Specific Adverse Events Predict Survival Benefit in Patients Treated With Tamoxifen or Aromatase Inhibitors: An International Tamoxifen Exemestane Adjuvant Multinational Trial Analysis
| Autor: | Hein Putter, Daniel Rea, Robert Paridaens, Caroline Seynaeve, Elysée T.M. Hille, Johan W.R. Nortier, Christos Markopoulos, Yasuo Hozumi, Elma Meershoek-Klein Kranenbarg, Willemien van de Water, D.B.Y. Fontein, Peyman Hadji, John M. S. Bartlett, J.M. Vannetzel, Annette Hasenburg, Cornelis J.H. van de Velde, Stephen E. Jones |
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| Přispěvatelé: | Medical Oncology, Public Health |
| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
Oncology
Adult Cancer Research medicine.medical_specialty Randomization Antineoplastic Agents Hormonal medicine.medical_treatment International Cooperation Breast Neoplasms Disease-Free Survival chemistry.chemical_compound Breast cancer Exemestane SDG 3 - Good Health and Well-being Internal medicine Outcome Assessment Health Care medicine Humans Multicenter Studies as Topic Musculoskeletal Diseases Adverse effect Aged Proportional Hazards Models Randomized Controlled Trials as Topic Gynecology Aged 80 and over business.industry Proportional hazards model Aromatase Inhibitors Hazard ratio Middle Aged medicine.disease Prognosis Androstadienes Vasomotor System Tamoxifen chemistry Clinical Trials Phase III as Topic Chemotherapy Adjuvant Female business Adjuvant Genital Diseases Female medicine.drug Follow-Up Studies |
| Zdroj: | Journal of Clinical Oncology, 31(18), 2257-U59 Journal of Clinical Oncology, 31(18), 2257-U59. American Society of Clinical Oncology |
| ISSN: | 0732-183X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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