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.
J Clin Oncol
; 31(26): 3197-204, 2013 Sep 10.
Article
em En
| MEDLINE
| ID: mdl-23940225
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 ANDMETHODS:
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 ACâP), or DD ACâP with four cycles of gemcitabine (G) added to the DD paclitaxel (DD ACâPG). 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 ACâPG and DD ACâP (80.6% v 82.2%; HR, 1.07; P = .41), between DD ACâPG and TAC (80.6% v 80.1%; HR, 0.93; P = .39), in 5-year overall survival (OS) between DD ACâPG and DD ACâP (90.8% v 89.1%; HR, 0.85; P = .13), between DD ACâPG and TAC (90.8% v 89.6%; HR, 0.86; P = .17), or between DD ACâP versus TAC for DFS (HR, 0.87; P = .07) and OS (HR, 1.01; P = .96). Grade 3 to 4 toxicities for TAC, DD ACâP, and DD ACâPG, 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 ACâP did not improve outcomes. No significant differences in efficacy were identified between DD ACâP and TAC, although toxicity profiles differed.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Mama
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Protocolos de Quimioterapia Combinada Antineoplásica
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Fator Estimulador de Colônias de Granulócitos
Tipo de estudo:
Clinical_trials
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Observational_studies
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Prognostic_studies
/
Risk_factors_studies
Limite:
Aged
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
J Clin Oncol
Ano de publicação:
2013
Tipo de documento:
Article