Abstract 5325
Background
Nab-paclitaxel (nab-P) in combination with gemcitabine (G) significantly improved overall survival in patients with pancreatic cancer and is considered as standard first line therapy. However, the efficacy and safety data in Korean patients are lacking as the phase III study was done only in Western countries.
Methods
This open-label, multicenter, phase II, single-arm study was conducted at seven hospitals in South Korea (NCT02426281). Patients with pathologically confirmed metastatic pancreatic cancer were enrolled. Patients received nab-P (125mg/m2) followed by G (1000mg/m2) on days 1, 8, and 15 every 4 weeks until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Through a randomized phase III trial, Von Hoff et al. observed a median PFS of 3.7 months from the G alone arm and 5.5 months from the nab-P + G arm. This study is to confirm this outcome from the Korean population. We will not be interested in the combination therapy of nab-P + G if its median PFS is 3.7 months or shorter and will be highly interested in it if its median PFS is 5.5 months or longer. (90% of power and by the one-sample log-rank test with a one-sided alpha=5%).
Results
A total of 65 patients were enrolled between May 2015 and November 2016. The median age of patients was 60 years (range 43-83), 75% of patients were male, and all had an ECOG performance status of 0 or 1. The median PFS was 7.0 months (95% CI; 5.6-8.3), which met primary endpoints. Median overall survival was 12.9 months (95% CI; 10.1-15.6) and the objective response rate was 41.5 % (95% CI; 29.5-53.5) according to RECIST v1.1. The median relative dose intensity was 84% for nab-paclitaxel and 88% for gemcitabine. Grade 3-4 adverse events included neutropenia (62%), anemia (14%), neuropathy (12%) and febrile neutropenia (9%). There was one treatment-related deaths of septic shock.
Conclusions
In Korean patients with metastatic pancreatic cancer, nab-paclitaxel plus gemcitabine regimen showed comparable efficacy and safety profile to previous phase III study of Western countries. Based on this result, we are conducting a phase II trial with the nab-P + G in an expansion cohort of locally advanced pancreatic cancer.
Clinical trial identification
NCT02426281.
Legal entity responsible for the study
Joon Oh Park (PI).
Funding
Nab-paclitaxel was provided by Celgene.
Editorial Acknowledgement
Disclosure
All 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