TY - JOUR
T1 - Patient-reported outcomes and tolerability in patients receiving ripretinib versus sunitinib after treatment with imatinib in INTRIGUE, a phase 3, open-label study
AU - Gelderblom, Hans
AU - Jones, Robin L.
AU - Blay, Jean Yves
AU - George, Suzanne
AU - von Mehren, Margaret
AU - Zalcberg, John R.
AU - Kang, Yoon Koo
AU - Razak, Albiruni Abdul
AU - Trent, Jonathan
AU - Attia, Steven
AU - Le Cesne, Axel
AU - Siontis, Brittany L.
AU - Goldstein, David
AU - Boye, Kjetil
AU - Sanchez, Cesar
AU - Steeghs, Neeltje
AU - Rutkowski, Piotr
AU - Druta, Mihaela
AU - Serrano, César
AU - Somaiah, Neeta
AU - Chi, Ping
AU - Harrow, Brooke
AU - Becker, Claus
AU - Reichmann, William
AU - Sherman, Matthew L.
AU - Ruiz-Soto, Rodrigo
AU - Heinrich, Michael C.
AU - Bauer, Sebastian
N1 - Publisher Copyright:
© 2023 The Authors
PY - 2023/10
Y1 - 2023/10
N2 - 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.
AB - 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.
KW - Gastrointestinal stromal tumours
KW - Patient reported outcome measures
KW - Protein kinase inhibitors
KW - Quality of life
UR - http://www.scopus.com/inward/record.url?scp=85168457467&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85168457467&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2023.113245
DO - 10.1016/j.ejca.2023.113245
M3 - Article
C2 - 37598656
AN - SCOPUS:85168457467
SN - 0959-8049
VL - 192
JO - European Journal of Cancer
JF - European Journal of Cancer
M1 - 113245
ER -