Retrospective Analysis of 2nd-line Nab-Paclitaxel + Gemcitabine After 1st-line FOLFIRINOX in Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Retrospective Analysis for Efficacy and Safety of Second-Line Nab-Paclitaxel Plus Gemcitabine After Progression on 1st-line FOLFIRINOX in Advanced Pancreatic Ductal Adenocarcinoma

Conditions
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Pancreatic Cancer, Metastatic Pancreatic Cancer

Intervention / Treatment
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* Drug: nab paclitaxel plus gemcitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| nab-P + GEM<br>Nab-paclitaxel plus gemcitabine | Drug: nab paclitaxel plus gemcitabine<br>* Nab-paclitaxel 125 mg/m2 weekly for 3 weeks, every 4 weeks Gemcitabine 1000 mg/m2 weekly for 3 weeks, every 4 weeks<br>* Other names: Abraxane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Time from the start of 2nd-line nab-P + GEM to disease progression or death from any cause, whichever came first | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from the start of 2nd-line nab-P+GEM to death from any cause | 1 year | 
| Objective response rates | Tumor response graded by Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 | 1 year | 
| Toxicity profile | Safety profile graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, FOLFIRINOX, nab-paclitaxel plus gemcitabine