A reduction in the requirements for mastectomy in a randomized trial of neoadjuvant chemoendocrine therapy in primary breast cancer
A reduction in the requirements for mastectomy in a randomized trial of neoadjuvant chemoendocrine therapy in primary breast cancer
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DOI：
10.1023/a:1008400706949
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发表时间：
1998-11-01
影响因子：
50.5
通讯作者：
Ford, HT
中科院分区：
文献类型：
--
作者：
Makris, A;Powles, TJ;Ford, HT
背景资料：我们进行了一项前瞻性随机试验，以评估手术前新辅助化疗内分泌治疗在原发性可手术乳腺癌患者中的作用。本研究招募了309名经细针穿刺（FNA）细胞学证实的原发性可手术乳腺癌女性（中位年龄56岁，范围27-70岁）。他们用米托蒽醌和甲氨蝶呤（+/-丝裂霉素-C）联合他莫昔芬（2 MT）治疗。患者接受8个周期的2 MT（新辅助治疗组手术前4个周期）和他莫昔芬治疗5年，并进行适当的手术和放疗。两组在年龄、绝经状态、分期和手术要求方面具有可比性。对新辅助治疗的临床应答率如下：22%完全应答（CR），29%微小残留病（MRD），33%部分应答（PR），15%无变化（NC），仅2例患者有疾病进展的临床证据。手术需求从辅助组的31名乳房切除术患者（22%）减少到新辅助组的14名（10%）（P < 0.003）。在中位随访48个月（范围10-70个月）时，两组在局部复发、转移性复发或总生存期方面无统计学显著差异。辅助治疗和新辅助治疗的症状和血液学急性毒性较低且相似。这项随机试验显示，新辅助化疗内分泌治疗后，乳房切除术的手术要求显著降低，局部或远端复发无恶化。
Background: A prospective randomised trial was undertaken to evaluate the role of neoadjuvant chemoendocrine therapy prior to surgery in primary operable breast cancer.Patients and methods. Three hundred nine women (median age 56 years, range 27-70) with primary operable breast cancer confirmed on fine needle aspiration (FNA) cytology were recruited to this study. They were treated with a combination of mitozantrone and methotrexate (+/- mitomycin-C) combined with tamoxifen (2MT). Patients received eight cycles of 2MT (four prior to surgery in the neoadjuvant group) and tamoxifen for five years with appropriate surgery and radiotherapy. The two groups were comparable for age, menopausal status, stage and surgical requirements.Results. The clinical response rates to neoadjuvant therapy were as follows: 22% complete response (CR), 29% minimal residual disease (MRD), 33% partial response (PR), 15% no change (NC) and only two patients had clinical evidence of progressive disease. Surgical requirements were reduced from 31 patients (22%) of the adjuvant group having mastectomy to 14 (10%) in the neoadjuvant group (P < 0.003). At a median follow-up of 48 months (range 10-70 months) there is no statistically significant difference between the two groups in terms of local relapse, metastatic relapse or overall survival. Symptomatic and haematologic acute toxicity was low and similar for adjuvant and neoadjuvant therapy.Conclusion. This randomised trial has shown a significant reduction in the surgical requirements for mastectomy, after treatment with neoadjuvant chemoendocrine therapy with no deterioration in local or distal relapse.