TY - JOUR
T1 - Phase III trial evaluating weekly paclitaxel versus docetaxel in combination with capecitabine in operable breast cancer
AU - Kelly, Catherine M.
AU - Green, Marjorie C.
AU - Broglio, Kristine
AU - Thomas, Eva S.
AU - Brewster, Abenaa M.
AU - Valero, Vicente
AU - Ibrahim, Nuhad K.
AU - Gonzalez-Angulo, Ana M.
AU - Booser, Daniel J.
AU - Walters, Ronald S.
AU - Hunt, Kelly K.
AU - Hortobagyi, Gabriel N.
AU - Buzdar, Aman U.
PY - 2012/3/20
Y1 - 2012/3/20
N2 - Purpose: We investigated whether capecitabine and docetaxel followed by fluorouracil, epirubicin, and cyclophosphamide (FEC) or weekly paclitaxel (WP) followed by FEC would improve relapse-free survival (RFS) in operable breast cancer. Patients and Methods: In this single-institution study, patients with clinical stages I to IIIC breast cancer were randomly assigned on a 1:1 basis to WP 80 mg/m 2 for 12 weeks followed by fluorouracil 500 mg/m2, epirubicin 100 mg/m 2, and cyclophosphamide 500 mg/m 2 (FEC-100) every 3 weeks for four cycles or docetaxel 75 mg/m 2 on day 1 and capecitabine (XT) 1,500 mg/m 2 on days 1 through 14 every 3 weeks for four cycles followed by FEC for four cycles and stratified by timing of chemotherapy (preoperative v adjuvant). Accrual was stopped short of 930 patients on the basis of a Bayesian predictive calculation that additional accrual would be unlikely to change the qualitative comparison of the two regimens. Results: After enrollment of 601 patients and a median follow-up of 50 months, we observed no improvement in RFS between XT (87.5%; 95% CI, 82.7% to 91.1%) and WP (90.7%; 95% CI, 86.4% to 93.7%; P = .51). In the preoperative group, the pathologic complete response rate was 19.8% and 16.4% in the XT and WP arms, respectively (P = .45). Rates of breast-conserving surgery were similar between the two groups (P = .48). The XT arm had a significantly higher incidence of stomatitis (P < .001), hand-foot syndrome (P < .001), and neutropenic infection (P < .001). Conclusion: There was no difference in efficacy between WP and XT as used in this randomized phase III trial. XT was associated with higher GI, skin, and neutropenic-related toxicities.
AB - Purpose: We investigated whether capecitabine and docetaxel followed by fluorouracil, epirubicin, and cyclophosphamide (FEC) or weekly paclitaxel (WP) followed by FEC would improve relapse-free survival (RFS) in operable breast cancer. Patients and Methods: In this single-institution study, patients with clinical stages I to IIIC breast cancer were randomly assigned on a 1:1 basis to WP 80 mg/m 2 for 12 weeks followed by fluorouracil 500 mg/m2, epirubicin 100 mg/m 2, and cyclophosphamide 500 mg/m 2 (FEC-100) every 3 weeks for four cycles or docetaxel 75 mg/m 2 on day 1 and capecitabine (XT) 1,500 mg/m 2 on days 1 through 14 every 3 weeks for four cycles followed by FEC for four cycles and stratified by timing of chemotherapy (preoperative v adjuvant). Accrual was stopped short of 930 patients on the basis of a Bayesian predictive calculation that additional accrual would be unlikely to change the qualitative comparison of the two regimens. Results: After enrollment of 601 patients and a median follow-up of 50 months, we observed no improvement in RFS between XT (87.5%; 95% CI, 82.7% to 91.1%) and WP (90.7%; 95% CI, 86.4% to 93.7%; P = .51). In the preoperative group, the pathologic complete response rate was 19.8% and 16.4% in the XT and WP arms, respectively (P = .45). Rates of breast-conserving surgery were similar between the two groups (P = .48). The XT arm had a significantly higher incidence of stomatitis (P < .001), hand-foot syndrome (P < .001), and neutropenic infection (P < .001). Conclusion: There was no difference in efficacy between WP and XT as used in this randomized phase III trial. XT was associated with higher GI, skin, and neutropenic-related toxicities.
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U2 - 10.1200/JCO.2011.36.2079
DO - 10.1200/JCO.2011.36.2079
M3 - Article
C2 - 22331946
AN - SCOPUS:84860638574
SN - 0732-183X
VL - 30
SP - 930
EP - 935
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 9
ER -