title: Lumpectomy plus tamoxifen with or without irradiation in women age 70 years or older with early breast cancer: long-term follow-up of CALGB 9343.
abstract: OBJECTIVE
  To determine whether there is a benefit to adjuvant radiation therapy after breast-conserving surgery and tamoxifen in women age ≥ 70 years with early-stage breast cancer.
  
  
  METHODS
  Between July 1994 and February 1999, 636 women (age ≥ 70 years) who had clinical stage I (T1N0M0 according to TNM classification) estrogen receptor (ER) -positive breast carcinoma treated by lumpectomy were randomly assigned to receive tamoxifen plus radiation therapy (TamRT; 317 women) or tamoxifen alone (Tam; 319 women). Primary end points were time to local or regional recurrence, frequency of mastectomy, breast cancer-specific survival, time to distant metastasis, and overall survival (OS).
  
  
  RESULTS
  Median follow-up for treated patients is now 12.6 years. At 10 years, 98% of patients receiving TamRT (95% CI, 96% to 99%) compared with 90% of those receiving Tam (95% CI, 85% to 93%) were free from local and regional recurrences. There were no significant differences in time to mastectomy, time to distant metastasis, breast cancer-specific survival, or OS between the two groups. Ten-year OS was 67% (95% CI, 62% to 72%) and 66% (95% CI, 61% to 71%) in the TamRT and Tam groups, respectively.
  
  
  CONCLUSIONS
  With long-term follow-up, the previously observed small improvement in locoregional recurrence with the addition of radiation therapy remains. However, this does not translate into an advantage in OS, distant disease-free survival, or breast preservation. Depending on the value placed on local recurrence, Tam remains a reasonable option for women age ≥ 70 years with ER-positive early-stage breast cancer.
authors.affiliation: Harvard Medical School, Boston, MA, USA. kshughes@partners.org
authors.forename: Kevin S
authors.initials: KS
authors.lastname: Hughes
authors.forename: Lauren A
authors.initials: LA
authors.lastname: Schnaper
authors.forename: Jennifer R
authors.initials: JR
authors.lastname: Bellon
authors.forename: Constance T
authors.initials: CT
authors.lastname: Cirrincione
authors.forename: Donald A
authors.initials: DA
authors.lastname: Berry
authors.forename: Beryl
authors.initials: B
authors.lastname: McCormick
authors.forename: Hyman B
authors.initials: HB
authors.lastname: Muss
authors.forename: Barbara L
authors.initials: BL
authors.lastname: Smith
authors.forename: Clifford A
authors.initials: CA
authors.lastname: Hudis
authors.forename: Eric P
authors.initials: EP
authors.lastname: Winer
authors.forename: William C
authors.initials: WC
authors.lastname: Wood
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000032:analysis*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy / Q000401:mortality / Q000473:pathology* / Q000601:surgery / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D015412:Mastectomy, Segmental; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D009367:Neoplasm Staging; D016017:Odds Ratio; D018714:Radiotherapy, Adjuvant / Q000706:statistics & numerical data; D011960:Receptors, Estrogen / Q000032:analysis*; D013629:Tamoxifen / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D014408:Biomarkers, Tumor; D011960:Receptors, Estrogen; D013629:Tamoxifen