Abstract 3159
Background
The available treatment for advanced hepatocellular carcinoma (aHCC) remained limited in 2016 when our study was initiated. The phase II, ALTER0802 study (NCT02809534) evaluated anti-tumor activity and safety of anlotinib, a small molecular tyrosine kinase inhibitor (TKI), in patients (pts) with aHCC.
Methods
Pts aged 18-75 yrs with histologically/cytologically confirmed unresectable or metastatic HCC or prior progression/intolerance on standard therapy were enrolled if they were Child-Pugh ≤8 and ECOG PS ≤ 1. Pts were divided into two cohorts: 1. those who did not receive prior systemic chemo or targeted therapy; 2. those who have received prior TKI treatment. Pts received anlotinib 12 mg, 2 weeks on/ 1 week off, until disease progression or unacceptable adverse events (AEs). The primary endpoint was progression-free survival rate at 12 weeks (PFR12w); ORR, DCR, TTP, OS, PFR24w, and safety were secondary endpoints.
Results
At the date of the interim analysis (Mar 7, 2019), 43 pts were enrolled (26 and 17 pts for cohort 1 and 2, respectively). In cohort 1, PFR12w was 80.8% (95%CI, 67.0-97.4); median OS (mOS) was 10.8 mo (months; 95%CI, 8.0-NE [not estimated]); median TTP (mTTP) was 5.5 mo (95%CI, 4.7-NE); DCR was 84.6% (95%CI, 65.1-95.6). In cohort 2, PFR12w was 58.8% (95%CI, 39.5-87.6); mOS was not reached; mTTP was 4.01 mo (95%CI, 1.94-11.4); DCR was 76.5% (95%CI, 50.1-93.2). Other outcomes for both cohorts were presented in the table. Overall, treatment related AEs (TRAEs) were limited to mild hypertention, hand-foot skin reaction and bone and muscular pain. No grade IV or above AEs occurred.Table:
751P
Cohort 1 (n = 26) | Cohort 2 (n = 17) | |
---|---|---|
ORR (n) | 3.85% (1) | 5.9% (1) |
CR (%) | 0 | 0 |
PR (%) | 1 (3.85) | 1 (5.9) |
SD (%) | 21 (80.8) | 12 (70.6) |
PD (%) | 4 (15.4) | 4 (23.5) |
PFR24w (95%CI) | 43.2% (26.5-70.6) | 22.1% (10.5-55.8) |
Conclusions
In this interim analysis, anlotinib showed durable anti-tumor activity and manageable toxicity in pts with aHCC regardless of in the first or second line treatment.
Clinical trial identification
NCT02809534.
Editorial acknowledgement
Legal entity responsible for the study
Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.
Funding
Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
870 - Selective Wnt/β-catenin small-molecule inhibitor CWP232228 impairs tumor growth of colon cancer
Presenter: Jin Young Kim
Session: Poster Display session 2
Resources:
Abstract
3425 - Feasibility and impact of prospective DPYD screening in the Irish population
Presenter: Mohammed Zameer
Session: Poster Display session 2
Resources:
Abstract
1972 - Diet-derived metabolites and the risk of colorectal cancer: a nested case-control study in a population-based cohort, the Singapore Chinese Health Study
Presenter: Dawn Chong
Session: Poster Display session 2
Resources:
Abstract
4103 - Loss of subcutaneous adipose tissue during chemotherapy predicts reduced survival in patients with incurable colorectal cancer undergoing palliative therapy
Presenter: Erin Stella Sullivan
Session: Poster Display session 2
Resources:
Abstract
4309 - Obese and overweight is associated with better prognosis in metastatic colorectal cancer patients treated with bevacizumab.
Presenter: Bozena Cybulska-Stopa
Session: Poster Display session 2
Resources:
Abstract
3554 - Patient characteristics associated with poor performance status, ECOG 2-3, and effect on survival in 1086 Finnish metastatic colorectal cancers (mCRC) nationwide (prospective RAXO study)
Presenter: Pia Österlund
Session: Poster Display session 2
Resources:
Abstract
4572 - Discovery and Diagnosis of Metastatic Colorectal Cancer (mCRC) in the Real World: Final Results from a European Survey
Presenter: Iga Rawicka
Session: Poster Display session 2
Resources:
Abstract
4783 - Adherence to recommended intake of calcium and colorectal cancer risk in the HEXA study
Presenter: Jeeyoo Lee
Session: Poster Display session 2
Resources:
Abstract
5106 - Body size, sex and sidedness of incident colorectal cancer in a prospective Swedish cohort study
Presenter: Christina Siesing
Session: Poster Display session 2
Resources:
Abstract
3364 - Middle East & North Africa Registry to characterize RAS mutation status and tumor specifications in recently diagnosed patients with metastatic colorectal cancer (MORE-RAS Study)
Presenter: Mohamed Oukkal
Session: Poster Display session 2
Resources:
Abstract