TY - JOUR
T1 - Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer
AU - Jones, Stephen E.
AU - Savin, Michael A.
AU - Holmes, Frankie Ann
AU - O'Shaughnessy, Joyce A.
AU - Blum, Joanne L.
AU - Vukelja, Svetislava
AU - McIntyre, Kristi J.
AU - Pippen, John E.
AU - Bordelon, James H.
AU - Kirby, Robert
AU - Sandbach, John
AU - Hyman, William J.
AU - Khandelwal, Pankaj
AU - Negron, Angel G.
AU - Richards, Donald A.
AU - Anthony, Stephen P.
AU - Mennel, Robert G.
AU - Boehm, Kristi A.
AU - Meyer, Walter G.
AU - Asmar, Lina
PY - 2006/12/1
Y1 - 2006/12/1
N2 - Purpose: The combination of doxorubicin and cyclophosphamide (AC) is a standard adjuvant chemotherapy regimen. Studies of docetaxel and cyclophosphamide (TC) in metastatic breast cancer (MBC) showed promise in MBC. In 1997, we initiated a randomized adjuvant trial of TC compared with standard-dose AC with a primary end point of disease-free survival (DFS). Patients and Methods: Patients were eligible if they had stage I to III operable invasive breast cancer with complete surgical excision of the primary tumor. Between June 1997 and December 1999, 1,016 patients were randomly assigned to four cycles of either standard-dose AC (60 and 600 mg/m2, respectively; n = 510) or TC (75 and 600 mg/m2, respectively; n = 506), administered intravenously every 3 weeks as adjuvant chemotherapy. Radiation therapy (as indicated) and tamoxifen, for patients with hormone receptor-positive disease, were administered after completion of chemotherapy. Results: Both treatment groups (TC and AC) were well balanced with respect to major prognostic factors. Patients were observed through 2005 for a median of 5.5 years. At 5 years, DFS rate was significantly superior for TC compared with AC (86% v80%, respectively; hazard ratio [HR] = 0.67; 95% CI, 0.50 to 0.94; P = .015). Overall survival rates for TC and AC were 90% and 87%, respectively (HR = 0.76; 95% CI, 0.52 to 1.1; P = .13). More myalgia, arthralgia, edema, and febrile neutropenia occurred on the TC arm; more nausea and vomiting occurred on the AC arm as well as one incident of congestive heart failure. Conclusion: At 5 years, TC was associated with a superior DFS and a different toxicity profile compared with AC.
AB - Purpose: The combination of doxorubicin and cyclophosphamide (AC) is a standard adjuvant chemotherapy regimen. Studies of docetaxel and cyclophosphamide (TC) in metastatic breast cancer (MBC) showed promise in MBC. In 1997, we initiated a randomized adjuvant trial of TC compared with standard-dose AC with a primary end point of disease-free survival (DFS). Patients and Methods: Patients were eligible if they had stage I to III operable invasive breast cancer with complete surgical excision of the primary tumor. Between June 1997 and December 1999, 1,016 patients were randomly assigned to four cycles of either standard-dose AC (60 and 600 mg/m2, respectively; n = 510) or TC (75 and 600 mg/m2, respectively; n = 506), administered intravenously every 3 weeks as adjuvant chemotherapy. Radiation therapy (as indicated) and tamoxifen, for patients with hormone receptor-positive disease, were administered after completion of chemotherapy. Results: Both treatment groups (TC and AC) were well balanced with respect to major prognostic factors. Patients were observed through 2005 for a median of 5.5 years. At 5 years, DFS rate was significantly superior for TC compared with AC (86% v80%, respectively; hazard ratio [HR] = 0.67; 95% CI, 0.50 to 0.94; P = .015). Overall survival rates for TC and AC were 90% and 87%, respectively (HR = 0.76; 95% CI, 0.52 to 1.1; P = .13). More myalgia, arthralgia, edema, and febrile neutropenia occurred on the TC arm; more nausea and vomiting occurred on the AC arm as well as one incident of congestive heart failure. Conclusion: At 5 years, TC was associated with a superior DFS and a different toxicity profile compared with AC.
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U2 - 10.1200/JCO.2006.06.5391
DO - 10.1200/JCO.2006.06.5391
M3 - Article
C2 - 17135639
AN - SCOPUS:34247270770
SN - 0732-183X
VL - 24
SP - 5381
EP - 5387
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 34
ER -