Calais G, Berger C, Descamps P, Chapet S, Reynaud-Bougnoux A, Body G, Bougnoux P, Lansac J, Le Floch O
Centre Hospitalier et Universitaire, Tours, France.
Cancer. 1994 Aug 15;74(4):1283-8. doi: 10.1002/1097-0142(19940815)74:4<1283::aid-cncr2820740417>3.0.co;2-s.
The traditional surgical treatment for operable breast carcinoma larger than 3 cm is mastectomy. To avoid mutilating surgery, the authors administered primary chemotherapy to 158 patients with operable nonmetastatic large breast carcinoma with a TNM classification of T2 greater than 3 cm and T3 with a lymph node status of N0-N1. Conservative treatment was proposed for patients responding to the chemotherapy and whose tumor was reduced to 3 cm or less. The purpose of the study was to evaluate the feasibility and treatment results of this strategy.
The mean patient age was 50.4 years. Eighty-two patients had T2 carcinomas greater than 3 cm, and 76 had T3 carcinoma. Fifty-four tumors were classified as lymph node status N0, and 104 as N1. Mean tumor size was 5.6 cm. Patients were treated with three courses of the NVCF regimen (mitoxantrone, vindesin, cyclophosphamide, and 5-fluorouracil) or the EVCF regimen, in which mitoxantrone was replaced by epirubicin every 4 weeks, and then administered with a radiosurgical combination.
The overall response rate to induction chemotherapy was 60.8% with 20.2% complete tumor regression. Twenty-one percent of the patients experienced grade 3 or 4 chemotherapy toxic effects, which were all acceptable and reversible. Breast-conserving treatment was feasible in 48.7% of patients (77 of 158). Forty-five patients (28.5%) were treated with a radiosurgical combination (tumorectomy plus radiation therapy), whereas 32 (20.2%) were treated with radiotherapy alone (external irradiation and brachytherapy). Other patients were treated with mastectomy. Age, tumor stage, histology, hormonal status, and hormonal receptor rate had no influence on the frequency of the observed regressions. Isolated recurrences occurred in 11 patients, 6 who were treated conservatively and 5 who were treated with mastectomy. Metastatic relapses were observed in 38 patients (14.6% in the chemotherapy responders and 38.7% in the nonresponders) (P < 0.02). Five-year actuarial survival was 73.2% and was significantly higher for responders to the induction treatment.
These preliminary results suggest that primary chemotherapy and radiosurgical breast-conserving treatment is feasible and is an alternative to mastectomy for patients with large operable breast carcinoma who are responders to the induction treatment. The long term benefit of this strategy must be evaluated in well designed controlled trials.
对于直径大于3 cm的可手术乳腺癌，传统的外科治疗方法是乳房切除术。为避免进行致残性手术，作者对158例可手术的非转移性大乳腺癌患者进行了新辅助化疗，这些患者的TNM分期为T2（直径大于3 cm）和T3，淋巴结状态为N0 - N1。对于化疗有反应且肿瘤缩小至3 cm或更小的患者，建议采用保乳治疗。本研究的目的是评估该策略的可行性和治疗效果。
患者的平均年龄为50.4岁。82例患者为直径大于3 cm的T2期癌，76例为T3期癌。54个肿瘤的淋巴结状态为N0，104个为N1。平均肿瘤大小为5.6 cm。患者接受三个疗程的NVCF方案（米托蒽醌、长春地辛、环磷酰胺和5-氟尿嘧啶）或EVCF方案治疗，其中每4周用表柔比星替代米托蒽醌，然后进行手术放疗联合治疗。
诱导化疗的总缓解率为60.8%，肿瘤完全消退率为20.2%。21%的患者出现3级或4级化疗毒性反应，均为可接受且可逆的。48.7%的患者（158例中的77例）可行保乳治疗。45例患者（28.5%）接受了手术放疗联合治疗（肿瘤切除术加放射治疗），而32例（20.2%）仅接受了放疗（外照射和近距离放疗）。其他患者接受了乳房切除术。年龄、肿瘤分期、组织学、激素状态和激素受体率对观察到的缓解频率没有影响。11例患者出现孤立性复发，6例接受保乳治疗，5例接受乳房切除术。38例患者出现远处转移复发（化疗有反应者中为14.6%，无反应者中为38.7%）（P < 0.02）。五年精算生存率为73.2%，诱导治疗有反应者的生存率显著更高。
这些初步结果表明，新辅助化疗和手术放疗保乳治疗对于诱导治疗有反应的可手术大乳腺癌患者是可行的，是乳房切除术的一种替代方法。该策略的长期益处必须在设计良好的对照试验中进行评估。
