Second-line chemotherapy with weekly paclitaxel and gemcitabine in patients with small-cell lung cancer pretreated with platinum and etoposide: a single institution phase II trial

Purpose: The safety and efficacy of a combined regimen of weekly paclitaxel and gemcitabine was tested in patients with refractory and sensitive small-cell lung cancer (SCLC). Methods: Treatment consisted of paclitaxel 80 mg/m2 on days 1, 8, 15 and gemcitabine 1,000 mg/m2 on days 1 and 8 every 3 weeks. Of the 31 patients enrolled, 10 had refractory and 21 had sensitive disease. Objective responses occurred in 8 patients (26%), including 2 out of 10 patients with refractory- and 6 out of 21 patients with sensitive SCLC. Median time to progression and median survival were 9.4 and 32 weeks, respectively. Results: The schedule was very well tolerated, with grade 3–4 thrombocytopenia in 26% of the patients, grade 3 neutropenia in 26%, grade 3–4 asthenia in 13% and grade 1–2 sensory neuropathy in 32%. Conclusion: To conclude, this weekly schedule of paclitaxel and gemcitabine was found to have moderate activity in platinum-etoposide pretreated SCLC patients and a favorable toxicity profile.