👉The NSABP B-04, A Protocol for the Evaluation of Radical Mastectomy (RM) and Total Mastectomy (TM) With and Without Radiation in the Primary Treatment of Cancer of the Female Breast.
👉It enrolled 1079 patients with clinically node-negative disease, and randomized them to RM, TM plus local-regional axillary irradiation, or TM alone.
👉In a parallel trial, 586 patients with clinically node-positive disease were randomized to RM or TM plus radiation.
👉After 25 years of follow-up, the study showed no significant difference in long-term outcome between clinically node-negative patients who received RM and those who received TM plus radiation, or between clinically node-positive patients who received RM and those who received TM with nodal irradiation.
👉When comparing the hazard ratio for death within the two arms, the results show no survival advantage from RM.
👉In patients with clinically node-negative disease, pathologic examination of the mastectomy specimen revealed that 40% of the patients had pathologically positive nodes.
👉However, because the axillary failure rate in the TM alone arm was only 19%, we are led to conclude that occult axillary disease may not always progress into clinically overt disease.
👉The similar overall survival (OS) among the three arms in this trial also indicates that an axillary dissection in this trial would be largely prophylactic, and the outcome would not be compromised should the dissection be deferred until there is clinical evidence of a diseased axilla.
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