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http://ir.nhri.org.tw/handle/3990099045/14879
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| Title: | BEAR study: A single-arm, phase II trial of BI-754091 and afatinib for refractory esophageal squamous cell carcinoma |
| Authors: | Chiang, NJ;Hung, YP;Lien, MY;Wu, SY;Chang, WL;Bai, LY;Hsiao, CF;Chen, SH;Wu, IC;Chen, MH |
| Contributors: | Institute of Population Health Sciences;National Institute of Cancer Research |
| Abstract: | Background: EGFR inhibitors could increase MHC class-I presentation and sensitize tumor cells to CD8+ T cell–mediated killing, leading to a synergic efficacy in combination with PD-1 blockade. Afatinib also showed response as monotherapy in the treatment of refractory esophageal squamous cell carcinoma (ESCC). Herein, we report preliminary results of a phase II study of BI-754091 and afatinib in refractory ESCC patients. Methods: Patients with refractory ESCC were eligible to receive afatinib 30 mg once daily and BI-754901 240 mg on day 1, in a 3-week cycle. With Optimal Simon’s two-stage design and (p0=0.17, p1=0.35) for objective response rate (ORR, proportion of patients with complete or partial response [CR/PR]) and given error probabilities (one-sided alpha=0.05; beta=0.2), 16 evaluable patients were needed in the first stage. If 4 or more patients with objective response, the study would be extended to the second stage. Tumor response was assessed by CT/MRI every 6 weeks according to RECIST v1.1. The PR should be confirmed by two consecutive image examinations. Results: Between August 2021 and February 2022, a total of 19 patients were enrolled as the intention-to-treat (ITT) population. Three patients withdrew early after the first cycle of treatment. With a median follow-up of 7.4 months (95% confidence interval [CI], 5.2-7.9), 7 patients achieved confirmed PR and 7 patients (36.8%) got stable disease, with the ORR of 36.8% (95% CI, 16-62%) in ITT population. The median progression-free survival was 5.3 months (95% CI, 3.8-6.1) in 16 evaluable cases. The common all grades of adverse events were afatinib-related diarrhea (47.5%), mucositis (36.9%), acneiform rash (31.6%). One patient suffered from grade 2 pneumonitis. No treatment-related death was reported. Conclusions: By the observation of 7 patients with confirmed PR in the first stage, the second stage would be started for final enrollment to 44 evaluable cases. |
| Date: | 2022-11 |
| Relation: | Annals of Oncology. 2022 Nov;33(Suppl. 9):S1472-S1473. |
| Link to: | http://dx.doi.org/10.1016/j.annonc.2022.10.133 |
| JIF/Ranking 2023: | http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR |
| Cited Times(WOS): | https://www.webofscience.com/wos/woscc/full-record/WOS:000897943700099 |
| Appears in Collections: | [蕭金福] 會議論文/會議摘要
[陳尚鴻] 會議論文/會議摘要
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| ISI000897943700099.pdf | | 160Kb | Adobe PDF | 95 | View/Open |
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