title: Symptoms of endocrine treatment and outcome in the BIG 1-98 study.
abstract: There may be a relationship between the incidence of vasomotor and arthralgia/myalgia symptoms and treatment outcomes for postmenopausal breast cancer patients with endocrine-responsive disease who received adjuvant letrozole or tamoxifen. Data on patients randomized into the monotherapy arms of the BIG 1-98 clinical trial who did not have either vasomotor or arthralgia/myalgia/carpal tunnel (AMC) symptoms reported at baseline, started protocol treatment and were alive and disease-free at the 3-month landmark (n = 4,798) and at the 12-month landmark (n = 4,682) were used for this report. Cohorts of patients with vasomotor symptoms, AMC symptoms, neither, or both were defined at both 3 and 12 months from randomization. Landmark analyses were performed for disease-free survival (DFS) and for breast cancer free interval (BCFI), using regression analysis to estimate hazard ratios (HR) and 95 % confidence intervals (CI). Median follow-up was 7.0 years. Reporting of AMC symptoms was associated with better outcome for both the 3- and 12-month landmark analyses [e.g., 12-month landmark, HR (95 % CI) for DFS = 0.65 (0.49-0.87), and for BCFI = 0.70 (0.49-0.99)]. By contrast, reporting of vasomotor symptoms was less clearly associated with DFS [12-month DFS HR (95 % CI) = 0.82 (0.70-0.96)] and BCFI (12-month DFS HR (95 % CI) = 0.97 (0.80-1.18). Interaction tests indicated no effect of treatment group on associations between symptoms and outcomes. While reporting of AMC symptoms was clearly associated with better DFS and BCFI, the association between vasomotor symptoms and outcome was less clear, especially with respect to breast cancer-related events.
authors.affiliation: Breast Center, Kantonsspital St. Gallen, St. Gallen, Switzerland, Jens.Huober@uniklinik-ulm.de.
authors.forename: J
authors.initials: J
authors.lastname: Huober
authors.forename: B F
authors.initials: BF
authors.lastname: Cole
authors.forename: M
authors.initials: M
authors.lastname: Rabaglio
authors.forename: A
authors.initials: A
authors.lastname: Giobbie-Hurder
authors.forename: J
authors.initials: J
authors.lastname: Wu
authors.forename: B
authors.initials: B
authors.lastname: Ejlertsen
authors.forename: H
authors.initials: H
authors.lastname: Bonnefoi
authors.forename: J F
authors.initials: JF
authors.lastname: Forbes
authors.forename: P
authors.initials: P
authors.lastname: Neven
authors.forename: I
authors.initials: I
authors.lastname: Láng
authors.forename: I
authors.initials: I
authors.lastname: Smith
authors.forename: A
authors.initials: A
authors.lastname: Wardley
authors.forename: K N
authors.initials: KN
authors.lastname: Price
authors.forename: A
authors.initials: A
authors.lastname: Goldhirsch
authors.forename: A S
authors.initials: AS
authors.lastname: Coates
authors.forename: M
authors.initials: M
authors.lastname: Colleoni
authors.forename: R D
authors.initials: RD
authors.lastname: Gelber
authors.forename: B
authors.initials: B
authors.lastname: Thürlimann
mesh_terms: D000328:Adult; D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects* / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000150:complications* / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D000077289:Letrozole; D008875:Middle Aged; D060787:Neoplasm Grading; D009362:Neoplasm Metastasis; D009570:Nitriles / Q000009:adverse effects / Q000627:therapeutic use; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D012307:Risk Factors; D013629:Tamoxifen / Q000009:adverse effects / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D014230:Triazoles / Q000009:adverse effects / Q000627:therapeutic use; D047368:Tumor Burden
chemical_list: D018931:Antineoplastic Agents, Hormonal; D009570:Nitriles; D014230:Triazoles; D013629:Tamoxifen; D000077289:Letrozole