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Randomized trial comparing neo‐adjuvant versus adjuvant chemotherapy in operable locally advanced breast cancer (T4b N0‐2 M0)
Author(s) -
Deo S.V.S.,
Bhutani Manisha,
Shukla Nootan K.,
Raina Vinod,
Rath Goura K.,
Purkayasth Joydeep
Publication year - 2003
Publication title -
journal of surgical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.201
H-Index - 111
eISSN - 1096-9098
pISSN - 0022-4790
DOI - 10.1002/jso.10323
Subject(s) - medicine , breast cancer , chemotherapy , axilla , adjuvant , randomized controlled trial , oncology , radiation therapy , inflammatory breast cancer , surgery , cancer
Background and Objectives Locally advanced breast cancer (LABC) remains a major problem in developing countries. While trials utilizing neo‐adjuvant chemotherapy demonstrate superior survival rates compared to historic controls, randomized studies evaluating the precise role of neo‐adjuvant chemotherapy in LABC are lacking. In the present trial, neo‐adjuvant chemotherapy was compared against adjuvant chemotherapy to assess survival advantage in operable T4b N0‐2 M0 breast cancer. Methods A total of 101 women with operable LABC (T4b N0‐2 M0) were randomized. In arm A, 50 patients received 3 cycles of CEF chemotherapy before and 3 cycles following surgery. In arm B, 51 patients had primary surgery followed by 6 cycles of CEF chemotherapy. In both arms, loco‐regional radiotherapy was given after completion of CEF. Results The response of primary tumor to neo‐adjuvant chemotherapy was 66%, complete response (CR) 14% and partial response (PR) 52%. Clinical nodal response occurred in 95% of node positive patients. Only two (4%) patients had pathologic CR both in tumor and axilla. There was a significant ( P = 0.02) increase in incidence of pathologically negative nodes in arm A. At a median follow up of 25 months, there was no significant difference in overall and disease free survival (DFS) in both arms ( P = 0.42 and 0.18). Patients showing a response to neo‐adjuvant chemotherapy had better DFS ( P = 0.04) compared to those who had no response. Conclusions Early results of the study indicate no survival benefit with the inclusion of neo‐adjuvant chemotherapy in LABC (T4b N0‐2 M0). Neo‐adjuvant chemotherapy resulted in significant down staging; good responders had a better DFS compared to those who did not respond. J. Surg. Oncol. 2003;84:192–197. © 2003 Wiley‐Liss, Inc.