Update of a phase II, multicenter clinical trial: Efficacy and safety of anlotinib plus XELOX regimen as first-line treatment followed by maintenance monotherapy of anlotinib for patients with mCRC.

Authors

null

Jin Yan

Department of Gastrointestinal Surgery, Sichuan Cancer Hospital and Institute/The Affiliated Cancer Hospital School of Medicine, UESTC, Chengdu, China

Jin Yan , Yunwei Han , Li Zhang , Yongdong Jin , Hao Sun

Organizations

Department of Gastrointestinal Surgery, Sichuan Cancer Hospital and Institute/The Affiliated Cancer Hospital School of Medicine, UESTC, Chengdu, China, Department of Medical Oncology, The Affiliated Hospital of Southwest Medical University, Luzhou, China, Department of Medical Oncology, Chongqing University Three Gorges Hospital, Chongqing, China, Department of Medical Oncology, Sichuan Cancer Hospital and Institute/The Affiliated Cancer Hospital School of Medicine, UESTC, Chengdu, China, Gastrointestinal Cancer Center, Chongqing University Cancer Hospital, Chongqing, China

Research Funding

No funding received

Background: The combination of anti-VEGF or anti-EGFR targeted drugs with chemotherapy is the standard first-line therapy for metastatic colorectal cancer (mCRC), and the followed maintenance treatment is an optional approach to balance the efficacy and toxicity. However, studies regarding the maintenance strategies based on antiangiogenic TKIs are limited currently. Anlotinib, a novel oral multi-target TKI which can inhibit both tumor angiogenesis and tumor cell proliferation simultaneously, substantially prolonged the PFS with manageable toxicity for refractory mCRC in the phase III ALTER0703 clinical trial. Here we report an update of efficacy and safety results which provide a longer follow up and increased number of patients. Methods: In this open label, single-arm, multi-center, phase II clinical trial, 29 mCRC patients without prior systemic treated, aged 18-75 and an ECOG performance status of 0 or 1 were planned to recruit. Eligible patients received capecitabine (1000 mg/m2, po, d1-14, q3w) and oxaliplatin (130 mg/m2, iv, d1, q3w) plus anlotinib (10mg, po, d1̃14, q3w) treatment for 6 cycles. After 6 cycles of inducing therapy, patients would receive anlotinib (12mg, po, d1̃14, q3w) as maintenance therapy until disease progression or intolerable adverse events (AEs). The primary endpoint was PFS; Secondary endpoints included ORR, DCR, DOR and safety. Results: At data cut-off date (January 18, 2022), the total 29 patients were enrolled, of which 23 patients were available for efficacy assessment. In best overall response assessment, there were 56.5% PR (13/23), 34.8% SD (8/23) and 8.7% PD (2/23). The ORR was 56.5% (95% CI, 34.5-76.8%) and DCR was 91.3% (95% CI, 72.0-98.9%). The longest duration of treatment was 17.5 months. The median PFS was not reached. The most common treatment related adverse events (TRAEs) of any grade (≥30%) were hypertension, leukopenia, nausea/vomiting, hypertriglyceridemia, neutropenia, hypohemoglobinemia, hypoalbuminemia. Grade 3/4 TRAEs (≥10%) were neutropenia (13.8%), hypertension (13.8%) and hypertriglyceridemia (10.3%). One grade 5 TRAE was pancytopenia that occurred at 2.7 months. Conclusions: The update results suggested that anlotinib combined with XELOX as first line regimen followed by anlotinib monotherapy showed favorable anti-tumor activity and manageable safety for patients with mCRC. And the conclusions needed to be confirmed in randomized study continued subsequently. Clinical trial information: ChiCTR1900028417.

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Gastrointestinal Cancer—Colorectal and Anal

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Colorectal Cancer–Advanced Disease

Clinical Trial Registration Number

ChiCTR1900028417

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr e15566)

DOI

10.1200/JCO.2022.40.16_suppl.e15566

Abstract #

e15566

Abstract Disclosures