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Amenorrhea in premenopausal women on the doxorubicin-and-cyclophosphamide-followed-by-docetaxel arm of NSABP B-30 trial

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Abstract

The NSABP B-30 trial addresses whether amenorrhea after adjuvant chemotherapy increases survival. Preliminary to the trial outcome analysis, we examined the incidence of amenorrhea and its relationship to symptoms and quality of life (QOL) in the standard-care arm of this adjuvant breast cancer trial. Premenopausal women treated on the doxorubicin-and-cyclophosphamide-followed-by-docetaxel arm were included. Questionnaires assessing menstrual history, QOL, and symptoms were administered at baseline, day 1 of cycle 4 (or 9 weeks from start of chemotherapy for those who stopped chemotherapy early), and at 6, 12, and 24 months. Seven hundred and eight patients were evaluable for the analysis, with median potential follow-up of 57.5 months. Of these, 321 patients also participated in the QOL substudy. Of the 708 patients, 83% reported ≥1 episode of amenorrhea for ≥6 months. The estimated rate of resumption of menses at 24 months was 45.3% for women <40 years, 10.9% for women 40–50, and 3.2% for women >50 years. Those treated with tamoxifen were more likely to become amenorrheic (p = 0.003). Menstrual status was not significantly associated with QOL or symptoms. Prolonged amenorrhea is associated with a regimen that contains doxorubicin, cyclophosphamide, and docetaxel, and is age dependent and impacted by tamoxifen use. Vasomotor symptoms are common in this patient population but are not associated with menstrual status. These results can be used to inform premenopausal women about the risk and time course of amenorrhea associated with this common adjuvant therapy regimen, along with the effects on symptoms and QOL.

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Acknowledgments

Public Health Service grants U10CA-12027, U10CA-37377, U10CA-69651, and U10CA-69974 from the National Cancer Institute, Department of Health and Human Services provided support for this article. The views expressed in this article are solely those of the authors and do not necessarily represent the official views of the National Cancer Institute or the U.S. federal government. We wish to thank Barbara C. Good, PhD, Director of Scientific Publications for the NSABP, for editorial assistance.

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Correspondence to Sandra M. Swain.

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This work represents original research by the authors. Previously presented at ASCO 2005 as a poster (abstr # 537).

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Swain, S.M., Land, S.R., Ritter, M.W. et al. Amenorrhea in premenopausal women on the doxorubicin-and-cyclophosphamide-followed-by-docetaxel arm of NSABP B-30 trial. Breast Cancer Res Treat 113, 315–320 (2009). https://doi.org/10.1007/s10549-008-9937-0

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