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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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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| author | Sanal Fernandes Sameer Rastogi Kanu Priya Bhatia Shamim A. Shamim Adarsh Barwad Rambha Pandey Shivanand Gammanagatti Ekta Dhamija |
| author_facet | Sanal Fernandes Sameer Rastogi Kanu Priya Bhatia Shamim A. Shamim Adarsh Barwad Rambha Pandey Shivanand Gammanagatti Ekta Dhamija |
| author_sort | Sanal Fernandes |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-9cde58972f0d4675960ed64ed3e7f3ab |
| institution | Kabale University |
| issn | 2687-8941 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | American Society of Clinical Oncology |
| record_format | Article |
| series | JCO Global Oncology |
| spelling | doaj-art-9cde58972f0d4675960ed64ed3e7f3ab2025-08-20T03:26:48ZengAmerican Society of Clinical OncologyJCO Global Oncology2687-89412025-06-011110.1200/GO-24-00558Efficacy and Tolerability of a Low-Dose Continuous Regimen of Regorafenib in Refractory Synovial Sarcomas: A Single-Arm, Phase II Trial From IndiaSanal Fernandes0Sameer Rastogi1Kanu Priya Bhatia2Shamim A. Shamim3Adarsh Barwad4Rambha Pandey5Shivanand Gammanagatti6Ekta Dhamija7Department of Medical Oncology, BRAIRCH, AIIMS, New Delhi, IndiaDepartment of Medical Oncology, BRAIRCH, AIIMS, New Delhi, IndiaDepartment of Medical Oncology, BRAIRCH, AIIMS, New Delhi, IndiaDepartment of Nuclear Medicine, AIIMS, New Delhi, IndiaDepartment of Pathology, AIIMS, New Delhi, IndiaDepartment of Radiation Oncology, AIIMS, New Delhi, IndiaDepartment of Radiodiagnosis, AIIMS, New Delhi, IndiaDepartment of Radiodiagnosis, AIIMS, New Delhi, IndiaPURPOSEAdvanced 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.https://ascopubs.org/doi/10.1200/GO-24-00558 |
| spellingShingle | Sanal Fernandes Sameer Rastogi Kanu Priya Bhatia Shamim A. Shamim Adarsh Barwad Rambha Pandey Shivanand Gammanagatti Ekta Dhamija Efficacy and Tolerability of a Low-Dose Continuous Regimen of Regorafenib in Refractory Synovial Sarcomas: A Single-Arm, Phase II Trial From India JCO Global Oncology |
| title | Efficacy and Tolerability of a Low-Dose Continuous Regimen of Regorafenib in Refractory Synovial Sarcomas: A Single-Arm, Phase II Trial From India |
| title_full | Efficacy and Tolerability of a Low-Dose Continuous Regimen of Regorafenib in Refractory Synovial Sarcomas: A Single-Arm, Phase II Trial From India |
| title_fullStr | Efficacy and Tolerability of a Low-Dose Continuous Regimen of Regorafenib in Refractory Synovial Sarcomas: A Single-Arm, Phase II Trial From India |
| title_full_unstemmed | Efficacy and Tolerability of a Low-Dose Continuous Regimen of Regorafenib in Refractory Synovial Sarcomas: A Single-Arm, Phase II Trial From India |
| title_short | Efficacy and Tolerability of a Low-Dose Continuous Regimen of Regorafenib in Refractory Synovial Sarcomas: A Single-Arm, Phase II Trial From India |
| title_sort | efficacy and tolerability of a low dose continuous regimen of regorafenib in refractory synovial sarcomas a single arm phase ii trial from india |
| url | https://ascopubs.org/doi/10.1200/GO-24-00558 |
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