© 2005 European Society for Medical Oncology
Original article |
Comparison of docetaxel and docetaxel–irinotecan combination as second-line chemotherapy in advanced non-small-cell lung cancer: a randomized phase II trial
1 Second Department of Internal Medicine – Propaedeutic, Athens University Medical School, Attikon University Hospital, Athens; 2 Second Department of Medical Oncology, Metaxas Memorial Cancer Hospital, Piraeus, Greece
* Correspondence to: Dr D. Pectasides, Gravias 5B, Aghia Paraskevi, Athens 15342, Greece. Tel/Fax: +30-210-600-8610; Email: pectasid{at}otenet.gr
Background: The aim of this study was to evaluate whether docetaxel (taxotere) treatment with or without irinotecan improved patient outcomes with similar toxicity in recurrent non-small-cell lung cancer (NSCLC).
Patients and methods: Patients with recurrent platinum-refractory NSCLC with Eastern Cooperative Oncology Group performance status of 0–2 were randomized to either docetaxel 30 mg/m2 and irinotecan 60 mg/m2 (days 1 and 8) or docetaxel 75 mg/m2 (day 1), both administered every 3 weeks.
Results: A total of 130 patients were randomized. The response rate (RR) (20% versus 14%), overall survival (6.5 months versus 6.4 months) and 1-year survival (37% versus 34%) were similar in the combination and docetaxel arms, respectively. The combination arm demonstrated a longer time to tumor progression (TTP) (5.6 versus 4.8 months; P=0.065). Grade 3–4 neutropenia and anemia were similar in the combination and docetaxel arms. Grades 3–4 non-hematological toxicity (except diarrhea) was mild and was similar in the two groups. Grade 3–4 thrombocytopenia (17% versus 6%; P=0.04) and diarrhea (12% versus 3%; P=0.05) occurred more frequently in the combination arm.
Conclusions: The administration of irinotecan with docetaxel in platinum-refractory NSCLC prolonged TTP, but did not improve significantly RR, median survival or 1-year survival. Second-line docetaxel monotherapy offers significant and reproducible efficacy in platinum-refractory NSCLC.
Key words: docetaxel, irinotecan, non-small-cell lung cancer, platinum-refractory, salvage regimen, second-line chemotherapy
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