The Breast Cancer Alternative Hypothesis

After nearly 50 years of research by one of us (B.F.) that provided scientific justification for replacing the Halstedian hypothesis, it was disheartening to read the editorial by Rabinovitch and Kavanagh entitled, “Double Helix of Breast Cancer Therapy: Intertwining the Halsted and Fisher Hypotheses,” which appeared in the Journal of Clinical Oncology. The idea that the Halsted and the Fisher hypotheses can be “intertwined” is unwarranted. Halsted’s hypothesis was based on empiricism, and his operation was governed by anatomic and mechanistic principles.

In contrast, the Fisher alternative thesis was the product of laboratory investigation and was supported by results obtained from a series of randomized clinical trials. Moreover, Halsted was attracted to concepts of tumor biology that were formulated by others during the 19th century and that were subsequently disproven, mainly as a result of the studies conducted by Fisher during the last 40 years of the 20th century.

Despite those circumstances, however, Rabinovitch and Kavanagh opine that there is “a need to re-evaluate the Fisher hypothesis and consider bringing Halsted back into view,” and that it “... might be that the place in which we now find ourselves is a place we may have been before” (one assumes, at the time of Halsted).

Has new, credible biologic and clinical information been obtained that would provide justification for rejecting the Fisher hypothesis and accepting Rabinovitch and Kavanagh’s thesis, or is their view the result of empirical thought? If the former, then it behooves them to make available the information that supports their position. If the latter, their thesis does a disservice to women with breast cancer and, moreover, repudiates science. Considering a return to “Halstedianism” without scientifically based evidence for doing so would result in therapeutic chaos similar to that which existed before the end of the Halstedian era.

In the Rabinovitch editorial, the authors “rewrite history” by presenting, decades after the fact, their perception of our thoughts and actions with regard to the research and treatment of breast cancer. They also misquote or misinterpret statements that they have taken from several of our previously published articles and, in some cases, they have omitted important details that accompany those statements. To preserve the accuracy of that part of breast cancer history to which we have made contributions, it is necessary that we set the record straight. Another aim of this commentary is to report on the current status of the Fisher alternative hypothesis. That thesis, which was formulated several decades ago, resulted in rejection of the Halstedian paradigm that governed breast cancer surgery for most of the 20th century.

In Rabinovitch and Kavanagh’s editorial, the authors infer that we have failed to both recognize the significance of locoregional tumor recurrence and to appreciate the need for the prevention and treatment of such recurrences. They imply that, as a consequence, the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-06 clinical trial, which provided the first data to justify the use of lumpectomy for the treatment of breast cancer, was flawed in both design and conduct. That notion is without basis in fact. Indeed, the idea that we have been indifferent to local disease control can be refuted by an examination of a few excerpts from some of our publications. We have stated that:

  • “Improper surgery, improper radiation therapy, along with inadequate backup systems, such as pathology, will destroy the credibility of breast conservation.”
  • “It continues to remain NSABP policy, however, that all patients treated by lumpectomy have tumor-free specimen margins. It is also our opinion that in no circumstance is there justification for surgeons to not make every effort to obtain tumor-free [specimen] margins. Nor is it justifiable for a radiation oncologist to dismiss the importance of free margins because ‘radiation therapy will take care of it.’ It is to be emphasized that abandonment of Halstedian principles of cancer surgery does not imply that sloppy surgery can be condoned.”
  • “[We have] emphasized the need for close interrelationships among surgeons, pathologists, and radiation and medical oncologists when a lumpectomy is performed. Orchestration of the event is more complex than that which is necessary for a mastectomy. When a surgeon makes the decision that a lumpectomy is appropriate, he or she must appreciate that a patient’s outcome is apt to depend on the surgeon’s skills as well as those that the other members of the ‘team’ possess.”

A more careful reading of our article on the subject of advances in the treatment of breast cancer, which was published in 1999, and which is cited as reference number 2 in the Rabinovitch editorial, would have led the authors to better understand our position with regard to the prevention of locoregional recurrence. The following statements appeared in that article:

* “... I [B.F.] do not dismiss the idea that all efforts should be made to prevent local-regional tumour. ... the treatment of breast cancer was governed by two independent paradigms, one concerned with eradicating local manifestations of the disease without compromising prospects for cure. ... “

Furthermore, because Rabinovitch and Kavanagh cite no references for their erroneous assertion that, “Local recurrences [in the B-06 trial] were not considered potential sources of subsequent metastatic spread,”  this comment is their impression of our position, rather than an actual statement of fact. Although we have maintained that, “IBTR [ipsilateral breast tumor recurrence] proved to be a powerful independent predictor of distant disease,”  never have we either stated or implied that the presence of an IBTR could not be a potential source of distant disease.

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