PMID- 27058233
OWN - NLM
STAT- MEDLINE
DCOM- 20170306
LR  - 20181202
IS  - 1532-3080 (Electronic)
IS  - 0960-9776 (Linking)
VI  - 27
DP  - 2016 Jun
TI  - New onset vasomotor symptoms but not musculoskeletal symptoms associate with 
      clinical outcomes on extended adjuvant letrozole - Analyses from NCIC CTG MA.17.
PG  - 99-104
LID - S0960-9776(16)00025-4 [pii]
LID - 10.1016/j.breast.2016.02.010 [doi]
AB  - PURPOSE: New onset symptoms on adjuvant aromatase inhibitors for hormone receptor 
      positive early breast cancer may associate with clinical outcomes. We performed 
      this exploratory analysis of the association of new onset musculoskeletal (MSK) 
      and vasomotor (VM) symptoms with clinical outcomes in the NCIC CTG MA.17 trial 5 
      years of extended adjuvant endocrine therapy with letrozole after tamoxifen. 
      METHODS: Symptoms were collected at baseline, 1, 6, and every 12 months on study. 
      Multivariate Cox Models adjusting for age, nodal status, duration of tamoxifen 
      and prior chemotherapy were used to compare disease-free survival (DFS), distant 
      disease-free survival (DDFS), and overall survival (OS) based on data collected 
      before, and after, the unblinding between women with VM or MSK symptoms and those 
      without. RESULTS: Data post-unblinding showed new VM symptoms on extended 
      letrozole significantly improved DFS and DDFS when occurring 1 month (DFS HR 
      0.52, 95% CI, 0.28-0.96; p = 0.04; DDFS HR 0.49, 95% CI, 0.24-0.99; p = 0.046) 
      and 6 months (DFS HR 0.43, 95% CI, 0.24-0.78; p = 0.006; DDFS HR 0.44, 95% CI, 
      0.22-0.85; p = 0.02) after treatment initiation. Those with new VM symptoms at 12 
      months also had a significantly better DFS (HR 0.47, 95% CI 0.26, 0.84; P = 0.01) 
      and a trend in improved DDFS. Only a trend to improved OS was found for those 
      with VM symptoms 6 month after treatment. No significant improvement was found 
      for those with new MSK symptoms at any time point or for any endpoint. 
      CONCLUSIONS: New onset VM symptoms with extended letrozole may be useful in 
      predicting treatment benefit.
CI  - Copyright (c) 2016 Elsevier Ltd. All rights reserved.
FAU - Liedke, P E R
AU  - Liedke PE
AD  - Department of Clinical Oncology, Hospital de Clinicas de Porto Alegre, Porto 
      Alegre, RS, Brazil; Mae de Deus Cancer Institute, Hospital Mae de Deus, Porto 
      Alegre, RS, Brazil; Brazilian Breast Cancer Study Group, Porto Alegre, RS, 
      Brazil; Massachusetts General Hospital Cancer Center, Avon International Breast 
      Cancer Research Program, Boston, MA, USA.
FAU - Tu, D
AU  - Tu D
AD  - Canadian Cancer Trials Group, Queen's University, Ontario, Canada.
FAU - Shepherd, L
AU  - Shepherd L
AD  - Canadian Cancer Trials Group, Queen's University, Ontario, Canada.
FAU - Chavarri-Guerra, Y
AU  - Chavarri-Guerra Y
AD  - Department of Hematology-Oncology, Instituto Nacional de Ciencias Medicas y 
      Nutricion, Salvador Zubiran, Mexico; Massachusetts General Hospital Cancer 
      Center, Avon International Breast Cancer Research Program, Boston, MA, USA.
FAU - Pritchard, K I
AU  - Pritchard KI
AD  - Canadian Cancer Trials Group, Queen's University, Ontario, Canada; Sunnybrook 
      Odette Cancer Center, University of Toronto, Toronto, ON, Canada.
FAU - Stearns, V
AU  - Stearns V
AD  - Kimmel Cancer Center at Johns Hopkins, Breast Cancer Program, Baltimore, MD, USA.
FAU - Goss, P E
AU  - Goss PE
AD  - Canadian Cancer Trials Group, Queen's University, Ontario, Canada; Massachusetts 
      General Hospital Cancer Center, Avon International Breast Cancer Research 
      Program, Boston, MA, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160405
PL  - Netherlands
TA  - Breast
JT  - Breast (Edinburgh, Scotland)
JID - 9213011
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Nitriles)
RN  - 0 (Triazoles)
RN  - 094ZI81Y45 (Tamoxifen)
RN  - 7LKK855W8I (Letrozole)
SB  - IM
MH  - Aged
MH  - Antineoplastic Agents/*administration & dosage
MH  - Autonomic Nervous System Diseases/*etiology
MH  - Breast Neoplasms/complications/drug therapy/*mortality
MH  - Chemotherapy, Adjuvant
MH  - Disease-Free Survival
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Letrozole
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Musculoskeletal Diseases/*etiology
MH  - Nitriles/*administration & dosage
MH  - Proportional Hazards Models
MH  - Tamoxifen/administration & dosage
MH  - Time Factors
MH  - Treatment Outcome
MH  - Triazoles/*administration & dosage
MH  - Vasomotor System/physiopathology
OTO - NOTNLM
OT  - Aromatase inhibitors
OT  - Breast cancer
OT  - Extended hormonal therapy
OT  - Letrozole
OT  - Musculoskeletal symptoms
OT  - Vasomotor symptoms
EDAT- 2016/04/09 06:00
MHDA- 2017/03/07 06:00
CRDT- 2016/04/09 06:00
PHST- 2015/10/02 00:00 [received]
PHST- 2016/01/14 00:00 [revised]
PHST- 2016/02/22 00:00 [accepted]
PHST- 2016/04/09 06:00 [entrez]
PHST- 2016/04/09 06:00 [pubmed]
PHST- 2017/03/07 06:00 [medline]
AID - S0960-9776(16)00025-4 [pii]
AID - 10.1016/j.breast.2016.02.010 [doi]
PST - ppublish
SO  - Breast. 2016 Jun;27:99-104. doi: 10.1016/j.breast.2016.02.010. Epub 2016 Apr 5.