Conversion therapy with sintilimab combined with chemotherapy and apatinib in stage IV gastric cancer.

IF 5.7 2区 医学 Q1 ONCOLOGY
Yong Liu, Qiang Xue, Baogui Wang, Xuewei Ding, Rupeng Zhang, Xiaona Wang, Bin Ke, Xuejun Wang, Ning Liu, Jingyu Deng, Hongjie Zhan, Bin Li, Liangliang Wu, Mingzhi Cai, Li Zhang, Wenbai Huang, Peng Jin, Han Liang
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引用次数: 0

Abstract

In selected patients with stage IV gastric cancer, radical surgery after conversion therapy may increase survival benefit; however, there is currently no standard protocol for conversion therapy. We explored the feasibility and efficacy of sintilimab plus two-drug chemotherapy (S-1 plus nab-paclitaxel) and apatinib as conversion therapy in patients with stage IV gastric cancer in China. This was a prospective, single-arm, single-center, phase 2 study. The primary endpoint was the R0 conversion rate, defined as the proportion of R0 surgical patients to the total number of patients treated. Of 56 patients screened, 47 were enrolled, received preoperative treatment, and were evaluated for tumor response. Most patients (28/47; 59.6%) had two or three unresectable factors. The objective response rate and disease control rate were 53.2% and 97.9%, respectively. Of the 46/47 patients who achieved disease control, 35 underwent surgery. The R0 conversion rate was 51.1% (24/47). A pathological complete response was observed in 14.3% (5/35) of patients. Median overall survival and event-free survival were 25.7 and 15.3 months, respectively. Overall survival and event-free survival were significantly better in surgical patients compared with non-surgical patients (p < 0.001). In the surgical population, R1/R2 resection was the only significant independent predictor of unfavorable event-free survival by multivariate analysis (p = 0.015). There were no chemotherapy- or perioperative-related deaths. The safety profile was manageable. Sintilimab plus chemotherapy and apatinib followed by conversional resection may be a new feasible and safe option for initially unresectable gastric cancer, potentially leading to long-term survival or even cure.

辛替单抗联合化疗和阿帕替尼治疗IV期胃癌。
在选定的IV期胃癌患者中,转换治疗后的根治性手术可能增加生存获益;然而,目前还没有转化治疗的标准方案。我们探讨了西替单抗联合两药化疗(S-1 + nab-紫杉醇)和阿帕替尼作为中国IV期胃癌患者转换治疗的可行性和疗效。这是一项前瞻性、单组、单中心、2期研究。主要终点是R0转换率,定义为R0手术患者占治疗总人数的比例。在筛选的56例患者中,47例入组,接受术前治疗,并评估肿瘤反应。大多数患者(28/47;59.6%)有2 ~ 3个不可切除因素。客观有效率为53.2%,疾病控制率为97.9%。47例患者中有46例获得疾病控制,其中35例接受了手术。R0转化率为51.1%(24/47)。14.3%(5/35)的患者病理完全缓解。中位总生存期和无事件生存期分别为25.7个月和15.3个月。手术患者的总生存期和无事件生存期明显优于非手术患者(p
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来源期刊
CiteScore
13.40
自引率
3.10%
发文量
460
审稿时长
2 months
期刊介绍: The International Journal of Cancer (IJC) is the official journal of the Union for International Cancer Control—UICC; it appears twice a month. IJC invites submission of manuscripts under a broad scope of topics relevant to experimental and clinical cancer research and publishes original Research Articles and Short Reports under the following categories: -Cancer Epidemiology- Cancer Genetics and Epigenetics- Infectious Causes of Cancer- Innovative Tools and Methods- Molecular Cancer Biology- Tumor Immunology and Microenvironment- Tumor Markers and Signatures- Cancer Therapy and Prevention
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