title: Quality of life among patients with Stage II and III breast carcinoma randomized to receive high-dose chemotherapy with autologous bone marrow support or intermediate-dose chemotherapy: results from Cancer and Leukemia Group B 9066.
abstract: BACKGROUND
  The objective of this study was to compare the quality of life (QOL) after treatment among patients who had breast carcinoma with multiple positive lymph nodes. The patients were randomized to receive either high-dose chemotherapy with autologous stem cell support (HDC) or intermediate-dose chemotherapy (IDC) in the adjuvant setting.
  
  
  METHODS
  Two hundred forty-six patients with AJCC Stage IIA, IIB, or IIIA breast carcinoma who had > or = 10 positive lymph nodes and who were participants in Cancer and Leukemia Group B (CALGB) 9082 were enrolled in this companion study, CALGB 9066. Patients were randomized to receive either high-dose cyclophosphamide, carmustine, and cisplatin (CPA/cDDP/BCNU) and autologous bone marrow transplantation (the HDC arm) or intermediate-dose CPA/cDDP/BCNU as consolidation to adjuvant chemotherapy (the IDC arm). QOL was assessed at baseline and at 3 months, 12 months, 24 months, and 36 months using the Functional Living Index-Cancer (FLIC), the Psychosocial Adjustment to Illness Scale (PAIS)-Self Report, and the McCorkle Symptom Distress Scale (SDS).
  
  
  RESULTS
  At the 3-month assessment, patients in the HDC arm demonstrated significant worsening of QOL compared with the IDC arm in terms of their physical well being (FLIC, P = 0.023), social functioning (FLIC, P = 0.026; PAIS, P < 0.0001), symptom distress (SDS, P = 0.0002), and total QOL scores (FLIC, P = 0.042). At 12 months, the differences in QOL scores between the HDC arm and the IDC arm had resolved.
  
  
  CONCLUSIONS
  Patients who received more intensive adjuvant therapy experienced transient declines in QOL. By 12 months after therapy, QOL was comparable between the 2 arms, regardless of therapy intensity, and many QOL areas were improved from baseline.
authors.affiliation: Department of Medical Oncology, Dana Farber Cancer Institute, Boston, Massachusetts 02115, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Peppercorn
authors.forename: James
authors.initials: J
authors.lastname: Herndon
authors.forename: Alice B
authors.initials: AB
authors.lastname: Kornblith
authors.forename: William
authors.initials: W
authors.lastname: Peters
authors.forename: Tim
authors.initials: T
authors.lastname: Ahles
authors.forename: James
authors.initials: J
authors.lastname: Vredenburgh
authors.forename: Gary
authors.initials: G
authors.lastname: Schwartz
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Shpall
authors.forename: David D
authors.initials: DD
authors.lastname: Hurd
authors.forename: Jimmie
authors.initials: J
authors.lastname: Holland
authors.forename: Eric
authors.initials: E
authors.lastname: Winer
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D016026:Bone Marrow Transplantation; D001943:Breast Neoplasms / Q000523:psychology / Q000628:therapy*; D002330:Carmustine / Q000008:administration & dosage; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D011788:Quality of Life; D015996:Survival Rate; D013997:Time Factors; D014182:Transplantation, Autologous
chemical_list: D003520:Cyclophosphamide; D002945:Cisplatin; D002330:Carmustine