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.
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
Item type | Current library | Collection | Call number | Status | Date due | Barcode |
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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).
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