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. 2025 Jan 15:64:69-77.
doi: 10.2340/1651-226X.2025.42333.

Long-term survival of participants in the PASART-1 and PASART-2 trials of neo-adjuvant pazopanib and radiotherapy in soft tissue sarcoma

Bauke H G Van Riet #  1 , Milan Van Meekeren #  2 , Marta Fiocco  3 , Aisha Miah  4 , Ilse De Pree  5 , Lisette M Wiltink  6 , Astrid Scholten  1 , Lotte Heimans  7 , Judith V M G Bovée  8 , Hans Gelderblom  2 , Neeltje Steeghs  9 , Rick L Haas  10
Affiliations

Long-term survival of participants in the PASART-1 and PASART-2 trials of neo-adjuvant pazopanib and radiotherapy in soft tissue sarcoma

Bauke H G Van Riet et al. Acta Oncol. .

Abstract

Objective: This study aims to assess the long-term safety and efficacy of adding pazopanib to neo-adjuvant radiotherapy followed by surgery in patients with high-risk non-metastatic soft tissue sarcoma of the trunk and extremities treated in the PASART-1 and PASART-2 trials, as well as to compare the PASART cohorts to a control cohort receiving standard treatment during the same time period from the Netherlands Cancer Registry (IKNL) to investigate if adding pazopanib improves Overall Survival (OS).

Methods: Updated follow-up data on disease control, survival and long-term toxicities of the PASART-trials were extracted from electronic patient records. The effect of adding pazopanib to neo-adjuvant radiotherapy on OS was investigated by comparing the combined PASART cohorts to the IKNL cohort via direct comparison and exact matching analysis.

Results: PASART-trials included 34 patients, IKNL cohort included 487 patients. After a median follow-up of 75.4 months (range: 30-131 months) the 1-year, 2-year and 5-year OS in the PASART-trials were 97% (95% confidence interval [CI]: 91.5-100), 85.3% (95% CI: 74.2-98.1), 79.3% (95% CI: 66.8-94.2), respectively. Matching resulted in 23 PASART and 89 IKNL patients. Adding pazopanib did not significantly improve OS when compared to standard treatment (IKNL) in a direct comparison (hazard ratio [HR]: 0.58; 95% CI: 0.30-1.13) or matched analysis (HR: 0.70; 95% CI: 0.29-1.73). Long-term toxicities, mainly fibrosis (n = 6) and edema (n = 2), were observed in 11 PASART patients and comparable to historical controls.

Interpretation: The addition of pazopanib had tolerable long-term toxicity but did not improve OS when compared to a control cohort receiving standard treatment.

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Conflict of interest statement

The authors have declared no conflicts of interest.

Figures

Figure 1
Figure 1
Long-term follow-up PASART-1 and PASART-2. Swimmer’s plot for patient of the PASART-1 and PASART-2 trials, stratified by the AJCC-stage. Dose alterations compared to the most common dose of 800 mg pazopanib and 50 Gy neo-adjuvant radiotherapy and pCR status of the resection specimen are next to each lane. AJCC: American Joint Committee on Cancer stage; Gy: Gray; pCR: pathological complete response.
Figure 2
Figure 2
Overall survival matched cohort. Estimated survival and HRs for OS for pazopanib in the matched cohort. Censoring is indicated by tick marks. CI: confidence interval; HR: hazard ratio; KM: Kaplan–Meier.
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