Mark Agulnik, MD, Medical Oncologist at the City of Hope speaks about Phase II study of pazopanib with oral topotecan in patients with metastatic and non-resectable soft tissue and bone sarcomas.
Abstract:
Background:
Pazopanib is effective in refractory soft-tissue sarcoma (STS) and extends PFS substantially. In previous trials, individuals with sarcoma showed preclinical indications of response to combinations of metronomic topotecan and pazopanib.
Methods:
The effectiveness of the combination of pazopanib and topotecan in patients with metastatic or unresectable non-adipocytic STS was investigated in this prospective, single-arm phase II trial. Additionally, it included osteosarcoma and liposarcoma exploratory arms. In the non-adipocytic STS cohort, the main outcome was a progression-free rate at 12 weeks.
Results:
At 12 weeks, 57.5 percent of patients in the non-adipocytic STS cohort were progression-free, which did not achieve the study’s primary objective (66 percent ). With a PFR of 69.55 percent at 12 weeks, the exploratory osteosarcoma cohort outperformed the previously established phase II trial comparative data standard of 12 percent. The combination of pazopanib and topotecan was associated with grade 3 or 4 toxicities in the majority of individuals.
Conclusions:
The combination of pazopanib and topotecan did not reach its primary goal of the progression-free rate at 12 weeks in this prospective study in refractory metastatic or unresectable STS and osteosarcoma. The use of pazopanib in conjunction with topotecan was linked to a significant level of toxicity.