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J Clin Oncol. 2013 Sep 10;31(26):3197-204. doi: 10.1200/JCO.2012.48.1275. Epub 2013 Aug 12.

Definitive results of a phase III adjuvant trial comparing three chemotherapy regimens in women with operable, node-positive breast cancer: the NSABP B-38 trial.

Author information

1
Sandra M. Swain, Gong Tang, Charles E. Geyer Jr, Priya Rastogi, James N. Atkins, Paul P. Donnellan, Louis Fehrenbacher, Catherine A. Azar, André Robidoux, Jonathan A. Polikoff, Adam M. Brufsky, David D. Biggs, Edward A. Levine, John L. Zapas, Louise Provencher, Soonmyung Paik, Joseph P. Costantino, Eleftherios P. Mamounas, and Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project (NSABP); Norman Wolmark, Allegheny General Hospital, Allegheny Health Network; Gong Tang and Joseph P. Costantino, NSABP Biostatistical Center and University of Pittsburgh Graduate School of Public Health; Priya Rastogi, University of Pittsburgh Cancer Institute; Adam M. Brufsky, Magee-Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA; Sandra M. Swain, MedStar Washington Hospital Center, Washington, DC; Charles E. Geyer Jr, Virginia Commonwealth University, Richmond, VA; James N. Atkins, Southeast Cancer Control Consortium-Community Clinical Oncology Program, Goldsboro; Edward A. Levine, Wake Forest University, Winston-Salem, NC; Paul P. Donnellan, University Hospital, Galway, and the All-Ireland Cooperative Oncology Research Group, Dublin, Ireland; Louis Fehrenbacher, Kaiser Permanente Northern California, Vallejo; Jonathan A. Polikoff, Kaiser Permanente Southern California, San Diego, CA; Catherine A. Azar, Kaiser Permanente, Denver, CO; André Robidoux, Centre hopitalier de l'Université de Montréal (CHUM), Montréal; Louise Provencher, CHU de Québec, Hôpital du Saint-Sacrement, Québec City, QC, Canada; David D. Biggs, Helen F. Graham Cancer Center, Christiana Care Health System, Newark, DE; John L. Zapas, Medstar Franklin Square Medical Center, Baltimore, MD; Donald W. Northfelt, Mayo Clinic Arizona, Scottsdale, AZ; and Eleftherios P. Mamounas, MD Anderson Cancer Center, Orlando, FL.

Abstract

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00093795.

PMID:
23940225
PMCID:
PMC3757290
DOI:
10.1200/JCO.2012.48.1275
[Indexed for MEDLINE]
Free PMC Article

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