Pectasides D, Samantas E, Fountzilas G, Briasoulis E, Kosmidis P, Skarlos D, Dimopoulos M A, Kalofonos H P, Economopoulos T, Syrigos K
Second Department of Internal Medicine-Propaedeutic, Oncology Section, University General Hospital Attikon, Athens, Greece.
Lung Cancer. 2007 Dec;58(3):355-61. doi: 10.1016/j.lungcan.2007.06.027. Epub 2007 Aug 15.
The purpose of this study was to evaluate the efficacy and toxicity of cisplatin, etoposide and irinotecan as first-line treatment in patients with extensive small-cell lung cancer (E-SCLC).
Chemo-naïve adult patients with a performance status (PS) of 0-2 and adequate organ function were eligible. Patients received cisplatin 20mg/m(2) i.v. daily for three consecutive days, etoposide 75mg/m(2) i.v. daily for three consecutive days and irinotecan 120mg/m(2) i.v. on day 2, every 21 days for six to eight cycles. Administration of G-CSF was given in the presence of febrile neutropenia and as a 5-day prophylaxis around the recorded nadir day in patients who developed grades 3-4 neutropenia.
Fifty-six patients were assessable. The median age was 62.2 years; 96.4% had PS 0-1, 33.5% had >3 metastatic sites. The overall response rate was 80.4% with 8 (14.3%) patients achieving a complete response. The median time to tumor progression was 7.8 months [95% confidence interval (CI), 7.1-8.6 months] with a median survival of 15.1 months [95% CI, 9.7-20.5 months] and 1-year survival rate of 56.5%. One patient died from toxicity. Grades 3-4 neutropenia occurred in 37.5% of patients, grades 3-4 thrombocytopenia occurred in 10.9% of patients and 11 (19.6%) patients developed febrile neutropenia. Grades 3-4 non-hematological toxicities were primarily nausea-vomiting 3.6%, diarrhea 7.1% and fatigue 3.6%.
This study strongly suggests that cisplatin, etoposide and irinotecan combination is very effective for the treatment of E-SCLC with good safety profile. The triplet regimen currently seems a promising regimen and has to be further explored in phase III trials.
本研究旨在评估顺铂、依托泊苷和伊立替康作为广泛期小细胞肺癌（E-SCLC）患者一线治疗的疗效和毒性。
符合条件的患者为初治成年患者，其体能状态（PS）为0 - 2且器官功能良好。患者接受顺铂20mg/m²静脉滴注，每日1次，连续3天；依托泊苷75mg/m²静脉滴注，每日1次，连续3天；伊立替康120mg/m²静脉滴注，于第2天给药，每21天为一周期，共进行6至8个周期。对于出现发热性中性粒细胞减少的患者给予G-CSF治疗，对于出现3 - 4级中性粒细胞减少的患者，在记录的最低点日前后给予5天的预防性治疗。
56例患者可评估。中位年龄为62.2岁；96.4%的患者PS为0 - 1，33.5%的患者有超过3个转移部位。总缓解率为80.4%，8例（14.3%）患者达到完全缓解。肿瘤进展的中位时间为7.8个月[95%置信区间（CI），7.1 - 8.6个月]，中位生存期为15.1个月[95% CI，9.7 - 20.5个月]，1年生存率为56.5%。1例患者死于毒性反应。3 - 4级中性粒细胞减少发生在37.5%的患者中，3 - 4级血小板减少发生在10.9%的患者中，11例（19.6%）患者发生发热性中性粒细胞减少。3 - 4级非血液学毒性主要为恶心呕吐3.6%、腹泻7.1%和疲劳3.6%。
本研究强烈提示顺铂、依托泊苷和伊立替康联合方案对E-SCLC的治疗非常有效且安全性良好。目前该三联方案似乎是一种有前景的方案，必须在III期试验中进一步探索。
