autologous blood and marrow transplantation - Blog Science ...

Fields et al. 343
PATIENTS AND METHODS
From 1 October 1989 through 30 December 1997, we enrolled patients with
high-risk breast cancer on various phase I and II protocols. All patients gave
written informed consent for protocols that were approved and reviewed annually
by the Institutional Review Board at the University of South Florida. All patients
had pathologically documented disease and were required to have adequate
cardiac, pulmonary, hepatic, and renal function as determined by standard
examinations. Patients also had bone marrow evaluations performed routinely,
generally from the posterior superior iliac crests, bilaterally, to exclude the
presence of metastatic disease.
Patients with stage II breast cancer with four or more positive nodes and
patients with stage III breast cancer were transplanted in the adjuvant setting after
four to six cycles of standard-dose therapy, generally with an anthracycline-based
regimen. Patients with stage III disease were defined as having noninflammatory
or inflammatory breast cancer. Patients transplanted in the adjuvant setting also
received chest wall irradiation, either before or after the completion of high-dose
chemotherapy. Patients that were estrogen receptor-positive received tamoxifen
after the completion of high-dose chemotherapy, for a minimum of 2 years and for
up to 5 years in most cases.
Patients with metastatic breast cancer were transplanted after inductionchemotherapy
or, in the case of patients with a solitary metastatic lesion, after
complete surgical resection with or without the addition of radiation therapy.
Patients with metastatic breast cancer were categorized as having achieved either a
complete response (defined as complete disappearance of all measurable lesions)
or a partial response (defined as >50% decrease in the size of all measurable
lesions) to induction therapy or as having refractory disease (defined as