ARST1321: Pazopanib neoadjuvant trial in non-rhabdomysarcoma soft tissue sarcomas: A report of major wound complications.

Abstract

11059 Background: The care of soft tissue sarcomas is complex and multidisciplinary in nature. Even without radiation or chemotherapy wound complications are common after surgical resection with a reported incidence of 6-42%. Wound complication rates with the use of neoadjuvant chemoradiation for high-grade soft tissue sarcomas has been reported and supported in the literature to be approximately 30%. Relevant to this study, a trial evaluating the use of a VEGF receptor inhibitor (bevacizumab) in combination with radiation pre-operatively in soft tissue sarcomas reported a wound complication rate of 25%. ARST 1321 is a phase II/III study evaluating the tyrosine kinase inhibitor Pazopanib +/- chemotherapy and radiation in select high-grade soft tissue sarcomas. The dose-finding phase has been completed and the objective of this report is to detail the major wound complications observed with this protocol. Methods: Patient enrolled on all arms of the study (Pre-operative radiation, +/- pazopanib, +/- doxorubicin and ifosphamide) were evaluated for wound complications (Grade I/II and Grade III). Patient demographics, tumor characteristics, and complication details were compiled and analyzed. Results: There were a total of 130 evaluable patients (100 patients on chemotherapy arm, 30 on non-chemotherapy arm). There were 38 overall wound complications reported (38/130, 29%). 23/38 (60%) occurred on the chemotherapy arm; therefore that cohort had 23/100 (23%) wound complication rate, while the non-chemotherapy cohort had an overall rate of 50% (15/30). Grade III wound complications represented 23/38 (66%) of all the complications. 30/38 (79%) of the complications were in the lower extremity. 23/38 (60%) patients were aged > 18 years. Conclusions: The overall rate of wound complications observed was 29% (38/130) which remains within the accepted historical rate based upon literature review without the use of a tyrosine kinase inhibitor. The overall major wound complication (grade III) rate was 19% (25/130). Also consistent with the literature is the finding that a majority of the complications occurred in the lower extremity. In conclusion, the addition of a tyrosine kinase inhibitor (pazopanib) has a wound complication toxicity profile comparable to current and historical literature. Clinical trial information: NCT02180867.