Anlotinib plus chemotherapy as a first-line treatment for gastrointestinal cancer patients with unresectable liver metastases: a multicohort, multicenter, exploratory trial.

Autor: Wu JW; Department of Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China., Zhou CF; Department of Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China., Han ZX; Department of Oncology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China., Zhang H; Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China., Yan J; Department of Oncology, Jiading District Central Hospital Affiliated Shanghai University of Medicine & Health Sciences, Shanghai, China., Chen J; Department of Chemoradiotherapy, The Affiliated People's Hospital of Ningbo University, Ningbo, China., Wang CB; Department of Oncology, The Third People's Hospital of Yancheng, Yancheng, China., Qin ZQ; Department of Medical Oncology, Zhejiang Provincial People's Hospital, Affiliated People's Hospital, Hangzhou, China., Mao Y; Department of Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China., Tang XY; Department of Oncology, Wuxi Branch of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Wuxi, China., Zhu LJ; Department of Medical Oncology, Jiangsu Cancer Hospital, Nanjing, China., Wei XW; Department of Oncology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China., Cui DH; Department of Internal Medicine, Anyang Tumor Hospital, Anyang, China., Yang XL; Department of Oncology, First Affiliated Hospital of Nanyang Medical College, Nanyang, China., Shi M; Department of Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China., Zhao LQ; Department of Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China., Jiang JL; Department of Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China., Zhu WY; Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China., Wang HM; Department of Oncology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China., Wang C; Department of Oncology, Jiading District Central Hospital Affiliated Shanghai University of Medicine & Health Sciences, Shanghai, China., Zhu LJ; Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. zhulingjun@njmu.edu.cn., Zhang J; Department of Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. junzhang10977@sjtu.edu.cn.
Jazyk: angličtina
Zdroj: Signal transduction and targeted therapy [Signal Transduct Target Ther] 2024 Dec 09; Vol. 9 (1), pp. 344. Date of Electronic Publication: 2024 Dec 09.
DOI: 10.1038/s41392-024-02051-4
Abstrakt: This multicohort phase II trial (ALTER-G-001; NCT05262335) aimed to assess the efficacy of first-line anlotinib plus chemotherapy for gastrointestinal (GI) cancer patients with unresectable liver metastases. Eligible patients with colorectal cancer (Cohort A) or noncolorectal and nonesophageal GI cancer (Cohort C) received six cycles of anlotinib plus standard chemotherapeutic regimens followed by anlotinib plus metronomic capecitabine as a maintenance therapy. Liver metastasectomy can be performed when liver metastases are converted to resectable lesions. The primary outcome was the investigator-confirmed objective response rate (ORR) in the intention-to-treat population. Among the 47 patients in Cohort A, the ORR was 40.4% (95% CI 26.4-55.7), including 1 with a complete response (CR) and 18 who achieved a partial response (PR). The median progression-free survival (PFS) was 8.7 months (95% CI 7.3-NE), and the median overall survival (OS) was not reached. In Cohort C, 14 of 44 patients achieved a PR, with an ORR of 31.8% (95% CI 18.6-47.6). The PFS and OS were 5.8 months (95% CI 4.8-6.5) and 11.4 months (95% CI 5.8-19.3), respectively. The liver metastasectomy rate in patients with liver-limited disease was 22.7% (5/22) in Cohort A and 6.7% (2/30) in Cohort C. For pancreatic cancer patients, the ORR of the efficacy-evaluable population was 36.0% (9/25), and those with liver-limited metastasis had better survival. Moreover, no new safety concerns emerged. In conclusion, an anlotinib-based first-line regimen demonstrated promising antitumor activity among GI cancer patients with unresectable liver metastases and led to liver metastasectomy in selected patients.
Competing Interests: Competing interests: The authors declare that they have no competing interests. Inclusion and Ethics: The trial was conducted in accordance with the Declaration of Helsinki, the Good Clinical Practice guidelines of the International Conference on Harmonization, and relevant laws and directives in China. The study protocols and all amendments were approved by the ethics committee of the Ruijin Hospital Ethics Committee, Shanghai Jiao Tong University School of Medicine (2021-223). All patients provided written informed consent before any trial-related activities. This trial is registered with CLINICALTRIALS.GOV (NCT05262335). The study protocols and all amendments were approved by the institutional review board or ethics committee of each participating center. Informed consent: All patients provided written informed consent before any trial-related activities.
(© 2024. The Author(s).)
Databáze: MEDLINE
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