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 comb ination with etoposide (VP-16) in metastatic non-small-cell lung cance r (NSCLC), to evaluate response and survival rates, and to determine t he qualitative and quantitative toxicities of the combination chemothe rapy, Patients and Methods: Sixty-one metastatic NSCLC patients receiv ed concurrent administration of CPT-11 and VP-16 for 3 days with recom binant human granulocyte colony-stimulating factor (rhG-CSF) support, Results: Fifty-nine patients were assessable for response and all 61 p atients were assessable far toxicity and survival, Fifty-six patients were treated with two or more courses of chemotherapy. Thirteen patien ts 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 neutr openia, respectively, The toxicities were feasible. Treatment-related death occurred in one patient who suffered hypovolemic shock induced b y hematemesis, The median survival time was 10.0 months and the 1-year survival sate was 36.1%, Conclusion: Combination chemotherapy with co ncurrent administration of CPT-11 and VP-16 with rhG-CSF support was o nly modestly effective against metastatic NSCLC, with feasible toxicit ies of moderate diarrhea and pulmonary toxicity. The results were equi valent Ya those expected with either cisplatin-based chemotherapy or w ith CPT-11 alone. (C) 1997 by American Society of Clinical Oncology.