Irinotecan and carboplatin in metastatic or recurrent non-small-cell lung cancer.

The outcome of patients with metastatic lung cancer is poor, with a 1-year survival rate of approximately 35%. We are evaluating the combination of irinotecan (CPT-11, Camptosar) and carboplatin (Paraplatin) in patients with stage IIIB and IV non-small-cell lung cancer. Eligible patients include those with histologic or cytologic diagnosis of non-small-cell lung cancer; no previous chemotherapy for metastatic lung cancer; and Eastern Cooperative Oncology Group performance status 0 or 1. The first five patients received irinotecan at 250 mg/m2 over 90 minutes followed by carboplatin at an area under the concentration-time curve (AUC) of 5 over 1 hour. Subsequently, the dose of irinotecan was reduced to 200 mg/m2 in view of febrile neutropenia in one of five patients. Chemotherapy cycles are repeated every 21 days. Patients are reevaluated every two cycles. Of a planned 37 patients, 14 have been enrolled and 9 are evaluable for toxicity and response at the time of this report. Thirty-two cycles have been administered, with seven 1-week delays and two dose reductions. To date there have been two partial responses and five patients with stable disease; two patients developed progressive disease on therapy. One patient had neutropenic fever; other toxicities included mild pancreatitis (n = 1) and diverticulitis (n = 1). The regimen of irinotecan and carboplatin administered once every 3 weeks demonstrates early evidence of activity, and is tolerable and convenient. The main toxicity is hematologic. This study is ongoing and actively accruing patients.