TY - JOUR
T1 - Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide
T2 - 7-year follow-up of us oncology research trial 9735
AU - Jones, Stephen
AU - Holmes, Frankie Ann
AU - O'Shaughnessy, Joyce
AU - Blum, Joanne L.
AU - Vukelja, Svetislava J.
AU - Mclntyre, Kristi J.
AU - Pippen, John E.
AU - Bordelon, James H.
AU - Kirby, Robert L.
AU - Sandbach, John
AU - Hyman, William J.
AU - Richards, Donald A.
AU - Mennel, Robert G.
AU - Boehm, Kristi A.
AU - Meyer, Wally G.
AU - Asmar, Lina
AU - Mackey, Daniel
AU - Riedel, Stefan
AU - Muss, Hyman
AU - Savin, Michael A.
N1 - Copyright:
Copyright 2012 Elsevier B.V., All rights reserved.
PY - 2009/3/10
Y1 - 2009/3/10
N2 - Purpose We previously reported that four cycles of docetaxel/ cyclophosphamide (TC) produced superior disease-free survival (DFS) compared with four cycles of doxorubicin/cyclophosphamide (AC) in early breast cancer. Older women are under-represented in adjuvant chemotherapy trials. In our trial 16% of patients were ≥ 65 years. We now report 7-year results for DFS and overall survival (OS) as well as the impact of age, hormone receptor status, and HEH2 status on outcome and toxicity. Patients and Methods Patients were randomly assigned to receive either four cycles of standard-dose AC (60/600 mg/m2; n = 510), or TC (75/600 mg/m2; n = 506), administered by intravenous infusion every 3 weeks. Results The median age in women younger than 65, was 50 years (range, 27 to 64) and for women ≥ 65 was 69 years (range, 65 to 77). Baseline characteristics in the two age subgroups were generally well matched, except that older women tended to have more lymph node involvement. At a median of 7 years follow-up, the difference in DFS between TC and AC was significant (81 % TC v 75% AC; P =.033; hazard ratio [HR], 0.74; 95% CI 0.56 to 0.98) as was OS (87% TC v 82% AC; P =.032; HR, 0.69; 95% CI, 0.50 to 0.97). TC was superior in older patients as well as younger patients. There was no interaction of hormone-receptor status or HER-2 status and treatment. Older women experienced more febrile neutropenia with TC and more anemia with AC. Conclusion With longer follow-up, four cycles of TC was superior to standard AC (DFS and OS) and was a tolerable regimen in both older and younger patients.
AB - Purpose We previously reported that four cycles of docetaxel/ cyclophosphamide (TC) produced superior disease-free survival (DFS) compared with four cycles of doxorubicin/cyclophosphamide (AC) in early breast cancer. Older women are under-represented in adjuvant chemotherapy trials. In our trial 16% of patients were ≥ 65 years. We now report 7-year results for DFS and overall survival (OS) as well as the impact of age, hormone receptor status, and HEH2 status on outcome and toxicity. Patients and Methods Patients were randomly assigned to receive either four cycles of standard-dose AC (60/600 mg/m2; n = 510), or TC (75/600 mg/m2; n = 506), administered by intravenous infusion every 3 weeks. Results The median age in women younger than 65, was 50 years (range, 27 to 64) and for women ≥ 65 was 69 years (range, 65 to 77). Baseline characteristics in the two age subgroups were generally well matched, except that older women tended to have more lymph node involvement. At a median of 7 years follow-up, the difference in DFS between TC and AC was significant (81 % TC v 75% AC; P =.033; hazard ratio [HR], 0.74; 95% CI 0.56 to 0.98) as was OS (87% TC v 82% AC; P =.032; HR, 0.69; 95% CI, 0.50 to 0.97). TC was superior in older patients as well as younger patients. There was no interaction of hormone-receptor status or HER-2 status and treatment. Older women experienced more febrile neutropenia with TC and more anemia with AC. Conclusion With longer follow-up, four cycles of TC was superior to standard AC (DFS and OS) and was a tolerable regimen in both older and younger patients.
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U2 - 10.1200/JCO.2008.18.4028
DO - 10.1200/JCO.2008.18.4028
M3 - Article
C2 - 19204201
AN - SCOPUS:62449193617
SN - 0732-183X
VL - 27
SP - 1177
EP - 1183
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 8
ER -