Abstract 2797
Background
Neoadjuvant chemotherapy is an accepted treatment method to improve the survival for advanced gastric cancer in worldwide. This phase II study, KSCC1601, aimed to investigate efficacy and safety of S-1 and Oxaliplatin for locally advanced gastric (LAGC) and esophago-gastric cancer (EGC).
Methods
Patients received oral S-1 40-60 mg twice daily on days 1 to 14 every 3 weeks plus intravenous oxaliplatin 130 mg/m2 on day 1 every 3 weeks for 3 courses, followed by gastrectomy with D2 lymphadenectomy. The primary endpoint was pathological response rate (pRR) according to the proportion of necrosis in the tumor: grade 0, no necrosis; grade 1a, < 1/3 necrosis; grade 1b, > 1/3 or < 2/3 necrosis; grade 2, > 2/3 or < all necrosis; and grade 3, all parts of the tumors affected by necrosis. A sample size of 46 was set according to one-sided significance level of 0.05 and power of 80% based on an exact binomial distribution, and assuming the null hypothesis of a 30% pRR and an alternative hypothesis of a 50% pRR. The incidence of anastomosis leakage in EGC was the main secondary endpoint. Other secondary endpoints were R0 resection rate, overall survival, relapse free survival and safety.
Results
Between 2016 April and 2017 July, 47 patients (24 EGC, 23 LAGC) were enrolled in this study. All patients were eligible for analysis. 42 patients (89.4%:95%CI 76.9-96.5) underwent surgery, and curative resection was performed in 41 patients. The rate of protocol treatment completeness was 42 patients (89.4%:95%CI 76.9-96.5%). pRR, the primary endpoint (grade 1b to 3), was 25 cases (59.5%:90%CI 45.7-72.3%) of primary lesions. The main toxicities of neoadjuvant chemotherapy were grade 3/4 thrombocytopenia (10.6%), neutropenia (6.4%), anemia (4.3%), grade 3/4 anorexia (12.8%). The number of anastomosis leakage so as to 20 EGC according to the Clavien–Dindo classification was 2 for grade IIIa, 2 for grade IIIb, and 1 for grade IV (25.0%:90%CI 10.4-45.6%). Survival data will be updated in further investigation.
Conclusions
The S-1 and oxaliplatin was well tolerated and is promising as a preoperative chemotherapy regimen for patients with LAGC and EGC.
Clinical trial identification
UMIN000021061.
Legal entity responsible for the study
KSCC.
Funding
Yakult Honsha Co., Ltd., Cres Kyushu.
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
4784 - Tranilast inhibits TGF-beta-induced EMT and invasion/metastasis via the suppression of Smad4 in lung cancer cell lines.
Presenter: Koji Takahashi
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
767 - Integrin beta-like 1 overexpression stimulates invasiveness of ovarian cancer cells in vitro
Presenter: Alexander Cortez
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
938 - MiR-449a suppresses endometrial cancer invasion and metastasis by targeting NDRG1
Presenter: Lihua Qiu
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
4866 - Cancer-associated fibroblasts-derived VEGFA mediates the migration of gastric cancer cells through VEGFR1
Presenter: xiaoxun Wang
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
4934 - Risk prediction of metastasis through study of circulating tumor cells
Presenter: Panagiotis Apostolou
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
3289 - First step to metastasis: miRNAome abnormalities impair cell-cell adhesion and facilitate detachment of breast cancer cells
Presenter: Volodymyr Halytskiy
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
4110 - Extracellular matrix of normal brain tissue is affected by temozolomide during anti-glioblastoma treatment
Presenter: Alexandra Tsidulko
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
1526 - Study of the activation of TLR receptors in neurospheres from glioblastoma cells in vitro
Presenter: David Albert Bellver
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
4862 - 5-Fluorouracil induced up-regulation of exosomal PD-L1 causing immunosuppression in gastric cancer patients
Presenter: Zhang Min
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
635 - Thrombocytosis and leukocytosis: are they negative prognostic factors in solid tumours?
Presenter: Filip Kohutek
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract