Meeting
2024 ASCO Gastrointestinal Cancers Symposium
Anlotinib plus chemotherapy as first-line therapy for patients with gastrointestinal tumor with unresectable liver metastasis: Updated results from multi-cohort, multi-center phase II trial ALTER-G-001-cohort A.
Authors
Junwei Wu
Department of Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Junwei Wu , Lingjun Zhu , Chenfei Zhou , Min Shi , Jun Chen , Liqin Zhao , Zhengxiang Han , Chunbing Wang , Jinling Jiang , Jun Yan , Chun Wang , Xiaowei Wei , Yong Mao , Donghai Cui , Xiuli Yang , Zhiquan Qin , Xinyu Tang , Jun Zhang
Organizations
Department of Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China, The Affiliated People’s Hospital of Ningbo University, Ningbo, China, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China, Department of Oncology, Yancheng Third People's Hospital, Yancheng, China, Department of Oncology, Jiading Central Hospital, Shanghai, China, Department of Oncology, Nanjing First Hospital, Nanjing, China, Department of Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China, Department of Oncology, Anyang Tumor Hospital, Anyang, China, Nanyang Medical College First Affiliated Hospital, Nanyang, China, Department of Medical Oncology, Zhejiang Provincal People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China, Department of Oncology, Wuxi Branch of Ruijin Hospital, Wuxi, China
Research Funding
No funding sources reported
Background: Advanced gastrointestinal (GI) tumors, such as colorectal, gastric and pancreatic cancers (CRC, GC, and PC), and esophageal squamous cell carcinoma (ESCC), 20%-50% with liver metastases (LMs). The prognosis of CRC with unresectable LMs is poor, with a 5-year survival rate of less than 5%. Previous trials showed that anlotinib plus chemotherapy has promising clinical activity and a tolerable safety profile for advanced CRC and ESCC, especially with LMs. In this phase II trial, we assessed the efficacy and safety of anlotinib plus chemotherapy as first-line treatment for LMs GI tumors. Methods: Patients with unresectable LMs GI tumors and without previous systemic treatment would be divided into cohort A (CRC), cohort B (ESCC), and cohort C (other GI tumors, such as PC, GC, etc.). In cohort A, CRC patients received induction therapy (6 cycles, q3w): anlotinib (12 mg, PO, QD, days 1-14), oxaliplatin (130 mg/m2, IV, day 1), capecitabine (850 mg/m2, PO, BID, days 1-14). Patients without PD and radical resection received anlotinib and metronomic capecitabine (500 mg, PO, BID, days 1-21, q3w) maintenance until PD or unacceptable toxicity. The primary endpoint was ORR (RECIST 1.1). Secondary endpoints were DoR, PFS, OS, DCR, radical resection rate for LMs, and safety. Results: As of September 14, 2023, 45 patients were enrolled in cohort A, the median age was 67 years (35-75), 66.7% male, 91.1% ECOG-PS 1 and 60% had LMs only. After induction therapy, 8 patients received surgical resection. Currently, 13 patients are receiving induction therapy and 10 are undergoing maintenance therapy, with a maximum duration of treatment (DOT) of 13.7 months. Of 39 evaluable patients in cohort A, ORR and DCR were 48.7% and 97.4% (PR, n=19; SD, n=19, 16 SD had reduced tumor size). The median PFS was not reached. 36 patients had TEAEs and ≥ grade 3 TEAEs (33.3%) mainly included neutropenia (11.1%), hypertension (6.7%), and white blood cell decreased (6.7%). Conclusions: Anlotinib plus chemotherapy as first-line treatment has shown promising efficacy and acceptable safety and maybe a favorable option for advanced LMs CRC tumors. Clinical trial information: NCT05262335.
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Abstract Details
Session Type
Poster Session
Session Title
Poster Session C: Cancers of the Colon, Rectum, and Anus
Track
Colorectal Cancer,Anal Cancer
Sub Track
Therapeutics
Clinical Trial Registration Number
NCT05262335
Citation
J Clin Oncol 42, 2024 (suppl 3; abstr 112)
DOI
10.1200/JCO.2024.42.3_suppl.112
Abstract #
112
Poster Bd #
G16
Abstract Disclosures
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