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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

التفاصيل البيبلوغرافية
العنوان:	Treatment-Associated Musculoskeletal and Vasomotor Symptoms and Relapse-Free Survival in the NCIC CTG MA.27 Adjuvant Breast Cancer Aromatase Inhibitor Trial
المؤلفون:	Paul E. Goss, G. Thomas Budd, Cynthia X. Ma, Pedro E.R. Liedke, George W. Sledge, Vered Stearns, Manuela Rabaglio, Judith-Anne W. Chapman, Matthew J. Ellis, Lois E. Shepherd, Kathleen I. Pritchard, Jessica Kundapur, James N. Ingle, Aurélie Le Maître
بيانات النشر:	American Society of Clinical Oncology, 2014.
سنة النشر:	2014
مصطلحات موضوعية:	Adult, Oncology, Cancer Research, medicine.medical_specialty, Antineoplastic Agents, Hormonal, medicine.drug_class, Anastrozole, Breast Neoplasms, Kaplan-Meier Estimate, Disease-Free Survival, chemistry.chemical_compound, Breast cancer, Exemestane, Internal medicine, Nitriles, medicine, Humans, Aromatase, Musculoskeletal System, Aged, Aromatase inhibitor, biology, Vasomotor, business.industry, Proportional hazards model, Aromatase Inhibitors, Common Terminology Criteria for Adverse Events, ORIGINAL REPORTS, Middle Aged, Triazoles, medicine.disease, Surgery, Androstadienes, Vasomotor System, chemistry, Chemotherapy, Adjuvant, Hot Flashes, biology.protein, Female, business, medicine.drug
الوصف:	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 anastrozole- or 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.
اللغة:	English
الوصول الحر:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::048c23daceaebdf7939de978a9cebf36Test https://europepmc.org/articles/PMC4289722Test/
حقوق:	OPEN
رقم الانضمام:	edsair.doi.dedup.....048c23daceaebdf7939de978a9cebf36
قاعدة البيانات:	OpenAIRE

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We hypothesized that MA.27 anastrozole- or 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. 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