Autologous Bone Marrow Transplantation - Blog Science Connections

Breast Cancer
E. Frei III and R. Bast, Chairmen
DR. K. ANTMAN: The planned protocol that we're actually beginning,
hopefully within a month, is an induction of Adriamycin (doxorubicin) and
methotrexate, with 5-fluorouracil (5-FCI) if we can get it into the regimen—we're
doing a phase I study of the induction regimen. The reasons for choosing that
regimen were to avoid alkylating agents and to use a high dose of Adriamycin
since the investigators at Mt. Sinai Hospital showed a very high complete
response (CR) rate to single-agent Adriamycin at doses in excess of 90 mg/m 2 .
Patients who have a response, complete or partial or even a minimal response,
will then receive transplants at this point, with cyclophosphamide and thio-
TEPA. If we can, we will add carbinoplatinum to our cyclophosphamide thio-
TEPA regimen as a phase 1 trial and, if that proves to be effective in patients with
advanced disease, the three-drug regimen will be moved into the setting.
DR. G. SPITZER: Karen (Dr. Antman), how are you going to determine the
relative effectiveness of this? What are the end points? How much better do the
durations of disease-free survival have to be to determine whether a regimen is
better?
DR. ANTMAN: At this point, these are all phase I studies. The idea is to see if
this approach is feasible in patients who are young and otherwise have a 100%
chance of dying. At the point when we find that it's feasible and also effective,
then it will probably go into leukemia group B for appropriate randomization.
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