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Reducing the risk for breast cancer recurrence after completion of tamoxifen treatment in postmenopausal women.

Abstract In postmenopausal women with hormone-sensitive early stage breast cancer, the risk for relapse persists after 5 years of treatment with adjuvant tamoxifen. Because tamoxifen is not indicated for adjuvant therapy beyond 5 years, the need for another therapy in the extended adjuvant setting to reduce late recurrence risk is clear. The National Cancer Institute of Canada Clinical Trials Group MA.17 and the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-33 trial found that extended adjuvant therapy with an aromatase inhibitor (AI) (eg, letrozole, exemestane, or anastrozole) rendered additional benefit in postmenopausal women with hormone receptor-positive breast cancer. The MA.17 trial was unblinded at the first interim analysis (median follow-up, 2.4 years) due to a significant reduction in relative risk for recurrence (P < 0.001). Following the publication of the final analysis, several other MA.17 trial analyses and a postblinding analysis were also conducted. Recent data on the NSABP B-33 trial, which investigated exemestane in the extended adjuvant setting, and Austrian Breast and Colorectal Cancer Study Group (ABCSG) trial 6a, which evaluated anastrozole in the extended adjuvant setting, have also been reported.
PMID
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Authors

Mayor MeshTerms

Postmenopause

Keywords
Journal Title clinical therapeutics
Publication Year Start




PMID- 17919537
OWN - NLM
STAT- MEDLINE
DA  - 20071008
DCOM- 20071206
LR  - 20161124
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 29
IP  - 8
DP  - 2007 Aug
TI  - Reducing the risk for breast cancer recurrence after completion of tamoxifen
      treatment in postmenopausal women.
PG  - 1535-47
AB  - BACKGROUND: In postmenopausal women with hormone-sensitive early stage breast
      cancer, the risk for relapse persists after 5 years of treatment with adjuvant
      tamoxifen. Because tamoxifen is not indicated for adjuvant therapy beyond 5
      years, the need for another therapy in the extended adjuvant setting to reduce
      late recurrence risk is clear. The National Cancer Institute of Canada Clinical
      Trials Group MA.17 and the National Surgical Adjuvant Breast and Bowel Project
      (NSABP) B-33 trial found that extended adjuvant therapy with an aromatase
      inhibitor (AI) (eg, letrozole, exemestane, or anastrozole) rendered additional
      benefit in postmenopausal women with hormone receptor-positive breast cancer. The
      MA.17 trial was unblinded at the first interim analysis (median follow-up, 2.4
      years) due to a significant reduction in relative risk for recurrence (P &lt;
      0.001). Following the publication of the final analysis, several other MA.17
      trial analyses and a postblinding analysis were also conducted. Recent data on
      the NSABP B-33 trial, which investigated exemestane in the extended adjuvant
      setting, and Austrian Breast and Colorectal Cancer Study Group (ABCSG) trial 6a, 
      which evaluated anastrozole in the extended adjuvant setting, have also been
      reported. OBJECTIVE: The goal of this article was to provide a current review of 
      the MA.17 and NSABP B-33 results, together with additional data, to determine the
      benefit and tolerability of extended adjuvant AI therapy and the potential
      benefits of late extended adjuvant therapy with AIs after a prolonged (&lt;or=5
      years) period after the completion of tamoxifen treatment. METHODS: A literature 
      search was performed. PubMed and MEDLINE were searched for descriptions of
      clinical trials published from 1990 to 2007 using the terms breast cancer,
      extended adjuvant, aromatase inhibitor, anastrozole, exemestane, and letrozole.
      Abstracts from several oncology meetings held between 2001 and 2007 also were
      searched to extract relevant data (disease-free survival [DFS], overall survival 
      [OS]). RESULTS: In MA.17 at 30 months, postmenopausal patients with early stage
      breast cancer who received extended adjuvant letrozole (n = 2593) experienced a
      significant (42%) improvement in DFS regardless of nodal status (P &lt; 0.001), and 
      there was a significant (39%) improvement in as in node-positive patients (P =
      0.04), compared with placebo. At median follow-up (54 months), a postunblinding
      analysis found that patients who were switched to letrozole after a prolonged
      period (up to 5 years) after discontinuation of tamoxifen experienced a 69%
      improvement in DFS (P &lt; 0.001), a 72% improvement in distant DFS (P = 0.002), and
      a 47% improvement in as (P = 0.05) compared with patients who elected to continue
      with no treatment at trial unblinding. Results from 2 other extended adjuvant
      trials, the NSABP B-33, investigating exemestane in the extended setting
      (relapse-free survival, P = 0.03; no significant improvement in DFS or as), and
      the smaller ABCSG 6a, also support a benefit of extended adjuvant AI therapy.
      CONCLUSIONS: Current evidence supports the use of letrozole and perhaps
      exemestane in the extended adjuvant setting, while data on anastrozole are
      emerging. Based on the results from this review, initiation of letrozole
      treatment following a prolonged interval after completion of 5 years of tamoxifen
      treatment might be beneficial.
CI  - Copyright 2007 Excerpta Medica, Inc.
FAU - Jahanzeb, Mohammad
AU  - Jahanzeb M
AD  - Division of Hematology-Oncology, University of Tennessee College of Medicine,
      Memphis, Tennessee 38104, USA. [email protected]
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Androstadienes)
RN  - 0 (Antineoplastic Agents, Hormonal)
RN  - 0 (Aromatase Inhibitors)
RN  - 0 (Nitriles)
RN  - 0 (Triazoles)
RN  - 094ZI81Y45 (Tamoxifen)
RN  - 2Z07MYW1AZ (anastrozole)
RN  - 7LKK855W8I (letrozole)
RN  - NY22HMQ4BX (exemestane)
SB  - IM
MH  - Androstadienes/therapeutic use
MH  - Antineoplastic Agents, Hormonal/administration &amp; dosage/adverse
      effects/*therapeutic use
MH  - Aromatase Inhibitors/administration &amp; dosage/adverse effects/*therapeutic use
MH  - Breast Neoplasms/*drug therapy/mortality
MH  - Chemotherapy, Adjuvant
MH  - Disease-Free Survival
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Nitriles/therapeutic use
MH  - *Postmenopause
MH  - Practice Guidelines as Topic
MH  - Quality of Life
MH  - Risk Assessment
MH  - Secondary Prevention
MH  - Tamoxifen/administration &amp; dosage/adverse effects/*therapeutic use
MH  - Treatment Outcome
MH  - Triazoles/therapeutic use
RF  - 55
EDAT- 2007/10/09 09:00
MHDA- 2007/12/07 09:00
CRDT- 2007/10/09 09:00
PHST- 2007/06/12 [accepted]
AID - S0149-2918(07)00248-2 [pii]
AID - 10.1016/j.clinthera.2007.08.013 [doi]
PST - ppublish
SO  - Clin Ther. 2007 Aug;29(8):1535-47.

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