CHICAGO--Because adjuvant systemic chemotherapy has led to real and meaningful improvement in long-term disease-free and overall survival of women with invasive breast cancer, "perhaps the primacy of surgery is not sacrosanct," said David Hyams, MD, executive medical officer of the NSABP, Allegheny General Hospital, Pittsburgh.
"Perhaps we should consider whether surgery should become the adjuvant of more effective systemic management of breast cancer," he added.
Speaking at the Society of Surgical Oncology meeting, Dr. Hyams said that in several clinical trials, "alternative surgical techniques have not resulted in a survival difference" for women with invasive carcinoma of the breast.
In NSABP protocol B18, women with operable breast cancer were randomized to receive surgery followed by chemotherapy--doxorubicin and cyclophosphamide(Drug information on cyclophosphamide), with adjuvant tamoxifen(Drug information on tamoxifen) (Nolvadex) for those over age 50--or chemotherapy first, then surgery. The trial included 1,508 women with cancer in stages T1, T2, or T3 that was palpable and confined to the breast but not fixed.
The 748 women who underwent preoperative chemotherapy had an overall response rate of 79% (35%, complete response, and 44%, partial response), and another 17% had stable disease. Of the 4% whose disease continued to progress after preoperative chemotherapy, all had operable tumors. Moreover, among the patients who had a complete clinical response, 24% showed no signs of tumor on pathologic evaluation, and 11% had only noninvasive cancer.
Preoperative chemotherapy decreased the number of positive nodes present at surgery by 18%, and most women (84%) had 0 to 3 positive nodes at surgery.
There are no data as yet from B18 on the effects of preoperative chemotherapy on disease-free or overall survival, Dr. Hyams said. He nevertheless believes that findings from B18, and from another ongoing trial (B27), could prove that surgery may become adjunctive. "If we can identify those patients who undergo a complete pathologic response, these individuals may not need surgery at all."