A total of 12 women in the chemotherapy-alone arm achieved pregnancy, as did 22 in the goserelin arm (OR, 2.45; P = 0.03). These pregnancies resulted in 16 patients (15% of the group) delivering at least one baby on the goserelin arm compared with eight patients (7%) on the control arm. An additional five patients on the goserelin arm and three on the standard arm had not had a documented delivery but were still pregnant. The study also found goserelin was not associated with an increased risk of either miscarriages (4 vs. 5 in the chemotherapy-alone arm), effective termination (3 vs. 2), or delivery complications (2 vs.2).
Dr. Halle also reported that in an exploratory analysis, goserelin use in premenopausal estrogen receptor–negative breast cancer was associated with improved DFS and OS.
“Goserelin use led to consistent evidence of better preserved ovarian function across multiple end points,” Dr. Moore said. She added that this is the first demonstration of improved fertility prospects and more successful pregnancies when goserelin was used with chemotherapy.
Based on the POEMS findings, premenopausal women beginning curative intent chemotherapy for breast cancer should consider this new option to prevent premature ovarian failure.
“Preserving fertility is an important component of quality survivorship care,” Patricia Ganz, MD, ASCO Expert, commented in a press release. “This study provides strong evidence for a safe and effective strategy for younger women with breast cancer to preserve ovarian function and the possibility of pregnancy.”
Limitations of the POEMS study are that it did not meet its full accrual; endpoint data are missing for 38% of patients—although there is no evidence that patterns of follow-up by arm significantly differed with respect to stratification variables—and it was not stratified for disease risk factors, such as stage, HER2, or nodal status. However, stage adjustment did not alter DFS or OS, Dr. Moore said.
- Moore HCF, Unger JM, Phillips KA et al. Abstract LBA505. Presented at: 2014 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2014; Chicago, IL.