Patient-reported outcomes and tolerability in patients receiving ripretinib versus sunitinib after treatment with imatinib in INTRIGUE, a phase 3, open-label study.
Patient-reported outcomes and tolerability in patients receiving ripretinib versus sunitinib after treatment with imatinib in INTRIGUE, a phase 3, open-label study.
复制标题
在 INTRIGUE（一项 3 期开放标签研究）中，接受瑞普替尼治疗的患者与接受伊马替尼治疗后接受舒尼替尼治疗的患者报告的结果和耐受性。
DOI：
10.1016/j.ejca.2023.113245
复制
发表时间：
2023
期刊：
影响因子：
--
通讯作者：
Sanchez
中科院分区：
文献类型：
--
作者：
Gelderblom,Hans;Jones,RobinL;Blay,Jean-Yves;George,Suzanne;vonMehren,Margaret;Zalcberg,JohnR;Kang,Yoon-Koo;Razak,AlbiruniAbdul;Trent,Jonathan;Attia,Steven;LeCesne,Axel;Siontis,BrittanyL;Goldstein,David;Boye,Kjetil;Sanchez
目的：在INTIGUE试验中，在接受伊马替尼治疗的晚期胃肠道间质瘤(GIST)患者中，利普替尼和舒尼替尼在无进展生存期方面没有显著差异。我们比较了这些治疗对健康相关生活质量(HRQOL)的影响。患者和方法被随机分为1：1到每天一次的利培尼150 mg或每天一次的舒尼替尼50 mg(为期4周/2周)。患者报告的结果使用欧洲癌症研究和治疗组织癌症生活质量问卷-30(EORTC QLQ-C30)问卷在第一天和第29个周期进行评估，直到治疗停止。计算与基线的变化。无症状或毒性时间(TWIST)是指在1年的随访中每个患者无进展、死亡或≥3级治疗紧急不良事件的平均天数。结果基线问卷完成率利普替尼为88.1%(199/226)，舒尼替尼为87.7%(199/227)，入选患者在整个治疗过程中仍然较高。接受舒尼替尼治疗的患者在自我报告的HRQL中表现出周期内的变化，与开/关给药方案相对应。接受利培尼治疗的患者在D29评估时的HRQOL在除便秘以外的所有量表上都好于接受舒尼替尼治疗的患者。未接受治疗的舒尼替尼患者在两周后的第1天评估中，HRQOL与治疗前相似。在服药期间接受利培尼治疗的患者比服用舒尼替尼的患者有更好的生活质量，而在除便秘外的所有QLQ-C30领域，接受利培尼治疗的患者的生活质量与2周内未接受舒尼替尼治疗的患者相似。利普利尼可能为先前使用伊马替尼治疗的晚期GIST患者提供临床上有意义的益处。
PurposeIn 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 methodsPatients 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.ResultsQuestionnaire 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).ConclusionPatients 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.
登录
查看更多内容
影响因子：
45.3
作者：
Blanke, Charles D.;Rankin, Cathryn;Borden, Ernest C.
通讯作者：
Borden, Ernest C.
DOI：
10.1016/s1470-2045(20)30168-6
发表时间：
2020-07
期刊：
The Lancet. Oncology
影响因子：
--
作者：
Blay JY;Serrano C;Heinrich MC;Zalcberg J;Bauer S;Gelderblom H;Schöffski P;Jones RL;Attia S;D'Amato G;Chi P;Reichardt P;Meade J;Shi K;Ruiz-Soto R;George S;von Mehren M
通讯作者：
von Mehren M
影响因子：
8.4
作者：
George, S.;Blay, J. Y.;Demetri, G. D.
通讯作者：
Demetri, G. D.
影响因子：
5.6
作者：
Vallilas C;Sarantis P;Kyriazoglou A;Koustas E;Theocharis S;Papavassiliou AG;Karamouzis MV
通讯作者：
Karamouzis MV
用于比较治疗的以生活质量为导向的终点。
影响因子：
1.9
作者：
R. Gelber;R. Gelman;A. Goldhirsch
通讯作者：
A. Goldhirsch