Clinical decision-making in the absence of definitive research data

“ Many of us were cautious about the use of tamoxifen in women with node-negative breast cancer in the 1980s and in premenopausal women until about 1995. Subsequently, the Breast Cancer Overview demonstrated that adjuvant tamoxifen was beneficial in those subsets. I am sure I had women die of breast cancer needlessly … if I had only possessed a crystal ball and given them tamoxifen. I feel bad about that, and it has worried me. On the other hand, I did not use high-dose chemotherapy outside the context of a clinical trial even though the data looked promising. Since the randomized trials failed to demonstrate a benefit, I feel good that I did not fast forward the clock and have patients die of leukemia or high-dose-related complications unless they had agreed to be part of a clinical trial. Admittedly, I am cautious and have been for years.”

—Daniel Hayes, MD
University of Michigan
Interview for Breast Cancer Update

The management of patients with breast cancer has always been fraught with challenging decisions. For more than two decades, physicians and patients have struggled with choices in breast conservation, and the emergence of neoadjuvant regimens to downstage tumors has made these decisions even more complex. As noted by Dr Hayes, the controversies surrounding the use of systemic therapy are similarly challenging.

Part of this formidable task is the result of the rapid evolution of breast cancer clinical research, which constantly generates provocative but often inconclusive data. Dan Hayes recapitulates the dilemma — if we move too quickly, our patients may experience morbidity from unnecessary treatment; however, if we act too slowly, we may abrogate an opportunity for a potentially life-saving intervention.

The Miami Breast Cancer Conference — now in its 19th year under the direction of Dr Daniel Osman — has always addressed these controversies directly. For years, using electronic keypad polling, we have posed questions about clinical scenarios and compared answers from attendees and faculty members. For our 2002 meeting, we took this process to a new level and obtained an unrestricted educational grant to allow a nationally recognized polling firm, ReedHaldyMcIntosh, to survey 200 randomly selected medical oncologists and surgeons in December 2001 about dozens of controversial breast cancer management issues, which included many specific case scenarios.

This special supplement documents key results from this survey, answers to the interactive questions posed to the Miami Breast Cancer Conference (MBCC) attendees and select answers f rom our faculty. The comprehensive results are available on the BreastCancerUpdate.com website. It is interesting to compare the responses from the physicians in this national survey to those attending the MBCC, who by their presence at a 3-day breast cancer meeting are presumably more “up to speed.” The following questions from the MBCC are particularly interesting in that regard:

MBCC attendees: Which statement best describes how you incorporate new clinical research results into your practice, relative to your colleagues?

MBCC attendees: How often do you encounter physicians in referral situations who practice outside the bounds of practice guidelines/standards of care?

These responses suggest that, as one might expect, Miami Breast Cancer Conference attendees view themselves as being proactive in the application of new research results. It is somewhat disconcerting to note that these physicians believe a significant number of their colleagues appear to practice outside the bounds of widely accepted practice standards. A casual perusal of the enclosed supplement also supports this notion. For instance, a small yet significant number of physicians prescribe aromatase inhibitors without ovarian suppression in premenopausal women — a practice that is not supported by research data.

When one considers the enormous investment in breast cancer clinical research, it is surprising how little attention is committed to defining whether these advances are being actualized in clinical practice. In part, this supplement is intended to stimulate discussion on precisely that issue.

The final section of this report summarizes seven tumor panel cases presented by the MBCC to the meeting attendees. Drs Stephen Jones, Kathy Miller, Patrick Borgen, Richard Margolese, Frank Vicini and Eleftherios Mamounas (who also served as consultants to our patterns of care study) selected interesting cases from their own practices, and the audience and other faculty members contributed their viewpoints on how they would manage these patients.

These cases typify the challenges encountered in breast cancer medicine. Even breast cancer research leaders struggle with the application of clinical trial results. Dr Margolese agonizes over a 70-old-woman who is BRCA1-positive, and he decides to follow her without intervention. Two years later, she develops a 6 cm, invasive breast tumor. Dr Jones’ patient enrolls in a randomized clinical trial and experiences a prolonged complete response to capecitabine/docetaxel. Now, 5 years later, Dr Jones must decide whether or not to continue therapy. Dr Mamounas uses pre -op chemotherapy after fine needle aspiration of a breast and axillary mass, but now, after complete pathologic tumor response, there is no estrogen receptor data available. Dr Borgen employs neoadjuvant tamoxifen and, later, anastrozole. Then, he must decide whether this frail, elderly woman with severe cardiovascular disease should undergo definitive local surgery.

Seventeen years ago, in a small Boston café, Dr Craig Henderson made an amusing analogy that seems even more relevant today. He said, “Most people who are breast cancer mavens today would have been sitting on a little knoll debating the Talmud 1,500 years ago.” The patterns of care data presented here confirms the diversity of viewpoints and proves that there is not yet a “Talmudic” truth when it comes to applying emerging research findings to breast cancer treatment decisions.

— Neil Love, MD
Editor, Breast Cancer Update

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