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dc.contributor.authorvan Meekeren, M
dc.contributor.authorBovee, JVMG
dc.contributor.authorvan Coevorden, F
dc.contributor.authorvan Houdt, W
dc.contributor.authorSchrage, Y
dc.contributor.authorKoenen, AM
dc.contributor.authorMiah, AB
dc.contributor.authorZaidi, S
dc.contributor.authorHayes, AJ
dc.contributor.authorThway, K
dc.contributor.authorKrol, S
dc.contributor.authorFiocco, M
dc.contributor.authorGelderblom, H
dc.contributor.authorSteeghs, N
dc.contributor.authorHaas, RL
dc.identifier.citationActa oncologica (Stockholm, Sweden), 2021, pp. 1 - 8
dc.description.abstract<h4>Purpose</h4>A prior phase I study showed that the neo-adjuvant combination of pazopanib and radiotherapy was well tolerated, and induced promising pathological responses in soft-tissue sarcoma patients. Results of the subsequent prospective, multicenter phase II, PASART-2 trial are presented here, further investigating the efficacy and safety of this combination.<h4>Patients and methods</h4>Patients with high-risk, localized soft-tissue sarcoma received neo-adjuvant radiotherapy, 50 Gy in 25 fractions (PASART-2A) or with a subsequent dose de-escalation to 36 Gy in 18 fractions (PASART-2B). This was combined with 800 mg once daily pazopanib, which started one week before radiotherapy and finished simultaneously. After an interval of 4-8 weeks, surgical resection was performed. The primary endpoint was the rate of pathological complete responses (pCR), defined as ≤5% viable cells.<h4>Results</h4>25 patients were registered in the study, 21 in PASART-2A and 4 in PASART-2B. After central pathology review, the combination treatment led to a pCR in 5 patients (20%). 17 patients (68%) experienced grade 3+ toxicities during neo-adjuvant treatment, of which the most common were alanine aminotransferase (ALT) elevation, aspartate aminotransferase (AST) elevation, and hypertension, all asymptomatic. Grade 3+ acute post-operative toxicities occurred in 5 patients (20%), of which the most common was wound infection. All patients completed the full radiotherapy regimen and underwent surgery. Pazopanib was discontinued before completion in 9 patients (36%), due to elevated ALT and/or AST, and shortly interrupted in 2 patients (8%), due to hypertension.<h4>Conclusion</h4>Apart from asymptomatic hepatotoxicity, the study regimen was well tolerated. Although the pre-specified efficacy endpoint (30% pCR) was not met, a more than doubling of historical pCR rates after neo-adjuvant radiotherapy alone was observed, which warrants further investigation.en_US
dc.format.extent1 - 8
dc.titleA phase II study on the neo-adjuvant combination of pazopanib and radiotherapy in patients with high-risk, localized soft tissue sarcoma.
dc.typeJournal Article
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfActa oncologica (Stockholm, Sweden)en_US
pubs.notesNot known
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Sarcoma and Melanoma Surgery
pubs.embargo.termsNot known
icr.researchteamSarcoma and Melanoma Surgery
dc.contributor.icrauthorHayes, Andrewen_US

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