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Poster Display session

107P - Anlotinib plus chemotherapy as first-line (1L) treatment in gastrointestinal cancer patients with unresectable liver metastases

Date

07 Dec 2024

Session

Poster Display session

Presenters

Junwei Wu

Citation

Annals of Oncology (2024) 35 (suppl_4): S1432-S1449. 10.1016/annonc/annonc1687

Authors

J. Wu1, L. Zhu2, C. Zhou1, M. Shi1, J. Chen3, L. Zhao1, Z. Han4, C. Wang5, Y. Mao6, L. Zhu7, X. Wei8, J. Jiang1, J. Yan9, C. Wang9, Z. Qin10, D. Cui11, X. Yang12, X. Tang13, J. Zhang1

Author affiliations

  • 1 Department Of Oncology, Ruijin Hospital - Shanghai Jiao Tong University School of Medicine, 200025 - Shanghai/CN
  • 2 Department Of Oncology, Jiangsu Province Hospital/The First Affiliated Hospital of Nanjing Medical University, 210029 - Nanjing/CN
  • 3 Department Of Chemoradiotherapy, Ningbo Yinzhou People’s Hospital, 315040 - Ningbo/CN
  • 4 Department Of Oncology, THE AFFILIATED HOSPITAL OF XUZHOU MEDICAL UNIVERSITY, Xuzhou/CN
  • 5 Department Of Oncology, 3rd People's Hospital of Yancheng, 224001 - Yancheng/CN
  • 6 Department Of Oncology, Affiliated Hospital of Jiangnan University - South Campus, 214122 - Wuxi/CN
  • 7 Department Of Medical Oncology, Jiangsu Institute of Cancer Research, the Affiliated Cancer Hospital of Nanjing Medical University, 210009 - Nanjing/CN
  • 8 Department Of Oncology, Nanjing First Hospital, 210006 - Nanjing/CN
  • 9 Department Of Oncology, Jiading Central Hospital, 200025 - Shanghai/CN
  • 10 Department Of Medical Oncology, Zhejiang Provincial People's Hospital, 310014 - Hangzhou/CN
  • 11 Department Of Internal Medicine, Anyang Tumor Hospital, 455001 - Anyang/CN
  • 12 Department Of Oncology, First Affiliated Hospital of Nanyang Medical College, 473000 - Nanyang/CN
  • 13 Department Of Oncology, Wuxi Branch of Ruijin Hospital, 473000 - Wuxi/CN

Resources

This content is available to ESMO members and event participants.

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.

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