ASCO--Immediate high-dose consolidation chemotherapy supported by transplant significantly improved disease-free survival in metastatic breast cancer patients who were in complete remission after induction therapy.
However, overall survival was significantly better in the complete responders who received transplant only at the time of relapse, suggesting that the timing of transplant in these patients may be important, William P. Peters, MD, PhD, said at an ASCO scientific session.
The results represent an 8-year effort by a group at Duke University led by Dr. Peters who is now chief and CEO of the Karmanos Cancer Institute, Detroit.
This trial enrolled 423 patients with hormone-insensitive metastatic breast cancer who were treated with up to four cycles of an intensive doxorubicin(Drug information on doxorubicin)-based regimen. Patients who achieved complete remission were randomized to immediate consolidation with high-dose cyclophosphamide(Drug information on cyclophosphamide)/platinum/carmustine and transplant or to observation. Patients in the observation arm who relapsed were given the same high-dose regimen with transplant. Partial responders were treated with immediate transplant.
The patients tended to be young, with a median age of 42 years. No prior chemotherapy for metastatic disease was allowed, although adjuvant chemotherapy was permitted. Patients could have no more than three involved sites on bone scan.
Dr. Peters noted that the data are mature, with a median follow-up of 4.7 years for the complete remission patients and 3.5 years for the partial responders.
Of the 105 patients who achieved a complete remission, seven were not randomized, in four cases because the insurance company refused to pay, he said.