As reported in the Journal of Clinical Oncology by Aaron R. Weiss, DO, and colleagues, follow-up in the Children’s Oncology Group/NRG Oncology phase II ARST1321 trial showed no differences in survival outcomes with the addition of pazopanib to preoperative chemoradiation in patients with nonrhabdomyosarcoma soft-tissue sarcoma. Trial enrollment was stopped early when an interim analysis showed that the addition of pazopanib resulted in a significantly greater rate of near-complete pathologic response in this patient population.
Aaron R. Weiss, DO
Study Details
The multicenter open-label trial included 85 children or adults with intermediate- or high-risk chemotherapy-sensitive body wall/extremity nonrhabdomyosarcoma soft-tissue sarcoma. Patients were randomly assigned to receive neoadjuvant pazopanib plus chemoradiotherapy with ifosfamide/doxorubicin (n = 44) or chemoradiotherapy alone (n = 41) followed by primary resection at week 13 and then further chemotherapy at week 25. Outcome data for the study cohort were analyzed as a secondary aim of the study.
Key Findings
As of the end of December 2021, median survivor follow-up was 3.3 years (range = 0.1–5.8 years).
On intent-to-treat analysis, 3-year event-free survival was 52.5% (95% confidence interval [CI] = 34.8%–70.2%) in the pazopanib group vs 50.6% (95% CI = 32%–69.2%) in the control group (P = .8677).
On intent-to treat analysis, 3-year overall survival was 75.7% (95% CI = 59.7%–91.7%) in the pazopanib group vs 65.4% (95% CI = 48.1%–82.7%) in the control group (P = .1919).
The investigators concluded, “Although the rate of near complete pathologic response was significantly greater with the addition of pazopanib, outcomes were not statistically significantly different between the two regimens.”
Dr. Weiss, of Maine Children’s Cancer Program, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by National Cancer Institute grants, St. Baldrick’s Foundation, Seattle Children’s Foundation, and others. For full disclosures of the study authors, visit ascopubs.org.
