Background: In a previous phase I dose-escalation study, we showed a weekly administration of paclitaxel (TAX) and gemcitabine (GEM) to be active and very well tolerated in non-small-cell lung cancer (NSCLC) patients, with the lack of interaction between drugs. The dose of GEM 1500 mg/m2 and TAX 100 mg/m2 was selected for phase II studies due to its predictable kinetic behaviour and less severe thrombocytopenia. Patients and methods: Fifty-four chemo-naïve patients with advanced NSCLC (53 patients: stage IV) received TAX (100 mg/m2 i.v. infusion over 1 h) followed by GEM 1500 mg/m2 over 30 min) on days 1, 8, 15 and 21 of a 28-day cycle. Results: The objective response rate was 46% (95% CI 32-61), median OS of 10.4 ms (95% CI 6.5-4.3), and a 1-year survival rate of 53%. Grades 3 and 4 haematological toxicity consisted of non-febrile neutropenia and thrombocytopenia in 13 and 4% of the cycles, respectively. Grade 3 non-haematological toxicities were observed in three patients (asthenia, diarrhoea and neuropathy), and were always reversible. Conclusions: This weekly schedule of TAX and GEM is highly active in chemo-naïve NSCLC patients and confirms the low toxicity profile already observed in a previous phase I study.
- Weekly administration
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