中国乳腺癌保乳治疗的前瞻性多中心研究

A prospective multicenter clinical trial of breast conserving therapy for early breast cancer in China

目的探讨早期乳腺癌保乳治疗的可行性,以及我国开展保乳综合治疗的模式。方法中国医学科学院中国协和医科大学肿瘤医院等全国共10家三级甲等医院协作,进行早期乳腺癌保乳治疗与切除乳房治疗的大样本前瞻性多中心对照研究。结果完成保乳手术872例,占符合保乳治疗条件乳腺癌患者的19.5%,占同期全部可手术乳腺癌患者的9.0%。保乳治疗组复发9例(1.0%),远处转移11例(1.3%),死亡1例(0.1%);切除乳房组复发18例(0.5%),远处转移49例(1.4%),死亡4例(0.1%)。两组术后局部复发率、远处转移率与死亡率差异无统计学意义(P均>0.05)。保乳治疗乳房美容效果评估优、良者术后6个月占89.7%,术后1年占91.1%,术后2年占86.6%。结论保乳治疗在中国是可行的,对早期乳腺癌患者的生存率、复发率无负面影响,提高了患者的生活质量。保乳治疗必须严格把握手术适应证,需要多学科的有机配合,综合治疗是保乳治疗成功的保证。

Objective To demonstrate the feasibility of breast conserving therapy （BCT） and establish a multimodality BCT model for early breast cancer in China. Methods A prospective multicenter case control study consisting of 4461 patients was carried out by the Cancer Hospital, Chinese Academy of Medical Sciences （CAMS） and nine other hospitals across China from November, 2001 to November, 2004, the result of BCT and mastectomy on early stage breast cancer were compared. Patients entry-primary tumor ≤3 cm, primary tumor in periphery quadrant, pathology showed infiltrating carcinoma and clinical absence of locoregional lymphtic or distant metastasis. Patients rejection-multiple center cancer or diffused malignant calcified spots, previous radical radiation therapy in the chest, accompanying collogenolytic vascular granuloma and simultaneous pregnancy. Results Of these 4461 patients, breast conserving surgery was performed in 872 （ 19, 5 % ） patients who were eligible for BCT, accounting for 9.0% of all operated breast cancer patients during the same period. The rates of local recurrence, metastasis and death were 1.0% （9/ 872）, 1.3% （11/872） and0.1% （1/872） inBCTgroup, versus0.5% （18/3589）, 1.4% （49/3589） and 0.1% （4/3589） in the mastectomy group. No statistical significant difference was found between these two groups （P 〉 0.05 ）. Cosmetic evaluation of breast in BCT group was carried out postoperativly at points of six months, one year and two years wth 89.7%, 91. 1% and 86.6% of the patients assessed as excellent or fine cosmetic state respectively. Conclusion Breast conserving therapy for early stage breast cancer is feasible in China, with no ominous effect on the survival and recurrence rate. Breast conserving therapy is able to improve not only the quality of life but also enhance the confidence of the patients, in addition to quasi-perfect cosmetic results. Standard comprehensive BCT involving multi-centers all concentrating on combination treatment should be widely adopted in China in the future. However, breast conserving surgery should selectively be used only for early stage breast cancer, and should be combined with postoperativeradiotherapy, chernotherapy and hormone therapy in order to guarantee success.