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The Desmoid Tumor Research Foundation

September 2023

Patient-reported outcomes and tolerability in patients receiving ripretinib versus sunitinib after treatment with imatinib in INTRIGUE, a phase 3, open-label study

Author Information

Hans Gelderblom 1, Robin L Jones 2, Jean-Yves Blay 3, Suzanne George 4, Margaret von Mehren 5, John R Zalcberg 6, Yoon-Koo Kang 7, Albiruni Abdul Razak 8, Jonathan Trent 9, Steven Attia 10, Axel Le Cesne 11, Brittany L Siontis 12, David Goldstein 13, Kjetil Boye 14, Cesar Sanchez 15, Neeltje Steeghs 16, Piotr Rutkowski 17, Mihaela Druta 18, César Serrano 19, Neeta Somaiah 20, Ping Chi 21, Brooke Harrow 22, Claus Becker 23, William Reichmann 23, Matthew L Sherman 23, Rodrigo Ruiz-Soto 23, Michael C Heinrich 24, Sebastian Bauer 25; INTRIGUE investigators

1Leiden University Medical Center, Leiden, the Netherlands. 2Royal Marsden Hospital and Institute of Cancer Research, London, UK. 3Centre Léon Bérard and University Claude Bernard Lyon 1, Lyon, France. 4Dana-Farber Cancer Institute, Boston, MA, USA. 5Fox Chase Cancer Center, Philadelphia, PA, USA. 6Department of Medical Oncology, Alfred Health and School of Public Health, Monash University, Melbourne, Australia. 7Asan Medical Center, University of Ulsan, Seoul, Korea. 8Princess Margaret Cancer Centre, Toronto, ON, Canada. 9Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL, USA. 10Mayo Clinic, Jacksonville, FL, USA. 11Gustave Roussy, Vellejuif, France. 12Mayo Clinic, Rochester, MN, USA. 13Prince of Wales Hospital and Clinical School University of New South Wales, New South Wales, Australia. 14Department of Oncology, Oslo University Hospital, Oslo, Norway. 15Department of Hematology and Oncology, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile. 16Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands. 17Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, Poland. 18Moffit Cancer Center, Tampa, FL, USA. 19Vall d'Hebron Institute of Oncology, Barcelona, Spain. 20MD Anderson Cancer Center, Houston, TX, USA. 21Memorial Sloan Kettering Cancer Center, New York, NY, USA. 22Deciphera Pharmaceuticals, LLC, Waltham, MA, USA. Electronic address: brooke.harrow@deciphera.com. 23Deciphera Pharmaceuticals, LLC, Waltham, MA, USA. 24Portland VA Healthcare System and Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA. 25Department of Medical Oncology and Sarcoma Center at the West German Cancer Center, University Hospital Essen, Essen, Germany; German Cancer Consortium (DKTK), Partner Site University Hospital Essen, Essen, Germany.

Publication

Eur J Cancer

Summary

Purpose: In the INTRIGUE trial, ripretinib showed no significant difference versus sunitinib in progression-free survival for patients with advanced gastrointestinal stromal tumour (GIST) previously treated with imatinib. We compared the impact of these treatments on health-related quality of life (HRQoL). Patients and methods: Patients were randomised 1:1 to once-daily ripretinib 150 mg or once-daily sunitinib 50 mg (4 weeks on/2 weeks off). Patient-reported outcomes were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer-30 (EORTC QLQ-C30) questionnaire at day (D)1, and D29 of all cycles until treatment discontinuation. Change from baseline was calculated. Time without symptoms or toxicity (TWiST) was estimated as the mean number of days without progression, death, or grade ?3 treatment-emergent adverse events per patient over 1 year of follow-up. Results: Questionnaire completion at baseline was 88.1% (199/226) for ripretinib and 87.7% (199/227) for sunitinib and remained high for enrolled patients throughout treatment. Patients receiving sunitinib demonstrated within-cycle variation in self-reported HRQoL, corresponding to the on/off dosing regimen. Patients receiving ripretinib reported better HRQoL at D29 assessments than patients receiving sunitinib on all scales except constipation. HRQoL was similar between treatments at D1 assessments, following 2 weeks without treatment for sunitinib patients. TWiST was greater for ripretinib patients (173 versus 126 days). Conclusion: Patients receiving ripretinib experienced better HRQoL than patients receiving sunitinib during the dosing period and similar HRQoL to patients who had not received sunitinib for 2 weeks for all QLQ-C30 domains except constipation. Ripretinib may provide clinically meaningful benefit to patients with advanced GIST previously treated with imatinib. Trial registration: ClinicalTrials.gov NCT03673501.

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