TY - JOUR
T1 - Definitive results of a phase III adjuvant trial comparing three chemotherapy regimens in women with operable, node-positive breast cancer
T2 - The NSABP B-38 trial
AU - Swain, Sandra M.
AU - Tang, Gong
AU - Geyer, Charles E.
AU - Rastogi, Priya
AU - Atkins, James N.
AU - Donnellan, Paul P.
AU - Fehrenbacher, Louis
AU - Azar, Catherine A.
AU - Robidoux, André
AU - Polikoff, Jonathan A.
AU - Brufsky, Adam M.
AU - Biggs, David D.
AU - Levine, Edward A.
AU - Zapas, John L.
AU - Provencher, Louise
AU - Northfelt, Donald W.
AU - Paik, Soonmyung
AU - Costantino, Joseph P.
AU - Mamounas, Eleftherios P.
AU - Wolmark, Norman
N1 - Funding Information:
Supported by Grants No. U10-CA- 37377, U10-CA-12027, U10-CA-69651, and U10-CA-69974 (National Surgical Adjuvant Breast and Bowel Project) from the Public Health Service; No. CA 44066-25 (A.R./Centre hopitalier de l'Université de Montréal), and No. U10-CA-25224 (North Central Cancer Treatment Group) from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services. Eli Lilly and Amgen provided funding and/or drug for this trial.
Funding Information:
Supported by Grants No. U10-CA- 37377, U10-CA-12027, U10-CA-69651, and U10-CA-69974 (National Surgical Adjuvant Breast and Bowel Project) from the Public Health Service; No. CA 44066-25 (A.R./Centre hopitalier de l’Université de Montréal), and No. U10-CA-25224 (North Central Cancer Treatment Group) from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services. Eli Lilly and Amgen provided funding and/or drug for this trial.
Publisher Copyright:
Copyright © 2017 American Society of Clinical Oncology. All rights reserved.
PY - 2013/9/10
Y1 - 2013/9/10
N2 - Purpose: Anthracycline- and taxane-based three-drug chemotherapy regimens have proven benefit as adjuvant therapy for early-stage breast cancer. This trial (NSABP B-38; Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Positive Breast Cancer) asked whether the incorporation of a fourth drug could improve outcomes relative to two standard regimens and provided a direct comparison of those two regimens. Patients and Methods: We randomly assigned 4,894 women with node-positive early-stage breast cancer to six cycles of docetaxel, doxorubicin, and cyclophosphamide (TAC), four cycles of dose-dense (DD) doxorubicin and cyclophosphamide followed by four cycles of DD paclitaxel (P; DD AC→P), or DD AC→P with four cycles of gemcitabine (G) added to the DD paclitaxel (DD AC→PG). Primary granulocyte colony-stimulating factor support was required; erythropoiesis-stimulating agents (ESAs) were used at the investigator's discretion. Results: There were no significant differences in 5-year disease-free survival (DFS) between DD AC→PG and DD AC→P (80.6% v 82.2%; HR, 1.07; P = .41), between DD AC→PG and TAC (80.6% v 80.1%; HR, 0.93; P = .39), in 5-year overall survival (OS) between DD AC→PG and DD AC→P (90.8% v 89.1%; HR, 0.85; P = .13), between DD AC→PG and TAC (90.8% v 89.6%; HR, 0.86; P = .17), or between DD AC→P versus TAC for DFS (HR, 0.87; P = .07) and OS (HR, 1.01; P = .96). Grade 3 to 4 toxicities for TAC, DD AC→P, and DD AC→PG, respectively, were febrile neutropenia (9%, 3%, 3%; P < .001), sensory neuropathy (< 1%, 7%, 6%; P < .001), and diarrhea (7%, 2%, 2%; P < .001). Exploratory analyses for ESAs showed no association with DFS events (HR, 1.02; P = .95). Conclusion: Adding G to DD AC→P did not improve outcomes. No significant differences in efficacy were identified between DD AC→P and TAC, although toxicity profiles differed.
AB - Purpose: Anthracycline- and taxane-based three-drug chemotherapy regimens have proven benefit as adjuvant therapy for early-stage breast cancer. This trial (NSABP B-38; Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Positive Breast Cancer) asked whether the incorporation of a fourth drug could improve outcomes relative to two standard regimens and provided a direct comparison of those two regimens. Patients and Methods: We randomly assigned 4,894 women with node-positive early-stage breast cancer to six cycles of docetaxel, doxorubicin, and cyclophosphamide (TAC), four cycles of dose-dense (DD) doxorubicin and cyclophosphamide followed by four cycles of DD paclitaxel (P; DD AC→P), or DD AC→P with four cycles of gemcitabine (G) added to the DD paclitaxel (DD AC→PG). Primary granulocyte colony-stimulating factor support was required; erythropoiesis-stimulating agents (ESAs) were used at the investigator's discretion. Results: There were no significant differences in 5-year disease-free survival (DFS) between DD AC→PG and DD AC→P (80.6% v 82.2%; HR, 1.07; P = .41), between DD AC→PG and TAC (80.6% v 80.1%; HR, 0.93; P = .39), in 5-year overall survival (OS) between DD AC→PG and DD AC→P (90.8% v 89.1%; HR, 0.85; P = .13), between DD AC→PG and TAC (90.8% v 89.6%; HR, 0.86; P = .17), or between DD AC→P versus TAC for DFS (HR, 0.87; P = .07) and OS (HR, 1.01; P = .96). Grade 3 to 4 toxicities for TAC, DD AC→P, and DD AC→PG, respectively, were febrile neutropenia (9%, 3%, 3%; P < .001), sensory neuropathy (< 1%, 7%, 6%; P < .001), and diarrhea (7%, 2%, 2%; P < .001). Exploratory analyses for ESAs showed no association with DFS events (HR, 1.02; P = .95). Conclusion: Adding G to DD AC→P did not improve outcomes. No significant differences in efficacy were identified between DD AC→P and TAC, although toxicity profiles differed.
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U2 - 10.1200/JCO.2012.48.1275
DO - 10.1200/JCO.2012.48.1275
M3 - Article
C2 - 23940225
AN - SCOPUS:84890281455
SN - 0732-183X
VL - 31
SP - 3197
EP - 3204
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 26
ER -