TY - JOUR
T1 - Phase III randomized trial of dose intensive neoadjuvant chemotherapy with or without G-CSF in locally advanced breast cancer
T2 - Long-term results
AU - Arun, Banu K.
AU - Dhinghra, Kapil
AU - Valero, Vicente
AU - Kau, Shu Wan
AU - Broglio, Kristine
AU - Booser, Daniel
AU - Guerra, Laura
AU - Yin, Guosheng
AU - Walters, Ronald
AU - Sahin, Aysegul
AU - Ibrahim, Nuhad
AU - Buzdar, Aman U.
AU - Frye, Debbie
AU - Sneige, Nour
AU - Strom, Eric
AU - Ross, Merrick
AU - Theriault, Richard L.
AU - Vadhan-Raj, Saroj
AU - Hortobagyi, Gabriel N.
PY - 2011
Y1 - 2011
N2 - Objective. To compare the pathologic complete response (pCR) rate of patients treated with 5-fluorouracil (5-FU), doxorubicin, and cyclophosphamide (FAC) versus dose-intense FAC plus G-CSF in the neoadjuvant setting and to compare the delivered dose intensity, disease-free survival (DFS) and overall survival (OS) times, and toxicity between treatment arms in patients with breast cancer. Methods. Patients were randomized to receive preoperative FAC (5-FU, 500 mg/m 2 doxorubicin, 50 mg/m 2 cyclophosphamide, 500 mg/m 2) every 21 days for four cycles or dose-intense FAC (5-FU, 600 mg/m 2 doxorubicin, 60 mg/m 2 cyclophosphamide, 1,000 mg/m 2) plus G-CSF every 18 days for four cycles. Results. Two hundred two patients were randomly assigned. The median follow-up was 7.5 years. Patients randomized to FAC plus G-CSF had a higher pCR rate as well as clinical complete response rate; however, these differences were not statistically different from those with the FAC arm. Patients in the FAC G-CSF arm had a higher delivered dose intensity of doxorubicin in the neoadjuvant and adjuvant settings than those in the standard FAC arm. DFS and OS times were not significantly different between the two groups. However, the OS and DFS rates were significantly higher for patients who achieved a pCR than for those who did not. Thrombocytopenia, febrile neutropenia, and infection rates were higher in the FAC G-CSF arm. Conclusions. A higher delivered dose intensity of doxorubicin with the FAC G-CSF regimen did not result in a statistically significant higher pCR rate. However, patients who achieved a pCR experienced longer DFS and OS times.
AB - Objective. To compare the pathologic complete response (pCR) rate of patients treated with 5-fluorouracil (5-FU), doxorubicin, and cyclophosphamide (FAC) versus dose-intense FAC plus G-CSF in the neoadjuvant setting and to compare the delivered dose intensity, disease-free survival (DFS) and overall survival (OS) times, and toxicity between treatment arms in patients with breast cancer. Methods. Patients were randomized to receive preoperative FAC (5-FU, 500 mg/m 2 doxorubicin, 50 mg/m 2 cyclophosphamide, 500 mg/m 2) every 21 days for four cycles or dose-intense FAC (5-FU, 600 mg/m 2 doxorubicin, 60 mg/m 2 cyclophosphamide, 1,000 mg/m 2) plus G-CSF every 18 days for four cycles. Results. Two hundred two patients were randomly assigned. The median follow-up was 7.5 years. Patients randomized to FAC plus G-CSF had a higher pCR rate as well as clinical complete response rate; however, these differences were not statistically different from those with the FAC arm. Patients in the FAC G-CSF arm had a higher delivered dose intensity of doxorubicin in the neoadjuvant and adjuvant settings than those in the standard FAC arm. DFS and OS times were not significantly different between the two groups. However, the OS and DFS rates were significantly higher for patients who achieved a pCR than for those who did not. Thrombocytopenia, febrile neutropenia, and infection rates were higher in the FAC G-CSF arm. Conclusions. A higher delivered dose intensity of doxorubicin with the FAC G-CSF regimen did not result in a statistically significant higher pCR rate. However, patients who achieved a pCR experienced longer DFS and OS times.
KW - Breast cancer
KW - Disease-free survival
KW - Dose intensity
KW - G-CSF
KW - Locally advanced
KW - Overall survival
UR - http://www.scopus.com/inward/record.url?scp=82355163145&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=82355163145&partnerID=8YFLogxK
U2 - 10.1634/theoncologist.2011-0134
DO - 10.1634/theoncologist.2011-0134
M3 - Article
C2 - 22042783
AN - SCOPUS:82355163145
SN - 1083-7159
VL - 16
SP - 1527
EP - 1534
JO - Oncologist
JF - Oncologist
IS - 11
ER -