Phase II trial of irinotecan and cisplatin with early concurrent radiotherapy in limited‐disease small‐cell lung cancer

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Abstract
BACKGROUND.: A Phase II trial of irinotecan and cisplatin (IP) with early concurrent radiotherapy was performed in limited‐disease small‐cell lung cancer (LD‐SCLC) to evaluate the efficacy and toxicity.METHODS.: For untreated LD‐SCLC patients, irinotecan (60 mg/m2, Days 1, 8, and 15) and cisplatin (40 mg/m2, Days 1 and 8) were repeated every 4 weeks for a maximum of 6 cycles. Thoracic radiotherapy of 1.8 Gy/day was begun on Day 1 of the second chemotherapy cycle, up to a total of 45 to 54 Gy. Prophylactic cranial irradiation (30 Gy in 10 fractions) was performed on patients with a complete response (CR).RESULTS.: Thirty‐three LD‐SCLC patients were enrolled. The median age was 60 years and 31 patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Twelve (36.4%) patients had N3 disease. The response rate was 87.9%, with a CR rate of 45.5%. At a median follow‐up period of 27 months the median progression‐free survival (PFS) and overall survival (OS) were 14.4 and 26.1 months, respectively, with 2‐year PFS and OS rates of 26.8% and 54.9%. The dominating toxicity was neutropenia, with grade 3–5 of 81.8%. The most common grade 3–5 nonhematologic toxicities were diarrhea (21.2%), anorexia (21.2%), and fatigue (21.2%). Grade 3–5 radiation esophagitis and pneumonitis occurred in 18.2% and 9.1% of patients, respectively. There were 2 treatment‐related deaths from sepsis and radiation pneumonitis.CONCLUSIONS.: IP with early concurrent radiotherapy was effective and tolerable in untreated LD‐SCLC. Cancer 2007. © 2007 American Cancer Society.

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