Patient reported outcomes and tolerability in patients receiving ripretinib versus sunitinib after imatinib treatment in INTRIGUE: A phase 3 open-label study.

11541 Background: Ripretinib (R) is a switch-control tyrosine kinase inhibitor (TKI) indicated for the treatment of patients (pts) with advanced gastrointestinal stromal tumor (GIST) after prior ?3 TKIs. In INTRIGUE study (NCT03673501) there was no significant difference in median PFS (primary endpoint) between R and sunitinib (S). We present exploratory analyses tolerability data selected pt reported outcomes (PROs). Methods: Pts were randomized 1:1 to 150 mg QD or S 50 4 weeks on/2 off.Dose modification allowed toxicity management. The event interest severe life-threatening (grade ?3) treatment-related adverse progression (sTRAE). Days at least one sTRAE summed all treated pts ?1 event. PROs assessed using questions from EORTC QLQ-C30 Dermatology Life Quality Index (DLQI) cycle 1 (C1) day (D1), D15, D29; D1 D29 other cycles; as well end treatment. Differences PRO scores baseline later assessments calculated across visits. Long-term will be presented. Results: receiving (n = 223) versus (vs) 221) experienced fewer sTRAEs (24% vs 51%, respectively). For pts, mean time 11 days 42 (ratio 0.27, P<0.0001). sTRAE, number 48 81 0.59, p 0.037). Completion two arms similar (baseline: [n 199], 199]; C1 D29: 167], 177]). Significant differences self-reported functioning symptoms observed by D29. relating commonly sTRAEs, except constipation, arm better than arm. significantly (p<0.05) less decline compared pt-reported role function increase, improvement, fatigue, appetite loss, diarrhea, nausea/vomiting, pain Moderate effect skin on life, measured DLQI 165) 175), 6.6% 14.8% (p 0.015). Conclusions: total S. also increase related Medical writing provided Costello Medical. Clinical trial information: NCT03673501.