title: Quantifying trade-offs: quality of life and quality-adjusted survival in a randomised trial of chemotherapy in postmenopausal patients with lymph node-negative breast cancer.
abstract: We evaluated quality of life (QL) and quality-adjusted survival in International Breast Cancer Study Group Trial IX, a randomised trial including 1669 eligible patients receiving tamoxifen for 5 years or three prior cycles of cyclophosphamide, methotrexate and 5-fluorouracil (CMF) followed by 57 months tamoxifen. During the time with CMF toxicity (Tox), without symptoms and toxicity (TWiST), and following relapse (Rel), patients scored their QL indicators and a utility indicator for subjective health estimation between 'perfect' and 'worst' health. Scores were averaged within Tox, TWiST and Rel and transformed to utilities. Mean durations for the three transition times were weighted with utilities to obtain mean quality-adjusted TWiST (Q-TWiST). Patients receiving CMF reported significantly worse scores for most QL domains at month 3, but less hot flushes. After completing chemotherapy, there were no differences by treatment groups. Benefits evaluated by Q-TWiST favoured the additional chemotherapy. CMF provided 3 more months of Q-TWiST for patients with ER-negative tumours, but CMF provided no benefit in Q-TWiST for patients with ER-positive tumours. Q-TWiST analysis based on patient ratings is feasible in large-scale cross-cultural clinical trials.
authors.affiliation: IBCSG Coordinating Center, Bern, Switzerland. juerg.bernhard@ibcsg.org
authors.forename: J
authors.initials: J
authors.lastname: Bernhard
authors.forename: D
authors.initials: D
authors.lastname: Zahrieh
authors.forename: A S
authors.initials: AS
authors.lastname: Coates
authors.forename: R D
authors.initials: RD
authors.lastname: Gelber
authors.forename: M
authors.initials: M
authors.lastname: Castiglione-Gertsch
authors.forename: E
authors.initials: E
authors.lastname: Murray
authors.forename: J F
authors.initials: JF
authors.lastname: Forbes
authors.forename: L
authors.initials: L
authors.lastname: Perey
authors.forename: J
authors.initials: J
authors.lastname: Collins
authors.forename: R
authors.initials: R
authors.lastname: Snyder
authors.forename: C-M
authors.initials: CM
authors.lastname: Rudenstam
authors.forename: D
authors.initials: D
authors.lastname: Crivellari
authors.forename: A
authors.initials: A
authors.lastname: Veronesi
authors.forename: B
authors.initials: B
authors.lastname: Thürlimann
authors.forename: M F
authors.initials: MF
authors.lastname: Fey
authors.forename: K N
authors.initials: KN
authors.lastname: Price
authors.forename: A
authors.initials: A
authors.lastname: Goldhirsch
authors.forename: C
authors.initials: C
authors.lastname: Hürny
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D009367:Neoplasm Staging; D017698:Postmenopause; D011788:Quality of Life; D011960:Receptors, Estrogen / Q000378:metabolism; D015996:Survival Rate; D013629:Tamoxifen / Q000008:administration & dosage
chemical_list: D011960:Receptors, Estrogen; D013629:Tamoxifen; D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate