title: Menstrual history and quality-of-life outcomes in women with node-positive breast cancer treated with adjuvant therapy on the NSABP B-30 trial.
abstract: OBJECTIVE
  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.
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: National Surgical Adjuvant Breast and Bowel Project Operations Center (NSABP), Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA. pganz@mednet.ucla.edu
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Ganz
authors.forename: Stephanie R
authors.initials: SR
authors.lastname: Land
authors.forename: Charles E
authors.initials: CE
authors.lastname: Geyer
authors.forename: Reena S
authors.initials: RS
authors.lastname: Cecchini
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Costantino
authors.forename: Eduardo R
authors.initials: ER
authors.lastname: Pajon
authors.forename: Louis
authors.initials: L
authors.lastname: Fehrenbacher
authors.forename: James N
authors.initials: JN
authors.lastname: Atkins
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: Polikoff
authors.forename: Victor G
authors.initials: VG
authors.lastname: Vogel
authors.forename: John K
authors.initials: JK
authors.lastname: Erban
authors.forename: Robert B
authors.initials: RB
authors.lastname: Livingston
authors.forename: Edith A
authors.initials: EA
authors.lastname: Perez
authors.forename: Eleftherios P
authors.initials: EP
authors.lastname: Mamounas
authors.forename: Norman
authors.initials: N
authors.lastname: Wolmark
authors.forename: Sandra M
authors.initials: SM
authors.lastname: Swain
mesh_terms: D000328:Adult; D000568:Amenorrhea / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology; D008207:Lymphatic Metastasis; D008598:Menstruation; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D015996:Survival Rate; D013629:Tamoxifen / Q000008:administration & dosage; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D013629:Tamoxifen; D000077143:Docetaxel; D004317:Doxorubicin; D003520:Cyclophosphamide