TY - JOUR
T1 - Randomized trial of high-dose chemotherapy and autologous hematopoietic stem cell support for high-risk primary breast carcinoma
T2 - Follow-up at 12 years
AU - Hanrahan, Emer O.
AU - Broglio, Kristine
AU - Frye, Deborah
AU - Buzdar, Aman U.
AU - Theriault, Richard L.
AU - Valero, Vicente
AU - Booser, Daniel J.
AU - Singletary, Sonja E.
AU - Strom, Eric A.
AU - Gajewski, James L.
AU - Champlin, Richard E.
AU - Hortobagyi, Gabriel N.
PY - 2006/6/1
Y1 - 2006/6/1
N2 - BACKGROUND. The authors previously reported results from a randomized trial of standard-dose chemotherapy with combined 5-fluorouracil (1000 mg/m 2 per cycle), doxorubicin (50 mg/m2 per cycle), and cyclophosphamide (500 mg/m2 per cycle) (FAC) versus FAC followed by high-dose chemotherapy (HDCT) and autologous stem cell support (ASCS) for patients with high-risk primary breast carcinoma. After a median follow-up of 6.5 years, no significant differences were observed in recurrence-free survival (RFS) or overall survival (OS) between the 2 arms. This report updates the survival analyses. METHODS. Patients with ≥ 10 positive axillary lymph nodes after primary surgery or ≥ 4 positive lymph nodes at surgery after neoadjuvant chemotherapy were eligible. All patients were to receive 8 cycles of FAC. Patients were assigned randomly to receive either no further chemotherapy or 2 cycles of combined high-dose cyclophosphamide (5250 mg/m2 per cycle), etoposide (1200 mg/m2 per cycle), and cisplatin (165 mg/m2 per cycle) with ASCS. Primary endpoints were RFS and OS. RFS and OS were calculated by using the Kaplan-Meier method. The log-rank statistic was used to compare treatment arms. RESULTS. Between 1990 and 1997, 78 patients were registered, and 39 patients were assigned randomly to each arm. The median follow-up for all patients who were alive at last follow-up was 142.5 months (range, 45-169 months). An intention-to-treat analysis showed no significant difference between the 2 arms in terms of RFS (at 10 years: 40% with FAC vs. 26% with FAC plus HDCT; P = .11) or OS (at 10 years: 47% with FAC vs. 42% with FAC plus HDCT; P = .13). CONCLUSIONS. With a median follow-up of nearly 12 years for patients who remained alive, this trial continued to demonstrate no RFS or OS advantage for patients with high-risk primary breast carcinoma treated with HDCT after standard-dose FAC chemotherapy.
AB - BACKGROUND. The authors previously reported results from a randomized trial of standard-dose chemotherapy with combined 5-fluorouracil (1000 mg/m 2 per cycle), doxorubicin (50 mg/m2 per cycle), and cyclophosphamide (500 mg/m2 per cycle) (FAC) versus FAC followed by high-dose chemotherapy (HDCT) and autologous stem cell support (ASCS) for patients with high-risk primary breast carcinoma. After a median follow-up of 6.5 years, no significant differences were observed in recurrence-free survival (RFS) or overall survival (OS) between the 2 arms. This report updates the survival analyses. METHODS. Patients with ≥ 10 positive axillary lymph nodes after primary surgery or ≥ 4 positive lymph nodes at surgery after neoadjuvant chemotherapy were eligible. All patients were to receive 8 cycles of FAC. Patients were assigned randomly to receive either no further chemotherapy or 2 cycles of combined high-dose cyclophosphamide (5250 mg/m2 per cycle), etoposide (1200 mg/m2 per cycle), and cisplatin (165 mg/m2 per cycle) with ASCS. Primary endpoints were RFS and OS. RFS and OS were calculated by using the Kaplan-Meier method. The log-rank statistic was used to compare treatment arms. RESULTS. Between 1990 and 1997, 78 patients were registered, and 39 patients were assigned randomly to each arm. The median follow-up for all patients who were alive at last follow-up was 142.5 months (range, 45-169 months). An intention-to-treat analysis showed no significant difference between the 2 arms in terms of RFS (at 10 years: 40% with FAC vs. 26% with FAC plus HDCT; P = .11) or OS (at 10 years: 47% with FAC vs. 42% with FAC plus HDCT; P = .13). CONCLUSIONS. With a median follow-up of nearly 12 years for patients who remained alive, this trial continued to demonstrate no RFS or OS advantage for patients with high-risk primary breast carcinoma treated with HDCT after standard-dose FAC chemotherapy.
KW - Autologous stem cell support
KW - Axillary lymph nodes
KW - Breast cancer
KW - High-dose chemotherapy
KW - Overall survival
KW - Recurrence-free survival
UR - http://www.scopus.com/inward/record.url?scp=33646863006&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33646863006&partnerID=8YFLogxK
U2 - 10.1002/cncr.21906
DO - 10.1002/cncr.21906
M3 - Article
C2 - 16639731
AN - SCOPUS:33646863006
SN - 0008-543X
VL - 106
SP - 2327
EP - 2336
JO - Cancer
JF - Cancer
IS - 11
ER -