This study was conducted using irinotecan and cisplatin (IP) concurrently with thoracic radiation therapy to evaluate the response and toxicity of this protocol in the treatment of patients with limited-disease small cell lung cancer (LD-SCLC). Twenty-seven chemotherapy-naive patients with LD-SCLC received two cycles of weekly irinotecan 60 mg/m(2) and cisplatin 60 mg/m(2) before the initiation of the thoracic radiation therapy. Of the 29 patients with LD-SCLC enrolled in the study, 27 were eligible for evaluation of response and toxicity. The median age was 62 years; 26 patients (90%) were men. Eastern Cooperative Oncology Group (ECOG) performance status was 0 in 5 patients (17%) and 1 in 18 patients (62%). Ten patients (37%) achieved a complete response (CR), 14 patients (52%) achieved a partial response (PR), while 3 patients (11%) had progressive disease (PD); one of the 3 nonresponders achieved a PR after commencing concurrent chemoradiotherapy; therefore, the overall response rate was 93%. The median survival time was 20.2 months and 1- and 2-year survival rates were 69% and 53.2%, respectively. The median progression-free survival (PFS) was 11.8 months, and 1- and 2-year PFS times were 52% and 34.1%, respectively. Neutropenia was the most prevalent hematological toxicity and it was evident as grade 3 in 14 patients (52%). Asthenia was the most prevalent nonhematological toxicity, in 18 patients (67%); esophagitis occurred in 15 patients (56%). No treatment-related deaths (due to sepsis or bleeding) were reported in the study. Irinotecan and cisplatin is considered to be an effective and safe chemotherapeutic regimen when used concurrently with thoracic radiation therapy for the treatment of patients with LD-SCLC.
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