EndoTAG-1 plus gemcitabine versus gemcitabine alone in patients with measurable locally advanced and/or metastatic adenocarcinoma of the pancreas failed on FOLFIRINOX treatment

Su; (Su, M.; Chen, M.).; (Chen, L.; Hitre, L.).; (Hitre, E.; Lee, E.).; (Lee, W.; Bai, W.).; (Bai, L.; Papai, L.).; (Papai, Z.; Kang, Z.).; (Kang, S.; Dvorkin, S.).; (Dvorkin, M.; Lee, M.).; (Lee, M.; Ludovic, M.).; (Ludovic, E.; Choi, E.).; (Choi, H.; Oh, H.).; (Oh, S.; Bodoky, S.).; (Bodoky, G.; Artru, G.).; (Artru, P.; Hwang, P.).; (Hwang, J.; Bazin, J.).; (Bazin, I.; Bosc, I.).; (Bosc, F.; Bachet, F.).; (Bachet, J.; Horvath, J.).; (Horvath, Z.; Chang, Z.).; (Chang, C.; Lin, C.).; (Lin, J.; ), J.

Авторы: Su, (Su M., Chen M.)., (Chen L., Hitre L.)., (Hitre E., Lee E.)., (Lee W., Bai W.)., (Bai L., Papai L.)., (Papai Z., Kang Z.)., (Kang S., Dvorkin S.)., (Dvorkin M., Lee M.)., (Lee M., Ludovic M.)., (Ludovic E., Choi E.)., (Choi H., Oh H.)., (Oh S., Bodoky S.)., (Bodoky G., Artru G.)., (Artru P., Hwang P.)., (Hwang J., Bazin J.)., (Bazin I., Bosc I.)., (Bosc F., Bachet F.)., (Bachet J., Horvath J.)., (Horvath Z., Chang Z.)., (Chang C., Lin C.)., (Lin J., ) J.
Журнал: Annals of Oncology
Том: 30
Номер: 4
Год издания: 2019
Издательство: Oxford University Press
Местоположение издательства: United Kingdom
Первая страница: 23
Номер статьи: P 086
DOI: 10.1093/annonc/mdz155.085
Аннотация: Introduction: Pancreatic cancer is the 4th deadliest cancer in Europe, with more than 95% of those affected dying from the disease and it is set to become the second greatest cause of death from cancer by 2020 (ECPC, European Cancer Patient Coalition). Less than 20% of pancreatic cancer patients are diagnosed with a resectable and potentially curable disease as the vast majority of patients have advanced disease at the time of diagnosis with a median survival of approximately 6 months. EndoTAG-1 is a novel formulation of cationic liposomes for the treatment of solid tumors, carrying paclitaxel embedded in the liposome membrane. EndoTAG-1 specifically displays antivascular and antiangiogenic activity. Cationic liposomes are known to bind and internalize at tumor endothelial cells after intravenous administration, which is the basis for the new mode of action of EndoTAG-1. Using a cationic liposome formulation, the cytostatic and cytotoxic activities of paclitaxel are targeted to the activated tumor endothelial cells. FOLFIRINOX regimen is the standard first-line treatment for pancreatic cancer patients with good performance status. However, the optimal management strategy for patients who fail initial FOLFIRINOX remains undefined. There is still no standard of care in second-line therapy for patients with disease progression.Methods: A total of 218 subjects will be enrolled and randomized in a 1:1 ratio to Arm A (EndoTAG-1 plus gemcitabine) and Arm B (gemcitabine monotherapy). Based on the sample size calculation, the primary endpoint analysis will require 167 events (deaths) for 196 subjects. This sample size is sufficient to detect a 40% reduction in the risk of death in Arm A, as compared with Arm B (hazard ratio, 0.60) using a 2-sided log-rank test with 90% power and an overall significance level of 0.05 two-sided test. The overall survival assumption for the sample size is based on published literature data comparing the therapeutic effects of gemcitabine monotherapy and gemcitabine combination regimen on patients with advanced pancreatic cancer after previous FOLFIRINOX treatment. The hazard ratio for death of 0.60 with median overall sur- vival of 4.4 months for gemcitabine monotherapy (Conroy et al. 2011) and 7.3 months for gemcitabine þ paclitaxel combination (Portal et al. 2015) was used for the sample size calculation.
Добавил в систему: Базин Игорь Сергеевич

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EndoTAG-1 plus gemcitabine versus gemcitabine alone in patients with measurable locally advanced and/or metastatic adenocarcinoma of the pancreas failed on FOLFIRINOX treatmentстатья