TY - JOUR
T1 - Treatment-associated musculoskeletal and vasomotor symptoms and relapse-free survival in the NCIC CTG MA.27 adjuvant breast cancer aromatase inhibitor trial
AU - Stearns, Vered
AU - Chapman, Judith Anne W.
AU - Le Maitre, Aurélie
AU - Kundapur, Jessica
AU - Shepherd, Lois E.
AU - Pritchard, Kathleen I.
AU - Ma, Cynthia X.
AU - Ellis, Matthew J.
AU - Ingle, James N.
AU - Budd, G. Thomas
AU - Sledge, George W.
AU - Liedke, Pedro E.R.
AU - Goss, Paul E.
AU - Goss, Paul E.
AU - Rabaglio, Manuela
AU - Liedke, Pedro E.R.
N1 - Publisher Copyright:
© 2014 by American Society of Clinical Oncology.
PY - 2015/1/20
Y1 - 2015/1/20
N2 - Purpose: Treatment-emergent symptoms with adjuvant tamoxifen and aromatase inhibitors (AIs) have been associated with superior recurrence-free survival (RFS). We hypothesized that MA.27 anastrozoleor exemestane-treated patients with new or worsening vasomotor and/or joint symptoms would have improved RFS. Patients and Methods: MA.27 randomly assigned 7,576 postmenopausal women with breast cancer to 5 years of anastrozole or exemestane. Patient-reported symptoms were collected using the Common Terminology Criteria for Adverse Events version 3.0 at protocol-specified baseline and 6- and 12-month clinical visits. Symptoms were considered present with either vasomotor and/or joint complaints. Associations between symptoms and baseline patient characteristics were examined with χ2 and Fisher's exact tests. Subsequent effects of new or worsening symptoms on RFS were examined with landmark analyses and stratified univariable and multivariable Cox models. We examined the effects of 3-month symptoms arising from unplanned clinic visits as a result of severe toxicity. Results: Patients were assessable if eligible for the MA.27 trial, received some trial therapy, and had no disease recurrence at the end of a symptom assessment period; 96% of patients (n = 7,306 patients) were included at 6 months, and 96% (n = 7,246) were included at 12 months. Thirty-four percent of patients had baseline symptoms. For patients without baseline symptoms, 25% and 52% had new symptoms by 6 and 12 months, respectively. Neither treatment-emergent nor baseline symptoms significantly impacted RFS (P > .10) in patients with or without baseline symptoms. Conclusion: In MA.27, anastrozole or exemestane treatment-emergent symptoms were not associated with improved RFS. Women should be supported through treatment and encouraged to remain on their AI regardless of their symptoms.
AB - Purpose: Treatment-emergent symptoms with adjuvant tamoxifen and aromatase inhibitors (AIs) have been associated with superior recurrence-free survival (RFS). We hypothesized that MA.27 anastrozoleor exemestane-treated patients with new or worsening vasomotor and/or joint symptoms would have improved RFS. Patients and Methods: MA.27 randomly assigned 7,576 postmenopausal women with breast cancer to 5 years of anastrozole or exemestane. Patient-reported symptoms were collected using the Common Terminology Criteria for Adverse Events version 3.0 at protocol-specified baseline and 6- and 12-month clinical visits. Symptoms were considered present with either vasomotor and/or joint complaints. Associations between symptoms and baseline patient characteristics were examined with χ2 and Fisher's exact tests. Subsequent effects of new or worsening symptoms on RFS were examined with landmark analyses and stratified univariable and multivariable Cox models. We examined the effects of 3-month symptoms arising from unplanned clinic visits as a result of severe toxicity. Results: Patients were assessable if eligible for the MA.27 trial, received some trial therapy, and had no disease recurrence at the end of a symptom assessment period; 96% of patients (n = 7,306 patients) were included at 6 months, and 96% (n = 7,246) were included at 12 months. Thirty-four percent of patients had baseline symptoms. For patients without baseline symptoms, 25% and 52% had new symptoms by 6 and 12 months, respectively. Neither treatment-emergent nor baseline symptoms significantly impacted RFS (P > .10) in patients with or without baseline symptoms. Conclusion: In MA.27, anastrozole or exemestane treatment-emergent symptoms were not associated with improved RFS. Women should be supported through treatment and encouraged to remain on their AI regardless of their symptoms.
UR - http://www.scopus.com/inward/record.url?scp=84921735027&partnerID=8YFLogxK
U2 - 10.1200/JCO.2014.57.6926
DO - 10.1200/JCO.2014.57.6926
M3 - Article
C2 - 25512454
AN - SCOPUS:84921735027
SN - 0732-183X
VL - 33
SP - 265
EP - 271
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 3
ER -