BACKGROUND: The present analysis focuses on real-world data of Everolimus- Exemestane in advanced HR+ve, HER2-ve elderly breast cancer patients (aged 65 years) included in the EVA study, with unique findings in those aged 70 years. METHODS: Data are collected from clinical records and analysed according to age cut-off (< 65 years; 65 - 69 years and [greater than or equal to] 70 years). Relationship of analyzed variables with response were tested by mean of a Mantel- Haenszel chi square test. Time to event analysis was described by Kaplan Meier approach and association with baseline characteristics was analysed by stratified log-rank test and proportional hazard model. RESULTS: From July 2013 to December 2015, the EVA study enrolled overall 404 pts. 154 patients out of 404 (38,1%) were aged [greater than or equal to] 65 years, of whom 87 were [greater than or equal to] 70 years. Median duration of EVE treatment was 28.5 weeks (95% CI 19.0 - 33.8) in patients aged 65-69 years and 24,4 weeks (95% CI 19,2 - 33,2) in those aged [greater than or equal to] 70 years. Fewer patients aged 65 years received the highest EVE Dose-Intensity (> 7.5 mg/day) in comparison to younger patients (49,6% vs. 66,8%). Grade 3-4 toxicities occurred to 55 patients (35,7%), mainly stomatitis (10,9%), rash (5,8%) and non-infectious pneumonitis (NIP) (3,6%). Some toxicities, such as weight loss and anaemia were peculiarly observed in patients aged [greater than or equal to] 70 years. Five treatment-related deaths were collected (3,2%). CONCLUSIONS: EVE-EXE combination remains one of the potential treatments in HR+ patients also for elderly ones.
Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study / Cazzaniga, M.; Verusio, C.; Ciccarese, M.; Fumagalli, A.; Sartori, D.; Ancona, C.; Airoldi, M.; Moretti, G.; Ficorella, C.; Arcangeli, V.; Diodati, L.; Zambelli, A.; Febbraro, A.; Generali, D.; Pistelli, M.; Garrone, O.; Musolino, A.; Vici, P.; Maur, M.; Mentuccia, L.; La Verde, N.; Bianchi, G.; Artale, S.; Blasi, L.; Piezzo, M.; Atzori, F.; Turletti, A.; Benedetto, C.; Cursano, M. C.; Fabi, A.; Gebbia, V.; Schirone, A.; Palumbo, R.; Ferzi, A.; Frassoldati, A.; Scavelli, C.; Clivio, L.; Torri, V.; On behalf of The EVA Study, Group. - In: ONCOTARGET. - ISSN 1949-2553. - 9:61(2018), pp. 31877-31887. [10.18632/oncotarget.25874]
Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study
Musolino A.;
2018-01-01
Abstract
BACKGROUND: The present analysis focuses on real-world data of Everolimus- Exemestane in advanced HR+ve, HER2-ve elderly breast cancer patients (aged 65 years) included in the EVA study, with unique findings in those aged 70 years. METHODS: Data are collected from clinical records and analysed according to age cut-off (< 65 years; 65 - 69 years and [greater than or equal to] 70 years). Relationship of analyzed variables with response were tested by mean of a Mantel- Haenszel chi square test. Time to event analysis was described by Kaplan Meier approach and association with baseline characteristics was analysed by stratified log-rank test and proportional hazard model. RESULTS: From July 2013 to December 2015, the EVA study enrolled overall 404 pts. 154 patients out of 404 (38,1%) were aged [greater than or equal to] 65 years, of whom 87 were [greater than or equal to] 70 years. Median duration of EVE treatment was 28.5 weeks (95% CI 19.0 - 33.8) in patients aged 65-69 years and 24,4 weeks (95% CI 19,2 - 33,2) in those aged [greater than or equal to] 70 years. Fewer patients aged 65 years received the highest EVE Dose-Intensity (> 7.5 mg/day) in comparison to younger patients (49,6% vs. 66,8%). Grade 3-4 toxicities occurred to 55 patients (35,7%), mainly stomatitis (10,9%), rash (5,8%) and non-infectious pneumonitis (NIP) (3,6%). Some toxicities, such as weight loss and anaemia were peculiarly observed in patients aged [greater than or equal to] 70 years. Five treatment-related deaths were collected (3,2%). CONCLUSIONS: EVE-EXE combination remains one of the potential treatments in HR+ patients also for elderly ones.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.