Phase II study of irinotecan and etoposide in patients with metastatic non-small-cell lung cancer

Purpose: To determine the effects of irinotecan (CPT-11) given in combination with etoposide (VP-16) in metastatic non-small-cell lung cancer (NSCLC), to evaluate response and survival rates, and to determine the qualitative and quantitative toxicities of the combination chemotherapy, Patients and Methods: Sixty-one metastatic NSCLC patients received concurrent administration of CPT-11 and VP-16 for 3 days with recombinant human granulocyte colony-stimulating factor (rhG-CSF) support, Results: Fifty-nine patients were assessable for response and all 61 patients were assessable far toxicity and survival, Fifty-six patients were treated with two or more courses of chemotherapy. Thirteen patients achieved ct partial response (PR), 36 showed no change (NC), and 10 showed progressive disease (PD), The overall response rate was 21.3% (95% confidence interval, 12.9% to 33.1%), The median duration of PRs was 141 days (range, 62 to 299), Of the hematologic toxicities, 14 (23%) and 24 (39%) patients experienced grade 3 or 4 leukopenia and neutropenia, respectively, The toxicities were feasible. Treatment-related death occurred in one patient who suffered hypovolemic shock induced by hematemesis, The median survival time was 10.0 months and the 1-year survival sate was 36.1%, Conclusion: Combination chemotherapy with concurrent administration of CPT-11 and VP-16 with rhG-CSF support was only modestly effective against metastatic NSCLC, with feasible toxicities of moderate diarrhea and pulmonary toxicity. The results were equivalent Ya those expected with either cisplatin-based chemotherapy or with CPT-11 alone. (C) 1997 by American Society of Clinical Oncology.