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Editor's Note

Doc, what would you do if you were in my shoes?

I recently chatted with a 64-year-old urologist whose life unraveled two years ago when a routine PSA screening led to the diagnosis of high-grade localized prostate cancer. While one might argue what defines “standard of care” in this situation, the most likely approach would be a combination of radiation therapy and two or more years of an LHRH agonist.

The treatment this physician/patient chose was quite nonstandard — radical prostatectomy, radiation therapy, combination chemotherapy and long-term maximal androgen blockade with an LHRH agonist and an antiandrogen.

“I wanted to do everything possible to attack the tumor,” he told me. One can hardly argue with his intent, and fortunately this man is currently free of cancer with an undetectable PSA. However, it is interesting to speculate whether this was an evidence-based decision that was acceptable for this patient’s physician to prescribe — or for our healthcare system to support. Many analogous therapeutic questions in the adjuvant breast cancer setting leave medical oncologists in a quandary.

Should adjuvant chemotherapy be used in women with smaller, nodenegative tumors?

This is an agonizing and very common decision. Many of us have referenced a classic 1987 Australian survey of 104 women who had previously received chemotherapy.1 More than half of the patients in that survey indicated that they would be treated with chemotherapy again for as little as a one percent improvement in five-year survival — the same benefit that is often projected for women with node-negative tumors. Some observers have noted that this sample population is biased because the surveyed patients had already chosen to receive adjuvant chemotherapy.

Peter Ravdin’s ADJUVANT! online computer model (www.adjuvantonline. com/) has been very helpful in this situation by providing an estimate of the actual benefit derived from systemic therapy. As discussed in this issue by Dr Dan Hayes, a new and important source of assistance may be on the horizon in the form of more sophisticated tumor prognostic factors such as the Oncotype™ DX assay.

Should dose-dense adjuvant chemotherapy be utilized?

I have been surprised by the relatively slow integration of this clinical strategy since Mark Citron’s presentation of the CALGB-9741 trial results in December 2002. While the benefits from a dose-dense strategy require further definition, the downside currently appears to be mainly economic.

Are patients being accurately informed about the implications of these data when they are counseled about treatment options? For breast cancer patients with mindsets like the aforementioned urologist, a non-dose-dense regimen of AC->T might be unacceptable.

Is adjuvant capecitabine an acceptable alternative for women not enrolled in a clinical trial?

This valuable form of targeted chemotherapy is particularly attractive because of its oral formulation. An ongoing randomized adjuvant trial (CALGB-49907) will compare capecitabine to AC or CMF in women over the age of 65.

Does the utilization of adjuvant capecitabine as one of the treatment arms provide support to oncologists wishing to use it for patients not enrolled in a clinical trial? Most breast cancer clinical research leaders do not currently support that approach.

A related and vexing problem may be encountered in the patient with an ER-negative, HER2-negative tumor who has received neoadjuvant chemotherapy with a taxane and an anthracycline. Should chemotherapy be administered when such a patient has extensive residual tumor in the mastectomy specimen or multiple residual axillary lymph nodes on axillary dissection? Many clinicians utilize “pseudo-adjuvant” capecitabine in this situation, but reliable clinical research data do not yet support this strategy.

Which type of adjuvant endocrine therapy is optimal?

Controversy over the treatment of the postmenopausal woman is fading quickly as clinical research data accumulates on the superiority of aromatase inhibitors over tamoxifen. Therapy for premenopausal women — on the other hand — is far more controversial.

Not only is the role of ovarian ablation or suppression unclear, but many clinicians combine this intervention with tamoxifen or an aromatase inhibitor — a still unproven strategy that is currently being tested in several important clinical trials.

Should adjuvant trastuzumab be utilized in women with ER-negative, HER2- positive disease and multiple positive axillary lymph nodes? While research leaders uniformly discourage this practice, a small but significant fraction of community-based oncologists selectively utilize this strategy.

One of the most provocative questions our group has posed at CME meetings is, “What therapy would you wish to receive if you were diagnosed with breast cancer and had an ER-negative, HER2-positive tumor with 12 positive axillary nodes?” It’s easy to say, “We have no evidence for the trastuzumab,” but like my urologist friend, a very high-risk tumor can make us throw out the rulebook.

Patients love to ask oncologists what they would do if they were in the “same shoes,” and many physicians refuse to answer to avoid misleading patients into believing an “optimal” alternative truly exists.

To add another perspective to these debates, last year our CME group conducted three “Breast Cancer Patient Perspectives Town Meetings” in which we provided survivors with electronic keypads and asked them to vote on a number of clinical scenarios and cases.

A print report of this project was included in a prior issue of our series, and we have also presented these findings at ASCO2 and in San Antonio.3 In response to the many requests we’ve received from oncologists, we have included a PowerPoint slide atlas with graphics of some of these data in this issue of Breast Cancer Update.

Like similar patient surveys, considerable heterogeneity was observed in the breast cancer survivors’ perceptions of the difficult trade-offs associated with adjuvant systemic therapy. Many were almost completely focused on reducing the risk of cancer recurrence, while others were much more intent on reducing treatment-related side effects and toxicities.

Physicians counseling patients who are facing these difficult-to-answer questions must be sensitized to the fact that a “one size fits all” approach denies patients the important opportunity to participate in making decisions with lifelong implications.

— Neil Love, MD
NLove@ResearchToPractice.net

1Simes RJ, Coates AS. Patient preferences for adjuvant chemotherapy of early breast cancer: how much benefit is needed? J Natl Cancer Inst Monogr 2001;(30):146-52. Abstract

2Love NH et al. Influence of prior therapy on breast cancer survivors’ preferences for adjuvant systemic therapy in hypothetical scenarios. Proc ASOC 2004; Abstract 591.

3Love NH et al. Heterogeneity in breast cancer survivors perceptions of adjuvant systemic therapy options after verbal counseling from a physician panel in a town meeting. Breast Cancer Res Treat 2003;82(1, Suppl);Abstract 142.

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Doc, what would you do
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Daniel F Hayes, MD
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PowerPoint® Atlas: Patient Perspectives Project
 
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