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298 Chapter 6: Breast Cancer
obtaining appropriate internal institutional consent to collect ORCC patient-related
information, the population from which the control group would be selected was
identified. This population was defined as all patients referred to the ORCC with a
diagnosis of metastatic breast cancer treated with chemotherapy for metastatic disease
at some point during the study period. This population was generated using a computerized
search strategy within the Oncology Patient Information System (OPIS). This
population was then sampled and individual patient charts reviewed to determine the
patients deemed eligible for high-dose chemotherapy/stem cell transplantation, but
who received conventional chemotherapy for their illness (the control group). The
inclusion criteria were designed to approximate as closely as possible the same
physiologic/biological characteristics as was represented by the experimental group to
minimize the effects of selection bias. Also, to minimize the introduction of any
possible bias incurred by a temporal or sequenced selection of patients, chart numbers
were selected at random using numbers generated from a random number table
(generated using the random number function in Microsoft Excel).
TREATMENT PROTOCOLS
Standard-dose chemotherapy
For patients who received adjuvant chemotherapy, CMF, FAC, and FEC
accounted for the vast majority of chemotherapy regimens. If a patient had not
received prior adjuvant therapy, the first-line treatment for metastatic disease was
most often anthracycline-based (FEC or FAC), although a few patients were
treated with CMF. For patients who had received anthracycline-based therapy in
the adjuvant setting, the first-line chemotherapy was most often single-agent
paclitaxel or docetaxel. Other chemotherapy regimens included vinorelbine
(generally as a single agent), 5-FU/folinic acid, 5-FU/folinic acid/mitoxantrone,
etoposide/cisplatin, mitomycin-C, and vinblastine. Only the response and
response duration of the first chemotherapy for metastatic disease were used to
calculate the failure-free survival. The duration of chemotherapy (number of
cycles) was at the treating physician's discretion and generally depended on
tolerance of therapy as well as ongoing response.
High-dose chemotherapy
At UNMC, the high-dose chemotherapy regimen was as follows: cyclophosphamide
1.5 g/m 2
/day intravenously as a continuous infusion for 4 days; thiotepa
150 mg/m 2
/day intravenously as a continuous infusion for 4 days; hydroxyurea 1.5
g/m 2
orally q 6 hours for 12 doses; and stem cell infusion 72 hours after the last
doses of thiotepa and cyclophosphamide.