Premium
Randomized phase II trial of two different schedules of docetaxel plus cisplatin as first‐line therapy in advanced nonsmall cell lung cancer
Author(s) -
Park Se Hoon,
Choi Soo Jin,
Kyung Sun Young,
An Chang Hyeok,
Lee Sang Pyo,
Park Jeong Woong,
Jeong Sung Hwan,
Cho Eun Kyung,
Shin Dong Bok,
Hoon Lee Jae
Publication year - 2007
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.22446
Subject(s) - medicine , docetaxel , cisplatin , oncology , lung cancer , cancer , randomized controlled trial , first line therapy , chemotherapy
BACKGROUND. There is increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. The purpose of the current randomized study was to evaluate the toxicity and efficacy of docetaxel plus cisplatin combination on 2 schedules in patients with previously untreated, advanced nonsmall‐cell lung cancer (NSCLC). METHODS. Consenting patients with advanced NSCLC were randomized to receive first‐line chemotherapy with cisplatin 75 mg/m 2 on Day 1, plus 3‐weekly (75 mg/m 2 on Day 1) or weekly (35 mg/m 2 on Days 1, 8, and 15 of a 4‐week cycle) docetaxel, for up to 6 cycles. RESULTS. Of 86 patients accrued, 41 patients were treated with 3‐weekly and 43 with weekly docetaxel plus cisplatin. The most frequent grade 3/4 toxicity in the 3‐weekly arm was neutropenia (56% of patients). In those receiving the weekly regimen, the frequent grade 3/4 toxicities were fatigue (44%) and nausea/vomiting (35%). The overall response rate was 40% with the 3‐weekly and 39% with the weekly arm ( P = .74). The median progression‐free survival was 4.3 months in the 3‐weekly arm and 3.9 months in the weekly arm ( P = .08) and the median survival was 10.3 and 10.0 months, respectively ( P = .76). Quality of life data showed no relevant difference between the arms. CONCLUSIONS. The weekly schedule of docetaxel plus cisplatin combination as first‐line chemotherapy for advanced NSCLC, while feasible, has no clear advantage over the standard 3‐weekly regimen. Cancer 2007. © 2007 American Cancer Society.