Skip to main content
SNO 28th Annual Meeting Main banner
Final Program


Program
Icon Legend
Presentation Icons
CME
CME
Non-CME
Non-CME
ISS CME
ISS CME
Named Award Winner
Named Award Winner
Award Winner
Award Winner
Poster Award Winner
Poster Award Winner
Back

Clinical trials: Non-immunologic

Session: Poster Session

CTNI-39 - REGOMA-OS: a large Italian multicenter, prospective, observational study analyzing regorafenib efficacy and safety in recurrent glioblastoma patients

Friday, November 17, 2023
7:30 PM – 9:30 PM PT
Location: Exhibit Hall A/B
Non-CME

    Author(s)

  • Mario Caccese

    Department of Oncology, Oncology 1, Veneto Institute of Oncology IOV-IRCCS
    Padua, Veneto, Italy

    • Author(s)

  • ID

    Isacco Desideri

    Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence
    Florence, Italy

  • VV

    Veronica Villani

    Neuro-Oncology, IRCCS-Regina Elena National Cancer Institute
    Rome, Italy

  • MS

    Matteo Simonelli

    Oncology Department, IRCCS Humanitas Research Hospital
    Milan, Italy

  • MB

    Michela Buglione

    Department of Radiation Oncology, University and Spedali Civili Hospital
    Brescia, Italy

  • SC

    Silvia Chiesa

    UOC Radioterapia Oncologica, Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli, IRCCS
    Rome, Italy

  • EF

    Enrico Franceschi

    Nervous System Medical Oncology Department, IRCCS Istituto delle Scienze Neurologiche di Bologna
    Bologna, Italy

  • PG

    Paola Gaviani

    Neuro-Oncology Unit, Fondazione IRCCS Istituto Neurologico C. Besta
    Milano, Italy

  • IS

    Irene Stasi

    Medical Oncology Department, Istituto Toscano Tumori, Ospedale Civile
    Livorno, Italy

  • CC

    Claudia Caserta

    Medical Oncology Unit, Azienda Ospedaliera S. Maria
    Terni, Italy

  • SB

    Sonia Brugnara

    Department of Medical Oncology, Santa Chiara Hospital
    Trento, Italy

  • IL

    Ivan Lolli

    Oncology Unit of National Institute of Gastroenterology "S. de Bellis", Research Hospital
    Castellana Grotte, Bari, Italy

  • EB

    Elisa Bennicelli

    Oncology Unit, IRCCS Ospedale Policlinico San Martino
    Genova, Italy

  • PB

    Paola Bini

    IRCCS "C. Mondino" Foundation, National Neurological Institute
    Pavia, Italy

  • AC

    Angelo Salvatore Cuccu

    Department of Oncology, Azienda Ospedaliero Universitaria di Sassari
    Sassari, Italy

  • SS

    Silvia Scoccianti

    Radiation Oncology Unit, Santa Maria Annunziata Hospital
    Florence, Italy

  • GM

    Giovanna Magni

    Clinical Research Unit, Veneto Institute of Oncology IOV-IRCCS
    Padua, Italy

  • GD

    Gian Luca De Salvo

    Clinical Research Unit, Veneto Institute of Oncology IOV-IRCCS
    Padua, Italy

  • VZ

    Vittorina Zagonel

    Department of Oncology, Oncology 1, Veneto Institute of Oncology IOV-IRCCS
    Padua, Veneto, Italy

    • Poster Presenter(s)

  • Giuseppe Lombardi

    Department of Oncology, Oncology 1, Veneto Institute of Oncology IOV-IRCCS
    Padua, Veneto, Italy

Background: in the randomized phase 2 REGOMA trial, regorafenib (REG) showed promising activity in recurrent glioblastoma (GBM) patients (PTS); subsequently, in Italy the National Health System has permitted the reimbursement of the REG as second-line therapy. We performed a large multicenter, prospective and observational study to confirm REGOMA data in a real-world setting. Materials and

Methods: major inclusion criteria were: histologically confirmed diagnosis of GBM according to WHO 2016 and relapse after Stupp treatment, good performance status (ECOG PS 0-1), good liver function. REG was administered at standard dose of 160mg/die for 3 weeks on/1 week off. Brain MRI was performed within 14 days before starting REG and every 8-12 weeks, subsequently. Primary endpoint was overall survival. RANO criteria were used for response evaluation, CTACAE v. 5 for adverse events.

Results: from Sept 2020 to Oct 2022, 192 recurrent GBM PTS were enrolled from 29 Cancer Centres in Italy: median age was 58ys (IQR 52.8-67.0), 68% male, ECOG PS was 0 in 85 (44%), 115 PTS (60%) undertook steroids at baseline. MGMT was methylated in 43%, IDHwt in 92%. Median follow-up was 16.6 months (IQR 12.6-19.6). Median OS was 8.2ms (95% CI 6.5-9.6), 12ms-OS 34.7% (95%CI 27.2-42.4); median PFS was 2.6ms (95%CI 2.3-2.9), 6ms-PFS 14.3%. Radiological response was PR and SD in 12 (8%) and 25 (16%) PTS. 77 (44%) PTS received third-line therapy. The median of REG cycles per patient was 3 (IQR 2.0-4.0). Grade 3-4 adverse events (AE) were reported in 53 (28%) PTS; reduction/delay and permanent discontinuation due to AE in 36% and 8% of PTS. No death was considered as treatment-related AE.

Conclusions: compared to the REGOMA trial, this large Italian multicenter, prospective and observational trial confirmed the results in terms of overall survival with a good toxicity profile of REG in recurrent GBM PTS.