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- W2247244435 abstract "629 Background: New AIs have been developed in controlled clinical trials after tamoxifen failure in MBC. A meta-analysis of the three FDA/EMEA-approved AIs revealed that they conferred a significant survival benefit when compared with megestrol (M) (Messori, Anticancer-Drugs 2000). We performed a comprehensive review (Simes, Stat Med 1987) including phase-III trials with new AIs (2nd generation - formestane, fadrozole - and 3rd generation - letrozole, anastrozole, vorozole, exemestane) approved or not by FDA-EMEA as 2nd-line ET for MBC pts between 1996 and 2003. Methods:Published or presented trials had to met the following criteria: phase-III studies evaluating AIs as 2nd-line ET in MBC. No phase-II trials were gathered. Letters/editorials, comparative trials of 3rd-generation vs 3rd-generation AIs or given as adjuvant/neoadjuvant ET were ruled-out. Overall response rate (ORR) and time to progression (TTP) were our end-points; survival was excluded because of lack of data. For this analysis, ratios (HR and RR) and 95% confidence intervals (CI) were derived. Results: Fourteen trials were eligible (5832 pts). No significant differences were seen in the whole group of 9 trials comparing AIs vs M (3908 pts, ORR-RR 1.07, 95% CI 0.88–1.30; TTP-HR 1.00, 95% CI 0.89–1.12), in the 6 trials including non-steroidal AIs vs M (2415 pts, ORR-RR 1.10, 95% CI 0.84–1.46; TTP-HR 0.95, 95% CI 0,85–1.07), in the 3 studies comprehending steroidal AIs vs M (1493 pts, ORR-RR 1.08, 95% CI 0.61–1.94; TTP-HR 1.08, 95% CI 0.61–1.94), in 3 trials comparing 3rd generation AIs (letrozole and vorozole) vs 1st and 2nd generation AIs (aminiglutethimide and fadrazole) (1073 pts, ORR-RR 1.50, 95% CI 0.78–2.88; TTP-HR 1.18, 95% CI 0.66–2.13), and finally in 2 only studies comparing the new AI anastrozole vs the steroidal antiestrogen fulvestrant (851 pts, ORR-HR 0.86, 95% CI 0.14–1.79; TTP-HR 0.77, 95% CI 0.07–9.01). Conclusions: When all subgroups were analyzed for ORR and TTP, no significant differences were found. AIs in 2nd-line ET for MBC pts did not seem to add any significant benefit to standard comparator arm in terms of ORR and TTP. No significant financial relationships to disclose." @default.
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- W2247244435 date "2004-07-15" @default.
- W2247244435 modified "2023-09-23" @default.
- W2247244435 title "New aromatase inhibitors (AIs) as 2nd-line endocrine therapy (ET) in metastatic breast cancer (MBC): A comprehensive review of 5832 women from 14 phase III trials" @default.
- W2247244435 doi "https://doi.org/10.1200/jco.2004.22.14_suppl.629" @default.
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