Abstract
SummaryBackground osteosarcoma is a rare, primary malignant bone tumour with limited available treatments for advanced or recurrent disease, resulting in a poor prognosis for patients. TAS-115 is a novel tyrosine kinase inhibitor under investigation in a phase I study in patients with solid tumours. We report data of osteosarcoma patients in the expansion cohort of this ongoing study. Patients and methods an analysis of this multicentre, open-label study was performed 6 months after the final patient was enrolled, and included patients aged ≥15 years, with unresectable or recurrent osteosarcoma, and who had refractory to standard therapy or for whom no standard therapy was available. TAS-115 650 mg/day was orally administered in a 5 days on/2 days off schedule. Results a total of 20 patients with osteosarcoma were enrolled. The most common adverse drug reactions (ADRs) were neutrophil count decreased (75%), aspartate aminotransferase increased (50%), and platelet count decreased (50%); 85% of patients had grade ≥ 3 ADRs. Long-term disease control (>1 year) with TAS-115 was achieved in three patients. The best overall response was stable disease (50%); no patient achieved a complete or partial response. Median progression-free survival was 3 months; 4-month and 12-month progression-free rates were 42% and 31%, respectively. Conclusion the safety and tolerability of TAS-115 and long-term disease stability for patients with unresectable or recurrent osteosarcoma were confirmed in this study, suggesting that TAS-115 is a promising novel therapy for advanced osteosarcoma patients. Trial registration number: JapicCTI-132333 (registered on November 8, 2013).
Highlights
Osteosarcoma is a rare, primary bone malignancy, with a worldwide annual incidence of 3.4 million [1]
After the maximum tolerated dose (MTD) was determined, an additional safety and efficacy investigation was performed using a dose ≤MTD based on the development of adverse drug reactions (ADRs) and pharmacokinetic data
Of 55 patients enrolled in the expansion cohort from five sites, 20 had osteosarcoma and were included in this analysis
Summary
Osteosarcoma is a rare, primary bone malignancy, with a worldwide annual incidence of 3.4 million [1]. Osteosarcomas are the most common primary bone tumour in children and adolescents; the incidence peaks during the 20s [2]. No effective treatment for osteosarcoma patients after MAP treatment has yet been confirmed. The 5-year survival rate for patients with advanced osteosarcoma is ~62% [1]. About 20% of patients have metastases at the time of diagnosis [5], with an estimated survival rate of 20% [6]. Bone and pulmonary metastases are prognostic factors of poor survival [2, 5]; pulmonary metastases are more common (80%) [5]
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