Amenorrhea in premenopausal women on the doxorubicin (A) and cyclophosphamide (C) → docetaxel (T) arm of NSABP B-30: Preliminary results

Abstract

537 Background: NSABP B-30, an adjuvant study with 3 chemotherapy treatment arms in node-positive breast cancer, accrued 5351 patients (pts) from 1999–2004. A secondary objective of this study was to document menstrual history (MH) in premenopausal women in each treatment arm and its relationship to symptoms, quality of life (QOL), disease-free survival, and survival. This report describes preliminary results re MH in the AC ⋄ T arm. Methods: Pts completed a baseline and MH follow-up form day 1 cycle 4 (D1C4), and 6, 12, 18, 24 months (mo) after randomization. Pts < 60 yrs who had been on study ≥ 24 mo were included in this analysis. Results: Of the 528 pts with 24-mo follow-up in the MH study, 490 pts (93%) were menstruating regularly at start of chemotherapy, with 17% of these pts amenorrheic for ≥ 3 mo by D1C4. Including full length of follow-up, 80% reported amenorrhea ≥ 6 mo, 11% for ≥ 3 mo, 4% changes in menstrual cycles, and 5% no changes. The table provides rates of amenorrhea at 6- and 12-month follow-up by age and tamoxifen usage. In a sensitivity analysis designed to account for missing data, median duration of amenorrhea for pts ≤ 30 yrs was estimated to be 3–13 mo; 30.1–40 yrs 9–17 mo; 40.1–60 yrs >24 mo. 354 pts participated in both QOL and MH studies. Menstrual status was not a significant predictor of the FACT-B Trial Outcome Index in repeated measures analysis (p=0.35). Conclusions: Amenorrhea occurred in a substantial percent of women after AC⋄ T, which increased with age. There was no correlation with QOL in this early analysis. Future studies include time to amenorrhea and examine the association of amenorrhea with body mass index and race. No significant financial relationships to disclose.