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Poster session 13

1199P - MAVERIC: Phase II randomized study of everolimus as maintenance therapy for metastatic neuroendocrine neoplasms (mNEN) with pulmonary or gastroenteropancreatic (GEP) origin. Results on behalf of the GOIRC


21 Oct 2023


Poster session 13


Tumour Site

Neuroendocrine Neoplasms


Lorenzo Antonuzzo


Annals of Oncology (2023) 34 (suppl_2): S701-S710. 10.1016/S0923-7534(23)01264-4


L. Antonuzzo1, S. Pillozzi2, R. Marconcini3, F. Spada4, F. Gelsomino5, V. Amoroso6, F. cosso1, L. messerini1, F. ZEPPONI1, F. Scolari1, E. Pellegrini1, C. Sparano7, D. Lavacchi1, M. Brugia1, E. Giommoni1, G. Massaro1, M. Milione1, F. DI COSTANZO1, L. Boni8, N. Fazio9

Author affiliations

  • 1 Medical Oncology Dept., AOUC - Azienda Ospedaliero-Universitaria Careggi, 50134 - Firenze/IT
  • 2 Department Of Experimental And Clinical Medicine, University of Florence, 50134 - Florence/IT
  • 3 Dipartimento Di Oncologia Medica, AOU Pisana - Stabilimento di Santa Chiara, 56126 - Pisa/IT
  • 4 Division Of Gastrointestinal Medical Oncology And Neuroendocrine Tumors, European Institute of Oncology (IEO), IRCCS, 20141 - Milan/IT
  • 5 Oncology Department, Azienda Ospedaliero - Universitaria Policlinico di Modena, 41125 - Modena/IT
  • 6 Medical Oncology Dept., Azienda Ospedaliera Spedali Civili di Brescia, 25123 - Brescia/IT
  • 7 Endocrinology Department, Azienda Ospedaliero-Universitaria Careggi, 50134 - Firenze/IT
  • 8 Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, 16132 - Genova/IT
  • 9 Gastrointestinal Medical Oncology And Neuroendocrine Tumors, IEO - Istituto Europeo di Oncologia IRCCS, 20141 - Milano/IT


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Abstract 1199P


NEN are a group of heterogeneous malignancies that most commonly arise in the GEP tract. Usually > 20% Ki-67 NEN, including both well and poorly differentiated, are treated with chemotherapy (CT) but the schedule and duration is debated and no evidence about a maintenance therapy exists.


MAVERIC is a randomized, multicentric, phase II trial. Patients (pts) with well/moderately or poorly differentiated mNEN from GEP or lung primary sites with Ki-67 between 20% and 55% in response after a first -line (1L) CT were randomized with a 2:1 ratio to maintenance therapy with everolimus 10 mg day or to observation until progression or treatment intolerance. Randomization was done using a centralized web-based system. The primary endpoint was progression free survival (PFS) and the secondary endpoints were overall survival (OS) and safety. The study design was formally non-comparative.


Of 30 patients enrolled between 2015 and 2022 in 5 centers, 20 were randomized to everolimus and 10 to observation; 29 resulted eligible for the analysis. 52% had a GEP and 48% a pulmonary primary site. The median follow-up was 30.3 mo. Median PFS was longer for the experimental arm (1.8 mo vs. 11.4 mo; p=0.022). Median OS was 38.3 and 38.2 mo for the experimental and control arms, respectively (p=0.43). In the experimental arm, G3 adverse events (AEs) occurred in 55% of pts (most commonly mucositis/stomatitis (27.7%) and neutropenia (27.7%)). No G4 AEs occurred. 65% of pts required a dose reduction and 2 pts discontinued treatment due to AEs.


This study may suggest a role for everolimus as a maintenance therapy following 1L CT in selected pts with high-grade GEP or lung NEN with Ki67 between 20% and 55%. Homogeneous prospective studies are warranted to validate this hypothesis.

Clinical trial identification

EudraCT n. 2014-003951-72.

Editorial acknowledgement

Legal entity responsible for the study

Lorenzo Antonuzzo.


Has not received any funding.


L. Antonuzzo: Financial Interests, Personal, Advisory Board: AstraZeneca, Pfizer, Roche, Lilly, BMS, MSD, Merck, Amgen. F. Spada: Financial Interests, Personal, Invited Speaker: Advanced Accelerator Applications, SAS SPA; Financial Interests, Personal, Writing Engagement: Ipsen, Merck, Advanced Accelerator Applications; Non-Financial Interests, Project Lead, Coordinator of neuroendocrine neoplasms guidelines: AIOM (Italian Association Of Medical Oncology); Non-Financial Interests, Leadership Role, I am member of Scientific Board and lead of neuroendocrine Neoplasms Guidelines: ITANET (Italian Association Of Medical Oncology). N. Fazio: Financial Interests, Personal, Advisory Board: Novartis, Merck, AAA, Hutchinson MediPharma, MSD; Financial Interests, Personal, Invited Speaker: AAA, Merck; Financial Interests, Institutional, Local PI: Astellas, MSD, BeiGene, Incyte, Nucana, Ipsen, 4SC, Fibrogen; Financial Interests, Institutional, Research Grant: IPSEN, AAA, Merck; Non-Financial Interests, Other, Steering committee: SPARC Europe; Non-Financial Interests, Member of Board of Directors: ENETS; Non-Financial Interests, Other, Member of the GI and NET Faculties: ESMO; Non-Financial Interests, Other, Internal reviewer of NET guidelines: AIOM. All other authors have declared no conflicts of interest.

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