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.

MedStar author(s):
Citation: Journal of Clinical Oncology. 31(26):3197-204, 2013 Sep 10.PMID: 23940225Institution: Washington Cancer InstituteForm of publication: Journal ArticleMedline article type(s): Clinical Trial, Phase III | Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, N.I.H., ExtramuralSubject headings: *Antineoplastic Combined Chemotherapy Protocols/tu [Therapeutic Use] | *Breast Neoplasms/dt [Drug Therapy] | *Granulocyte Colony-Stimulating Factor/tu [Therapeutic Use] | Aged | Breast Neoplasms/mo [Mortality] | Breast Neoplasms/pa [Pathology] | Chemotherapy, Adjuvant | Cyclophosphamide/ad [Administration & Dosage] | Deoxycytidine/aa [Analogs & Derivatives] | Deoxycytidine/ad [Administration & Dosage] | Doxorubicin/ad [Administration & Dosage] | Drug Therapy, Combination | Female | Follow-Up Studies | Humans | Middle Aged | Neoplasm Invasiveness | Paclitaxel/ad [Administration & Dosage] | Prognosis | Survival Rate | Taxoids/ad [Administration & Dosage]Year: 2013Local holdings: Available online from MWHC library: 1999 - present, Available in print through MWHC library: 1999 - 2008ISSN:
  • 0732-183X
Name of journal: Journal of clinical oncology : official journal of the American Society of Clinical OncologyAbstract: 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.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.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.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).All authors: Atkins JN, Azar CA, Biggs DD, Brufsky AM, Costantino JP, Donnellan PP, Fehrenbacher L, Geyer CE Jr, Levine EA, Mamounas EP, Northfelt DW, Paik S, Polikoff JA, Provencher L, Rastogi P, Robidoux A, Swain SM, Tang G, Wolmark N, Zapas JLFiscal year: FY2014Digital Object Identifier: Date added to catalog: 2014-02-24
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 23940225 Available 23940225

Available online from MWHC library: 1999 - present, Available in print through MWHC library: 1999 - 2008

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.

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.

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.

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).

English

Powered by Koha