NSABP B-38: Definitive analysis of a randomized adjuvant trial comparing dose-dense (DD) AC→paclitaxel (P) plus gemcitabine (G) with DD AC→P and with docetaxel, doxorubicin, and cyclophosphamide (TAC) in women with operable, node-positive breast cancer.
2012; Lippincott Williams & Wilkins; Volume: 30; Issue: 18_suppl Linguagem: Inglês
10.1200/jco.2012.30.18_suppl.lba1000
ISSN1527-7755
AutoresSandra M. Swain, Gong Tang, Charles E. Geyer, Priya Rastogi, James N. Atkins, Paul Donnellan, Louis Fehrenbacher, Catherine A. Azar, André Robidoux, Jonathan Polikoff, Adam Brufsky, David D. Biggs, Edward A. Levine, John L. Zapas, Louise Provencher, Edith A. Perez, Soonmyung Paik, Joseph P. Costantino, Eleftherios P. Mamounas, Norman Wolmark,
Tópico(s)Prostate Cancer Treatment and Research
ResumoLBA1000 Background: The primary aims were to determine whether adjuvant DD AC→PG will be superior to DD AC→P as well as to TAC in DFS and to compare the relative DFS of TAC and DD AC→P. Secondary endpoints include survival and toxicity. Methods: From Nov 3, 2004 to May 3, 2007, 4894 women were randomized; 1630 to TAC (docetaxel [T] 75 mg/m 2 , doxorubicin [A] 50 mg/m 2 , cyclophosphamide [C] 500 mg/m 2 q3 wks x 6), 1634 to DD AC→P (A 60 mg/m 2 and C 600 mg/m 2 q2 wks x 4 followed by P 175 mg/m 2 q2 wks x 4), and 1630 to DD AC→PG (A 60 mg/m 2 and C 600 mg/m 2 q2 wks x 4 → P 175 mg/m 2 + G 2000 mg/m 2 q2 wks x 4). Primary G-CSF support was required and erythropoiesis-stimulating agents (ESA) were used at investigator discretion. 52% were postmenopausal, 65% had 1 - 3 positive nodes, and 80% had HR+ breast cancer. Log-rank tests were used for pair-wise comparisons of the primary (DFS) and secondary (OS) endpoints among the three treatment arms. Results: With 64 months median follow-up, 5-year DFS in DD AC→PG group was 80.6% compared with 82.2% in DD AC→P group (HR=1.1; p=0.27) and 80.1 % (HR=0.97; p=0.71) in TAC group. 5-year OS was 90.8% in DD AC→PG group as compared with 89.1% (HR=.89; p=0.25) in DD AC→P group and 89.6 % (HR=0.90; p=0.32) in TAC group. HR for DFS and OS of DD AC→P vs. TAC were 0.89 (p=0.14) and 1.01 (p=0.92) respectively. Toxicities for TAC, DD AC→P, DD AC→PG, respectively: febrile neutropenia (Gr 3/4: 9%, 4%, 4% [p<0.001]), sensory neuropathy (Gr 3/4: <1%, 7%, 6% [p<0.001]), diarrhea (Gr 3/4: 8 %, 2%, 2% [p<0.001]). Hgb was <10 in 12%, 26%, 33% with ESA use in 35.2%, 47%, 51.6% and transfusions in 3.7%, 6.3%, 9.4%. Deaths on treatment: N=13, 5, 7 (p=0.2). AML/MDS: N=5, 8, 11. All cycles completed in 91% for TAC and 88% for DD regimens. Conclusions: Addition of G to DD AC→P did not improve outcomes. No significant differences in efficacy endpoints were identified between DD AC→P and TAC, though toxicity profiles differed. Funding: NCI PHS U10-CA-37377, -69974, -12027, -69651 and NCCTG U10-CA25224, with additional funding from Eli Lilly & Company, and Amgen, Inc.
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