Editor’s Note
	The “Kaplan Regimen”

Our Continuing Medical Education (CME) group focuses on emerging clinical research data and the perspectives of clinical investigators. We also know that the viewpoints of community-based physicians are another valuable resource for our work. To that end, we gather data about decision-making by community-based physicians via national telephone surveys and editorial working group meetings. Arecent Breast Cancer Update working group meeting in New York was very informative. As part of that platform, the 35 participating medical oncologists submitted four cases from their practices that we evaluated beforehand, and in some cases, discussed with the working group. Dr Barry Kaplan, an oncologist from Queens, submitted a particularly provocative case. This premenopausal woman, in her late 30s, presented with primary breast cancer and multiple bone metastases. The patient’s tumor was ER/PR-positive and HER2-positive, and the patient — who was very well-versed about her prognosis and usual therapeutic options — pressed Dr Kaplan for the most intense treatment regimen that would be rational.

After reviewing a variety of options, Dr Kaplan, with strong support and agreement from the patient, utilized a combination of docetaxel, capecitabine, an LHRH agonist, anastrozole, trastuzumab, and a bisphosphonate. Our two faculty members for this part of the meeting — Drs Hy Muss and Eric Winer — seemed to blanch at the concluding Powerpoint comment from Dr Kaplan’s case write-up: “I think this was a good choice for this woman; do you?” I asked the group, knowing there would be a variety of responses.

Dr Kaplan, a regular listener of our series, is well-aware that most research leaders — including Drs Muss and Winer — espouse a sequential, single-agent approach to the treatment of metastatic breast cancer. Certainly, this “shotgun” approach of chemotherapy, endocrine treatment and biologic therapy was very atypical in Dr Kaplan’s practice. While one might argue that there is no evidence to support this approach, it is also clear that a randomized, postprogression, crossover trial of the “Kaplan Regimen” would encounter significant accrual challenges if eligibility were restricted to young, premenopausal women with ER/PR-positive, HER2- positive breast cancer.

This case sparked a lively, although not totally conclusive, discussion. While it was clear that most attendees would not have utilized the “Kaplan Regimen,” I found a new appreciation for the depth and complexity of evidence-based oncology. In that regard, our CME group developed a new simplified graphical model for clinical decision-making (Figure 1). For any given situation, treatments in the “blue” area represent accepted standards of care based on credible clinical research results. In metastatic breast cancer, there are the multiple treatment options in this category, and the light “blue” area depicts the therapy an individual oncologist might recommend. The treatments in the “red” area are critical from a CME perspective in that these types of options are not supported by research evidence, although they might move into the “blue” area as clinical trial data evolve.

The lead interview in this issue of Breast Cancer Update provides a perfect example of how this model can be applied. Dr Mark Pegram comments on adjuvant systemic therapy options for the patient with ER-negative, HER2-positive breast cancer. Dr Pegram describes his enthusiasm for the ongoing BCIRG-006 adjuvant trastuzumab trial, but he clearly believes that the nonprotocol use of adjuvant trastuzumab should be in the “red” area (Figure 1).

On the other hand, as first-line therapy for patients with ER-negative, HER2- positive metastatic disease, Dr Pegram believes that trastuzumab either alone or in combination with chemotherapy are the two main options in the “blue” area, and he disagrees with the small number of physicians utilizing chemotherapy without trastuzumab.

While one can argue that palliative situations like metastatic breast cancer must be managed with empathetic creativity, there are many effective therapies that can minimize morbidity and prolong survival. Do you believe the “Kaplan Regimen” has merit in a nonprotocol setting? Have you ever utilized such a strategy? Or is it a choice that belongs in the “red zone”? Kindly email your input on these and any other challenging questions in your practice to NLove@med.miami.edu.

— Neil Love, MD

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