دورية أكاديمية
Tislelizumab versus chemotherapy as second-line treatment for European and North American patients with advanced or metastatic esophageal squamous cell carcinoma: a subgroup analysis of the randomized phase III RATIONALE-302 study.
| العنوان: | Tislelizumab versus chemotherapy as second-line treatment for European and North American patients with advanced or metastatic esophageal squamous cell carcinoma: a subgroup analysis of the randomized phase III RATIONALE-302 study. |
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| المؤلفون: | Ajani, Jaffer, El Hajbi, Farid, Cunningham, David, Alsina, Maria, Thuss-Patience, Peter, Scagliotti, Giorgio V, Van den Eynde, Marc, Kim, Sung-Bae, Kato, Ken, Shen, Lin, Li, Liyun, Ding, Ningning, Shi, Jingwen, Barnes, Gisoo, Van Cutsem, Eric |
| المساهمون: | UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Service d'oncologie médicale, UCL - (SLuc) Service d'hépato-gastro-entérologie, UCL - (SLuc) Centre du cancer |
| المصدر: | ESMO open, Vol. 9, no.1, p. 102202 [1-9] (2024) |
| بيانات النشر: | Elsevier |
| سنة النشر: | 2024 |
| المجموعة: | DIAL@USL-B (Université Saint-Louis, Bruxelles) |
| مصطلحات موضوعية: | Humans, Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms, Quality of Life, Antibodies, Monoclonal, Humanized, anti-programmed cell death protein 1 antibody, tislelizumab |
| الوصف: | BACKGROUND: The phase III RATIONALE-302 study evaluated tislelizumab, an anti-programmed cell death protein 1 antibody, as second-line (2L) treatment for advanced/metastatic esophageal squamous cell carcinoma (ESCC). This prespecified exploratory analysis investigated outcomes in patients from Europe and North America (Europe/North America subgroup). PATIENTS AND METHODS: Patients with tumor progression during/after first-line systemic treatment were randomized 1 : 1 to open-label tislelizumab or investigator's choice of chemotherapy (paclitaxel, docetaxel, or irinotecan). RESULTS: The Europe/North America subgroup comprised 108 patients (tislelizumab: n = 55; chemotherapy: n = 53). Overall survival (OS) was prolonged with tislelizumab versus chemotherapy (median: 11.2 versus 6.3 months), with a hazard ratio (HR) of 0.55 [95% confidence interval (CI) 0.35-0.87]; HR was similar irrespective of programmed death-ligand 1 score [≥10%: 0.47 (95% CI 0.18-1.21); <10%: 0.55 (95% CI 0.30-1.01)]. Median progression-free survival was 2.3 versus 2.7 months with tislelizumab versus chemotherapy [HR: 0.97 (95% CI 0.64-1.47)]. Overall response rate was greater with tislelizumab (20.0%) versus chemotherapy (11.3%), with more durable response (median duration of response: 5.1 versus 2.1 months). Tislelizumab had a favorable safety profile versus chemotherapy, with fewer patients experiencing ≥grade 3 treatment-related adverse events (13.0% versus 51.0%). Those on tislelizumab experienced less deterioration in health-related quality of life, physical functioning, and/or disease- and treatment-related symptoms (i.e. fatigue, pain, and eating problems) as compared to those on chemotherapy, per the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and QLQ-OES18 scores. CONCLUSIONS: As a 2L therapy for advanced/metastatic ESCC, tislelizumab improved OS and had a favorable safety profile as compared to chemotherapy in European/North American ESCC patients in the ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 2059-7029 |
| العلاقة: | boreal:285071; http://hdl.handle.net/2078.1/285071Test; info:pmid/38118368; urn:EISSN:2059-7029 |
| DOI: | 10.1016/j.esmoop.2023.102202 |
| الإتاحة: | https://doi.org/10.1016/j.esmoop.2023.102202Test http://hdl.handle.net/2078.1/285071Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.70D477BC |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 20597029 |
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| DOI: | 10.1016/j.esmoop.2023.102202 |