Journal of Clinical Oncology, Vol 10, 102-110, Copyright © 1992 by American Society of Clinical Oncology
A phase II study of high-dose cyclophosphamide, thiotepa, and carboplatin with autologous marrow support in women with measurable advanced breast cancer responding to standard-dose therapy
K Antman, L Ayash, A Elias, C Wheeler, M Hunt, JP Eder, BA Teicher, J Critchlow, J Bibbo and LE Schnipper
Department of Medicine, Dana-Farber Cancer Institute, Boston, MA 02115.
PURPOSE: The study was designed to determine the duration of complete
response (CR) for patients with unresectable or metastatic breast cancer
treated with high-dose cyclophosphamide, thiotepa, and carboplatin (CTCb)
while responding to conventional-dose therapy. METHODS: Eligibility
criteria included histologically documented metastatic or unresectable
breast cancer, at least a partial response (PR) to conventional-dose
therapy, no prior pelvic radiotherapy, cumulative doxorubicin of less than
500 mg/m3, and physiologic age between 18 and 55 years. Patients with
inadequate renal, hepatic, pulmonary, and/or cardiac function or tumor
involvement of marrow or CNS were excluded. Cyclophosphamide 6,000 mg/m2,
thiotepa 500 mg/m2, and carboplatin 800 mg/m2 were given by continuous
infusion over 4 days. After recovery, sites of prior bulk disease were to
be radiated or resected if feasible. RESULTS: Of 29 registered patients,
one died of toxicity (3%; hemorrhage). CRs and PRs continued a median of 16
and 5 months after transplant, respectively (26 and 9 months from
initiation of chemotherapy for metastatic disease). Of 10 patients
transplanted in CR, four have not progressed at 17 to 31 months after
transplantation (25 to 43 months after beginning standard-dose therapy).
One of four patients with uptake on bone scan as their only sites of
residual disease before transplant and one of three who converted from PR
to CR with transplant have not progressed at 27 and 29 months,
respectively, after transplant. CONCLUSIONS: CTCb is an intensification
regimen with a low mortality that delivers a significantly increased dose
of agents with known activity at conventional doses in breast cancer.
Although the duration of PR is short as expected, CRs appear to be durable.
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