The challenge of glioblastoma recurrence treatment: a real-life experience with regorafenib.
PO-1135
Abstract
The challenge of glioblastoma recurrence treatment: a real-life experience with regorafenib.
Authors: Ciro Mazzarella1, Silvia Chiesa1, Antonella Martino1, Serena Bracci1, Francesco Beghella Bartoli1, Maria Chiara Cannatà1, Alessia Nardangeli1, Valeria Masiello1, Giorgio D'Alessandris2, Simona Gaudino1, Elisabetta Lepre1, Vincenzo Frascino1, Elisa Meldolesi1, Alessandro Olivi3, Maria Antonietta Gambacorta1, Vincenzo Valentini1, Mario Balducci1
1Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy, UOC di Radioterapia Oncologica, Dipartimento Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Rome, Italy; 2Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy, UOC di Neuroradiologia, Dipartimento Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Rome, Italy; 3Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy, UOC di Neurochirurgia, Rome, Italy
Show Affiliations
Hide Affiliations
Purpose or Objective
Glioblastoma (GBM) is the most frequent and aggressive malignant central nervous system primary tumor. Despite multidisciplinary management in first-line, all GBM may relapse and the therapeutic option for GBM recurrence remains a challenge. The recent REGOMA trial suggested an OS benefit of regorafenib in recurrent GBM patients. We aimed to assess the safety and efficacy of regorafenib in the treatment of recurrent GBM in our “real-life” clinical practice.
Material and Methods
Consecutive patients with GBM recurrence treated with regorafenib were included in a retrospective evaluation. Data collected include diagnosis, patient demographics, performance status, number of previous lines of treatment, surgery at the time of relapse, number of treatment cycles, side effects and toxicities scales, treatment discontinuation and survival data. PFS and OS were estimated using the Kaplan-Meier method.
Results
Data from 41 patients (20 males and 21 females) woth Glioblastoma recurrence were considered for this analysis. Median age was 54 years (range 26-76), and all patients had a performance status between 0-2. Thirty eight (92.7%) patients received regorafenib as second-line treatment; 3 (7.3%) patients received regorafenib as third-line due to a recurrence occurred before January 2018?. Surgery at the time of recurrence was done in 13 (31,7%) patients. MGMT status was methylated for 19 (46.3%), unmethylated for 18 (43.9%), while in 4 patients the data was not available. The median number of cycles received was 4 (range 1-12) and 4 (9.7%) patients were still on active treatment at the time of analysis. The most common adverse events (grade 1-2) were fatigue (75%), rash and desquamation (12.2%), hand-foot skin reaction (9.7%), hypertension (18%), hyperbilirubinemia (2.4%) and hypertransaminasaemia (18%). The most common grade 3 or 4 were fatigue (10%), oedema (14%), rash (4.8%), neutropenia (2.4%) and thrombocytopenia (2.4%). Common reasons for discontinuing regorafenib included progressive disease (70.5%) and toxicity (12%). In patients treated with regorafenib, median PFS was 4 months (95% confidence interval: 3 to 6 months) and OS was 22 months (95% confidence interval: 19 to 41 months).
Conclusion
In our “real-life” experience, regorafenib is associated with survival similar to that reported in clinical trials. Side effects lead to treatment discontinuation in nearly one third of our patients and the most frequent limit is the severe fatigue in patients already compromised. Further investigations are needed to identify the patients most likely to benefit in order to maximize the results and reduce side effects.