贝伐珠单抗联合奥沙利铂放化疗治疗不可切除食管鳞癌的Ⅱ期临床研究解析：这是一个药物临床试验，涉及的是贝伐珠单抗（Avastin）联合奥沙利铂（Oxaliplatin）治疗不可切除食管鳞癌的效果。在翻译时，需要根据原文进行分析，找到药物的对应名称，并使用中文进行解释。

Endostatin and Oxaliplatin-Based Chemoradiotherapy for Inoperable Esophageal Squamous Cell Carcinoma: Results of a Phase II Study.

机构信息

Department of Radiation Oncology, Hangzhou Cancer Hospital, Hangzhou, People's Republic of China.

Department of Radiation Oncology, Hangzhou Cancer Hospital, Hangzhou, People's Republic of China

出版信息

Oncologist. 2019 Apr;24(4):461-e136. doi: 10.1634/theoncologist.2019-0119. Epub 2019 Mar 8.

DOI:10.1634/theoncologist.2019-0119

PMID:30850562

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6459259/

Abstract

LESSONS LEARNED

Definitive concurrent chemoradiotherapy based on oxaliplatin and endostatin was effective with the objective response rate exceeding 80%, and the treatment-related toxicities were acceptable.The treatment compliance of the current combination was much higher, without significant reduction in survival outcomes, than historical reports.

BACKGROUND

This phase II trial aimed at assessing the efficiency and safety of definitive concurrent chemoradiotherapy (dCRT) using oxaliplatin (OHP) and endostatin in patients with inoperable esophageal squamous cell carcinoma (ESCC).

METHODS

Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60.0 Gy over 6 weeks. Endostatin and OHP were both intravenously administered at doses of 7.5 mg/m daily for 2 weeks and 135 mg/m on day 1, respectively, every 3 weeks. The primary endpoint was the objective response rate (ORR).

RESULTS

The analysis included 37 patients. The median age was 63 years (range: 49-71 years), and all patients were stage III-IVA. Of these patients, 97.3% (36/37) completed the dCRT course with an ORR of 83.8%, including 10 (27.0%) patients with complete response and 21 (56.8%) patients with partial response. The median overall survival (OS) time was 18.5 months (95% confidence interval [CI]: 10.6-26.4) with a 2-year OS rate of 39.6% (95% CI: 0.202-0.590). The median progression-free survival (PFS) time was 11.5 months (95% CI: 7.6-15.4) with a 2-year PFS rate of 20.2% (95% CI: 0.049-0.355). Grade 3 toxicities included esophagitis (five patients) and leukocytopenia (three patients). Grade 4 leukopenia was observed in one patient. Late toxicity was infrequent, and no treatment-related death occurred. Posttreatment dysphagia scores were significantly improved when compared with baseline ( < .001).

CONCLUSION

dCRT based on OHP and endostatin resulted in high treatment compliance with manageable toxicities. This combination resulted in encouraging ORR without compromising survival outcomes. It should be validated in future clinical studies.

摘要

经验教训

基于奥沙利铂和内皮抑素的确定性同期放化疗具有 80%以上的客观缓解率，治疗相关毒性可接受。与历史报告相比，目前联合治疗的治疗依从性更高，生存结果没有显著降低。

背景

本Ⅱ期试验旨在评估奥沙利铂（OHP）和内皮抑素在不可切除食管鳞状细胞癌（ESCC）患者中确定性同期放化疗（dCRT）的疗效和安全性。

方法

放疗采用每日 2.0Gy 的分割剂量，总剂量为 60.0Gy，持续 6 周。内皮抑素和 OHP 分别静脉内给药，剂量为 7.5mg/m2，每 2 周给药 1 天，第 1 天给药 135mg/m2，每 3 周给药 1 次。主要终点是客观缓解率（ORR）。

结果

分析纳入 37 例患者。中位年龄为 63 岁（范围：49-71 岁），所有患者均为 III-IVA 期。这些患者中，97.3%（36/37）完成了 dCRT 疗程，ORR 为 83.8%，包括 10 例（27.0%）完全缓解和 21 例（56.8%）部分缓解。中位总生存（OS）时间为 18.5 个月（95%置信区间[CI]：10.6-26.4），2 年 OS 率为 39.6%（95%CI：0.202-0.590）。中位无进展生存（PFS）时间为 11.5 个月（95%CI：7.6-15.4），2 年 PFS 率为 20.2%（95%CI：0.049-0.355）。3 级毒性包括食管炎（5 例）和白细胞减少（3 例）。1 例患者出现 4 级白细胞减少。晚期毒性少见，无治疗相关死亡。与基线相比，治疗后吞咽困难评分显著改善（ < .001）。