Meeting
2022 ASCO Gastrointestinal Cancers Symposium
Tislelizumab versus chemotherapy as second-line treatment for advanced or metastatic esophageal squamous cell carcinoma (ESCC, RATIONALE 302): Impact on health-related quality of life (HRQoL).
Authors
Eric Van Cutsem
University of Leuven (KUL) and University Hospitals Gasthuisberg, Leuven, Belgium
Eric Van Cutsem , Ken Kato , Jaffer A. Ajani , Lin Shen , Tianyu Xia , Ningning Ding , Lin Zhan , Gisoo Barnes , Sung-Bae Kim
Organizations
University of Leuven (KUL) and University Hospitals Gasthuisberg, Leuven, Belgium, Department of Head and Neck Esophageal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan, The University of Texas MD Anderson Cancer Center, Houston, TX, Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing, China, BeiGene, Ltd., Cambridge, MA, BeiGene Ltd, Zhongguancun Life Science Park, Beijing, China, BeiGene, Ltd., San Mateo, CA, BeiGene, Ltd., Emeryville, CA, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
Research Funding
Pharmaceutical/Biotech Company
Background: RATIONALE 302 was a global phase 3 study (NCT03430843) that investigated tislelizumab (TIS) compared with investigator-chosen chemotherapy (ICC) as second-line treatment for patients (pts) with advanced or metastatic ESCC, in which TIS demonstrated a significant and clinically meaningful improvement in overall survival hazard ratio (HR = 0.70 [95% CI 0.57–0.85], P=0.0001), and a favorable safety profile compared with ICC. Here we assess the HRQoL of pts receiving TIS vs ICC in a pt population that usually experiences HRQoL deterioration. Methods: Adults with advanced or metastatic ESCC whose disease progressed following prior systemic therapy were randomized 1:1 to either TIS 200 mg IV every 3 weeks or ICC (paclitaxel, docetaxel, or irinotecan). HRQoL was measured using the global health status/quality of life (GHS/QoL), physical functioning, and fatigue scores from EORTC QLQ-C30 and the dysphagia, reflux, eating, and pain scores from the EORTC QLQ-OES18 from screening through Cycle 6 or until treatment discontinuation (whichever occurs first) Least-squares mean score change from baseline to Cycles 4 and 6 in HRQoL scores was assessed using a mixed model for repeated measurements. Time to deterioration (TTD) for the GHS/QoL score and the symptom scales of the QLQ-OES18 was examined using the Kaplan-Meier method. Results: Overall, 512 pts (median age 62) were randomized to TIS (n=256) or ICC (n=256). Compared with ICC, TIS-treated pts had stable GHS/QoL and fatigue scores as well as less decline in physical functioning at Cycles 4 and 6 (table). Except for pain, the TIS arm experienced less OES18 symptoms relative to baseline than the ICC arm. TTD analysis showed pts in TIS arm were at lower risk of worsening dysphagia (HR = 0.76 [95% CI 0.53, 1.07], P=0.0562) compared with ICC. Conclusions: The analysis showed that ESCC pts treated with TIS in the second line had a longer maintenance of HRQoL compared to pts treated with ICC. These results, along with improved survival and favorable safety profile, suggest TIS represents a potential new second-line treatment option for pts with advanced or metastatic ESCC. Clinical trial information: NCT03430843.
| Tislelizumab (N=256) | ICC (N=256) | ||||
|---|---|---|---|---|---|
| Cycle 4 | Cycle 6 | Cycle 4 | Cycle 6 | ||
| QLQ-C30 | GHS/QoL | 0.0 (-2.5, 2.4) | -0.8 (-3.5, 2.0) | -5.8 (-8.8, -2.8) | -8.9 (-12.8, -4.9) |
| Physical functioning | -4.0 (-6.3, -1.8) | -4.6 (-7.1, -2.1) | -6.6 (-9.3, -4.0) | -8.9 (-12.1, -5.6) | |
| Fatigue | 3.5 (0.4, 6.6) | 1.0 (-2.1, 4.2) | 11.3 (7.5, 15.1) | 6.4 (2.0, 10.9) | |
| QLQ-OES18 | Dysphagia | 2.7 (-1.7, 7.1) | 1.6 (-3.5, 6.6) | 7.7 (2.2, 13.2) | 1.9 (-5.5, 9.2) |
| Reflux | -2.3 (-4.6, -0.1) | -1.8 (-4.7, 1.2) | 1.8 (-1.1, 4.7) | -1.1 (-5.4, 3.2) | |
| Eating | 0.0 (-2.8, 2.8) | -0.5 (-3.6, 2.6) | 2.7 (-0.8, 6.2) | 4.7 (0.3, 9.1) | |
| Pain | -1.6 (-3.4, 0.2) | -1.4 (-3.9, 1.0) | -1.1 (-3.6, 1.3) | 0.2 (-3.6, 4.1) | |
ICC, investigator-chosen chemotherapy.
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Abstract Details
Session Type
Poster Session
Session Title
Poster Session A: Cancers of the Esophagus and Stomach and Other GI Cancers
Track
Esophageal and Gastric Cancer,Other GI Cancer
Sub Track
Quality of Care/Quality Improvement
Clinical Trial Registration Number
NCT03430843
DOI
10.1200/JCO.2022.40.4_suppl.268
Abstract #
268
Poster Bd #
E10
Abstract Disclosures
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