title: Timing of adjuvant chemotherapy and tamoxifen in women with breast cancer: findings from two consecutive trials of Gruppo Oncologico Nord-Ovest-Mammella Intergruppo (GONO-MIG) Group.
abstract: BACKGROUND
  The timing of adjuvant chemotherapy and tamoxifen (TAM) has been investigated only in postmenopausal women with breast cancer. We analyzed the outcome of both pre- and postmenopausal women who entered two randomized trials (Gruppo Oncologico Nord-Ovest-Mammella Intergruppo studies) on adjuvant chemotherapy and received either concomitant or sequential TAM.
  
  
  METHODS
  Patients who received anthracycline-based regimens and either concomitant or sequential TAM were eligible. The primary end point was overall survival (OS). Hazard ratios (HRs) of death or recurrence for treatment comparisons were estimated by Cox proportional hazards regression models.
  
  
  RESULTS
  Among the 1096 eligible patients, 507 (46.3%) and 589 (53.7%) received concomitant and sequential TAM, respectively. The median follow-up time was 6.6 years. Ten-year OS was 83% [95% confidence interval (CI) 78-88%] and 80% (95% CI 74-86%) in the concomitant and sequential groups, respectively. Multivariate analyses confirmed no significant difference in the hazard of death (HR = 1.13; 95% CI 0.78-1.64; P = 0.534) and recurrence (HR = 1.03; 95% CI 0.80-1.33; P = 0.88) between the two groups. A decreasing trend (P = 0.015) in HR of death with increasing age was observed indicating, that concomitant therapy might be more effective than sequential therapy in young patients.
  
  
  CONCLUSIONS
  We observed no outcome difference between sequential and concomitant chemo-endocrine therapy. The potential advantage of concomitant TAM in young patients needs to be further addressed in prospective trials.
authors.affiliation: Oncologia Medica A, Istituto Nazionale per Ricerca sul Cancro, Largo Rosanna Benzi, Genova, Italy. lucia.delmastro@istge.it
authors.forename: L
authors.initials: L
authors.lastname: Del Mastro
authors.forename: B
authors.initials: B
authors.lastname: Dozin
authors.forename: E
authors.initials: E
authors.lastname: Aitini
authors.forename: T
authors.initials: T
authors.lastname: Catzeddu
authors.forename: E
authors.initials: E
authors.lastname: Baldini
authors.forename: A
authors.initials: A
authors.lastname: Contu
authors.forename: A
authors.initials: A
authors.lastname: Durando
authors.forename: S
authors.initials: S
authors.lastname: Danese
authors.forename: G
authors.initials: G
authors.lastname: Cavazzini
authors.forename: G
authors.initials: G
authors.lastname: Canavese
authors.forename: P
authors.initials: P
authors.lastname: Bruzzi
authors.forename: P
authors.initials: P
authors.lastname: Pronzato
authors.forename: M
authors.initials: M
authors.lastname: Venturini
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000367:Age Factors; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D016001:Confidence Intervals; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015412:Mastectomy, Segmental / Q000379:methods; D008875:Middle Aged; D015999:Multivariate Analysis; D009367:Neoplasm Staging; D017698:Postmenopause; D017697:Premenopause; D011336:Probability; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D018570:Risk Assessment; D016019:Survival Analysis; D013629:Tamoxifen / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors
chemical_list: D013629:Tamoxifen