The Desmoid Tumor Research Foundation

February 2026

Clinico-radiological outcomes after discontinuation of sorafenib in non-abdominal desmoid-type fibromatosis: Final results from a phase-II SORASTOP study from India

Author Information

Kinjal Singh 1, Sameer Rastogi 2, Akash Singh 1, Simran Kaur 3, Shivanand Gamanagatti 4, Stanzin Spalkit 4, Ghazal Tansir 1, Bharath B Gangadharaiah 1, Vikas Garg 1, Adarsh Barwad 5, Sandeep Bhoriwal 6, Puneet Tanwar 1

1Department of Medical Oncology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi 110029, India. 2Department of Medical Oncology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi 110029, India. Electronic address: samdoc_mamc@yahoo.com. 3Department of Physiology, All India Institute of Medical Sciences, New Delhi 110029, India. 4Department of Radio-diagnosis, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi 110029, India. 5Department of Pathology, All India Institute of Medical Sciences, New Delhi 110029, India. 6Department of Surgical Oncology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi 110029, India.

Publication

Eur J Cancer

Summary

Introduction: The SORASTOP study reports long-term outcomes following planned sorafenib discontinuation in responding patients with extremity desmoid-type fibromatosis (DTF). Materials and methods: In this prospective, single-arm phase 2 Simon's two-stage trial, adults with non-progressive, extremity DTF, ESAS pain < 2, after ≥ 12 months of sorafenib were enrolled. Sorafenib was stopped and patients were monitored with MRI, ESAS, and EORTC QLQ-C30, ACE-III. Progression was defined as ≥ 20 % tumour increase or ≥ 10 % increase with ESAS pain score > 5. The primary endpoint was 1-year PFS. Results: 33 patients (median age 30 years; 54.5 % female) were enrolled between 2021-2023. At 12 months, 31 (93.9 %) were evaluable; at 24 months, 30 (90.9 %). After 12 months of discontinuation, 4/31 (12.9 %) had PR, 24/31 (77.4 %) SD and 3/31 (9.6 %) PD and at 24 months 8/30 (26.6 %) had PR, 16/30 (53.3 %) SD and 6/30 (20 %) PD (RECIST v1.1). ESAS pain showed a transient rise: pain-free patients (ESAS=0) decreased from 69.7 % at baseline to 35.5 % at 12 months, recovering to 66.7 % at 24 months. Nine patients (27 %) progressed; four required sorafenib re-initiation and five were managed conservatively, all ultimately achieving disease stabilisation. PFS at 12, 24 and 36 months were 90.8 %, 74.5 % and 74.5 % respectively; with median follow-up of 37 months. EORTC QLQ-C30 showed stable global health status and improvements in emotional, physical, and cognitive functioning, with reductions in fatigue and pain. Conclusion: Planned sorafenib discontinuation in responding extremity DTF patients is feasible, yields durable disease control, and improves QoL. Patients who progressed were successfully managed with sorafenib re-challenge or observation.

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