Giuseppe Lombardi1, Paola Del Bianco2, Alba A Brandes3, Marica Eoli4, Roberta Rudà5, Toni Ibrahim6, Ivan Lolli7, Simona Rizzato8, Bruno Daniele9, Andrea Pace10, Francesco Pasqualetti11, Mario Caccesse1, Eleonora Bergo1, Giovanna Magni2, Gian Luca De Salvo12, Vittorina Zagonel1. 1. Department of Oncology, Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy. 2. Clinical Research Unit, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy. 3. Medical Oncology Department, AUSL/IRCCS, Neurological Science Institute, Bologna, Italy. 4. Molecolar Neuro-Oncology Unit, IRCCS Foundation, "Carlo Besta" Neurological Institute, Milan, Italy. 5. Department of Neuro-Oncology, University of Turin and City of Health and Science Hospital, Turin, Italy. 6. Osteoncology and Rare Tumors Center, IRST-IRCCS "Dino Amadori", Meldola, Italy. 7. Medical Oncology Unit, IRCCS Saverio de Bellis Hospital, Castellana Grotte, Bari, Italy. 8. Department of Oncology, Santa Maria della Misericordia University Hospital, Udine, Italy. 9. Oncology Unit, Ospedale del Mare, Napoli, Italy. 10. Neuroncology Unit, IRCCS Regina Elena Cancer Institute, Roma, Italy. 11. Radiotherapy Unit, University Hospital S. Chiara, Pisa, Italy. 12. Clinical Research Unit, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy. Electronic address: gianluca.desalvo@iov.veneto.it.
Abstract
BACKGROUND: The REGOMA trial showed that regorafenib significantly improved overall survival in patients with recurrent glioblastoma compared with lomustine. Patients treated with regorafenib experienced a higher occurrence of grade 3-4 drug-related adverse events than those receiving the standard treatment. Because this safety profile was expected, it was considered of great importance to assess the patient point of view regarding the disease and treatment impact on different aspects of life and patient well-being. We here report the final results of the health-related quality of life (HRQoL) assessment, a secondary end-point of the study. This trial is registered with ClinicalTrials.gov, NCT02926222. METHODS: Patient-reported outcomes were assessed, within a prospective, randomised, multicentre, open-label phase II trial, by the European Organisation for Research and Treatment of Cancer core questionnaire and brain module at baseline and every 8-weekly neuroradiological assessment till disease progression. Mixed-effect linear models were fitted for each of the HRQoL domain to examine the change over progression-free time within and between arms. Furthermore, differences were also classified as clinically meaningful changes. To correct for multiple comparisons and avoid type I errors, the level of significance was set at P = 0.01 (2-sided). RESULTS: Of 119 enrolled patients, 56/59 (95%) patients and 58/60 (97%) patients treated with regorafenib and lomustime completed questionnaires at baseline, respectively. No significant differences were observed in any generic or cancer-specific domain during treatment in both arms, or between the two arms, except for the appetite loss and diarrhoea scales which were significantly worse in patients treated with regorafenib. The rate of patients with a clinically meaningful worsening for appetite loss, diarrhoea and for any other domain was not statistically different between the two arms. CONCLUSIONS: Regorafenib did not negatively affect HRQoL in patients with recurrent glioblastoma. These data combined with the survival benefit shown in the REGOMA trial support the use of regorafenib as a treatment option for these patients.
BACKGROUND: The REGOMA trial showed that regorafenib significantly improved overall survival in patients with recurrent glioblastoma compared with lomustine. Patients treated with regorafenib experienced a higher occurrence of grade 3-4 drug-related adverse events than those receiving the standard treatment. Because this safety profile was expected, it was considered of great importance to assess the patient point of view regarding the disease and treatment impact on different aspects of life and patient well-being. We here report the final results of the health-related quality of life (HRQoL) assessment, a secondary end-point of the study. This trial is registered with ClinicalTrials.gov, NCT02926222. METHODS: Patient-reported outcomes were assessed, within a prospective, randomised, multicentre, open-label phase II trial, by the European Organisation for Research and Treatment of Cancer core questionnaire and brain module at baseline and every 8-weekly neuroradiological assessment till disease progression. Mixed-effect linear models were fitted for each of the HRQoL domain to examine the change over progression-free time within and between arms. Furthermore, differences were also classified as clinically meaningful changes. To correct for multiple comparisons and avoid type I errors, the level of significance was set at P = 0.01 (2-sided). RESULTS: Of 119 enrolled patients, 56/59 (95%) patients and 58/60 (97%) patients treated with regorafenib and lomustime completed questionnaires at baseline, respectively. No significant differences were observed in any generic or cancer-specific domain during treatment in both arms, or between the two arms, except for the appetite loss and diarrhoea scales which were significantly worse in patients treated with regorafenib. The rate of patients with a clinically meaningful worsening for appetite loss, diarrhoea and for any other domain was not statistically different between the two arms. CONCLUSIONS: Regorafenib did not negatively affect HRQoL in patients with recurrent glioblastoma. These data combined with the survival benefit shown in the REGOMA trial support the use of regorafenib as a treatment option for these patients.
Authors: A M Zeitlberger; P M Putora; S Hofer; P Schucht; D Migliorini; A F Hottinger; U Roelcke; H Läubli; P Spina; O Bozinov; M Weller; M C Neidert; T Hundsberger Journal: J Neurooncol Date: 2022-04-29 Impact factor: 4.130
Authors: Jan-Michael Werner; Lena Wolf; Caroline Tscherpel; Elena K Bauer; Michael Wollring; Garry Ceccon; Martina Deckert; Anna Brunn; Roberto Pappesch; Roland Goldbrunner; Gereon R Fink; Norbert Galldiks Journal: J Neurooncol Date: 2022-06-18 Impact factor: 4.506