Gastrointestinal Cancer

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SU_7_2071 - Combination of radiation therapy and anti-PD-1 antibody SHR-1210 in treating patients with esophageal squamous cell cancer

Sunday, October 21
1:15 PM - 2:45 PM
Location: Innovation Hub, Exhibit Hall 3

Combination of radiation therapy and anti-PD-1 antibody SHR-1210 in treating patients with esophageal squamous cell cancer
Z. Jing1, D. Du2, N. Zhang1, H. Dai1, X. Wang1, Y. Hua1, M. Jiang1, and S. Wu1; 1Hangzhou Cancer Hospital, Hangzhou, China, 2Lishui's Central Hospital, Lishui, China

Purpose/Objective(s): Preclinical and clinical evidence suggests that the combination of radiotherapy with anti-PD-1 treatment can have a synergistic effect in the treatment of cancer. The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 in patients with locally advanced esophageal squamous cell cancer (ESCC).

Materials/Methods: In this open-label,single center,non-randomized,single arm study. We recruited patients (aged 18-75 years), male or female, histologically confirmed primary squamous cell cancer of the esophagus, local advanced esophageal cancer diagnosed by pathology and imaging, pre-treatment evaluation can not tolerate concurrent radiochemotherapy or rejection of the concurrent use of chemotherapy with radiotherapy, measurable diseases, Eastern Cooperative Oncology Group performance status of 0 - 1, life expectancy of 6 months or more, and adequate organ function. The patients received radiotherapy (60 Gy in 5 fractions per week for 6 weeks) with SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles). The primary endpoint was local control. Secondary endpoints included overall survival, objective response rate and treatment toxicity.

Results: From Jul 2017 through Jan 2018, 16 pts were enrolled. The median age was 61 years (range, 35–70 years). The primary cancer lesions were located upper, middle and lower thoracic segments of the esophagus in 6, 8 and 2 patients, respectively. Among those, there were 9, 3 and 4 patients with stage II, III and IVa of ESCC, respectively. 14 pts were evaluable. Six patients (42.9%) experienced grade 1-2 treatment-related adverse events (AEs), with leucopenia (21.4%), neutropenia (21.4%), esophagitis (35.7%), fatigue (28.6%), and rash (14.3%). No patient experienced grade 3 or grade 4 AE, and no patient discontinued treatment because of an AE. The CR and PR were observed in 1 (7.1%) and 13 (92.9%) patients, respectively. With a 3 months of median follow-up, there was no local recurrence and the distance metastasis was observed in 2 (14.3%) patients. 1 cancer progression related death occurred. The median survival time has not been reached yet.

Conclusion: Anti-PD-1 antibody SHR-1210 in combination with radiotherapy may be well-tolerated and effective for the treatment of patients with locally advanced ESCC. Long-period toxicity and long-term efficacy need to be further evaluated.

Author Disclosure: Z. Jing: None. D. Du: None. N. Zhang: None. H. Dai: None.

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