Abstract 169P
Background
The TALENTop study (NCT04649489) is aiming to clarify whether hepatic resection may provide additional benefit in HCC patients with macrovascular invasion (MVI) who responded to conversion therapy with atezolizumab plus bevacizumab (atezo/bev). This study is onging and the primary analysis is expected at a later time; instead, this analyse is to demonstrate the conversion results of atezo/bev. To describe the response and safety outcomes of the conversion therapy and prognostic factors associated with being suitable for R0 hepatic resection.
Methods
HCC patients with MVI and without extrahepatic metastasis are eligible for this study. After received 3 cycles of atezo/bev and 1 cycle of atezo (induction phase), patients assessed as PR or SD (RECIST v1.1) and considered suitable for R0 hepatic resection are 1:1 randomized to Arm A, hepatic resection followed by atezo/bev for 1 year, or Arm B, continuing atezo/bev therapy. The primary endpoint is the time to treatment failure (tumor recurrence or progression or death). Treatment efficacy in the induction phase were analysed.
Results
From Apr 2021 to Dec 2022, 201 patients were enrolled and entered induction phase and completed induction phase therapy of atezo/bev at cut-off date (Apr 2023). The patients were characterized with a median age of 55 (26-78) and 187 (93%) had HBV infection. Mean tumor diameter evaluated by IRF is 100 mm (26-231 mm). All patients had MVI at baseline and 191 (95%) had PVTT. According to RECIST v1.1 criteria, 38 patients (18.9%) achieved PR and 106 patients (52.7%) achieved SD with 3 cycles of atezo/bev and 1 cycle of atezo. ORR and DCR were 18.9% and 71.6%, respectively. Grades ≥3 TRAEs occurred in 26 patients (12.9%). Most common TRAE was fever (13.4%) and proteinuria (10.9%). Of 201 patients, 73 patients (36.3%) were evaluated as suitable for R0 resection and randomized. In univariate logistic regression, PVTT with vp1-2, AFP<400ng/mL, NLR (neutrophil-lymphocyte ratio)<2.63, tumor diameter<100mm were associated with randomization.
Conclusions
Atezo/bev showed high response rate and conversion rate in the HCC patients with MVI, suggesting a promising conversion strategy in this population.
Clinical trial identification
NCT04649489.
Editorial acknowledgement
Legal entity responsible for the study
Zhongshan Hospital, Fudan University.
Funding
Shanghai Roche Pharmaceuticals Ltd., China.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
26P - Subcutaneous trastuzumab versus intravenous trastuzumab for treatment of patients with HER2-positive breast cancer: A time, motion and cost-benefit assessment in a day care oncology unit in China
Presenter: Bei Sun
Session: Poster Display
Resources:
Abstract
27P - The biological characteristics of HER2-low in TNBC using mRNA profiling and molecular subtypes
Presenter: Asako Tsuruga
Session: Poster Display
Resources:
Abstract
28P - One-week ultra-hypofractionated partial breast RT in early breast cancer: 3DCRT vs IMRT
Presenter: Nurilla Zaynutdinov
Session: Poster Display
Resources:
Abstract
30P - Stereotactic body radiotherapy using cyberknife versus interstitial brachytherapy in accelerated partial breast irradiation on left-sided breast: A comparison of preliminary clinical result and dosimetric characteristics
Presenter: Ting-Na Wei
Session: Poster Display
Resources:
Abstract
31P - Prognostic implication of breast edema on preoperative breast MRI in breast cancer
Presenter: Ki-tae Hwang
Session: Poster Display
Resources:
Abstract
32P - Efficacy of olanzapine in the prophylaxis of delayed chemotherapy-induced nausea and vomiting in breast cancer patients receiving dose-dense AC with a steroid-sparing regimen: A single-center pilot study
Presenter: Manami Tada
Session: Poster Display
Resources:
Abstract
34P - Social support as the mediator of the association between unmet needs and happiness among women with early breast cancer
Presenter: Nithiya Sinarajoo
Session: Poster Display
Resources:
Abstract
35P - Prospective study assessing the efficacy and safety of a scalp cooling device for the prevention of alopecia in breast cancer patients undergoing (neo)adjuvant chemotherapy
Presenter: Winnie Yeo
Session: Poster Display
Resources:
Abstract
37P - To excise or not to excise: Preventive management of early breast cancer in atypical ductal hyperplasia patients
Presenter: Clarisse Hing
Session: Poster Display
Resources:
Abstract
38P - Exploring prognostic factors in patients achieving PCR after neoadjuvant therapy for triple-negative breast cancer: A retrospective study based on SEER data
Presenter: Lv Wenjie
Session: Poster Display
Resources:
Abstract