Metastatic Pancreatic Cancer, Pancreatic Cancer
Conditions
Keywords
Pancreatic cancer, FOLFIRINOX, nab-paclitaxel plus gemcitabine
Brief summary
In this study, clinical data of patients who received 2nd-line Nab-paclitaxel plus Gemcitabine (nab-P+GEM) after progression on 1st-line FOLFIRINOX will be reviewed retrospectively.
Detailed description
FOLFIRINOX is one of standard 1 st-line regimens for patients with advanced PDAC. However, there is no globally established 2 nd-line regimen after the failure of FOLFIRINOX. Although gemcitabine-based regimens are recommended by multiple guidelines and widely used in daily practice, further analysis is needed to reveal the magnitude of clinical benefit with these regimens. Nab-paclitaxel plus Gemcitabine (Nab-P+Gem) is another standard 1 st-line regimen for PDAC, but there are limited data as 2 nd-line therapy in PDAC. Therefore, the investigators are conducting a multicenter retrospective analysis of 2 nd-line nab-P+Gem after progression on FOLFIRINOX in patients with advanced PDAC.
Interventions
Nab-paclitaxel 125 mg/m2 weekly for 3 weeks, every 4 weeks Gemcitabine 1000 mg/m2 weekly for 3 weeks, every 4 weeks
Sponsors
Bundang CHA Hospital
Ulsan University Hospital
Asan Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed pancreatic ductal adenocarcinoma * Administration of 2nd-line nab-paclitaxel plus gemcitabine * Progression on 1st-line FOLFIRINOX
Exclusion criteria
* Pathologic diagnosis other than pancreatic ductal adenocarcinoma * Administration of nab-paclitaxel plus gemcitabine as 3rd or greater lines of therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 1 year | Time from the start of 2nd-line nab-P + GEM to disease progression or death from any cause, whichever came first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 1 year | Time from the start of 2nd-line nab-P+GEM to death from any cause |
| Objective response rates | 1 year | Tumor response graded by Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 |
| Toxicity profile | 1 year | Safety profile graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 |
Countries
South Korea
Outcome results
None listed