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Resound Trial: A phase 2 study of regorafenib in patients with thymoma (type B2-B3) and thymic carcinoma previously treated with chemotherapy.
- Source :
-
Cancer [Cancer] 2022 Feb 15; Vol. 128 (4), pp. 719-726. Date of Electronic Publication: 2021 Oct 27. - Publication Year :
- 2022
-
Abstract
- 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.<br />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).<br />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%).<br />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.<br /> (© 2021 American Cancer Society.)
- Subjects :
- Disease-Free Survival
Humans
Neoplasm Recurrence, Local pathology
Pyridines
Receptor, Platelet-Derived Growth Factor beta antagonists & inhibitors
Receptors, Fibroblast Growth Factor antagonists & inhibitors
Receptors, Vascular Endothelial Growth Factor antagonists & inhibitors
Phenylurea Compounds therapeutic use
Thymoma drug therapy
Thymoma pathology
Thymus Neoplasms drug therapy
Thymus Neoplasms pathology
Subjects
Details
- Language :
- English
- ISSN :
- 1097-0142
- Volume :
- 128
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 34706060
- Full Text :
- https://doi.org/10.1002/cncr.33990