Background: To explore the activity of axitinib in advanced solitary fibrous tumour (SFT). Patients and methods: In this investigator-driven phase II study on axitinib in advanced and progressive SFT, patients received axitinib, 5 mg bis in day (BID), until progression or limiting toxicity. Pathologic diagnosis was centrally reviewed, distinguishing malignant SFT (M-SFT) and high-grade/dedifferentiated SFT (HG/D-SFT) subtypes. The primary end-point was the overall response rate (ORR) by Choi criteria (Choi). Secondary end-points were response by Response Evaluation Criteria in Solid Tumours (RECIST), progression-free survival (PFS) and overall survival (OS). Results: From April 2015 and October 2017, 17 eligible patients entered the study (metastatic: 17; SFT subtype: 13 M-SFT, 4 HG/D-SFT; prior treatment: 9 antiangiogenics, 5 cytotoxics). All patients were evaluable for response. The best Choi response was seven partial response (PR) (ORR, 41.2%), six stable disease (SD) and four progressions. Choi-ORR was 54% (7/13) when only M-SFTs were considered. Four of seven responsive patients were pretreated with pazopanib. No responses were detected in HG/D-SFT. Best RECIST response was one PR (5.9%), 14 SD and two progressions. Toxicity was as expected. Median Choi-PFS was 5.1 (interquartile range [IQR]: 2.5–14.8) months. Median Choi-PFS was 14.8 (IQR: 5.1–18.0) and 2.8 (IQR: 2.0–5.9) months for patients responsive and non-responsive by Choi, respectively (p = 0.0416). At a 14.4-month median follow-up, median OS was 25.3 months. Conclusion: This study showed that axitinib is active in progressive advanced SFT. One-half of patients carrying the malignant variant of the disease responded, with a >12-month median progression arrest. Responses were better detected with Choi and seen even in patients resistant to other antiangiogenics. Tolerability was good.
Activity of axitinib in progressive advanced solitary fibrous tumour: Results from an exploratory, investigator-driven phase 2 clinical study / S. Stacchiotti, N. Simeone, S. Lo Vullo, C. Morosi, F.G. Greco, A. Gronchi, M. Barisella, P. Collini, N. Zaffaroni, G.P. Dagrada, A.M. Frezza, L. Mariani, P.G. Casali. - In: EUROPEAN JOURNAL OF CANCER. - ISSN 0959-8049. - 106(2019), pp. 225-233.
|Titolo:||Activity of axitinib in progressive advanced solitary fibrous tumour: Results from an exploratory, investigator-driven phase 2 clinical study|
STACCHIOTTI, SILVIA (Corresponding)
|Parole Chiave:||Antiangiogenic; Axitinib; Hemangiopericytoma; Sarcoma; Solitary fibrous tumour; Target therapy; Oncology; Cancer Research|
|Settore Scientifico Disciplinare:||Settore MED/06 - Oncologia Medica|
|Data di pubblicazione:||2019|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1016/j.ejca.2018.10.024|
|Appare nelle tipologie:||01 - Articolo su periodico|