Menstrual History and Quality-of-Life Outcomes in Women With Node-Positive Breast Cancer Treated With Adjuvant Therapy on the NSABP B-30 Trial

Author:

Ganz Patricia A.1,Land Stephanie R.1,Geyer Charles E.1,Cecchini Reena S.1,Costantino Joseph P.1,Pajon Eduardo R.1,Fehrenbacher Louis1,Atkins James N.1,Polikoff Jonathan A.1,Vogel Victor G.1,Erban John K.1,Livingston Robert B.1,Perez Edith A.1,Mamounas Eleftherios P.1,Wolmark Norman1,Swain Sandra M.1

Affiliation:

1. From the National Surgical Adjuvant Breast and Bowel Project Operations Center (NSABP); NSABP Biostatistical Center, Graduate School of Public Health, University of Pittsburgh; University of Pittsburgh Cancer Center; Allegheny General Hospital, Pittsburgh; Eastern Cooperative Oncology Group, Philadelphia, PA; University of California, Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles; Kaiser Permanente Northern California, Vallejo; Southern California Kaiser Permanente, San Diego, CA;...

Abstract

Purpose Premenopausal women with breast cancer receiving adjuvant chemotherapy are at risk for amenorrhea. The National Surgical Adjuvant Breast and Bowel Project B-30 trial included menstrual history (MH) and quality-of-life (QOL) studies to compare treatments on these outcomes. Patients and Methods Patients were randomly assigned to sequential doxorubicin (A) and cyclophosphamide (C) followed by docetaxel (T; AC→T), concurrent TAC, or AT, which varied in duration (24, 12, 12 weeks, respectively), and use of C. Endocrine therapy was prescribed for women with hormone receptor–positive tumors. MH and QOL were assessed with standardized questionnaires at baseline; cycle 4, day 1; and every 6 months through 24 months. Prespecified analyses examined rates of amenorrhea by treatment arm, the relationship between amenorrhea and QOL, and QOL by treatment arm. Results Amenorrhea 12 months after random assignment was significantly different between treatment groups: 69.8% for AC→T, 57.7% for TAC, and 37.9% for AT (P < .001). The AT group without tamoxifen had the lowest rate of amenorrhea. QOL was poorer for patients receiving AC→T at 6 months but similar to others by 12 months. Post-treatment symptoms were increased above baseline for all treatments. Multivariable repeated measures modeling demonstrated that treatment arm, time point, age, and tamoxifen use were significantly associated with symptom severity (all P values < .002). Conclusion Amenorrhea rates differed significantly by treatment arm, with the AT arm having the lowest rate. Patients treated with longer duration therapy (AC→T) had greater symptom severity and poorer QOL at 6 months, but did not differ from shorter duration treatments at 12 months.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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