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The Professors Vol. 1 2003: Editor's
Note
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Editor’s Note
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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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