Sohn Joo Hyuk, Moon Yong Wha, Lee Chang Geol, Kim Gwi Eon, Chung Kyung Young, Chang Joon, Kim Se Kyu, Kim Young Sam, Choi Byoung Wook, Choi Hye Jin, Kim Joo-Hang
Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Cancer. 2007 May 1;109(9):1845-950. doi: 10.1002/cncr.22621.
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.
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).
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.
IP with early concurrent radiotherapy was effective and tolerable in untreated LD-SCLC.
开展了一项伊立替康和顺铂（IP）联合早期同步放疗治疗局限期小细胞肺癌（LD-SCLC）的II期试验，以评估疗效和毒性。
对于未经治疗的LD-SCLC患者，伊立替康（60mg/m²，第1、8和15天）和顺铂（40mg/m²，第1和8天）每4周重复一次，最多6个周期。在第二个化疗周期的第1天开始进行每天1.8Gy的胸部放疗，总量达45至54Gy。对完全缓解（CR）的患者进行预防性颅脑照射（30Gy，分10次）。
纳入33例LD-SCLC患者。中位年龄为60岁，31例患者东部肿瘤协作组（ECOG）体能状态为0至1。12例（36.4%）患者有N3期疾病。缓解率为87.9%，CR率为45.5%。中位随访期为27个月时，中位无进展生存期（PFS）和总生存期（OS）分别为14.4个月和26.1个月，2年PFS率和OS率分别为26.8%和54.9%。主要毒性为中性粒细胞减少，3-5级发生率为81.8%。最常见的3-5级非血液学毒性为腹泻（21.2%）、厌食（21.2%）和疲劳（21.2%）。3-5级放射性食管炎和肺炎分别发生在18.2%和9.1%的患者中。有2例因败血症和放射性肺炎导致的治疗相关死亡。
IP联合早期同步放疗在未经治疗的LD-SCLC中有效且耐受性良好。
