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原文：
Phase III trial (Prevention of EarlyMenopause Study [POEMS]-SWOG S0230) of LHRH analog during chemotherapy (CT) toreduce ovarian failure in early-stage, hormone receptor-negative breast cancer:An international Intergroup trial of SWOG, IBCSG, ECOG, and CALGB (Alliance). Sub-category: ER+ Category: Breast Cancer - HER2/ER Meeting: 2014 ASCO Annual Meeting Abstract No: LBA505 Citation: J Clin Oncol 32:5s, 2014 (suppl;abstr LBA505) Author(s): Halle C. F. Moore, Joseph M.Unger, Kelly-Anne Phillips, Frances M. Boyle, Erika Hitre, David James Porter,Prudence A. Francis, Lori M. Minasian, Richard D. Gelber, Lori J. Goldstein,Henry Leonidas Gomez, Carlos Vallejos, Ann H. Partridge, Shaker R. Dakhil,Silvana Martino, William E. Barlow, Carol J. Fabian, Frank L. Meyskens, GabrielN. Hortobagyi, Kathy S. Albain; Cleveland Clinic, Cleveland, OH; SWOGStatistical Center, Seattle, WA; Peter MacCallum Cancer Center, Melbourne,Australia; The Mater Hospital, Sydney, Australia; National Institute ofOncology, Budapest, Hungary; Department of Oncology, Auckland City Hospital,Auckland, New Zealand; Peter MacCallum Cancer Centre, East Melbourne,Australia; National Cancer Institute, Bethesda, MD; Department of Biostatisticsand Computational Biology, Dana-Farber Cancer Institute, Boston, MA; Fox ChaseCancer Center, Philadelphia, PA; Instituto Nacional de EnfermedadesNeoplásicas, Lima, Peru; ONCOSALUD, Lima, Peru; Dana-Farber Cancer Institute,Boston, MA; Wichita Community Clinical Oncology Program, Wichita, KS; TheAngeles Clinic and Research Institute, Santa Monica, CA; Cancer Research andBiostatistics, Seattle, WA; University of Kansas Medical Center, Kansas City,KS; Chao Family Comprehensive Cancer Center, Orange, CA; The University ofTexas MD Anderson Cancer Center, Houston, TX; Loyola University Medical Center,Maywood, IL Background Premature ovarian failure (POF) is a commontoxicity of CT. Risk depends on type and amount of CT, age, and perhaps ovariancycling at the time of CT. POEMS is a SWOG-coordinated phase III randomizedstudy to evaluate whether LHRH analog administration with CT for early-stagebreast cancer (BC) would reduce POF. Methods Premenopausal patients (PT) age <50 withstage I-IIIA ER/PR-negative BC to be treated with CT were randomized to receivestandard cyclophosphamide-containing CT with or without monthly goserelin (GN)3.6 mg SQ starting 1 week prior to the first CT dose. The primary endpoint is2-year POF, defined as amenorrhea for the prior 6 months and post-menopausalFSH. Other endpoints include pregnancies and survival. Endpoints were analyzedin multivariable regression adjusting for stratification factors (age and CTregimen). Results Between 2/04 and 5/11, 257 PT enrolled.Among 218 evaluable PT, 62% had complete primary endpoint data. Dropouts (n=83)were mostly due to deaths (n=14) or lack of FSH data. There was no strongevidence of informative missing data by arm according to stratification factors(p>.05). POF rates were 22% in the standard arm and 8% in the GN arm(OR=0.30, 95% CI: 0.10-0.87, p=.03 [unadjusted analysis]; OR=0.36, 95%CI:0.11-1.14, p=0.08 [adjusted logistic regression analysis]). In a sensitivityanalysis defining 2-year POF more liberally as either amenorrhea or elevatedFSH, 45% in the standard arm and 20% in the GN arm had POF (OR=0.29, 95% CI:0.12-0.70, p=.006). There were 13 pregnancies in the standard arm and 22 in theGN arm (OR=2.22, 95% CI: 1.00-4.92, p=.05). DFS and OS were better in the GNarm (Cox regression, including stage: HR=0.49, 95% CI: 0.24-0.97, p=.04;HR=0.43, 95% CI: 0.18-1.00, p=.05, respectively). Conclusions LHRH analog administration with CT wasassociated with less POF and more pregnancies. In an exploratory analysis, GNuse in premenopausal ER-negative BC was associated with improved DFS and OS. |
