丝裂霉素C加长春地辛加依托泊苷（MEV）与丝裂霉素C加长春地辛加顺铂（MVP）治疗IV期非小细胞肺癌的III期多中心随机试验。“中南岛屿肿瘤协作组”（G.O.C.S.I.）

Mitomycin C plus vindesine plus etoposide (MEV) versus mitomycin C plus vindesine plus cisplatin (MVP) in stage IV non-small-cell lung cancer: A phase III multicentre randomised trial. The "Gruppo Oncologico Centro-Sud-Isole' (G.O.C.S.I.).

作者信息

Gridelli C, Perrone F, Palmeri S, D'Aprile M, Cognetti F, Rossi A, Gebbia V, Pepe R, Veltri E, Airoma G, Russo A, Incoronato P, Scinto A F, Palazzolo G, Natali M, Leonardi V, Gallo C, De Placido S, Bianco A R

机构信息

Divisione di Oncologia Medica B, Istituto Nazionale Tumori G. Pascale, Napoli, Italy.

出版信息

Ann Oncol. 1996 Oct;7(8):821-6. doi: 10.1093/oxfordjournals.annonc.a010761.

DOI:10.1093/oxfordjournals.annonc.a010761

PMID:8922196

Abstract

PURPOSE

To compare mitomycin C plus vindesine plus etoposide (MEV) vs. mitomycin C plus vindesine plus cisplatin (MVP) in the treatment of stage IV non-small-cell lung cancer.

PATIENTS AND METHODS

204 patients were entered in a phase III multicentre randomised trial from June 1990 to December 1994 and stratified according to the ECOG performance status (0-1 vs. 2). MVP was given in the following dosages: mitomycin C 8 mg/m2+vindesine 3 mg/m2+cisplatin 100 mg/m2 i.v. day 1 and vindesine 3 mg/m2 i.v. day 8 with cycles repeated every 4 weeks. MEV was given in the following dosages: mitomycin C 8 mg/m2+vindesine 3 mg/ m2 i.v. day 1 and etoposide 100 mg/m2 i.v. days 1 to 3 with cycles repeated every 3 weeks. For both treatments a maximum of 6 cycles was planned. Response and toxicity were evaluated according to WHO. Subjective responses were assessed by numerical scales. Analyses were made on the basis of intent to treat.

RESULTS

The objective response rate was 21.4% (1 CR + 21 PR among 103 patients) in the MEV and 28.7% (1 CR + 28 PR among 101 patients) in the MVP arm (P = 0.48). Symptoms were similar in the two arms. 196 patients progressed and 182 died. The median times to progression were 10 weeks (95% CI 9-12) and 12 weeks (95% CI 10-15) and median survivals were 29 weeks (95% CI 25-36) and 28 weeks (95% CI 25-35) in the MEV and MVP arms, respectively. The relative risks of progressing and of dying were 0.89 (95% CL 0.66-1.20) and 0.96 (95% CL 0.71-1.30), respectively, for patients receiving MVP as compared with those receiving MEV at multivariate analysis adjusted by sex, age, histologic type, number of metastatic sites, performance status at entry, and centre.

CONCLUSIONS

In the present study, no significant differences were observed in response rate, survival or palliation of symptoms between the MEV and MVP regimens, while toxicity was significantly more frequent and severe with MVP. Thus, MEV should be considered a reasonable alternative to the MVP regimen in the treatment of stage IV NSCLC.

摘要

目的

比较丝裂霉素C加长春地辛加依托泊苷（MEV）与丝裂霉素C加长春地辛加顺铂（MVP）治疗IV期非小细胞肺癌的疗效。

患者与方法

1990年6月至1994年12月，204例患者进入一项III期多中心随机试验，并根据东部肿瘤协作组（ECOG）体能状态（0 - 1对比2）进行分层。MVP的给药剂量如下：丝裂霉素C 8 mg/m²、长春地辛3 mg/m²、顺铂100 mg/m²静脉滴注，第1天给药，长春地辛3 mg/m²静脉滴注，第8天给药，每4周重复1个周期。MEV的给药剂量如下：丝裂霉素C 8 mg/m²、长春地辛3 mg/m²静脉滴注，第1天给药，依托泊苷100 mg/m²静脉滴注，第1至3天给药，每3周重复1个周期。两种治疗方案均计划最多进行6个周期。根据世界卫生组织（WHO）标准评估疗效和毒性。主观反应采用数字评分法进行评估。分析基于意向性治疗原则。

结果

MEV组的客观缓解率为21.4%（103例患者中1例完全缓解 + 21例部分缓解），MVP组为28.7%（101例患者中1例完全缓解 + 28例部分缓解）（P = 0.48）。两组症状相似。196例患者病情进展，182例死亡。MEV组和MVP组的中位进展时间分别为10周（95%可信区间9 - 12）和12周（95%可信区间10 - 15），中位生存期分别为29周（95%可信区间25 - 三十六）和28周（95%可信区间25 - 35）。在根据性别、年龄、组织学类型、转移部位数量、入组时的体能状态和中心进行多因素分析调整后，接受MVP治疗的患者与接受MEV治疗的患者相比，进展和死亡的相对风险分别为0.89（95%可信区间0.66 - 1.20）和0.96（95%可信区间0.71 - 1.30）。