4) and 21.4% (10.3-36.8) in arms A and B. Overall survival after randomization was 9.6 months (7.0 -13.8) in arm A and 9.3 months (7.4 -13.3) in arm B. Adverse events were similar in the two arms for hematological and non hematological toxicities. Conclusions: Sequential first-line chemotherapy in these patients is feasible with no difference in response rates. These results do not warrant a phase III trial.