Background: Despite endocrine therapy being the mainstay of treatment for hormone receptor positive (HR+)/HER2− metastatic breast cancer, patients at risk of visceral crisis or doubt for endocrine sensitivity are still offered first-line chemotherapy. Maintenance hormonal therapy is generally offered at the discontinuation of chemotherapy. The MAINtenance Afinitor study is a randomised, phase III trial comparing maintenance everolimus combined with aromatase inhibitors (AIs) versus AI monotherapy in patients with disease control after first-line chemotherapy. Methods: Patients with stable disease, partial response or complete response after first-line chemotherapy were randomised to everolimus plus AIs (exemestane or letrozole or anastrozole) or to AIs alone. Primary aim was progression-free survival (PFS). Secondary aims included response rate, safety and overall survival (OS). Results: In total, 110 patients were randomised to everolimus + AIs (n = 52) or to AIs (n = 58). Median PFS was 11.0 months (95% confidence interval [CI] 8.1–13.8) in the everolimus + AI arm and 7.2 months (95% CI 4.7–10.9) in the AI monotherapy arm (hazard ratio [HR] 0.71, 95% CI 0.47–1.06). Objective response rate was 22.4% in everolimus + AI arm and 19.2% in AI monotherapy arm. A higher proportion of disease progression as best response was reported in the AI monotherapy arm (28.8% versus 14.3%). Median OS was 35.7 months (95% CI 26.0–47.8) in the combination arm versus 33.5 (95% CI 26.4–42.7) in the AI alone arm (HR 1.0, 95% CI 0.61–1.62). Conclusions: EVE + AIs did not significantly impact on the outcome of metastatic breast cancer patients deemed suitable for first-line chemotherapy. Also taking into account treatment tolerability, maintenance endocrine therapy remains the standard. Trial registration: EudraCT: 2013-004153-24.

Everolimus plus aromatase inhibitors as maintenance therapy after first-line chemotherapy: Final results of the phase III randomised MAIN-A (MAINtenance Afinitor) trial / Guarneri, V.; Giorgi, C. A.; Cinieri, S.; Bengala, C.; Mariani, G.; Bisagni, G.; Frassoldati, A.; Zamagni, C.; De Rossi, C.; Amoroso, V.; Andreetta, C.; Ferro, A.; Zambelli, A.; Gori, S.; Garrone, O.; Dieci, M. V.; Orlando, L.; Pastina, I.; Beninato, T.; Moretti, G.; Genovesi, E.; Cinefra, M.; Vicini, R.; Magni, G.; De Salvo, G. L.; Conte, P.. - In: EUROPEAN JOURNAL OF CANCER. - ISSN 0959-8049. - 154:(2021), pp. 21-29. [10.1016/j.ejca.2021.05.008]

Everolimus plus aromatase inhibitors as maintenance therapy after first-line chemotherapy: Final results of the phase III randomised MAIN-A (MAINtenance Afinitor) trial

Guarneri V.;Frassoldati A.;Dieci M. V.;Orlando L.;Vicini R.;Magni G.;Conte P.;
2021

Abstract

Background: Despite endocrine therapy being the mainstay of treatment for hormone receptor positive (HR+)/HER2− metastatic breast cancer, patients at risk of visceral crisis or doubt for endocrine sensitivity are still offered first-line chemotherapy. Maintenance hormonal therapy is generally offered at the discontinuation of chemotherapy. The MAINtenance Afinitor study is a randomised, phase III trial comparing maintenance everolimus combined with aromatase inhibitors (AIs) versus AI monotherapy in patients with disease control after first-line chemotherapy. Methods: Patients with stable disease, partial response or complete response after first-line chemotherapy were randomised to everolimus plus AIs (exemestane or letrozole or anastrozole) or to AIs alone. Primary aim was progression-free survival (PFS). Secondary aims included response rate, safety and overall survival (OS). Results: In total, 110 patients were randomised to everolimus + AIs (n = 52) or to AIs (n = 58). Median PFS was 11.0 months (95% confidence interval [CI] 8.1–13.8) in the everolimus + AI arm and 7.2 months (95% CI 4.7–10.9) in the AI monotherapy arm (hazard ratio [HR] 0.71, 95% CI 0.47–1.06). Objective response rate was 22.4% in everolimus + AI arm and 19.2% in AI monotherapy arm. A higher proportion of disease progression as best response was reported in the AI monotherapy arm (28.8% versus 14.3%). Median OS was 35.7 months (95% CI 26.0–47.8) in the combination arm versus 33.5 (95% CI 26.4–42.7) in the AI alone arm (HR 1.0, 95% CI 0.61–1.62). Conclusions: EVE + AIs did not significantly impact on the outcome of metastatic breast cancer patients deemed suitable for first-line chemotherapy. Also taking into account treatment tolerability, maintenance endocrine therapy remains the standard. Trial registration: EudraCT: 2013-004153-24.
154
21
29
Everolimus plus aromatase inhibitors as maintenance therapy after first-line chemotherapy: Final results of the phase III randomised MAIN-A (MAINtenance Afinitor) trial / Guarneri, V.; Giorgi, C. A.; Cinieri, S.; Bengala, C.; Mariani, G.; Bisagni, G.; Frassoldati, A.; Zamagni, C.; De Rossi, C.; Amoroso, V.; Andreetta, C.; Ferro, A.; Zambelli, A.; Gori, S.; Garrone, O.; Dieci, M. V.; Orlando, L.; Pastina, I.; Beninato, T.; Moretti, G.; Genovesi, E.; Cinefra, M.; Vicini, R.; Magni, G.; De Salvo, G. L.; Conte, P.. - In: EUROPEAN JOURNAL OF CANCER. - ISSN 0959-8049. - 154:(2021), pp. 21-29. [10.1016/j.ejca.2021.05.008]
Guarneri, V.; Giorgi, C. A.; Cinieri, S.; Bengala, C.; Mariani, G.; Bisagni, G.; Frassoldati, A.; Zamagni, C.; De Rossi, C.; Amoroso, V.; Andreetta, C.; Ferro, A.; Zambelli, A.; Gori, S.; Garrone, O.; Dieci, M. V.; Orlando, L.; Pastina, I.; Beninato, T.; Moretti, G.; Genovesi, E.; Cinefra, M.; Vicini, R.; Magni, G.; De Salvo, G. L.; Conte, P.
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