Meta-analyses of phase 3 randomised controlled trials of third generation aromatase inhibitors versus tamoxifen as first-line endocrine therapy in postmenopausal women with hormone receptor-positive advanced breast cancer
Autor: | Ian Bradbury, Jasmine Lichfield, John F.R. Robertson, Christine Campbell, Robert Paridaens |
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Rok vydání: | 2020 |
Předmět: |
0301 basic medicine
Oncology Selective Estrogen Receptor Modulators Cancer Research medicine.medical_specialty Time Factors Anastrozole Breast Neoplasms law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Exemestane Randomized controlled trial law Internal medicine medicine Humans Aged Randomized Controlled Trials as Topic business.industry Aromatase Inhibitors Letrozole Hazard ratio Cancer Middle Aged medicine.disease Progression-Free Survival Postmenopause Tamoxifen 030104 developmental biology chemistry Clinical Trials Phase III as Topic Receptors Estrogen Selective estrogen receptor modulator 030220 oncology & carcinogenesis Female business medicine.drug |
Zdroj: | European journal of cancer (Oxford, England : 1990). 145 |
ISSN: | 1879-0852 |
Popis: | Background Four randomised controlled trials (RCTs) in postmenopausal women with advanced breast cancer (ABC) comparing aromatase inhibitors (AIs) versus the selective estrogen receptor modulator tamoxifen, each individually reported significantly longer progression free survival (PFS) but none showed a significant difference in overall survival (OS). In these trials between 6.8%–55% of tumours were hormone receptor (HR) status unknown or negative. This meta-analysis restricted the comparison to HR-positive (HR+) tumours. MethodsAnonymised individual patient data were obtained from three RCTs, EORTC (exemestane versus tamoxifen), Study 0027 and Study 0030 (both anastrozole versus tamoxifen). For the remaining RCT (Femara Study PO25; letrozole versus tamoxifen), odds ratio (OR) or hazard ratio (HzR), with confidence intervals were obtained from the clinical study report, for patients with HR+ tumours, in addition to published data. In total, data were obtained from 2296 patients; 1560 (68%) had HR+ ABC. FindingsThe OR for clinical benefit rate was 1·56, in favour of AIs (p[less than] 0·001). The duration of clinical benefit was not significantly increased by AIs (hazard ratio [HzR] 0·88; p=0·08). For PFS the HzR (0·82) was in favour of AIs (p=0·007). However, for OS the HzR (1·05) was not significantly different between AIs and tamoxifen (p=0·42).InterpretationAlthough third generation AIs put significantly more patients into ‘clinical benefit’, their tumours were not controlled for significantly longer. Overall, while this resulted in a significantly greater PFS in favour of the AIs, this did not translate into improvement in OS. |
Databáze: | OpenAIRE |
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