A phase I-II study of gemcitabine and paclitaxel in advanced non-small- cell lung cancer patients
Annals of Oncology , Volume 11 - Issue 1 p. 109- 112
Thirty patients with chemotherapy-naive advanced non-small-cell lung cancer (NSCLC) were given escalating doses of paclitaxel (150, 175, 200 mg/m2) on day 1 in three consecutive cycles, together with a fixed dose of gemcitabine 1000 mg/m2 on days 1 and 8; cycles were repeated every three weeks. The dose escalation of paclitaxel was feasible in the majority of patients. Subsequently, 30 other NSCLC patients received a dose of 200 mg/m2 paclitaxel with gemcitabine 1000 mg/m2 in a phase II study. The major side effect was mild myelosuppression. A response rate of 24% was achieved in 49 fully evaluable patients. This regimen proved to be safe and easy to administer on an out-patient setting, and constitutes now one of the arms of the current EORTC randomized study for advanced NSCLC.
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Giaccone, G, Smit, E.F, van Meerbeeck, J.P, Splinter, T.A.W, Golding, R.P, Pinedo, M, … Postmus, D. (2000). A phase I-II study of gemcitabine and paclitaxel in advanced non-small- cell lung cancer patients. Annals of Oncology, 11(1), 109–112. doi:10.1023/A:1008321000887