Originally published as JCO Early Release 10.1200/JCO.2008.20.2127 on February 9 2009

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Phase II Trial of Irinotecan and Carboplatin for Extensive or Relapsed Small-Cell Lung Cancer

From the University of California, Davis Cancer Center, Sacramento; Veteran Administration Northern California Health System, Mather; Kaiser Permanente of Northern California, Oakland, CA; and Swedish Institute of Seattle, Seattle, WA.

Corresponding author: Derick Lau, MD, PhD, University of California, Davis Cancer Center, 4501 X St, Sacramento, CA 95817; e-mail: derick.lau{at}ucdmc.ucdavis.edu.

Purpose The regimens of weekly irinotecan with platinum have been used for treatment of metastatic small-cell lung cancer (SCLC). We conducted a multi-institution phase II trial to evaluate a novel 21-day schedule of irinotecan and carboplatin in patients with relapsed or extensive SCLC.

Patients and Methods Eighty patients were enrolled with the following characteristics: 39 male patients, 41 female patients; median age, 65 years; and Zubrod performance status, 0 to 1 in 85% and 2 in 15% of patients. Dosing schemas were based on the maximum-tolerated dose derived in a previous phase I study. Chemotherapy-naive patients with extensive SCLC were treated with irinotecan 200 mg/m² and carboplatin area under the curve (AUC) of 5 (arm A). Patients, who had previously been treated with chemotherapy and had relapsed disease received irinotecan 150 mg/m² and carboplatin AUC of 5 (arm B). In each study arm, the treatment was given every 21 days for up to six cycles.

Results The most common grade 3 to 4 toxicities included neutropenia (54%), thrombocytopenia (22%), anemia (13%), diarrhea (22%), and nausea/emesis (11%) in both study arms. There were three treatment-related deaths owing to neutropenic sepsis. Among 72 assessable patients, response rates of 65% and 50% were observed, respectively, for arm A and arm B. The median survival for both study arms was identical at 10 months (95% CI, 6 to 14 months). A response rate of 65% was observed in the intracranial disease of 14 patients with known brain metastases.

Conclusion This 21-day regimen of irinotecan and carboplatin seems promising for the treatment of relapsed SCLC.

Supported by Grant No. K24CA10014 and Pfizer Inc.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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