对于淋巴结阳性的乳腺癌患者，采用环磷酰胺、阿霉素和5-氟尿嘧啶（CAF）进行辅助化学激素治疗，同时或不同时使用醋酸甲羟孕酮。

Adjuvant chemohormonal therapy with cyclophosphamide, doxorubicin and 5-fluorouracil (CAF) with or without medroxyprogesterone acetate for node-positive breast cancer patients.

作者信息

Hupperets P S, Wils J, Volovics L, Schouten L, Fickers M, Bron H, Schouten H C, Jager J, Smeets J, de Jong J

机构信息

Department of Internal Medicine, Academic Hospital Maastricht, The Netherlands.

出版信息

Ann Oncol. 1993 Apr;4(4):295-301. doi: 10.1093/oxfordjournals.annonc.a058485.

DOI:10.1093/oxfordjournals.annonc.a058485

PMID:8518219

Abstract

BACKGROUND

The Comprehensive Cancer Center trial 82-01 is a prospective randomized study to investigate the value of the addition of high-dose medroxyprogesterone acetate (MPA) to chemotherapy in patients with node-positive operable breast cancer. MPA may be of advantage in this setting because of its activity in estrogen receptor ER-positive as well as ER-negative tumors and since it may protect against chemotherapy-induced myelosuppression and thus enable maintenance of the appropriate chemotherapeutic scheduling.

PATIENTS AND METHODS

Four hundred eight evaluable patients with node-positive (N+) operable breast cancer (T1-3, N1) were entered in a multicenter randomized trial. Two hundred nine patients were randomized in the MPA- arm and 199 in the MPA+ arm. CAF chemotherapy was given as a short i.v. bolus infusion: cyclophosphamide 500 mg/m2 i.v. day 1, doxorubicin 40 mg/m2 i.v. day 1, and 5-fluorouracil 500 mg/m2 i.v. day 1, q 4 wks x 6. MPA was given intramuscularly (i.m.) 500 mg q d x 28 days, followed by 500 mg i.m. twice weekly during 5 months.

RESULTS

The main side effects of MPA were weight gain with a mean of 5.5 kg as opposed to 1.8 kg in the control group (p = 0.01) and vaginal bleeding in 30/199 in the MPA+ group and 0 in the MPA- group. MPA ameliorated vomiting grade III, IV (45% vs. 28%, p < 0.001), nausea grade III, IV (50% vs. 34%, p < 0.001) and leucocyte nadir grade III, IV (20% vs. 11%, p = 0.003). Disease-free survival (DFS) after 5 years was 59% in the MPA+ and 49% in the MPA- group (p = 0.12). Patients > or = 60 years benefitted most from MPA treatment, in particular if freedom from distant metastases was taken as the endpoint (p = 0.02). Overall survival (OS) was not significantly different between the two treatment groups (p = 0.18), but within subgroups analysed there was an advantage for MPA+ in patients > or = 55 years (p = 0.002) and in pT1 patients (p = 0.045).

CONCLUSIONS

High-dose MPA ameliorates CAF side effects and reduces the risk of metastatic disease, especially in elderly breast cancer patients.

摘要

背景

综合癌症中心试验82 - 01是一项前瞻性随机研究，旨在探讨在可手术的淋巴结阳性乳腺癌患者中，化疗联合大剂量醋酸甲羟孕酮（MPA）的价值。MPA在这种情况下可能具有优势，因为它对雌激素受体（ER）阳性和ER阴性肿瘤均有活性，并且可能预防化疗引起的骨髓抑制，从而能够维持适当的化疗方案。

患者与方法

408例可评估的淋巴结阳性（N +）可手术乳腺癌（T1 - 3，N1）患者进入一项多中心随机试验。209例患者被随机分配至MPA -组，199例患者被分配至MPA +组。CAF化疗采用短时间静脉推注：环磷酰胺500 mg/m²静脉注射第1天，多柔比星40 mg/m²静脉注射第1天，5 -氟尿嘧啶500 mg/m²静脉注射第1天，每4周重复1次，共6次。MPA采用肌肉注射，500 mg每日1次，共28天，随后在5个月内每周2次，每次500 mg肌肉注射。

结果

MPA的主要副作用是体重增加，平均增加5.5 kg，而对照组为1.8 kg（p = 0.01），MPA +组199例中有30例出现阴道出血，MPA -组无阴道出血。MPA改善了III、IV级呕吐（45%对28%，p < 0.001）、III、IV级恶心（50%对34%，p < 0.001）以及III、IV级白细胞最低点（20%对11%，p = 0.003）。5年后无病生存率（DFS）在MPA +组为59%，在MPA -组为49%（p = 0.12）。年龄≥60岁的患者从MPA治疗中获益最大，特别是以无远处转移作为终点时（p = 0.02）。两组治疗组的总生存期（OS）无显著差异（p = 0.18），但在分析的亚组中，MPA +组在年龄≥55岁的患者（p = 0.002）和pT1患者中具有优势（p = 0.045）。