Treatment-associated musculoskeletal and vasomotor symptoms and relapse-free survival in the NCIC CTG MA.27 adjuvant breast cancer aromatase inhibitor trial

Vered Stearns, Judith Anne W Chapman, Aurélie Le Maitre, Jessica Kundapur, Lois E. Shepherd, Kathleen I. Pritchard, Cynthia X. Ma, Matthew J. Ellis, James N. Ingle, G. Thomas Budd, George W. Sledge, Pedro E R Liedke, Paul E. Goss, Paul E. Goss, Manuela Rabaglio, Pedro E R Liedke

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)265-271
Number of pages7
JournalJournal of Clinical Oncology
Volume33
Issue number3
DOIs
StatePublished - Jan 20 2015

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Aromatase Inhibitors
exemestane
Breast Neoplasms
Recurrence
Survival
Therapeutics
Joints
Symptom Assessment
Tamoxifen
Ambulatory Care
Proportional Hazards Models
Terminology

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Treatment-associated musculoskeletal and vasomotor symptoms and relapse-free survival in the NCIC CTG MA.27 adjuvant breast cancer aromatase inhibitor trial. / Stearns, Vered; Chapman, Judith Anne W; Le Maitre, Aurélie; Kundapur, Jessica; Shepherd, Lois E.; Pritchard, Kathleen I.; Ma, Cynthia X.; Ellis, Matthew J.; Ingle, James N.; Budd, G. Thomas; Sledge, George W.; Liedke, Pedro E R; Goss, Paul E.; Goss, Paul E.; Rabaglio, Manuela; Liedke, Pedro E R.

In: Journal of Clinical Oncology, Vol. 33, No. 3, 20.01.2015, p. 265-271.

Research output: Contribution to journalArticle

Stearns, V, Chapman, JAW, Le Maitre, A, Kundapur, J, Shepherd, LE, Pritchard, KI, Ma, CX, Ellis, MJ, Ingle, JN, Budd, GT, Sledge, GW, Liedke, PER, Goss, PE, Goss, PE, Rabaglio, M & Liedke, PER 2015, 'Treatment-associated musculoskeletal and vasomotor symptoms and relapse-free survival in the NCIC CTG MA.27 adjuvant breast cancer aromatase inhibitor trial', Journal of Clinical Oncology, vol. 33, no. 3, pp. 265-271. https://doi.org/10.1200/JCO.2014.57.6926
Stearns, Vered ; Chapman, Judith Anne W ; Le Maitre, Aurélie ; Kundapur, Jessica ; Shepherd, Lois E. ; Pritchard, Kathleen I. ; Ma, Cynthia X. ; Ellis, Matthew J. ; Ingle, James N. ; Budd, G. Thomas ; Sledge, George W. ; Liedke, Pedro E R ; Goss, Paul E. ; Goss, Paul E. ; Rabaglio, Manuela ; Liedke, Pedro E R. / Treatment-associated musculoskeletal and vasomotor symptoms and relapse-free survival in the NCIC CTG MA.27 adjuvant breast cancer aromatase inhibitor trial. In: Journal of Clinical Oncology. 2015 ; Vol. 33, No. 3. pp. 265-271.
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abstract = "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.",
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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

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.

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