顺铂与5-氟尿嘧啶（PF）以及丝裂霉素C、长春新碱、顺铂与5-氟尿嘧啶（MVPF）用于转移性大肠癌患者的II期研究：一项东部肿瘤协作组研究（EST 1285）

Phase II study of cisplatin and 5-fluorouracil (PF) and mitomycin C, vincristine, cisplatin and 5-fluorouracil (MVPF) in patients with metastatic large bowel cancer: an Eastern Cooperative Oncology Group study (EST 1285).

作者信息

Pandya Kishan J, Lefkopoulou Myrto, Petrelli Nicholas J, Vaughn David J, Smith Thomas J, Harris Jules E, Haller Daniel G

机构信息

University of Rochester Cancer Center, Rochester, NY 14642, USA.

出版信息

Oncology. 2004;66(2):118-25. doi: 10.1159/000077437.

DOI:10.1159/000077437

PMID:15138363

Abstract

PURPOSE

To compare the efficacy and the toxicity of cisplatin and 5-fluorouracil (PF) and mitomycin C, vincristine, cisplatin and 5-fluorouracil (MVPF) in patients with metastatic large bowel cancer.

PATIENTS AND METHODS

A total of 94 patients with no prior chemotherapy and measurable metastatic large bowel cancer were randomly assigned to one of the two treatment regimens. Eastern Cooperative Oncology Group (ECOG) criteria were used to evaluate response and toxicity.

RESULTS

Fifty patients were randomized to PF and 44 to MVPF. Toxicity was evaluable in all patients except one; response was evaluable in 40 and 31, with response rate of 13 and 42%, respectively. Intent-to-treat analysis showed a response rate of 12 and 32%, respectively (p = 0.076), where it was assumed that none of the ineligible or unevaluable patients responded. Median survival for all patients was 9 months, with no difference between PF and MVPF. ECOG Performance Status (0 vs. 1), weight loss (< or =10 vs. >10%) and site of metastatic lesion had statistically significant impact on survival. MVPF was definitely more toxic than PF (p < 0.000005).

CONCLUSION

Both treatment regimens showed clinical activity. The MVPF regimen resulted in more responses than PF, no improvement in survival, and more toxicity.

摘要

目的

比较顺铂与5-氟尿嘧啶（PF）方案和丝裂霉素C、长春新碱、顺铂与5-氟尿嘧啶（MVPF）方案治疗转移性大肠癌患者的疗效和毒性。

患者与方法

共有94例未接受过化疗且有可测量转移性大肠癌的患者被随机分配至两种治疗方案之一。采用东部肿瘤协作组（ECOG）标准评估疗效和毒性。

结果

50例患者被随机分配至PF方案组，44例被分配至MVPF方案组。除1例患者外，所有患者的毒性均可评估；40例和31例患者的疗效可评估，有效率分别为13%和42%。意向性分析显示有效率分别为12%和32%（p = 0.076），假设所有不符合条件或无法评估的患者均未缓解。所有患者的中位生存期为9个月，PF方案组和MVPF方案组之间无差异。ECOG体能状态（0 vs. 1）、体重减轻（≤10% vs. >10%）和转移病灶部位对生存期有统计学显著影响。MVPF方案的毒性肯定比PF方案更大（p < 0.000005）。