PMID- 23610112
OWN - NLM
STAT- MEDLINE
DCOM- 20130828
LR  - 20220408
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 31
IP  - 18
DP  - 2013 Jun 20
TI  - Specific adverse events predict survival benefit in patients treated with 
      tamoxifen or aromatase inhibitors: an international tamoxifen exemestane adjuvant 
      multinational trial analysis.
PG  - 2257-64
LID - 10.1200/JCO.2012.45.3068 [doi]
AB  - PURPOSE: Specific adverse events (AEs) associated with endocrine therapy and 
      related to depletion or blocking of circulating estrogens may be related to 
      treatment efficacy. We investigated the relationship between survival outcomes 
      and specific AEs including vasomotor symptoms (VMSs), musculoskeletal adverse 
      events (MSAEs), and vulvovaginal symptoms (VVSs) in postmenopausal patients with 
      breast cancer participating in the international Tamoxifen Exemestane Adjuvant 
      Multinational (TEAM) trial. PATIENTS AND METHODS: Primary efficacy end points 
      were disease-free survival (DFS), overall survival (OS), and distant metastases 
      (DM). VMSs, MSAEs, and VVSs arising in the first year of endocrine treatment were 
      considered. Patients who did not start or who discontinued their allocated 
      therapy and/or had an event (recurrence/death) within 1 year after randomization 
      were excluded. Landmark analyses and time-dependent multivariate Cox proportional 
      hazards models assessed survival differences up to 5 years from the start of 
      treatment. RESULTS: A total of 9,325 patients were included. Patients with 
      specific AEs (v nonspecific or no AEs) had better DFS and OS (multivariate hazard 
      ratio [HR] for DFS: VMSs, 0.731 [95% CI, 0.618 to 0.866]; MSAEs, 0.826 [95% CI, 
      0.694 to 0.982]; VVSs, 0.769 [95% CI, 0.585 to 1.01]; multivariate HR for OS: 
      VMSs, 0.583 [95% CI, 0.424 to 0.803]; MSAEs, 0.811 [95% CI, 0.654 to 1.005]; 
      VVSs, 0.570 [95% CI, 0.391 to 0.831]) and fewer DM (VMSs, 0.813 [95% CI, 0.664 to 
      0.996]; MSAEs, 0.749 [95% CI, 0.601 to 0.934]; VVSs, 0.687 [95% CI, 0.436 to 
      1.085]) than patients not reporting these symptoms. Increasing numbers of 
      specific AEs were also associated with better survival outcomes. Outcomes were 
      unrelated to treatment allocation. CONCLUSION: Certain specific AEs are 
      associated with superior survival outcomes and may therefore be useful in 
      predicting treatment responses in patients with breast cancer treated with 
      endocrine therapy.
FAU - Fontein, Duveken B Y
AU  - Fontein DB
AD  - Leiden University Medical Center, Leiden, The Netherlands.
FAU - Seynaeve, Caroline
AU  - Seynaeve C
FAU - Hadji, Peyman
AU  - Hadji P
FAU - Hille, Elysee T M
AU  - Hille ET
FAU - van de Water, Willemien
AU  - van de Water W
FAU - Putter, Hein
AU  - Putter H
FAU - Kranenbarg, Elma Meershoek-Klein
AU  - Kranenbarg EM
FAU - Hasenburg, Annette
AU  - Hasenburg A
FAU - Paridaens, Robert J
AU  - Paridaens RJ
FAU - Vannetzel, Jean-Michel
AU  - Vannetzel JM
FAU - Markopoulos, Christos
AU  - Markopoulos C
FAU - Hozumi, Yasuo
AU  - Hozumi Y
FAU - Bartlett, John M S
AU  - Bartlett JM
FAU - Jones, Stephen E
AU  - Jones SE
FAU - Rea, Daniel William
AU  - Rea DW
FAU - Nortier, Johan W R
AU  - Nortier JW
FAU - van de Velde, Cornelis J H
AU  - van de Velde CJ
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20130422
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Androstadienes)
RN  - 0 (Antineoplastic Agents, Hormonal)
RN  - 0 (Aromatase Inhibitors)
RN  - 094ZI81Y45 (Tamoxifen)
RN  - NY22HMQ4BX (exemestane)
SB  - IM
CIN - J Clin Oncol. 2013 Jun 20;31(18):2233-5. PMID: 23610120
CIN - J Clin Oncol. 2013 Dec 10;31(35):4476. PMID: 24190125
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Androstadienes/*adverse effects/therapeutic use
MH  - Antineoplastic Agents, Hormonal/*adverse effects/therapeutic use
MH  - Aromatase Inhibitors/*adverse effects/therapeutic use
MH  - Breast Neoplasms/*drug therapy/pathology
MH  - Chemotherapy, Adjuvant
MH  - Clinical Trials, Phase III as Topic
MH  - Disease-Free Survival
MH  - Female
MH  - Follow-Up Studies
MH  - Genital Diseases, Female/chemically induced
MH  - Humans
MH  - International Cooperation
MH  - Middle Aged
MH  - Multicenter Studies as Topic
MH  - Musculoskeletal Diseases/chemically induced
MH  - Outcome Assessment, Health Care/methods/*statistics & numerical data
MH  - Prognosis
MH  - Proportional Hazards Models
MH  - Randomized Controlled Trials as Topic
MH  - Tamoxifen/*adverse effects/therapeutic use
MH  - Vasomotor System/drug effects/pathology
EDAT- 2013/04/24 06:00
MHDA- 2013/08/29 06:00
CRDT- 2013/04/24 06:00
PHST- 2013/04/24 06:00 [entrez]
PHST- 2013/04/24 06:00 [pubmed]
PHST- 2013/08/29 06:00 [medline]
AID - JCO.2012.45.3068 [pii]
AID - 10.1200/JCO.2012.45.3068 [doi]
PST - ppublish
SO  - J Clin Oncol. 2013 Jun 20;31(18):2257-64. doi: 10.1200/JCO.2012.45.3068. Epub 
      2013 Apr 22.