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

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 < or = 3 cm, primary tumor in periphery quadrant, pathology showed infiltrating carcinoma and clinical absence of locoregional lymphatic 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) and 0.1% (1/872) in BCT group, versus 0.5% (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 postoperatively at points of six months, one year and two years with 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 postoperative radiotherapy, chemotherapy and hormone therapy in order to guarantee success.