Efficacy and Tolerability of a Low-Dose Continuous Regimen of Regorafenib in Refractory Synovial Sarcomas: A Single-Arm, Phase II Trial From India
PURPOSEAdvanced synovial sarcomas are associated with poor outcomes and a lack of efficacious therapeutic agents. The aim of this study was to assess the efficacy and safety of a novel, low-dose, continuous schedule of regorafenib in these patients.METHODSThis is a single-arm, Simon 2-stage trial. P...
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| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
American Society of Clinical Oncology
2025-06-01
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| Series: | JCO Global Oncology |
| Online Access: | https://ascopubs.org/doi/10.1200/GO-24-00558 |
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| Summary: | PURPOSEAdvanced synovial sarcomas are associated with poor outcomes and a lack of efficacious therapeutic agents. The aim of this study was to assess the efficacy and safety of a novel, low-dose, continuous schedule of regorafenib in these patients.METHODSThis is a single-arm, Simon 2-stage trial. Patients with synovial sarcomas who had progressed on at least two lines were administered daily regorafenib (80/120 mg alternating once daily per orally). The primary outcome measure was the 3-month progression-free rate (PFR). Quality-of-life (QoL) parameters using the EORTC C-30 questionnaire were assessed at baseline and at 3 months.RESULTSTwenty-five patients were recruited in the study (14 male and 11 female patients). The median number of previous lines was 2 (2-4) with 76% exposed to pazopanib. The 3-month PFR was 56% with a median progression-free survival of 5 months at a follow-up of 24 months. Grade 3 toxicities seen were hand-foot-skin reaction (52%) and diarrhea (4%). No decline in QoL parameters was seen with regorafenib administration.CONCLUSIONThe low-dose, continuous schedule of regorafenib demonstrated durable responses in a heavily pretreated population of patients with synovial sarcoma and represents a viable therapeutic option in this group. |
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| ISSN: | 2687-8941 |