Abstract 3172
Background
Anti-VEGF target therapy is proven to be effective both in second and third line treatment in metastatic gastric cancer. As for Apatinib, which is the tyrosine kinase inhibitor showed highly affinity for VEGFR2, could not only reverse paclitaxel resistance but also improve the R0 resection rate in previous unresected gastric cancer in conversional settings. However, the safety and efficacy of Apatinib in combination with docetaxel plus S1 in the first line treatment of metastatic gastric cancer is unknown and worthy of investigation.
Methods
The study was expected to enroll 48 patients diagnosed with metastatic gastric cancer. Each participant was supposed to finish six cycles of chemotherapy plus apatinib (docetaxel 75mg/m2, d1, Q3W; S1 according to BSA: <1.25 40mg po bid; 1.25∼1.5 50mg po bid; >1.5 60mg po bid; d1-14, Q3W; apatinib 500mg po qd). The toxicity was determined according to CTCAE 4.0. Efficacy assessed every two cycles (6 weeks) during the study and every 2 months after finish the study. The primary endpoint was progression free survival (PFS). The secondary endpoint was OS, the objective response rate (ORR), the disease control rate (DCR). The tumor response was determined according to RECIST 1.1 criteria.
Results
From July 2017 to April 2019, 32 patients were enrolled. 11 female and 21 male, median age 54 years old, median matastasis organs are 3.5. 80% patients reported adverse events (AEs), most of them are 1-2 AEs. The incidence of grade 3-4 AEs was 35.7%, mainly oral mucositis (23.3%) and myelosuppression (21.5%). For ITT polulation, 24 patients were evaluable for response, 13 patients achieved PR, 4 patients achieved SD, 7 patients experienced PD. The ORR is 54.2%, the DCR is 70.8%. 8 out of 11 per protocol patients have reached primary endpoint, the median PFS is near 6.5 month.
Conclusions
Combination therapy with docetaxel and S1 plus apatinib as the first line treatment could be well tolerant, the spectrum of toxicity were not exceeding expectation. This modality also exhibits promising efficacy,which might provide a new therapeutic strategy for metastatic gastric cancer.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5185 - Systemic administration of the hyaluronidase-expressing oncolytic adenovirus VCN-01 in patients with advanced or metastatic pancreatic cancer: first-in-human clinical trial
Presenter: Rocio Garcia-Carbonero
Session: Poster Display session 2
Resources:
Abstract
4842 - The analysis of genomic signatures of head and body/tail of pancreatic cancer in Chinese patients
Presenter: Qi Ling
Session: Poster Display session 2
Resources:
Abstract
4988 - MGMT methylation in metastatic pancreatic cancer (mPAC): a single center experience
Presenter: Monica Niger
Session: Poster Display session 2
Resources:
Abstract
5035 - Advantage of three-dimensional image analysis of pancreatic cancer using computed tomography
Presenter: Seung Bae Yoon
Session: Poster Display session 2
Resources:
Abstract
1465 - Phase I study of the oncolytic viral immunotherapy agent Canerpaturev (C-REV) with S-1 in patients with stage IV pancreatic cancer.
Presenter: Susumu Hijioka
Session: Poster Display session 2
Resources:
Abstract
1982 - Impact of anatomic site of biliary tract tumour origin and conditional probability of survival (CS): results from 15 prospective advanced first-line clinical trial
Presenter: Mairead McNamara
Session: Poster Display session 2
Resources:
Abstract
2244 - FOLFOXIRI versus FOLFIRINOX in first-line chemotherapy in patients with advanced pancreatic cancer: a propensity score analysis
Presenter: Angélique Vienot
Session: Poster Display session 2
Resources:
Abstract
4557 - Cellfree tumor-DNA (cfDNA) as a very early predictor of therapeutic outcome in pancreatic ductal adenocarcinoma (PDAC)
Presenter: Sabine Payr
Session: Poster Display session 2
Resources:
Abstract
4406 - Comprehensive genomic profiling (CGP) of gall bladder adenocarcinoma (GBAC) in patients from distinct ancestral populations
Presenter: Milind Javle
Session: Poster Display session 2
Resources:
Abstract
4283 - Phase II Monotherapy Efficacy of Cancer Metabolism Targeting SM-88 in Heavily Pre-Treated PDAC Patients.
Presenter: Allyson Ocean
Session: Poster Display session 2
Resources:
Abstract