Abstract 3959
Background
Our previous studies showed a triplet GOFL regimen consisting of gemcitabine plus modified FOLFOX4 was well-tolerated and moderate active in advanced PDAC, and the feasibility of replacing infusion 5-FU/LV with oral S-1/LV, the SLOG regimen, in a dose-escalating, phase I study. Herein, we report the phase II results of the SLOG in mPDAC patients.
Methods
Patients with chemo-naïve mPDAC, ECOG PS 0-1, and 20-75 y/o of age were eligible. Intravenous fixed-rate infusion of 800 mg/m2 gemcitabine followed by 2-hr infusion of 85mg/m2 oxaliplatin on D1 plus oral S-1/LV 35/20 mg/m2, twice daily, D1-D7 were given Q 14 days as a cycle. The primary endpoint was objective response rate (ORR). Simon’s optimal two-stage design was used with estimated p0=25% and p1=40%.
Results
Between Jun. 2013 and Oct. 2015, a total of 54 patients were included, with median age of 59 y/o, ECOG PS = 1 in 82%, and the presence of liver metastases in 66.7%. At the cut-off Feb.01, 2017, nine patients remained alive and their median follow-up time was 21.3 months. The ORR was partial response in 22 patients (ORR=40.7%, 95% CI, 28-55%) and stable diseases in 19 patients (35.2%). Long-term disease control rate (stable disease >16 weeks) was 64.8% (95% CI, 51-77%). The median progression-free survival and overall survival was 7.6 (95% CI, 4.4-10.7) and 11.4 (95% CI, 8.1-16.3) months, respectively. One-year and two-year survival rates were 46% and 17%, respectively. The most common treatment-related grade 3-4 adverse events included neutropenia (40.7%), anorexia (14.8%), nausea (11.1%), thrombocytopenia (9.3%), and diarrhea (7.4%).
Conclusions
Current study demonstrated SLOG is a highly active regimen with manageable and favorable safety profiles for mPDAC patients. A randomized phase II trial comparing SLOG vs. modified FOLFIRINOX in advanced PDAC patients is ongoing.
Clinical trial identification
NCT01415713.
Legal entity responsible for the study
Taiwan Cooperative Oncology Group, National Health Research Institutes.
Funding
National Health Research Institutes.
Editorial Acknowledgement
We thank the Clinical Trial Information Management System (CTIMeS) at NHRI for the data collection. Free drug sponsors for this study: oxalip, oral leucovorin and S-1 (tegafur/gimeracil/oteracil potassium) from TTY Biopharm Co., Ltd., Taipei, Taiwan; Taiho Pharmaceutical Co., Ltd, Tokyo, Japan.
Disclosure
J-S. Chen: Honoraria: Ono, Eli Lilly, MSD, TTY, Novartis. Y-S. Shan: Honoraria: TTY, PharmaEngine. L-T. Chen: Research funding: Novartis, Merck Serono, TTY, Polaris, SyncorePharm, Pfizer, BMS; Honoraria: Ono, Eli Lilly, MSD, PharmaEngine, TTY, SyncorePharm, Novartis, Astra Zeneca, Ipsen; Patents & royalties: ENO-1 mAb/HuniLife; Membership on any entity’s Board of directors or advisory committees: PharmaEngine. All other authors have declared no conflicts of interest.
Resources from the same session
1159 - Molecular characterization and search for founding effects in Canarian families with Hereditary Breast and Ovarian Cancer Syndrome
Presenter: Elisenda Llabres Valenti
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
3725 - Effect of the polymorphism rs2066844 of the NOD2 gene on colon cancer incidence in a high cardiovascular risk population. Modulation by gender
Presenter: Judith Begona Ramirez Sabio
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
3708 - Effect of the polymorphisms rs1476413, rs1801131, rs4846052 and rs6541003 of the MTHFR gene on prostate cancer in a high cardiovascular risk population
Presenter: Judith Begona Ramirez Sabio
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
5057 - Association of a genetic variant in cyclin-dependent kinase Inhibitor 2A gene with the increased risk of breast cancer
Presenter: Soodabeh Shahid Sales
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
5970 - Investigating the role of HAT protein TIP60 in regulating functional dynamics of nuclear receptor PXR
Presenter: KARISHMA BAKSHI
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
1360 - The role of downregulated SIRT3 expression in patients with hepatocellular carcinoma
Presenter: Hanhee Jo
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
1634 - Prediction and Intervention of Colorectal Cancer Risk with Artificial Intelligent System
Presenter: Yang Ge
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
4921 - Measuring the Efficiency of Cancer Care in Europe
Presenter: Rikard Althin
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
1235 - Circulating cell-free DNA isolated from plasma of mesenteric veins predicts prognosis in stage II colorectal cancer patients
Presenter: Chih-Yung Yang
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
5169 - _lonality of uterine carcinosarcoma as a factor of clinical prognosis.
Presenter: Natalia Levitskaya
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