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Patients with thymic carcinoma that has progressed following treatment with platinum-based chemotherapy may benefit from treatment with lenvatinib, according to findings from a phase II study reported by Itoh et al at the European Society for Medical Oncology (ESMO) Congress 2019 (Abstract 1844O).
Currently, the standard treatment for thymic carcinoma is platinum-based chemotherapy, but no standard treatment is in place for patients who experience disease progression following this therapy. Reports from several trials suggest that multitargeted inhibitors primarily targeting the vascular endothelial growth factor receptor (VEGFR) have antitumor activity in several cancer types. A team of Japanese researchers thus investigated the efficacy of lenvatinib, a novel multitargeted inhibitor of VEGFR and key elements of other pathways in thymic carcinoma.
Methods
They conducted the open-label, single-arm, multicenter phase II REMORA trial to assess the efficacy and safety of lenvatinib in patients with advanced or metastatic thymic carcinoma. Eligible patients had histologically confirmed thymic carcinoma, disease progression after at least one prior platinum-based chemotherapy, an ECOG performance status of 0 or 1, measurable lesions, and adequate organ function. A total of 42 patients were enrolled from eight institutions across Japan, and they were treated with oral lenvatinib, 24 mg once daily, until disease progression or unacceptable toxicities.
The primary endpoint was objective response rate by independent radiologic review.
The study utilized a SWOG two-stage design, which provided 80% power with a sample size of 40, one-sided alpha error of 5%, a threshold objective response rate of 10%, and an expected objective response rate of 25%.
KEY POINTS
- The objective response rate was 38.1%, thus meeting the primary endpoint.
- Of the assessable 42 patients, 16 patients had partial responses and 24 patients had stable disease.
Findings
With a median follow-up of 15.5 months, the objective response rate was 38.1% (90% confidence interval [CI] = 25.6–52.0), thus meeting the primary endpoint. Of the assessable 42 patients, 16 patients had partial responses and 24 patients had stable disease. Frequently reported treatment-related adverse events of any grade included hypertension, diarrhea, hand-foot syndrome, proteinuria, hypothyroidism, and decreased platelet count.
The investigators concluded that the efficacy and safety of lenvatinib in patients with advanced or metastatic thymic carcinoma was confirmed.
Disclosure: REMORA was funded by Center for Clinical trials, Japan Medical Association and Eisai. For full disclosures of the study authors, visit esmo.org.
