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PMID- 8901852
DA  - 19961204
DCOM- 19961204
LR  - 20131121
IS  - 0027-8874 (Print)
IS  - 0027-8874 (Linking)
VI  - 88
IP  - 21
DP  - 1996 Nov 06
TI  - Randomized trial of two versus five years of adjuvant tamoxifen for
      postmenopausal early stage breast cancer. Swedish Breast Cancer Cooperative
PG  - 1543-9
AB  - BACKGROUND: Postsurgical treatment with tamoxifen has been shown to improve
      overall survival among patients with early stage breast cancer. However, the
      optimal duration of tamoxifen treatment remains controversial. PURPOSE: A
      multicenter, randomized trial was initiated in Sweden in the early 1980s to
      compare 2 years with 5 years of adjuvant tamoxifen in the treatment of
      postmenopausal women younger than 75 years of age who had early stage, axillary
      lymph node-negative or -positive, invasive disease. METHODS: The trial was
      planned and organized by the Swedish Breast Cancer Group, and it involved five
      regional breast cancer study organizations (South Sweden, South-East Sweden,
      Stockholm, Uppsala-Orebro, and North Sweden). During the period from 1983 through
      1991, a total of 3887 patients were entered in the trial; 3545 (91%) women
      remained alive and recurrence free at 2 years and could thus contribute
      meaningful information to the 2-year (n = 1801) versus 5-year (n = 1744)
      comparison. Primary surgery consisted of either modified radical mastectomy or
      breast-conserving surgery. Radiation therapy was indicated for patients with
      lymph node-positive disease and was generally offered to all women who were
      treated with breast-conserving surgery. Only 89 (2.5%) of the 3545 women who were
      recurrence free at 2 years received adjuvant chemotherapy concurrently with
      tamoxifen. Twenty-milligram daily doses of tamoxifen were used at two centers,
      and 40-mg daily doses were used at the remaining three centers. Estrogen receptor
      status of the tumor was known for 2987 women (77% of the entered patients).
      Primary end points in the trial were event-free survival (local-regional
      recurrence, distant metastasis, contralateral breast cancer, or death) and
      overall survival. Survival curves were estimated by use of the life-table method.
      The Cox proportional hazards model was used to make comparisons between the 2-
      and 5-year treatment groups. RESULTS: Patients assigned to receive 5 years of
      tamoxifen, compared with 2 years of tamoxifen, experienced statistically
      significant improvements in event-free survival (relative hazard = 0.82; 95%
      confidence interval [CI] = 0.71-0.96) and overall survival (relative hazard =
      0.82; 95% CI = 0.69-0.99). These findings translate into an 18% relative
      reduction in both first events (95% CI = 4%-29%) and mortality (95% CI = 1%-31%) 
      with the longer treatment. Overall survival at 10 years was estimated to be 80%
      among patients in the 5-year tamoxifen group who were alive and recurrence free
      at 2 years, compared with 74% among corresponding patients in the 2-year
      treatment group. The benefit associated with the longer treatment extended to
      women with lymph node-positive as well as lymph node-negative disease, but it
      appeared to be restricted to women whose tumors were classified as estrogen
      receptor positive. CONCLUSION: Five years of adjuvant tamoxifen is more
      beneficial than 2 years in the treatment of postmenopausal women with estrogen
      receptor-positive, early stage, invasive breast cancer.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Natl Cancer Inst
JT  - Journal of the National Cancer Institute
JID - 7503089
RN  - 0 (Antineoplastic Agents, Hormonal)
RN  - 0 (Estrogen Antagonists)
RN  - 0 (Receptors, Estrogen)
RN  - 094ZI81Y45 (Tamoxifen)
SB  - IM
CIN - J Natl Cancer Inst. 1996 Nov 6;88(21):1510-2. PMID: 8901846
CIN - J Natl Cancer Inst. 1997 May 7;89(9):659-60. PMID: 9150193
MH  - Aged
MH  - Antineoplastic Agents, Hormonal/*administration & dosage
MH  - Breast Neoplasms/*drug therapy/pathology
MH  - Chemotherapy, Adjuvant
MH  - Disease-Free Survival
MH  - Estrogen Antagonists/*administration & dosage
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Neoplasm Invasiveness
MH  - Neoplasm Staging
MH  - *Postmenopause
MH  - Proportional Hazards Models
MH  - *Receptors, Estrogen
MH  - Survival Analysis
MH  - Sweden
MH  - Tamoxifen/*administration & dosage
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 1996/11/06
MHDA- 1996/11/06 00:01
CRDT- 1996/11/06 00:00
PST - ppublish
SO  - J Natl Cancer Inst. 1996 Nov 6;88(21):1543-9.

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