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; Milan Van Meekeren; Marta Fiocco; Aisha Miah; Ilse De Pree; Lisette M Wiltink; Astrid Scholten; Lotte Heimans; Judith V M G Bovée; Hans Gelderblom; Neeltje Steeghs; Rick L Haas

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, Milan Van Meekeren, Marta Fiocco, Aisha Miah, Ilse De Pree, Lisette M Wiltink, Astrid Scholten, Lotte Heimans, Judith V M G Bovée, Hans Gelderblom, Neeltje Steeghs, Rick L Haas^*

^*Corresponding author for this work

Dept of Medical Oncology

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Pages (from-to)	69-77
Number of pages	9
Journal	Acta Oncologica
Volume	64
DOIs	https://doi.org/10.2340/1651-226X.2025.42333
Publication status	Published - 15 Jan 2025

Keywords

Pre-operative
chemoradiotherapy
pazopanib
soft-tissue sarcoma

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Van Riet, B. H. G., Van Meekeren, M., Fiocco, M., Miah, A., De Pree, I., Wiltink, L. M., Scholten, A., Heimans, L., Bovée, J. V. M. G., Gelderblom, H., Steeghs, N., & Haas, R. L. (2025). Long-term survival of participants in the PASART-1 and PASART-2 trials of neo-adjuvant pazopanib and radiotherapy in soft tissue sarcoma. Acta Oncologica, 64, 69-77. https://doi.org/10.2340/1651-226X.2025.42333

@article{c78fa8d0cfa74f1fb37e0550262da9db,

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

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.",

keywords = "Pre-operative, chemoradiotherapy, pazopanib, soft-tissue sarcoma",

author = "{Van Riet}, {Bauke H G} and {Van Meekeren}, Milan and Marta Fiocco and Aisha Miah and {De Pree}, Ilse and Wiltink, {Lisette M} and Astrid Scholten and Lotte Heimans and Bov{\'e}e, {Judith V M G} and Hans Gelderblom and Neeltje Steeghs and Haas, {Rick L}",

note = "Publisher Copyright: {\textcopyright} 2025 The Author(s).",

year = "2025",

month = jan,

day = "15",

doi = "10.2340/1651-226X.2025.42333",

language = "English",

volume = "64",

pages = "69--77",

journal = "Acta Oncologica",

issn = "0284-186X",

publisher = "Informa Healthcare",

}

Van Riet, BHG, Van Meekeren, M, Fiocco, M, Miah, A, De Pree, I, Wiltink, LM, Scholten, A, Heimans, L, Bovée, JVMG, Gelderblom, H, Steeghs, N & Haas, RL 2025, 'Long-term survival of participants in the PASART-1 and PASART-2 trials of neo-adjuvant pazopanib and radiotherapy in soft tissue sarcoma', Acta Oncologica, vol. 64, pp. 69-77. https://doi.org/10.2340/1651-226X.2025.42333

TY - JOUR

T1 - Long-term survival of participants in the PASART-1 and PASART-2 trials of neo-adjuvant pazopanib and radiotherapy in soft tissue sarcoma

AU - Van Riet, Bauke H G

AU - Van Meekeren, Milan

AU - Fiocco, Marta

AU - Miah, Aisha

AU - De Pree, Ilse

AU - Wiltink, Lisette M

AU - Scholten, Astrid

AU - Heimans, Lotte

AU - Bovée, Judith V M G

AU - Gelderblom, Hans

AU - Steeghs, Neeltje

AU - Haas, Rick L

PY - 2025/1/15

Y1 - 2025/1/15

N2 - 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.

AB - 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.

KW - Pre-operative

KW - chemoradiotherapy

KW - pazopanib

KW - soft-tissue sarcoma

UR - http://www.scopus.com/inward/record.url?scp=85215967669&partnerID=8YFLogxK

U2 - 10.2340/1651-226X.2025.42333

DO - 10.2340/1651-226X.2025.42333

M3 - Article

C2 - 39813174

SN - 0284-186X

VL - 64

SP - 69

EP - 77

JO - Acta Oncologica

JF - Acta Oncologica

ER -

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

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Keywords

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