Multi-institutional european single-arm phase II trial of pazopanib in advanced typical solitary fibrous tumors (SFT): A collaborative Spanish (GEIS), Italian (ISG), and French (FSG) sarcoma groups study.

Authors

null

Josefina Cruz Jurado

Hospital Universitario de Canarias, GEICAM Spanish Breast Cancer Group, Santa Cruz de Tenerife, Spain

Josefina Cruz Jurado , Sarah Naomie Dumont , Nicolas Penel , Pablo Luna Fra , Enrique Alava , Nadia Hindi , Jean-Yves Blay , Silvia Stacchiotti , Paola Collini , Andres Redondo , Daniel Bernabeu , Antonio Lopez-Pousa , Giovanni Grignani , David Silva Moura , Javier Martinez-Trufero , Philippe Terrier , Marie Karanian , Axel Le Cesne , Paolo Giovanni Casali , Javier Martin Broto

Organizations

Hospital Universitario de Canarias, GEICAM Spanish Breast Cancer Group, Santa Cruz de Tenerife, Spain, Gustave Roussy Cancer Campus, Villejuif, France, Oscar Lambret Cancer Center, Lille, France, Hospital Universitario Son Espases, Palma De Mallorca, Spain, Hospital Virgen del Rocío-IBis, Seville, Spain, Institute of Biomedicine Research (IBIS)-Universitary Hospital Virgen del Rocio/CSIC/Universidad de Sevilla, Seville, Spain, Centre Léon Bérard, Lyon, France, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, Soft Tissue and Bone Pathology, Histopathology and Pediatric Pathology Unit, Department of Diagnostic Pathology and Laboratory Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain, Hospital Universitario La Paz, Madrid, Spain, Hospital Sant Pau, Barcelona, Spain, Medical Oncology-Sarcoma Unit, Istituto di Candiolo-Fondazione del Piemonte per l'Oncologia IRCCS Candiolo, Turin, Italy, Group of Advanced Therapies and Biomarkers in Oncology, Institute of Biomedicine of Seville, Ibis/Hospital Universitario Virgen Del Rocío/Csic/Universidad De Sevilla, Seville, Spain, Hospital Universitario Miguel Servet, Zaragoza, Spain, Pathology Department, Centre Léon Bérard, Lyon, France, Adult Mesenchymal and Rare Tumor Unit, Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, Virgen del Rocio University Hospital, Institute of Biomedicine Research (IBIS)/CSIC/Universidad de Sevilla, Seville, Spain

Research Funding

Other

Background: SFT is a ubiquitous uncommon soft tissue sarcoma with a pronounced hemangiopericytoma-like vascular pattern, exhibiting rich VEGF (tumor and endothelial cells) and VEGFR1/2 (endothelial cells) expression. Pathologists distinguish typical SFT (T-SFT) and malignant SFT (M-SFT) based on mitosis (≤4 vs > 4), pleomorphism or necrosis. Yet, not clear boundaries are always seen between both subtypes. We have recently published a phase II trial exploring the activity of pazopanib (P) in M-SFT (Lancet Oncol Dec 2018). Here, we present the outcome of the T-SFT cohort of the same trial. Methods: Most relevant inclusion criteria were: unresectable or metastatic, T-SFT (tumor tissue from diagnostic time) confirmed by central pathology review before accrual, with evidence of STAT6 overexpression (IHC and FISH and/or NGS), ≥18 years, ECOG 0-2, progressive, measurable disease and no previous antiangiogenic agents. Main endpoint was response rate according to Choi criteria. Central radiological assessment was mandatory. P was administered at 800 mg/d continuously till progression or toxicity. Results: From June 2014 to December 2018, 34 patients were enrolled in this cohort. The median age was 64 y (31-81). At baseline, ECOG 0/1/2 was distributed as 16/15/3; whereas, locally advanced/metastatic distribution was 11 (32%) and 23 (68%) respectively. At the time of the present analysis, 24 patients were deemed eligible and evaluable for response. Response rates according to local and central assessment were PR 6 (25%), SD 15 (62%), PD 3 (12%) and PR 12 (50%), SD 11 (46%), PD 1 (4%). With a median follow-up of 21 months, the median PFS following local and central assessment were 18.4 (6.6-30.1) and 9.8 (7.5-12.2) months respectively, both were clearly superior to that previously published in M-SFT cohort (5.57 m). The median of OS was 49.8 months. High tumor burden at baseline > 116 mm, ECOG 1-2 vs 0, and PD by local or central response assessment showed significantly worse OS. Metastatic vs locally advanced patients had a similar outcome regarding OS. Conclusions: T-SFT cohort exhibited clearly longer PFS than previous reported M-SFT cohort to pazopanib treatment, and pazopanib showed to improve the historical outcome obtained with chemotherapy in advanced SFT. Clinical trial information: NCT02066285

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Sarcoma

Track

Sarcoma

Sub Track

Soft Tissue Tumors

Clinical Trial Registration Number

NCT02066285

Citation

J Clin Oncol 37, 2019 (suppl; abstr 11038)

DOI

10.1200/JCO.2019.37.15_suppl.11038

Abstract #

11038

Poster Bd #

361

Abstract Disclosures