Comparison of radical mastectomy with alternative treatments for primary breast cancer: A first report of results from a prospective randomized clinical trial

Bernard Fisher, Eleanor Montague, Carol Redmond, Bruce Barton, Donna Borland, Edwin R. Fisher, Melvin Deutsch, George Schwarz, Richard Margolese, William Donegan, Herbert Volk, Carl Konvolinka, Bernard Gardner, Isidore Cohn, Gerson Lesnick, Anatolio B. Cruz, Walter Lawrence, Thomas Nealon, Harvey Butcher, Richard LawtonOther Nsabp Investigators

Research output: Contribution to journalArticlepeer-review

323 Scopus citations


In 1971, the National Surgical Adjuvant Breast Project (NSABP) implemented a prospective randomized clinical trial to compare the worth of alternative treatments with radical mastectomy in women with primary operable breast cancer. Information has been obtained from 1,665 patients eligible for follow‐up from 34 NSABP member institutions in Canada and the United States. Results from that trial, at present in its sixth year with patients on study for an average of 36 months, (26 to 62 months), fail to demonstrate an advantage for those who had a radical mastectomy. No significant difference in the treatment failure or survival has as yet been observed in clinically negative node patients who have been randomly managed by conventional radical mastectomy, total mastectomy with postoperative regional radiation or total mastectomy followed by axillary dissection of those patients who subsequently develop positive nodes. Similarly, there presently exists no difference between patients with clinically positive nodes treated by radical mastectomy or by total mastectomy followed by radiation. Of particular interest is the observation that based upon findings from radical mastectomy patients, there may be as many as 40% of patients having a total mastectomy who had histologically positive nodes unremoved, to date only 15% have developed positive nodes requiring an axillary dissection. The persistence of such a difference in incidence would have profound biological significance. The discovery that leaving behind positive axillary nodes has as yet not been influential in enhancing the incidence of distant metastases or the overall proportion of treatment failures and that a disproportionate number of treatment failures in the total mastectomy group occurred in those patients who subsequently required axillary dissection provides reinforcement to the view that positive axillary lymph nodes are not the predecessor of distant tumor spread but are a manifestation of disseminated disease.

Original languageEnglish (US)
Pages (from-to)2827-2839
Number of pages13
Issue number6
StatePublished - Jun 1977
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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