title: Quality of life of older patients with early-stage breast cancer receiving adjuvant chemotherapy: a companion study to cancer and leukemia group B 49907.
abstract: OBJECTIVE
  A phase III trial (Cancer and Leukemia Group B CALGB-49907) was conducted to test whether older patients with early-stage breast cancer would have equivalent relapse-free and overall survival with capecitabine compared with standard chemotherapy. The quality of life (QoL) substudy tested whether capecitabine treatment would be associated with a better QoL than standard chemotherapy.
  
  
  METHODS
  QoL was assessed in 350 patients randomly assigned to either standard chemotherapy (cyclophosphamide, methotrexate, and fluorouracil [CMF] or doxorubicin and cyclophosphamide [AC]; n = 182) or capecitabine (n = 168). Patients were interviewed by telephone before treatment (baseline), midtreatment, within 1 month post-treatment, and at 12, 18, and 24 months postbaseline by using questionnaires from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), a breast systemic adverse effects scale (EORTC BR23), and the Hospital Anxiety and Depression Scale (HADS).
  
  
  RESULTS
  Compared with patients who were treated with standard chemotherapy, patients who were treated with capecitabine had significantly better QoL, role function, and social function, fewer systemic adverse effects, less psychological distress, and less fatigue during and at the completion of treatment (P ≤ .005). Capecitabine treatment was associated with less nausea, vomiting, and constipation and with better appetite than standard treatment (P ≤ .004), but worse hand-foot syndrome and diarrhea (P < .005). These differences all resolved by 12 months.
  
  
  CONCLUSIONS
  Standard chemotherapy was superior to capecitabine in improving relapse-free and overall survival for older women with early-stage breast cancer. Although capecitabine was associated with better QoL during treatment, QoL was similar for both groups at 1 year. The brief period of poorer QoL with standard treatment is a modest price to pay for a chance at improved survival.
authors.affiliation: Dana-Farber Cancer Institute, Boston, MA, USA. akornblith@gmail.com
authors.forename: Alice B
authors.initials: AB
authors.lastname: Kornblith
authors.forename: Lan
authors.initials: L
authors.lastname: Lan
authors.forename: Laura
authors.initials: L
authors.lastname: Archer
authors.forename: Ann
authors.initials: A
authors.lastname: Partridge
authors.forename: Gretchen
authors.initials: G
authors.lastname: Kimmick
authors.forename: Clifford
authors.initials: C
authors.lastname: Hudis
authors.forename: Eric
authors.initials: E
authors.lastname: Winer
authors.forename: Rebecca
authors.initials: R
authors.lastname: Casey
authors.forename: Samantha
authors.initials: S
authors.lastname: Bennett
authors.forename: Harvey Jay
authors.initials: HJ
authors.lastname: Cohen
authors.forename: Hyman B
authors.initials: HB
authors.lastname: Muss
mesh_terms: D000367:Age Factors; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000523:psychology / Q000601:surgery; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D009367:Neoplasm Staging; D011788:Quality of Life; D018570:Risk Assessment; D012307:Risk Factors; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D004317:Doxorubicin; D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate