High-dose chemotherapy with hematopoietic stem-cell rescue for high-risk XXXX .

@entity1 @entity0 @entity440 @entity5 @entity3003 @entity1259 @entity786 @entity1487
BACKGROUND: The use of high-dose adjuvant chemotherapy for high-risk primary @entity0 is controversial. We studied its efficacy in @entity1 with 4 to 9 or 10 or more @entity5 -positive axillary lymph nodes. METHODS: @entity1 younger than 56 years of age who had undergone surgery for @entity0 and who had no distant metastases were eligible if they had at least four @entity5 -positive axillary lymph nodes. @entity1 in the conventional-dose group received @entity1487 , @entity1259 , and @entity786 (FEC) every three weeks for five courses, followed by radiotherapy and @entity440 . The high-dose treatment was identical, except that high-dose chemotherapy (6 g of @entity786 per square meter of body-surface area, 480 mg of thiotepa per square meter, and 1600 mg of @entity3003 per square meter) with autologous peripheral-blood hematopoietic progenitor-cell transplantation replaced the fifth course of FEC. RESULTS: Of the 885 @entity1 , 442 were assigned to the high-dose group and 443 to the conventional-dose group. After a median follow-up of 57 months, the actuarial 5-year relapse-free survival rates were 59 percent in the conventional-dose group and 65 percent in the high-dose group (hazard ratio for relapse in the high-dose group, 0.83; 95 percent confidence interval, 0.66 to 1.03; P=0.09). In the group with 10 or more positive nodes, the relapse-free survival rates were 51 percent in the conventional-dose group and 61 percent in the high-dose group (P=0.05 by the log-rank test; hazard ratio for relapse, 0.71; 95 percent confidence interval, 0.50 to 1.00). CONCLUSIONS: High-dose alkylating therapy improves relapse-free survival among @entity1 with @entity0 and 10 or more positive axillary lymph nodes. This benefit may be confined to @entity1 with @entity5 .
