Editor’s Note
	A Successful “Phase I” Trial

In a recent interview for the Breast Cancer Update audio series, Dr Mark Pegram discussed a breast cancer patient who presented with extensive pulmonary metastases. Histology from a supraclavicular node confirmed that the patient had a HER2-positive recurrence, and she agreed to participate in one of the first Phase I trastuzumab plus chemotherapy trials conducted at UCLA. Based on laboratory data demonstrating synergy between the plantinum salts and trastuzumab, the woman received this combination and her cancer quickly had a complete response. The trial called for treatment discontinuation after a few months, and the patient has been followed for more than 10 years in complete remission without further treatment.

Dr Pegram cited this case as perhaps providing important insight into the biology of HER2- positive breast cancer, and as part of the rationale for the current major BCIRG adjuvant trial evaluating trastuzumab, docetaxel and carboplatin. Another intriguing lesson from this remarkable story is the human impact of entering a Phase I trial — in which there is usually minimal or no hope for significant benefit — and experiencing such an extraordinary response to treatment. We always hold out hope for such an occurrence, but unfortunately, the result is usually disappointing. To see such a profound response in such an early trial is truly extraordinary.

A similar analogy might be made to this CME program. Clinicians form the core of our “Breast Cancer Update” continuing medical education group, and we have a research-like orientation to our work that is objectively evaluated both internally and externally. In March of this year, we decided to pilot a “Phase I” program. We invited attendees to the 20th annual Miami Breast Cancer Conference to present challenging cases from their practices to breast cancer research leaders. A similar format has been used for many years at the San Antonio Breast Cancer Symposium lunch meetings.

The interactivity of our pilot program was very dynamic. We were so encouraged that we implemented another “Phase I” endeavor, this time in Dallas during the American Society of Breast Disease meetings, and we audiotaped the proceedings and developed this CME program based upon the discussions. Our four faculty members — Drs Perez, Robert, Seidman and Tripathy — walked into these sessions without any preparation for the cases about to be presented by the 11 community-based medical oncologists who practice in the Dallas area. We are very interested in your feedback about this novel CME approach. Did you find real cases more relevant than hypothetical ones? How useful were the discussions about psychosocial issues, such as the emotional impact of metastatic disease on the patient and physician? Was this format as useful as a more didactic, topic-based CME approach? What other topics related to these cases could have been discussed? What other challenging clinical situations would be of interest? As with Dr Pegram’s case, only prolonged follow-up will determine whether this type of “therapy” holds promise for the future.

— Neil Love, MD

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