Prospective randomized clinical trial of primary treatment in breast cancer stages T3/4, N+/-, MO. Chemotherapy vs. radiotherapy. Arbeitskreis für Perioperative Chemotherapie.
209 patients entered a randomized trial. We compared a) pre- and postoperative chemotherapy (= treatment A) [5-drug combination chemotherapy+tamoxifen] versus b) pre- and postoperative radiotherapy (= treatment B). Nonresponders to preoperative chemotherapy were << crossed over >> to postoperative radiotherapy. The study was started in 1983. We now report on 8 years of results. The reduction in tumor size following preoperative treatment was comparable in both legs of the study. No differences were seen with regard to the response of patients with primary tumors or axillary lymph node involvement. Remission rates for treatments A and B were around 60%. In isolated cases the extent of mastectomy could be reduced as a result of preoperative treatments (breast conserving surgery was done in selected cases). While the initially large tumor size often defied even an extended radical operation, the tumor reduction achieved by prior treatment permitted the removal of macroscopically visible tumor tissue by radical surgery using Rotter's procedure. Relapse-free survival (RFS) and overall survival (OAS) on chemotherapy (N = 76) proved to be significantly superior in treatment A (chemotherapy) compared to B (radiotherapy) (N = 75) [(p for A:B RFS = 0.018) (p for A:B OAS = 0.047)]. RFS for << responders >> to chemotherapy was 65% (N = 47) and only 20% (N = 29) for non-responders (p responders vs. non-responder = 0.005). OAS for responders in group A was 79%, and for non-responders 24% (p = 0.005). OAS in group B (radiotherapy) was only 25%. (p A:B = 0.047).
Rainer
H
H
Medizinische Univ. Klinik I, Wien, Austria.
D001943:Breast Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D002277:Carcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D011446:Prospective Studies; D016019:Survival Analysis