Comparison of docetaxel and docetaxel–irinotecan combination as second-line chemotherapy in advanced non-small-cell lung cancer: a randomized phase II trial

• Published in: Annals of oncology Vol. 16; no. 2; pp. 294 - 299
• Main Authors: Pectasides, D., Pectasides, M., Farmakis, D., Kostopoulou, V., Nikolaou, M., Gaglia, A., Koumpou, M., Mylonakis, N., Xiros, N., Economopoulos, T., Raptis, S. A.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.02.2005
• Subjects: Adult; Aged; Antineoplastic agents; Antineoplastic Agents, Phytogenic - administration & dosage; Antineoplastic Agents, Phytogenic - adverse effects; Antineoplastic Agents, Phytogenic - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Camptothecin - administration & dosage; Camptothecin - adverse effects; Camptothecin - analogs & derivatives; Camptothecin - therapeutic use; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Docetaxel; Female; Humans; Irinotecan; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Medical sciences; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - pathology; non-small-cell lung cancer; Pharmacology. Drug treatments; platinum-refractory; Pneumology; salvage regimen; second-line chemotherapy; Survival Analysis; Taxoids - administration & dosage; Taxoids - adverse effects; Taxoids - therapeutic use; Treatment Outcome; Tumors of the respiratory system and mediastinum; Antineoplastic agent; Lung cancer; non-small cell lung carcinoma; Isomerases; Platinum; platinum-refractory; Taxane derivatives; Phase II trial; Bronchus disease; Clinical trial; Advanced stage; Antimitotic; Lung disease; Treatment resistance; Respiratory disease; Enzyme; second-line chemotherapy; DNA topoisomerase; Docetaxel; Enzyme inhibitor; Malignant tumor; Irinotecan; salvage regimen; Chemotherapy; Treatment; Comparative study; non-small-cell lung cancer
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdi053

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.