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Everolimus plus aromatase inhibitors as maintenance therapy after first-line chemotherapy: Final results of the phase III randomised MAIN-A (MAINtenance Afinitor) trial.
Guarneri, Valentina; Giorgi, Carlo Alberto; Cinieri, Saverio; Bengala, Carmelo; Mariani, Gabriella; Bisagni, Giancarlo; Frassoldati, Antonio; Zamagni, Claudio; De Rossi, Costanza; Amoroso, Vito; Andreetta, Claudia; Ferro, Antonella; Zambelli, Alberto; Gori, Stefania; Garrone, Ornella; Dieci, Maria Vittoria; Orlando, Laura; Pastina, Ilaria; Beninato, Teresa; Moretti, Gabriella; Genovesi, Elisa; Cinefra, Margherita; Vicini, Roberto; Magni, Giovanna; De Salvo, Gian L; Conte, PierFranco.
Afiliación
  • Guarneri V; Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy; Medical Oncology 2, Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy. Electronic address: valentina.guarneri@unipd.it.
  • Giorgi CA; Medical Oncology 2, Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.
  • Cinieri S; Department of Oncology, Di Summa - Perrino Hospital, Brindisi, Italy.
  • Bengala C; Medical Oncology, Ospedale Misericordia, Azienda Toscana Sud-Est, Grosseto, Italy.
  • Mariani G; Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
  • Bisagni G; Department of Oncology and Advanced Technologies, Oncology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
  • Frassoldati A; Clinical Oncology, Department of Morphology, Surgery and Experimental Medicine, S. Anna University Hospital, Ferrara, Italy.
  • Zamagni C; Medical Oncology Unit, Addarii Institute of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy.
  • De Rossi C; Medical Oncology, Ospedale dell'Angelo, AULSS3 Serenissima, Mestre, Italy.
  • Amoroso V; Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, Medical Oncology, University of Brescia at ASST Spedali Civili, Brescia, Italy.
  • Andreetta C; Department of Oncology, ASUFC Udine University Hospital, Udine, Italy.
  • Ferro A; Breast Center, Santa Chiara Hospital, Trento, Italy.
  • Zambelli A; Unit of Oncology, Ospedale Papa Giovanni XXIII, Bergamo, Italy.
  • Gori S; Medical Oncology, IRCCS Ospedale Sacro Cuore-Don Calabria, Negrar di Valpolicella, Italy.
  • Garrone O; Breast Unit, Medical Oncology AO S. Croce and Carle Teaching Hospital, Cuneo, Italy.
  • Dieci MV; Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy; Medical Oncology 2, Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.
  • Orlando L; Department of Oncology, Di Summa - Perrino Hospital, Brindisi, Italy.
  • Pastina I; Medical Oncology, Ospedale Misericordia, Azienda Toscana Sud-Est, Grosseto, Italy.
  • Beninato T; Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
  • Moretti G; Department of Oncology and Advanced Technologies, Oncology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
  • Genovesi E; Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.
  • Cinefra M; Department of Oncology, Di Summa - Perrino Hospital, Brindisi, Italy.
  • Vicini R; Department of Medical and Surgical Sciences for Children and Adults, Statistics Unit, University Hospital of Modena and Reggio Emilia, Modena, Italy.
  • Magni G; Clinical Trials and Biostatistics Unit, Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.
  • De Salvo GL; Clinical Trials and Biostatistics Unit, Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.
  • Conte P; Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy; Medical Oncology 2, Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.
Eur J Cancer ; 154: 21-29, 2021 09.
Article en En | MEDLINE | ID: mdl-34225066
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Protocolos de Quimioterapia Combinada Antineoplásica / Inhibidores de la Aromatasa / Everolimus Tipo de estudio: Clinical_trials Límite: Adult / Aged / Aged80 / Female / Humans / Middle aged Idioma: En Revista: Eur J Cancer Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Protocolos de Quimioterapia Combinada Antineoplásica / Inhibidores de la Aromatasa / Everolimus Tipo de estudio: Clinical_trials Límite: Adult / Aged / Aged80 / Female / Humans / Middle aged Idioma: En Revista: Eur J Cancer Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido