Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinoma
Objective: The mainstay treatment of esophageal squamous cell carcinoma (ESCC) involves chemotherapy and immunotherapy. However, alternative therapies are required for patients who are refractory or intolerant to existing therapies. Methods: In this single-arm, multicenter, open-label phase Ib study...
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| Format: | Article |
| Language: | English |
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China Anti-Cancer Association
2022-03-01
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| Series: | Cancer Biology & Medicine |
| Subjects: | |
| Online Access: | http://www.cancerbiomed.org/index.php/cocr/article/view/2010 |
| _version_ | 1811337713964548096 |
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| author | Ming Bai Meng Wang Ting Deng Yuxian Bai Kai Zang Zhanhui Miao Wenlin Gai Liangzhi Xie Yi Ba |
| author_facet | Ming Bai Meng Wang Ting Deng Yuxian Bai Kai Zang Zhanhui Miao Wenlin Gai Liangzhi Xie Yi Ba |
| author_sort | Ming Bai |
| collection | DOAJ |
| description | Objective: The mainstay treatment of esophageal squamous cell carcinoma (ESCC) involves chemotherapy and immunotherapy. However, alternative therapies are required for patients who are refractory or intolerant to existing therapies. Methods: In this single-arm, multicenter, open-label phase Ib study, 30 patients received an intravenous infusion of SCT200, an anti-epidermal growth factor receptor (EGFR) monoclonal antibody, 6.0 mg/kg once a week for 6 weeks, followed by 8.0 mg/kg once every 2 weeks until disease progression or intolerable toxicity. The primary endpoint was the objective response rate (ORR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. Results: Thirty patients were enrolled between July 2018 and May 2019. The ORR was 16.7% (95% CI: 5.6%–34.7%). The median PFS and OS were 3.1 months (95% CI: 1.5–4.3) and 6.8 months (95% CI: 4.7–10.1), respectively. A numerical difference without any statistical significance in ORR was observed in patients with different EGFR expressions (≥ 50%: 25.0% vs. < 50%: 0%, P = 0.140) or TP53 mutation abundance (< 10%: 23.8% vs. ≥ 10%: 0%, P = 0.286). Improved median PFS (3.4 vs. 1.4 months, P = 0.006) and OS (8.0 vs. 4.2 months, P = 0.027) were associated with TP53 mutation abundance of < 10%. The most common treatment-related adverse events of grade 3 or 4 (occurring in ≥ 2 patients) were hypomagnesemia [7 (23.3%)] and rash [2 (6.7%)]. No treatment-related death occurred. Conclusions: SCT200 monotherapy as the second- or further-line treatment for advanced ESCC showed favorable efficacy, with an acceptable safety profile. TP53 mutation abundance might serve as a potential predictive biomarker. |
| first_indexed | 2024-04-13T18:00:01Z |
| format | Article |
| id | doaj.art-8c85852caef749888b4c18d96281305c |
| institution | Directory Open Access Journal |
| issn | 2095-3941 |
| language | English |
| last_indexed | 2024-04-13T18:00:01Z |
| publishDate | 2022-03-01 |
| publisher | China Anti-Cancer Association |
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| series | Cancer Biology & Medicine |
| spelling | doaj.art-8c85852caef749888b4c18d96281305c2022-12-22T02:36:18ZengChina Anti-Cancer AssociationCancer Biology & Medicine2095-39412022-03-0119335836910.20892/j.issn.2095-3941.2021.0388Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinomaMing Bai0Meng Wang1Ting Deng2Yuxian Bai3Kai Zang4Zhanhui Miao5Wenlin Gai6Liangzhi Xie7Yi Ba8Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin’s Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin 300060, ChinaTianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin’s Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin 300060, ChinaTianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin’s Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin 300060, ChinaDepartment of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, ChinaDepartment of Medical Oncology, Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, ChinaOncology Department, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang 453100, ChinaSinocelltech Ltd., Beijing 100176, ChinaSinocelltech Ltd., Beijing 100176, ChinaTianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin’s Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin 300060, ChinaObjective: The mainstay treatment of esophageal squamous cell carcinoma (ESCC) involves chemotherapy and immunotherapy. However, alternative therapies are required for patients who are refractory or intolerant to existing therapies. Methods: In this single-arm, multicenter, open-label phase Ib study, 30 patients received an intravenous infusion of SCT200, an anti-epidermal growth factor receptor (EGFR) monoclonal antibody, 6.0 mg/kg once a week for 6 weeks, followed by 8.0 mg/kg once every 2 weeks until disease progression or intolerable toxicity. The primary endpoint was the objective response rate (ORR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. Results: Thirty patients were enrolled between July 2018 and May 2019. The ORR was 16.7% (95% CI: 5.6%–34.7%). The median PFS and OS were 3.1 months (95% CI: 1.5–4.3) and 6.8 months (95% CI: 4.7–10.1), respectively. A numerical difference without any statistical significance in ORR was observed in patients with different EGFR expressions (≥ 50%: 25.0% vs. < 50%: 0%, P = 0.140) or TP53 mutation abundance (< 10%: 23.8% vs. ≥ 10%: 0%, P = 0.286). Improved median PFS (3.4 vs. 1.4 months, P = 0.006) and OS (8.0 vs. 4.2 months, P = 0.027) were associated with TP53 mutation abundance of < 10%. The most common treatment-related adverse events of grade 3 or 4 (occurring in ≥ 2 patients) were hypomagnesemia [7 (23.3%)] and rash [2 (6.7%)]. No treatment-related death occurred. Conclusions: SCT200 monotherapy as the second- or further-line treatment for advanced ESCC showed favorable efficacy, with an acceptable safety profile. TP53 mutation abundance might serve as a potential predictive biomarker.http://www.cancerbiomed.org/index.php/cocr/article/view/2010epidermal growth factor receptoresophageal squamous cell carcinomasct200monoclonal antibody |
| spellingShingle | Ming Bai Meng Wang Ting Deng Yuxian Bai Kai Zang Zhanhui Miao Wenlin Gai Liangzhi Xie Yi Ba Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinoma Cancer Biology & Medicine epidermal growth factor receptor esophageal squamous cell carcinoma sct200 monoclonal antibody |
| title | Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinoma |
| title_full | Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinoma |
| title_fullStr | Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinoma |
| title_full_unstemmed | Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinoma |
| title_short | Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinoma |
| title_sort | safety and efficacy of anti egfr monoclonal antibody sct200 as second line therapy in advanced esophageal squamous cell carcinoma |
| topic | epidermal growth factor receptor esophageal squamous cell carcinoma sct200 monoclonal antibody |
| url | http://www.cancerbiomed.org/index.php/cocr/article/view/2010 |
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