scholarly journals NAPOLI-1 phase III trial outcomes by prior surgery, and disease stage, in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC)

2018 ◽  
Vol 29 ◽  
pp. viii249-viii250
Author(s):  
T. Macarulla Mercade ◽  
G. Bodoky ◽  
J. Siveke ◽  
K.-H. Lee ◽  
J. Chen ◽  
...  
Keyword(s):  
Pancreatic Ductal Adenocarcinoma ◽  
Phase Iii ◽  
Disease Stage ◽  
Ductal Adenocarcinoma ◽  
Phase Iii Trial ◽  
Prior Surgery ◽  
Trial Outcomes

ESPAC-3(v2): A multicenter, international, open-label, randomized controlled phase III trial of adjuvant 5-fluorouracil/folinic acid (5-FU/FA) versus gemcitabine (GEM) in patients with resected pancreatic ductal adenocarcinoma

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. LBA4505-LBA4505
Author(s):  
J. Neoptolemos ◽  
M. Büchler ◽  
D. D. Stocken ◽  
P. Ghaneh ◽  
D. Smith ◽  
...  
Keyword(s):  
Pancreatic Ductal Adenocarcinoma ◽  
Folinic Acid ◽  
Annual Meeting ◽  
Clinical Oncology ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Open Label ◽  
Phase Iii Trial ◽  
Randomized Controlled ◽  
Final Text

LBA4505 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. [Table: see text]

scholarly journals Mechanisms of drug resistance of pancreatic ductal adenocarcinoma at different levels

2020 ◽  
Vol 40 (7) ◽  
Author(s):  
Jiali Du ◽  
Jichun Gu ◽  
Ji Li
Keyword(s):  
Drug Resistance ◽  
Clinical Trials ◽  
Phase I ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Solid Tumours ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Phase Iii Trials ◽  
Exploitation And Exploration ◽  
Different Levels

Abstract Pancreatic ductal adenocarcinoma (PDAC) is the fourth leading cause of cancer-related death worldwide, and the mortality of patients with PDAC has not significantly decreased over the last few decades. Novel strategies exhibiting promising effects in preclinical or phase I/II clinical trials are often situated in an embarrassing condition owing to the disappointing results in phase III trials. The efficacy of the current therapeutic regimens is consistently compromised by the mechanisms of drug resistance at different levels, distinctly more intractable than several other solid tumours. In this review, the main mechanisms of drug resistance clinicians and investigators are dealing with during the exploitation and exploration of the anti-tumour effects of drugs in PDAC treatment are summarized. Corresponding measures to overcome these limitations are also discussed.

scholarly journals Nomogram for Predicting Survival in Patients Treated with Liposomal Irinotecan Plus Fluorouracil and Leucovorin in Metastatic Pancreatic Cancer

Cancers ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 1068 ◽  
Author(s):  
Chen ◽  
Macarulla ◽  
Blanc ◽  
Mirakhur ◽  
Jong ◽  
...  
Keyword(s):  
Carbohydrate Antigen ◽  
Phase Iii ◽  
Disease Stage ◽  
Ductal Adenocarcinoma ◽  
Karnofsky Performance Score ◽  
Neutrophil Lymphocyte Ratio ◽  
Baseline Factors ◽  
Liposomal Irinotecan ◽  
Aid Decision ◽  
Post Hoc

NAPOLI-1 (NCT01494506) was a phase III study of liposomal irinotecan (nal-IRI) plus 5-fluorouracil/leucovorin (5-FU/LV) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy. This post hoc analysis of NAPOLI-1 aimed to develop a predictive nomogram for overall survival (OS) at 6 and 12 months. Analyses were derived from all patients in NAPOLI-1 randomized to receive nal-IRI+5-FU/LV, nal-IRI monotherapy, or 5-FU/LV combination therapy. OS was associated with baseline factors using univariate and multivariable Cox analyses. A predictive nomogram was derived and validated using a concordance index and calibration plots. The univariate analyses identified 21 independent factors that contributed to OS, with eight factors significantly associated with OS. The Karnofsky Performance Score contributed the largest number of points (100), followed by presence of liver metastasis (98) and randomization to nal-IRI+5-FU/LV (96). The other baseline factors showing effects were albumin (g/dL), neutrophil/lymphocyte ratio, carbohydrate antigen 19-9 (U/mL), disease stage at diagnosis, and body mass index (kg/m2). The nomogram was used to predict the 6- and 12-month survival probability. The mean absolute errors between the observed and predicted probabilities for OS at 3, 6, and 9 months were 0.07, 0.08, and 0.07, respectively. This nomogram, based on NAPOLI-1, provides additional insight to aid decision-making for patients with mPDAC after previous gemcitabine-based therapy.

Sign in / Sign up

Export Citation Format

Share Document