Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Hospital, 1198 Guwol-dong, Namdong-gu, Incheon 405-760, Korea.
Med Oncol. 2011 Mar;28(1):342-50. doi: 10.1007/s12032-010-9453-z. Epub 2010 Mar 3.
This study was designed to evaluate the efficacy and safety of irinotecan in combination with carboplatin in previously untreated, extensive-disease small-cell lung cancer (ED-SCLC). Patients with histologically or cytologically confirmed ED-SCLC received irinotecan (60 mg/m(2) on days 1, 8, and 15) plus carboplatin (AUC 5 on day 1) every 4 weeks. Treatment was repeated until disease progression, unacceptable toxicity, or up to 6 cycles. Forty-four patients were enrolled. In an intent-to-treat analysis, the overall response rate (RR) was 75% (8 complete responses and 25 partial responses). The median progression-free (PFS) and overall survival (OS) were 5.6 and 8.7 months, respectively. The principle toxicities were neutropenia and diarrhea. Grade 3-4 neutropenia occurred in 30% of the patients and 7% of patients presented with febrile neutropenia. Grade 3-4 diarrhea occurred in 21% of the patients. A subgroup consisting of patients ≥ 65 years of age had outcomes similar to the younger group <65 years of age. The objective RR was 72% in the patients <65 years of age and 77% in the patients ≥ 65 years of age (P = .738). The median PFS and OS (<65 years vs. ≥ 65 years) were 5.3 vs. 5.6 months (P = .835) and 9.0 vs. 8.7 months (P = .648), respectively. The combination of irinotecan and carboplatin is active and tolerable in patients with ED-SCLC. This regimen could be considered as a treatment option for patients of advanced age.
这项研究旨在评估伊立替康联合卡铂治疗未经治疗的广泛期小细胞肺癌（ED-SCLC）的疗效和安全性。组织学或细胞学证实为 ED-SCLC 的患者接受伊立替康（第 1、8 和 15 天 60mg/m²）联合卡铂（第 1 天 AUC 5），每 4 周重复一次，直至疾病进展、不可接受的毒性或最多 6 个周期。共纳入 44 例患者。意向治疗分析中，总缓解率（RR）为 75%（8 例完全缓解和 25 例部分缓解）。中位无进展生存期（PFS）和总生存期（OS）分别为 5.6 个月和 8.7 个月。主要毒性为中性粒细胞减少和腹泻。30%的患者发生 3-4 级中性粒细胞减少，7%的患者发生发热性中性粒细胞减少。21%的患者发生 3-4 级腹泻。年龄≥65 岁的患者亚组与<65 岁的年轻组具有相似的结局。<65 岁患者的客观 RR 为 72%，≥65 岁患者的 RR 为 77%（P =.738）。<65 岁患者的中位 PFS 和 OS（5.3 个月比 5.6 个月；P =.835）和≥65 岁患者的中位 PFS 和 OS（9.0 个月比 8.7 个月；P =.648）。伊立替康联合卡铂在 ED-SCLC 患者中具有活性且可耐受。该方案可作为老年患者的治疗选择之一。
