國家衛生研究院 NHRI:Item 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:	[Chin-Fu Hsiao] Conference Papers/Meeting Abstract [Shang-Hung Chen] Conference Papers/Meeting Abstract

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