Gemcitabine and paclitaxel associated pneumonitis in non-small cell lung cancer: report of a phase I/II dose-escalating study

The aim of this phase I/II dose escalating study was to establish the maxim um tolerated dose (MTD) of gemcitabine and paclitaxel given in combination in non-small cell lung cancer (NSCLC). 12 patients with stage IIIB and IV N SCLC received paclitaxel administered intravenously over 1 h followed by ge mcitabine given over 30 min on days 1, 8 and 15 every 28 days. Pneumonitis was the principal side-effect observed with 4 patients affected. Of these, 1 experienced grade 3 toxicity after one cycle of treatment and the others had grade 2 toxicity. All 4 cases responded to prednisolone. No other signi ficant toxicities were observed. Of the 8 evaluable patients, 3 had a parti al response and 2 had minor responses. The study was discontinued due to th is dose-limiting toxicity. The combination of paclitaxel and gemcitabine sh ows promising antitumour activity in NSCLC, however, this treatment schedul e may predispose to pneumonitis. (C) 2000 Elsevier Science Ltd. All rights reserved.