顺铂、异环磷酰胺和伊立替康联合重组人粒细胞集落刺激因子（rhG-CSF）支持治疗Ⅲb期和Ⅳ期非小细胞肺癌的Ⅱ期研究

Phase II study of cisplatin, ifosfamide, and irinotecan with rhG-CSF support in patients with stage IIIb and IV non-small-cell lung cancer.

作者信息

Fujita A, Ohkubo T, Hoshino H, Takabatake H, Tagaki S, Sekine K, Abe S

机构信息

Division of Respiratory Disease, Minami-ichijo Hospital, South-1 West-13, Chuo-ku, Sapporo 060-0061, Japan.

出版信息

Br J Cancer. 2003 Sep 15;89(6):1008-12. doi: 10.1038/sj.bjc.6601230.

DOI:10.1038/sj.bjc.6601230

PMID:12966417

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2376953/

Abstract

A phase II study of cisplatin, ifosfamide, and irinotecan with recombinant human granulocyte colony stimulating factor (rhG-CSF) support was conducted in previously untreated patients with stage IIIB or IV non-small-cell lung cancer (NSCLC). Between June 1998 and August 2001, 50 patients were registered in this phase II study. Cisplatin (20 mg m(-2)) and ifosfamide (1.5 g m(-2)) were administered on days 1-4 and irinotecan (60 mg m(-2)) was given on days 1, 8, and 15, respectively. This regimen was repeated every 4 weeks. rhG-CSF was administered subcutaneously at a dose of 50 microg m(-2) on days 5-18 except on the days of irinotecan treatment. In total, 49 patients were assessable for toxicity and response and 50 for survival. In all, 33, patients (67.3%; 95% confidence interval 57.4-77.2%) achieved an objective response. The median response duration was 192 days and the median time to progression for 49 patients was 170 days. The median survival time was 540 days with 1- and 2-year survival rates of 63.5 and 30.7%, respectively. Grade 3 or 4 neutropenia and thrombocytopenia developed in 63.3 and 38.8% of the patients, respectively. In conclusion, the combination of cisplatin, ifosfamide, and irinotecan with rhG-CSF support was highly effective for the treatment of stage IIIB or IV NSCLC with acceptable toxicities.

摘要

对先前未经治疗的 IIIB 期或 IV 期非小细胞肺癌（NSCLC）患者进行了一项顺铂、异环磷酰胺和伊立替康联合重组人粒细胞集落刺激因子（rhG-CSF）支持的 II 期研究。1998 年 6 月至 2001 年 8 月期间，50 例患者登记参加了该 II 期研究。顺铂（20 mg m(-2)）和异环磷酰胺（1.5 g m(-2)）于第 1 - 4 天给药，伊立替康（60 mg m(-2)）分别于第 1、8 和 15 天给药。该方案每 4 周重复一次。除伊立替康治疗当天外，rhG-CSF 于第 5 - 18 天以 50 μg m(-2) 的剂量皮下给药。共有 49 例患者可评估毒性和反应，50 例可评估生存情况。总共有 33 例患者（67.3%；95%置信区间 57.4 - 77.2%）获得客观缓解。中位缓解持续时间为 192 天，49 例患者的中位疾病进展时间为 170 天。中位生存时间为 540 天，1 年和 2 年生存率分别为 63.5%和 30.7%。分别有 63.3%和 38.8%的患者发生 3 级或 4 级中性粒细胞减少和血小板减少。总之，顺铂、异环磷酰胺和伊立替康联合 rhG-CSF 支持对治疗 IIIB 期或 IV 期 NSCLC 高效且毒性可接受。