Resound Trial: A phase 2 study of regorafenib in patients with thymoma (type B2‐B3) and thymic carcinoma previously treated with chemotherapy
| Autor: | Silvia Bozzarelli, Federica D'Antonio, Nunzio Digiacomo, Armando Santoro, Federica Borea, Paolo Andrea Zucali, Fabio Conforti, Nadia Cordua, Matteo Perrino, Tommaso De Pas, Fabio De Vincenzo, Laura Giordano |
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| Rok vydání: | 2021 |
| Předmět: |
Cancer Research
medicine.medical_specialty Thymoma Pyridines medicine.medical_treatment Phases of clinical research Gastroenterology Disease-Free Survival Receptor Platelet-Derived Growth Factor beta chemistry.chemical_compound Regorafenib Internal medicine medicine Clinical endpoint Humans Thymic carcinoma Chemotherapy business.industry Phenylurea Compounds Thymus Neoplasms medicine.disease Receptors Fibroblast Growth Factor Vascular endothelial growth factor Receptors Vascular Endothelial Growth Factor Oncology chemistry Neoplasm Recurrence Local business Progressive disease |
| Zdroj: | Cancer. 128:719-726 |
| ISSN: | 1097-0142 0008-543X |
| DOI: | 10.1002/cncr.33990 |
| Popis: | Background Angiogenesis has an important role in thymic epithelial tumors (TETs). Regorafenib inhibits vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptor β (PDGFR-β), and fibroblast growth factor receptors (FGFRs). This study explored the activity of regorafenib as monotherapy in patients with advanced or recurrent B2-B3 thymoma (T) and thymic carcinoma (TC) previously treated with platinum-containing chemotherapy. Methods A Fleming single-arm, single-stage, phase 2 trial to evaluate the activity of regorafenib (160 mg once a day by mouth for 3 weeks on/1 week off) was planned. The study was designed to reject the null hypothesis of an 8-week progression-free survival (PFS) rate ≤25% with a type I error of 0.10 and a statistical power of 80% at the alternative hypothesis of an 8-week PFS rate of ≥50% (≥8 of 19 evaluable patients progression-free at 2 months). Results From June 2016 to November 2017, 19 patients were enrolled (11T/8TC). We observed partial response (PR) in 1 patient (1T) (5.3%), stable disease (SD) in 14 patients (9T/5TC) (73.7%), and progressive disease in 2 patients (1T/1TC) (10.5%), with a disease control rate of 78.9%. According to Choi-criteria, 13 patients (68.4%) achieved PR, and 2 patients SD (10.5%). The median PFS was 9.6 months whereas median overall survival was 33.8 months. The 8-week PFS rate was 78.9% (15 of 19 patients). Grade 3-4 treatment-related adverse events were observed in 10 patients (52.6%). Conclusions The primary end point of this study was reached. The high rate of PR (Choi-criteria) suggests antitumor activity of regorafenib in TETs. On the basis of survival outcomes, the efficacy of regorafenib should be further evaluated in larger studies. |
| Databáze: | OpenAIRE |
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