Details

Autor(en) / Beteiligte

• SWAIN, Sandra M
• GONG TANG
• BRUFSKY, Adam M
• BIGGS, David D
• LEVINE, Edward A
• ZAPAS, John L
• PROVENCHER, Louise
• NORTHFELT, Donald W
• PAIK, Soonmyung
• COSTANTINO, Joseph P
• MAMOUNAS, Eleftherios P
• WOLMARK, Norman
• GEYER, Charles E
• RASTOGI, Priya
• ATKINS, James N
• DONNELLAN, Paul P
• FEHRENBACHER, Louis
• AZAR, Catherine A
• ROBIDOUX, André
• POLIKOFF, Jonathan A

Titel

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

Ist Teil von

• Journal of clinical oncology, 2013-09, Vol.31 (26), p.3197-3204

Ort / Verlag

Alexandria, VA: American Society of Clinical Oncology

Erscheinungsjahr

2013

Quelle

MEDLINE

Beschreibungen/Notizen

• 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. 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. 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). 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.