Change of Treatment Landscape and Survival in Metastatic Pancreatic Cancer After Nal-IRI in Republic of Korea

Study Overview
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Brief Summary
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Pancreatic cancer is a very aggressive disease and its prognosis is poor. Large proportion of patients diagnosed with pancreatic cancer is already in metastatic or locally advanced phases. Although there have been huge improvements in survival for many other cancers over the last few decades, the same isn't true for pancreatic cancer. Median 5-year survival rate for pancreatic cancer is around 10% and there are limited number of treatments approved for pancreatic cancer. There is no definite consensus on the best second-line chemotherapy for patients with metastatic pancreatic cancer who have progressed after first-line chemotherapy. The randomized phase III study, NAPOLI-1 trial has revealed that liposomal irinotecan (nal-IRI) plus fluorouracil/leucovorin (FL) regimen could be an acceptable treatment option in patients with metastatic pancreatic cancer who had been previously treated with gemcitabine-based chemotherapy. In this study, The investigators will evaluate how the treatment landscape has been changed since the appearance of nal-IRI in Korea. By retrospectively comparing treatment efficacy and safety outcomes before (cohort 1; without nal-IRI/FL) and after the launch of nal-IRI (cohort 2; with nal-IRI/FL), investigators will identify the degree of improvement in treatment outcome brought about by nal-IRI and will confirm whether the nal-IRI could be applied as an effective treatment option in patients with metastatic pancreatic cancer who failed first-line chemotherapy.

Official Title
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Change of Treatment Landscape and Survival in Metastatic Pancreatic Cancer After Nal-IRI in Republic of Korea

Conditions
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Pancreatic Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients initially diagnosed as locally advanced pancreatic cancer or metastatic pancreatic cancer and received chemotherapy between 2012 and 2021 Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas Documented metastatic disease; disease status may be measurable or non-measurable as defined by RECIST v1.1 guidelines Locally advanced pancreatic cancer; disease status was defined by NCCN guidelines. Recovered from the effects of any prior surgery, radiotherapy, or other antineoplastic therapy At least 18 years of age Exclusion Criteria: Other histology (ex. Neuroendocrine tumor, etc.) Cohort 2 (other regimens); Patients who received nal-IRI at least once after diagnosis

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Cohort 1<br>Without Nal-IRI/FL; From Jan. 2012 to Jan. 2018 (Before launch of nal-IRI) | |
| Cohort 2<br>With Nal-IRI/FL; From Jan. 2018 to Dec. 2021 (After launch of nal-IRI) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS1) | the duration from diagnosis of pancreatic cancer to death or last follow-up - OS1 : the duration from diagnosis of pancreatic cancer to death or last follow-up | The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. (Up to 100 weeks) | 
| Overall survival (OS 2) | the duration from nal-IRI treatment initiation to death or last follow-up | The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. (Up to 100 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | the duration from treatment initiation to disease progression | The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse (Up to 100 weeks) | 
| Objective response rate | the ratio of complete remission and partial remission | The assessment of the tumor burden after a given treatment in patients with solid tumors and has a long history(Up to 100 weeks) | 
| Disease control rate | the ratio of complete remission, partial remission and stable disease | the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents.(Up to 100 weeks) | 
| Adverse event | adverse event during the treatment | Any undesirable experience associated with the use of a medical product in a patient.(Up to 100 weeks) |