KH903 + FOLFIRI作为不可切除复发或转移性结直肠癌二线治疗的疗效和安全性：一项随机2期研究

IF 3.3 3区医学 Q2 ONCOLOGY

Clinical colorectal cancer Pub Date : 2024-11-10 DOI:10.1016/j.clcc.2024.10.003

Jian Li , YI BA , Rongbo Lin , Xiao Ke , Xianli yin , Jieer Ying , Ying Cheng , Nong Xu , Jiangming Xu , Yali Shen , Jianfeng Zhou , Jufeng Wang , Xiaoping Qian , Rong wu , Yanqiao Zhang , Lin Shen

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引用次数: 0

摘要

背景：复发或转移性晚期结直肠癌（mCRC）的患者常常面临临床困境，因为这种不可切除的疾病不断发展并危及患者的生命。在本研究中，我们探讨了KH903联合FOLFIRI化疗作为mCRC新的临床适应症的临床可行性。方法：122例患者以1:1的比例随机分配至4mg/kg q1w KH903或5mg/kg q2w KH903，两组患者均在接受KH903治疗的同时给予FOLFIRI固定治疗方案（每2周）。主要终点为无进展生存期（PFS），次要终点为总生存期（OS）、客观缓解率（ORR）和疾病控制率（DCR）。结果：截至2020年12月30日，4mg/kg q2w组的中位PFS为5.68个月（95% CI, 4.67-7.13），而5mg/kg q2w组的中位PFS为5.19个月（95% CI, 4.04, 5.78） (HR, 0.76；95% CI, 0.50-1.16)， mOS分别为13.14个月（95% CI, 10.61-19.52）和16.03个月（95% CI, 10.28- NE） (HR, 1.11；95% CI, 0.65-1.89)，两组的ORR分别为15.9%和11.9%，两组的DCR分别为85.7%和83.1%。两组3级及以上治疗相关不良事件发生率分别为68.3%和52.5%。结论：与同类药物（Avastin®、ZALTRAP®、Cyramza®）相比，KH903联合FORFIRI在二线治疗mCRC患者中可延长mPFS和mOS，且未观察到新的安全性信号。

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Efficacy and Safety of KH903 Plus FOLFIRI as a Second-Line Treatment in Unresectable Recurrent or Metastatic Colorectal Cancer: A Randomized Phase 2 Study

Background

Patients with recurrent or metastatic advanced colorectal cancer (mCRC) often face the clinical dilemma as this unresectable disease is continuously progressing and endangering the patients’ lives. In the current study, we explored the clinical feasibility of KH903 in combination with FOLFIRI chemotherapy as a new clinical indication for mCRC.

Methods

Patients (N = 122) were randomized 1:1 to 4mg/kg q1w KH903 or 5mg/kg q2w KH903, and both groups of patients were treated with the fixed regimen of FOLFIRI (every 2 weeks) along with the KH903 therapy. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were Overall Survival (OS), objective response rate (ORR), and disease control rate (DCR).

Results

As of December 30, 2020, median (m)PFS was 5.68 months (95% CI, 4.67-7.13) with 4mg/kg q1w versus 5.19 months (95% CI, 4.04, 5.78) with 5mg/kg q2w (HR, 0.76; 95% CI, 0.50-1.16),and mOS was 13.14 months (95% CI, 10.61-19.52) versus 16.03 months (95% CI, 10.28- NE), respectively (HR, 1.11; 95% CI, 0.65-1.89), The ORR was 15.9% and 11.9% for both groups, respectively, and The DCR for both groups was 85.7% and 83.1%, respectively. Grade 3 or higher treatment-related adverse event rates for both groups were 68.3% vs.52.5%, respectively.

Conclusions

KH903 in combination with FORFIRI in second-line treatment of patients with mCRC showed prolonged mPFS and mOS, comparing to the similar agents (Avastin®, ZALTRAP®, Cyramza®) and no new safety signals were observed.

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来源期刊

Clinical colorectal cancer 医学-肿瘤学

CiteScore

5.50

自引率

2.90%

发文量

审稿时长

27 days

期刊介绍： Clinical Colorectal Cancer is a peer-reviewed, quarterly journal that publishes original articles describing various aspects of clinical and translational research of gastrointestinal cancers. Clinical Colorectal Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of colorectal, pancreatic, liver, and other gastrointestinal cancers. The main emphasis is on recent scientific developments in all areas related to gastrointestinal cancers. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.