1096 Preliminary report of a phase II study of docetaxel (taxotere® and cisplatin in advanced non small cell lung cancer (NSCLC)

Docetaxel is a tubulin polymerizing agent that shows activity as a single agent in advanced NSCLC. Its combination with cisplatin has been investigated in different phase II trials. In this study, we used a treatment schedule consisting of docetaxel 75mg/m2and cisplatin 100mg/m2every 3 weeks during 3 cycles and then every 6 weeks, with a standard premedication: dexamethasone, antihistaminic, antiemetic and hyperhydration. Evaluation of activity was performed every 6 weeks. Eligible patients (pts) had histologically proven locally advanced or metastatic NSCLC, measurable tumor, no previous chemotherapy, KPS≥60, age≤75, normal hematological, hepatic and renal functions, no brain or leptomeningeal involvement and signed informed consent. Fifty-one patients have been included: 3 were not eligible, the characteristics of the 48 remaining pts are: 44 males, 4 females; mean age: 54 years (range 34–75); stage IIIB: 13%, stage IV: 87%; they received a mean of 4 cycles (range 1–6). Among these 48 pts, 1 CR and 13 PR (29%) were observed, including 9 PR continned today by an independent panel, lasting from 15+ to 31+ weeks. Main toxicities (G 3–4) were: febrile neutropenia: 5 pts, documented sepsis: 5 patients. No toxic death was reported. As a result of using routine premedication, previously reported side effects were considerably lessened Based on this preliminary analysis combination of docetaxel 75mg/m2and cisplatin 100mg/m2, indicates an interesting result which should deserve other investigations of this drug combination.