Retrospective Study of Ramucirumab and Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma

Study Overview
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Brief Summary
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This is a retrospective, multicenter, non-interventional study for the evaluation of real-world efficacy and safety of ramucirumab plus paclitaxel in gastric or gastroesophageal junction adenocarcinoma as part of the establishment of hospital medical record collection system to evaluate drug effectiveness by Health Insurance Review & Assessment Service (HIRA). The medical records in approximately 1400 patients with locally-advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, who have received ramucirumab plus paclitaxel combination therapy will be collected.

Detailed Description
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Ramucirumab plus paclitaxel combination therapy has shown a survival benefit in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. However, the real-world efficacy and safety of ramucirumab plus paclitaxel combination therapy in Korea have only been evaluated once outside of controlled clinical trials. Therefore, this large multicenter retrospective analysis was designed to evaluate the real-world efficacy and safety of ramucirumab plus paclitaxel under the Korea National Health Insurance System. The medical records in approximately 1400 patients with locally-advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, who have received ramucirumab plus paclitaxel combination therapy between May 2018 and December 2018 will be collected. Eligibility criteria included age ≥ 19 years, histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma, locally advanced unresectable or metastatic disease, and previous first-line systemic therapy including fluoropyrimidine and platinum. Efficacy was evaluated by overall survival, progression free survival, time to progression, objective response rate, disease control rate, and duration of response. Safety was evaluated by hematologic or non-non hematologic toxicities and adverse events of special interest with ramucirumab plus paclitaxel combination therapy.

Official Title
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A Retrospective Study for Evaluation of Real-world Efficacy and Safety of Ramucirumab Plus Paclitaxel in Patients With Locally-advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Conditions
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Gastric or Gastroesophageal Junction Adenocarcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥19 years at the time of study registration Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma Locally advanced unresectable or metastatic disease Patients who have received previous palliative first-line systemic therapy including fluoropyrimidine and platinum for advanced gastric or gastroesophageal junction adenocarcinoma Patients who have received ramucirumab plus paclitaxel combination therapy between May 2018 and December 2018 under the Korea National Health Insurance System Exclusion Criteria: Patients who have received ramucirumab plus paclitaxel combination therapy outside of the Korea National Health Insurance System Patients who have received ramucirumab monotherapy

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from the start of ramucirumab plus paclitaxel to death from any cause | Until September 30, 2019 | 
| Progression free survival | Time from the start of ramucirumab plus paclitaxel to disease progression or death from any cause | Until September 30, 2019 | 
| Incidence of adverse events | Number (percentage) of subjects reporting adverse events | Until September 30, 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression | Time from the start of ramucirumab plus paclitaxel to disease progression | Until September 30, 2019 | 
| Objective response rate | The proportion of subjects confirmed complete or partial response | Until September 30, 2019 | 
| Disease control rate | The proportion of subjects confirmed complete or partial response or stable disease | Until September 30, 2019 | 
| Duration of response | Time from documentation of tumor response to disease progression | Until September 30, 2019 | 
| Adverse events of special interest | Number (percentage) of subjects reporting adverse events of special interest associated with ramucirumab plus paclitaxel | Until September 30, 2019 |