Intra-patient alternated dose escalation of paclitaxel and gemcitabine versus paclitaxel followed by fixed dose rate infusion of gemcitabine in fit elderly non-small cell lung cancer patients: A Southern Italy Cooperative Oncology Group randomised phase I

SummaryPurposeThis study was undertaken to select the best schedule of administration for the paclitaxel plus gemcitabine combination in fit elderly patients affected by locally advanced or metastatic non-small cell lung cancer (NSCLC).Patients and methodsNinety-eight patients in stage III or IV NSCLC, aged 70 years or more and in ECOG performance status (PS) ≤ 1, were randomly allocated to receive: paclitaxel 80 mg/m2 plus gemcitabine 1000 mg/m2 i.v. on days 1 and 8, with an intra-patient alternated dose escalation up to 100 and 1200 mg/m2, respectively, over three cycles (arm A); or paclitaxel 80 mg/m2 followed by gemcitabine 1000 mg/m2 i.v. (100 min) on days 1 and 8 (arm B). Treatment was repeated in both arms every 3 weeks for a maximum of six cycles.ResultsWith a median of 3 (range, 1–6) delivered cycles, the two schedules yielded a similar response rate (25% versus 26%), failure-free survival (median, 3.3 months versus 3.2 months), progression-free survival (median, 5.1 months versus 5.2 months), and overall survival (median, 9.7 months versus 9.6 months). Survival was independently affected by the PS of patients and by the metastatic spread. Severe side effects were comparable and negligible in both arms.ConclusionA substantial difference between these two schedules in terms of efficacy and safety can be ruled-out. Paclitaxel plus gemcitabine is an advisable combination for treating fit elderly patients with advanced NSCLC.