Amenorrhea in premenopausal women on the doxorubicin-and-cyclophosphamide-followed-by-docetaxel arm of NSABP B-30 trial.
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 > or =1 episode of amenorrhea for > or =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.
Swain
Sandra M
SM
National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA. Sandra.M.Swain@Medstar.net
Land
Stephanie R
SR
Ritter
Marcie W
MW
Costantino
Joseph P
JP
Cecchini
Reena S
RS
Mamounas
Eleftherios P
EP
Wolmark
Norman
N
Ganz
Patricia A
PA
D000328:Adult; D000568:Amenorrhea / Q000139:chemically induced* / Q000523:psychology; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000401:mortality / Q000523:psychology; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects*; D003520:Cyclophosphamide / Q000008:administration & dosage; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D020847:Estrogen Receptor Modulators / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008875:Middle Aged; D017697:Premenopause; D011788:Quality of Life; D017584:Reproductive History; D011795:Surveys and Questionnaires; D015996:Survival Rate; D013629:Tamoxifen / Q000008:administration & dosage / Q000009:adverse effects; D043823:Taxoids / Q000008:administration & dosage; D055815:Young Adult
D018931:Antineoplastic Agents, Hormonal; D020847:Estrogen Receptor Modulators; D043823:Taxoids; D013629:Tamoxifen; D000077143:Docetaxel; D004317:Doxorubicin; D003520:Cyclophosphamide