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
5629 - Outcome of triple negative inflammatory breast cancers (TNIBC) treated with dose dense neoadjuvant epirubicin cyclophosphmide, prognostic impact of pre and post neoadjuvant chemotherapy (NAC) tumor infiltrating lymphocytes (TIL) and post NAC lymphovascular invasion
Presenter: Luca Campedel
Session: Poster Display session 2
Resources:
Abstract
5792 - A novel PET parameter for cancer stem cell metabolism: early prediction of chemosensitivity to neoadjuvant chemotherapy in locally advanced breast cancer
Presenter: Chanwoo Kim
Session: Poster Display session 2
Resources:
Abstract
3728 - Using nodal ratio to predict recurrence in patients with 4 or more positive lymph nodes early stage breast cancer
Presenter: Besma Graja
Session: Poster Display session 2
Resources:
Abstract
3395 - Re-sentinel node biopsy for local recurrence after breast-conserving surgery
Presenter: Yuka Matsubara
Session: Poster Display session 2
Resources:
Abstract
4302 - Assessment of prognostic and therapeutic factors in men with breast cancer
Presenter: Daniel Herrero Rivera
Session: Poster Display session 2
Resources:
Abstract
4263 - Genomic Profiling of Chinese Breast Cancer Patients
Presenter: Zhonghua Tao
Session: Poster Display session 2
Resources:
Abstract
2406 - Genome copy number alteration burden represents predictor of response in long-term, never relapse exceptional responders of trastuzumab-treated HER2+ metastatic breast cancer
Presenter: Naomi Walsh
Session: Poster Display session 2
Resources:
Abstract
2575 - Next-generation DNA Sequencing (NGS) Results for Tumors From Phase 2 ABRAZO Study of Talazoparib After Platinum or Cytotoxic Non-Platinum Regimens in Patients (pts) With Advanced Breast Cancer (ABC) and Germline BRCA1/2 (gBRCA) Mutations
Presenter: Nicholas C. Turner
Session: Poster Display session 2
Resources:
Abstract
4499 - FGFR1 and CCND1 gene amplifications are associated with breast cancer resistance to aromatase inhibitors
Presenter: Evgeny Imyanitov
Session: Poster Display session 2
Resources:
Abstract
4110 - Clinicopathologic features of BRCA mutated breast cancer patients: Hacettepe Experience
Presenter: Sercan Aksoy
Session: Poster Display session 2
Resources:
Abstract