Patient-reported outcomes and tolerability in patients receiving ripretinib versus sunitinib after treatment with imatinib in INTRIGUE, a phase 3, open-label study.
Hans Gelderblom, Robin L Jones, Jean-Yves Blay, Suzanne George, Margaret von Mehren, John R Zalcberg, Yoon-Koo Kang, Albiruni Abdul Razak, Jonathan Trent, Steven Attia, Axel Le Cesne, Brittany L Siontis, David Goldstein, Kjetil Boye, Cesar Sanchez, Neeltje Steeghs, Piotr Rutkowski, Mihaela Druta, C��sar Serrano, Neeta Somaiah, Ping Chi, Brooke Harrow, Claus Becker, William Reichmann, Matthew L Sherman, Rodrigo Ruiz-Soto, Michael C Heinrich, Sebastian Bauer, INTRIGUE investigators
Author Information
Hans Gelderblom: Leiden University Medical Center, Leiden, the Netherlands.
Robin L Jones: Royal Marsden Hospital and Institute of Cancer Research, London, UK.
Jean-Yves Blay: Centre L��on B��rard and University Claude Bernard Lyon 1, Lyon, France.
Suzanne George: Dana-Farber Cancer Institute, Boston, MA, USA.
Margaret von Mehren: Fox Chase Cancer Center, Philadelphia, PA, USA.
John R Zalcberg: Department of Medical Oncology, Alfred Health and School of Public Health, Monash University, Melbourne, Australia.
Yoon-Koo Kang: Asan Medical Center, University of Ulsan, Seoul, Korea.
Albiruni Abdul Razak: Princess Margaret Cancer Centre, Toronto, ON, Canada.
Jonathan Trent: Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL, USA.
Steven Attia: Mayo Clinic, Jacksonville, FL, USA.
Axel Le Cesne: Gustave Roussy, Vellejuif, France.
Brittany L Siontis: Mayo Clinic, Rochester, MN, USA.
David Goldstein: Prince of Wales Hospital and Clinical School University of New South Wales, New South Wales, Australia.
Kjetil Boye: Department of Oncology, Oslo University Hospital, Oslo, Norway.
Cesar Sanchez: Department of Hematology and Oncology, School of Medicine, Pontificia Universidad Cat��lica de Chile, Santiago, Chile.
Neeltje Steeghs: Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
Piotr Rutkowski: Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, Poland.
Mihaela Druta: Moffit Cancer Center, Tampa, FL, USA.
C��sar Serrano: Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Neeta Somaiah: MD Anderson Cancer Center, Houston, TX, USA.
Ping Chi: Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Claus Becker: Deciphera Pharmaceuticals, LLC, Waltham, MA, USA.
William Reichmann: Deciphera Pharmaceuticals, LLC, Waltham, MA, USA.
Matthew L Sherman: Deciphera Pharmaceuticals, LLC, Waltham, MA, USA.
Rodrigo Ruiz-Soto: Deciphera Pharmaceuticals, LLC, Waltham, MA, USA.
Michael C Heinrich: Portland VA Healthcare System and Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA.
Sebastian Bauer: Department 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.
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.
