Phase III trial of LHRH analog during chemotherapy to reduce ovarian failure in early-stage, hormone receptor-negative breast cancer: An international Intergroup trial of SWOG, IBCSG, ECOG, and CALGB

Abstract

LBA505 Background: Premature ovarian failure is a common toxicity of CT. Risk depends on type and amount of CT, age, and perhaps ovarian cycling at the time of CT. POEMS is a SWOG-coordinated phase III randomized study to evaluate whether LHRH analog administration with CT for early-stage breast cancer would reduce POF.Premenopausal patients age.05). POF rates were 22% in the standard arm and 8% in the GN arm. In a sensitivity analysis defining 2-year POF more liberally as either amenorrhea or elevated FSH, 45% in the standard arm and 20% in the GN arm had POF. There were 13 pregnancies in the standard arm and 22 in the GN arm. DFS and OS were better in the GN arm.LHRH analog administration with CT was associated with less POF and more pregnancies. In an exploratory analysis, GN use in premenopausal ER-negative BC was associated with improved DFS and OS.NCT00068601.

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