Phase II study of pazopanib with oral topotecan in patients with metastatic and non-resectable soft tissue and bone sarcomas

Brian Schulte, Nisha Mohindra, Mohammed Milhem, Steven Attia, Steven Robinson, Varun Monga, Angela C. Hirbe, Peter Oppelt, John Charlson, Irene Helenowski, Susan Abbinanti, Rasima Cehic, Scott Okuno, Brian A. Van Tine, Mark Agulnik

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Background: Pazopanib is active in refractory soft-tissue sarcoma (STS) and significantly prolongs PFS. Prior studies of combinations of metronomic topotecan with pazopanib have indicated preclinical evidence of response in patients with sarcoma. Methods: This prospective, single arm, phase II study evaluated the efficacy of the combination of pazopanib with topotecan in patients with metastatic or unresectable non-adipocytic STS. Furthermore, it incorporated exploratory arms for osteosarcoma and liposarcoma. The primary endpoint was progression-free rate at 12 weeks in the non-adipocytic STS cohort. Results: 57.5% of patients in the non-adipocytic STS cohort were progression free at 12 weeks, which did not meet the primary endpoint of the study (66%). The exploratory osteosarcoma cohort exceeded previously established phase II trial comparator data benchmark of 12% with a PFR at 12 weeks of 69.55%. Treatment with the combination of pazopanib and topotecan was accompanied by a grade 3 or 4 toxicities in most patients. Conclusions: In this prospective trial in refractory metastatic or unresectable STS and osteosarcoma, the combination of pazopanib with topotecan did not meet its primary endpoint of progression-free rate at 12 weeks. The combination of pazopanib with topotecan was associated with a high degree of toxicity.

Original languageEnglish
Pages (from-to)528-533
Number of pages6
JournalBritish Journal of Cancer
Volume125
Issue number4
DOIs
StatePublished - Aug 17 2021

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