7135 Background: There has been increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. The purpose of this randomized study is to evaluate the toxicity and efficacy of docetaxel and cisplatin combination on two schedules in patients with previously untreated, advanced non-small cell lung cancer (NSCLC). Methods: Consenting patients with stage IIIB/IV or recurrent NSCLC were randomized to receive first-line chemotherapy with cisplatin 75 mg/m2 on day 1, plus either weekly (35 mg/m2 on day 1, 8, 15 of a 4-week cycle) or 3-weekly (75 mg/m2 on day 1 of a 3-week cycle) docetaxel, both for up to 6 cycles. Objectives of this randomized phase II trial were response, toxicity and quality of life (QOL; measured with EORTC QLQ-C30). With a two-stage phase II design, the required number of patients was 39 per each arm. Results: Of 85 patients accrued, 71 patients were evaluable for response and 83 for safety. Baseline characteristics were well-balanced between the two arms: male (56 patients); median age (64 years); adenocarcinoma/squamous cell carcinoma (53/32); stage IIIB/IV/recurrent (12/63/10); ECOG performance status 0/1/2 (20/44/21). Median number of chemotherapy cycles was 3 (1–6) for both arms. Median dose intensities were docetaxel 88%, cisplatin 98% in weekly arm, and docetaxel 97%, cisplatin 98% in 3-weekly arm. The objective responses of weekly and 3-weekly arm were 38% (95% CI, 23–53) and 42% (95% CI, 27–57), respectively. There was significantly more grade 3/4 neutropenia (66% v 12%; P < .001) and febrile neutropenia (40% v 7%; P < .001) on 3-weekly arm but less grade 3/4 diarrhea (2% v 14%; P = .05) and severe skin/nail toxicity (5% v 29%; P = .003). No difference in the rates of treatment delay or dose reduction for both arms; however, 19% of day 15 docetaxel were omitted in weekly arm due to toxicity. Conclusions: Both weekly and 3-weekly docetaxel plus cisplatin appear to be active as first-line chemotherapy for advanced NSCLC, with different safety profiles. Updated results and QOL data, including a prolonged follow-up, will be presented. No significant financial relationships to disclose.
Randomized phase II study with two gemcitabine- and docetaxel-based combinations as first-line chemotherapy for metastatic non-small cell lung cancer
