Adjuvant docetaxel for node-positive breast cancer

Miguel Martin, Tadeusz Pienkowski, John Mackey, Marek Pawlicki, Jean Paul Guastalla, Charles Weaver, Eva Tomiak, Taher Al-Tweigeri, Linnea Chap, Eva Juhos, Raymond Guevin, Anthony Howell, Tommy Fornander, John Hainsworth, Robert Coleman, Jeferson Vinholes, Manuel Modiano, Tamas Pinter, Shou C. Tang, Bruce ColwellCatherine Prady, Louise Provencher, David Walde, Alvaro Rodriguez-Lescure, Judith Hugh, Camille Loret, Matthieu Rupin, Sandra Blitz, Philip Jacobs, Michael Murawsky, Alessandro Riva, Charles Vogel

Research output: Contribution to journalArticle

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Abstract

BACKGROUND We compared docetaxel plus doxorubicin and cyclophosphamide (TAC) with fluorouracil plus doxorubicin and cyclophosphamide (FAC) as adjuvant chemotherapy for operable node-positive breast cancer. METHODS We randomly assigned 1491 women with axillary node-positive breast cancer to six cycles of treatment with either TAC or FAC as adjuvant chemotherapy after surgery. The primary end point was disease-free survival. RESULTS At a median follow-up of 55 months, the estimated rates of disease-free survival at five years were 75 percent among the 745 patients randomly assigned to receive TAC and 68 percent among the 746 randomly assigned to receive FAC, representing a 28 percent reduction in the risk of relapse (P=0.001) in the TAC group. The estimated rates of overall survival at five years were 87 percent and 81 percent, respectively. Treatment with TAC resulted in a 30 percent reduction in the risk of death (P=0.008). The incidence of grade 3 or 4 neutropenia was 65.5 percent in the TAC group and 49.3 percent in the FAC group (P<0.001); rates of febrile neutropenia were 24.7 percent and 2.5 percent, respectively (P<0.001). Grade 3 or 4 infections occurred in 3.9 percent of the patients who received TAC and 2.2 percent of those who received FAC (P=0.05); no deaths occurred as a result of infection. Two patients in each group died during treatment. Congestive heart failure and acute myeloid leukemia occurred in less than 2 percent of the patients in each group. Quality-of-life scores decreased during chemotherapy but returned to baseline levels after treatment. CONCLUSIONS Adjuvant chemotherapy with TAC, as compared with FAC, significantly improves the rates of disease-free and overall survival among women with operable node-positive breast cancer.

Original languageEnglish (US)
Pages (from-to)2302-2313
Number of pages12
JournalNew England Journal of Medicine
Volume352
Issue number22
DOIs
StatePublished - Jun 2 2005

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docetaxel
Adjuvant Chemotherapy
Breast Neoplasms
Disease-Free Survival
Risk Reduction Behavior
Doxorubicin
Cyclophosphamide
Febrile Neutropenia
Therapeutics
Infection
Neutropenia
Acute Myeloid Leukemia
Fluorouracil
Survival Rate
Heart Failure
Quality of Life
Recurrence
Drug Therapy
Incidence

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Martin, M., Pienkowski, T., Mackey, J., Pawlicki, M., Guastalla, J. P., Weaver, C., ... Vogel, C. (2005). Adjuvant docetaxel for node-positive breast cancer. New England Journal of Medicine, 352(22), 2302-2313. https://doi.org/10.1056/NEJMoa043681

Adjuvant docetaxel for node-positive breast cancer. / Martin, Miguel; Pienkowski, Tadeusz; Mackey, John; Pawlicki, Marek; Guastalla, Jean Paul; Weaver, Charles; Tomiak, Eva; Al-Tweigeri, Taher; Chap, Linnea; Juhos, Eva; Guevin, Raymond; Howell, Anthony; Fornander, Tommy; Hainsworth, John; Coleman, Robert; Vinholes, Jeferson; Modiano, Manuel; Pinter, Tamas; Tang, Shou C.; Colwell, Bruce; Prady, Catherine; Provencher, Louise; Walde, David; Rodriguez-Lescure, Alvaro; Hugh, Judith; Loret, Camille; Rupin, Matthieu; Blitz, Sandra; Jacobs, Philip; Murawsky, Michael; Riva, Alessandro; Vogel, Charles.

In: New England Journal of Medicine, Vol. 352, No. 22, 02.06.2005, p. 2302-2313.

Research output: Contribution to journalArticle

Martin, M, Pienkowski, T, Mackey, J, Pawlicki, M, Guastalla, JP, Weaver, C, Tomiak, E, Al-Tweigeri, T, Chap, L, Juhos, E, Guevin, R, Howell, A, Fornander, T, Hainsworth, J, Coleman, R, Vinholes, J, Modiano, M, Pinter, T, Tang, SC, Colwell, B, Prady, C, Provencher, L, Walde, D, Rodriguez-Lescure, A, Hugh, J, Loret, C, Rupin, M, Blitz, S, Jacobs, P, Murawsky, M, Riva, A & Vogel, C 2005, 'Adjuvant docetaxel for node-positive breast cancer', New England Journal of Medicine, vol. 352, no. 22, pp. 2302-2313. https://doi.org/10.1056/NEJMoa043681
Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C et al. Adjuvant docetaxel for node-positive breast cancer. New England Journal of Medicine. 2005 Jun 2;352(22):2302-2313. https://doi.org/10.1056/NEJMoa043681
Martin, Miguel ; Pienkowski, Tadeusz ; Mackey, John ; Pawlicki, Marek ; Guastalla, Jean Paul ; Weaver, Charles ; Tomiak, Eva ; Al-Tweigeri, Taher ; Chap, Linnea ; Juhos, Eva ; Guevin, Raymond ; Howell, Anthony ; Fornander, Tommy ; Hainsworth, John ; Coleman, Robert ; Vinholes, Jeferson ; Modiano, Manuel ; Pinter, Tamas ; Tang, Shou C. ; Colwell, Bruce ; Prady, Catherine ; Provencher, Louise ; Walde, David ; Rodriguez-Lescure, Alvaro ; Hugh, Judith ; Loret, Camille ; Rupin, Matthieu ; Blitz, Sandra ; Jacobs, Philip ; Murawsky, Michael ; Riva, Alessandro ; Vogel, Charles. / Adjuvant docetaxel for node-positive breast cancer. In: New England Journal of Medicine. 2005 ; Vol. 352, No. 22. pp. 2302-2313.
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abstract = "BACKGROUND We compared docetaxel plus doxorubicin and cyclophosphamide (TAC) with fluorouracil plus doxorubicin and cyclophosphamide (FAC) as adjuvant chemotherapy for operable node-positive breast cancer. METHODS We randomly assigned 1491 women with axillary node-positive breast cancer to six cycles of treatment with either TAC or FAC as adjuvant chemotherapy after surgery. The primary end point was disease-free survival. RESULTS At a median follow-up of 55 months, the estimated rates of disease-free survival at five years were 75 percent among the 745 patients randomly assigned to receive TAC and 68 percent among the 746 randomly assigned to receive FAC, representing a 28 percent reduction in the risk of relapse (P=0.001) in the TAC group. The estimated rates of overall survival at five years were 87 percent and 81 percent, respectively. Treatment with TAC resulted in a 30 percent reduction in the risk of death (P=0.008). The incidence of grade 3 or 4 neutropenia was 65.5 percent in the TAC group and 49.3 percent in the FAC group (P<0.001); rates of febrile neutropenia were 24.7 percent and 2.5 percent, respectively (P<0.001). Grade 3 or 4 infections occurred in 3.9 percent of the patients who received TAC and 2.2 percent of those who received FAC (P=0.05); no deaths occurred as a result of infection. Two patients in each group died during treatment. Congestive heart failure and acute myeloid leukemia occurred in less than 2 percent of the patients in each group. Quality-of-life scores decreased during chemotherapy but returned to baseline levels after treatment. CONCLUSIONS Adjuvant chemotherapy with TAC, as compared with FAC, significantly improves the rates of disease-free and overall survival among women with operable node-positive breast cancer.",
author = "Miguel Martin and Tadeusz Pienkowski and John Mackey and Marek Pawlicki and Guastalla, {Jean Paul} and Charles Weaver and Eva Tomiak and Taher Al-Tweigeri and Linnea Chap and Eva Juhos and Raymond Guevin and Anthony Howell and Tommy Fornander and John Hainsworth and Robert Coleman and Jeferson Vinholes and Manuel Modiano and Tamas Pinter and Tang, {Shou C.} and Bruce Colwell and Catherine Prady and Louise Provencher and David Walde and Alvaro Rodriguez-Lescure and Judith Hugh and Camille Loret and Matthieu Rupin and Sandra Blitz and Philip Jacobs and Michael Murawsky and Alessandro Riva and Charles Vogel",
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T1 - Adjuvant docetaxel for node-positive breast cancer

AU - Martin, Miguel

AU - Pienkowski, Tadeusz

AU - Mackey, John

AU - Pawlicki, Marek

AU - Guastalla, Jean Paul

AU - Weaver, Charles

AU - Tomiak, Eva

AU - Al-Tweigeri, Taher

AU - Chap, Linnea

AU - Juhos, Eva

AU - Guevin, Raymond

AU - Howell, Anthony

AU - Fornander, Tommy

AU - Hainsworth, John

AU - Coleman, Robert

AU - Vinholes, Jeferson

AU - Modiano, Manuel

AU - Pinter, Tamas

AU - Tang, Shou C.

AU - Colwell, Bruce

AU - Prady, Catherine

AU - Provencher, Louise

AU - Walde, David

AU - Rodriguez-Lescure, Alvaro

AU - Hugh, Judith

AU - Loret, Camille

AU - Rupin, Matthieu

AU - Blitz, Sandra

AU - Jacobs, Philip

AU - Murawsky, Michael

AU - Riva, Alessandro

AU - Vogel, Charles

PY - 2005/6/2

Y1 - 2005/6/2

N2 - BACKGROUND We compared docetaxel plus doxorubicin and cyclophosphamide (TAC) with fluorouracil plus doxorubicin and cyclophosphamide (FAC) as adjuvant chemotherapy for operable node-positive breast cancer. METHODS We randomly assigned 1491 women with axillary node-positive breast cancer to six cycles of treatment with either TAC or FAC as adjuvant chemotherapy after surgery. The primary end point was disease-free survival. RESULTS At a median follow-up of 55 months, the estimated rates of disease-free survival at five years were 75 percent among the 745 patients randomly assigned to receive TAC and 68 percent among the 746 randomly assigned to receive FAC, representing a 28 percent reduction in the risk of relapse (P=0.001) in the TAC group. The estimated rates of overall survival at five years were 87 percent and 81 percent, respectively. Treatment with TAC resulted in a 30 percent reduction in the risk of death (P=0.008). The incidence of grade 3 or 4 neutropenia was 65.5 percent in the TAC group and 49.3 percent in the FAC group (P<0.001); rates of febrile neutropenia were 24.7 percent and 2.5 percent, respectively (P<0.001). Grade 3 or 4 infections occurred in 3.9 percent of the patients who received TAC and 2.2 percent of those who received FAC (P=0.05); no deaths occurred as a result of infection. Two patients in each group died during treatment. Congestive heart failure and acute myeloid leukemia occurred in less than 2 percent of the patients in each group. Quality-of-life scores decreased during chemotherapy but returned to baseline levels after treatment. CONCLUSIONS Adjuvant chemotherapy with TAC, as compared with FAC, significantly improves the rates of disease-free and overall survival among women with operable node-positive breast cancer.

AB - BACKGROUND We compared docetaxel plus doxorubicin and cyclophosphamide (TAC) with fluorouracil plus doxorubicin and cyclophosphamide (FAC) as adjuvant chemotherapy for operable node-positive breast cancer. METHODS We randomly assigned 1491 women with axillary node-positive breast cancer to six cycles of treatment with either TAC or FAC as adjuvant chemotherapy after surgery. The primary end point was disease-free survival. RESULTS At a median follow-up of 55 months, the estimated rates of disease-free survival at five years were 75 percent among the 745 patients randomly assigned to receive TAC and 68 percent among the 746 randomly assigned to receive FAC, representing a 28 percent reduction in the risk of relapse (P=0.001) in the TAC group. The estimated rates of overall survival at five years were 87 percent and 81 percent, respectively. Treatment with TAC resulted in a 30 percent reduction in the risk of death (P=0.008). The incidence of grade 3 or 4 neutropenia was 65.5 percent in the TAC group and 49.3 percent in the FAC group (P<0.001); rates of febrile neutropenia were 24.7 percent and 2.5 percent, respectively (P<0.001). Grade 3 or 4 infections occurred in 3.9 percent of the patients who received TAC and 2.2 percent of those who received FAC (P=0.05); no deaths occurred as a result of infection. Two patients in each group died during treatment. Congestive heart failure and acute myeloid leukemia occurred in less than 2 percent of the patients in each group. Quality-of-life scores decreased during chemotherapy but returned to baseline levels after treatment. CONCLUSIONS Adjuvant chemotherapy with TAC, as compared with FAC, significantly improves the rates of disease-free and overall survival among women with operable node-positive breast cancer.

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