Abstract 107P
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) and have poor prognosis. Previous trials showed anlotinib plus chemotherapy has promising clinical activity and a tolerable safety profile for advanced CRC and ESCC, especially with LMs. This multi-cohort, multi-center trial (ALTER-G-001) aimed to assess the efficacy of 1L anlotinib plus chemotherapy for GI cancer patients with unresectable LMs.
Methods
Previous untreated pts with unresectable LMs GI tumors received induction therapy (6 cycles, q3w) in 3 cohorts: cohort A (CRC): anlotinib (12 mg, po, qd, d1-d14), oxaliplatin (130 mg/m2, iv, d1), capecitabine (850 mg/m2, po, bid, d1-14). B (ESCC): anlotinib, cisplatin (60-75 mg/m2, iv, d1/d1-3), paclitaxel (135 mg/m2, iv, d1) or docetaxel (75 mg/m2, iv, d1). C (other GI tumors, e.g., PC, GC): anlotinib plus standard CT. Pts without PD and radical resection received anlotinib and metronomic capecitabine (500 mg, po, bid, d1-21, q3w) maintenance until PD or unacceptable toxicity. The primary endpoint was ORR (RECIST 1.1). Secondary endpoints were DoR, PFS, OS, DCR, the conversion rate of LMs and safety.
Results
As of February 29, 2024, 47 pts were enrolled in cohort A, the median age was 66 years (35-75), 68.1% male, 89.4% ECOG-PS 1 and 46.8% (22/47) were diagnosed with liver-limited disease (LLD) at baseline. Of 40 efficacy-evaluable pts, ORR and DCR were 44.2% and 97.7%. The median TTR was 1.9 months (range 1.3-13.6) and the DoR was 7.5 months (95% CI 4.4-NE) in the ITT population. At a median follow-up of 6.9 months (95%CI 5.7-7.5), the median PFS was 8.7 months (95% CI 7.3-NE). The median OS was not reached. For LLD pts, 6 pts (6/22, 27.3%) in Cohort A underwent conversion liver metastasectomy. 11 pts were enrolled in cohort B, ORR and DCR were 66.7% and 100% in evaluable pts. 96.6% pts had TEAEs and ≥ grade 3 TEAEs (46.6%) mainly included neutropenia (20.7%), blood platelet decreased (10.3%), and hypertension (8.6%).
Conclusions
Anlotinib plus chemotherapy as 1L treatment has shown promising efficacy and acceptable safety and may be a favorable option for advanced CRC and ESCC with LMs.
Clinical trial identification
NCT05262335.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
National Natural Science Foundation of China (82273126 and 82273407).
Disclosure
All authors have declared no conflicts of interest.