Abstract 2310
Background
The aim of this single center, open label, single arm phase II trial was to assess the efficacy and toxicity of gemcitabine, S-1 and leucovorin (LV) combination therapy for advanced pancreatic cancer (UMIN-CTR 000010678).
Methods
Chemotherapy-naïve patients with histologically or cytologically proven advanced pancreatic cancer were enrolled. Gemcitabine was administered at a dose of 1,000 mg/m2 by 30min infusion on days 1, S-1 40mg/m2 orally twice daily and LV 25mg orally twice daily on days 1 to 7 every 2 weeks. Primary end point was progression free survival (PFS), and secondary endpoints were overall survival (OS), response rate, disease control rate and adverse events.
Results
A total of 49 patients with advanced pancreatic cancer (19 locally advanced and 30 metastatic) were enrolled between May 2013 and March 2017. Median age was 68 (range, 44-84) and PS was 0 in 26 and 1 in 23. Overall response rate and disease control rate were 32.7% and 87.8%. The median PFS and OS were 10.8 (95% confidence interval [CI], 7.4-13.5) and 20.7 (95% CI 13.0-NA) months with 1-year survival rate of 73.4%. The median PFS of locally advanced and metastatic diseases was 12.7 and 7.4 months, and the median OS of locally advanced and metastatic diseases was 26.1 and 18.8 months, respectively. Conversion surgery was performed in 2 patients among 19 locally advanced diseases. The reasons for treatment failure was disease progression in 31, unacceptable toxicities in 4, deteriorated general conditions in 6, consent withdrawn in 3, others in 3. A second line chemotherapy was introduced in 29 patients. Major Grade 3-4 toxicities were neutropenia (22.4%) and mucositis (14.3%). No toxicity related death was observed.
Conclusions
In this phase II trial, gemcitabine, S-1 and LV combination therapy was tolerable and can potentially be a treatment option for advanced pancreatic cancer.
Clinical trial identification
Legal entity responsible for the study
The University of Tokyo.
Funding
Has not received any funding.
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1978 - FAM115c that upregulates proliferation and invasion under hypoxia could be a predictive biomarker for pancreatic cancer.
Presenter: Kiyoshi Saeki
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
3682 - Pathologic assessment following neoadjuvant immunotherapy or chemotherapy demonstrates similar patterns in non-small cell lung cancer (NSCLC)
Presenter: Annikka Weissferdt
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
3319 - Tumor-infiltrating CD3+ lymphocytes and ICOS+ T-cells predict a favorable survival in resected esophageal squamous cell carcinoma
Presenter: Min Hee Hong
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
5130 - Chemokine receptor CXCR7 expression, function and clinical implications in head and neck squamous cell carcinoma
Presenter: Myung-Won Lee
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
4483 - Assessment of PD-1/PD-L1 colocalization in hepatocellular carcinoma (HCC) using bright-field double labeling and quantitative digital image analysis
Presenter: Thomas Mrowiec
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
1175 - Pulmonary tumor thrombotic microangiopathy (PTTM): 24 case series and its criteria for pathological diagnosis.
Presenter: Naoko Sato
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
1359 - Autofluorescence: a new marker for identifying cancer stem cells (CSCs) in primary tumors
Presenter: Miriam López Gómez
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
2651 - NACC1 as a target of microRNA-331-3p regulates cell proliferation in urothelial carcinoma cells
Presenter: Kohei Morita
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
2233 - Somatic-stem transition of tumor cells is a key link in the metastasis
Presenter: Nicolai Litviakov
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
2601 - Profile of individuals who never undergo colorectal cancer screening
Presenter: Jérôme Viguier
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