Objective: To evaluate the therapeutic efficacy (in terms of overall survival [OS] and progression-free survival [PFS]) of a high-dose chemotherapy protocol including four drugs and peripheral stem cell rescue (PSCR) plus posttransplant G-CSF (filgrastim) in disseminated breast cancer patients.
Patients and methods: Fifty-three metastatic breast cancer patients were treated with a four-drug program of high-dose chemotherapy including cyclophosphamide (6 g/m2), thiotepa (500 mg/m2), carboplatin (800-1,600 mg/m2) and mitoxantrone (20-60 mg/m2) with autologous peripheral blood progenitor cell support followed by filgrastim. Most cases (92%) had previously received conventional induction chemotherapy with anthracycline-containing combinations.
Results: After a median follow-up of 27 months (range 12-43 months) from transplant, the median survival of the overall group was 25 months, with an OS projected at 43 months of 31%. Patients in complete remission after induction chemotherapy or status NED (no evidence of disease: surgical resection of metastases) presented the best outcome, with a projected PFS of 50% at 43 months. Patients intensified without complete response had a poor outcome. The most important extramedullary toxicity was mucositis. Four patients (7.5%) died as a consequence of treatment (2 with sepsis-associated ARDS, one with venooclussive disease of the liver, one with congestive cardiac failure).
Conclusions: The outcome of metastatic breast cancer patients in complete remission after induction chemotherapy or NED status seems to be good with our high-dose chemotherapy including four drug and PSCR. On the other hand, patients intensified without complete response presented a bad outcome and do not seem candidates for future trials with this therapeutic approach.