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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastric or Gastroesophageal Junction Adenocarcinoma
- Sponsor
- Hallym University Medical Center
- Enrollment
- 1063
- Locations
- 57
- Primary Endpoint
- Incidence of adverse events
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Zang, Dae Young
Dae Young Zang MD, PhD
Hallym University Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: Until September 30, 2019
Number (percentage) of subjects reporting adverse events
Overall survival
Time Frame: Until September 30, 2019
Time from the start of ramucirumab plus paclitaxel to death from any cause
Progression free survival
Time Frame: Until September 30, 2019
Time from the start of ramucirumab plus paclitaxel to disease progression or death from any cause
Secondary Outcomes
- Objective response rate(Until September 30, 2019)
- Disease control rate(Until September 30, 2019)
- Adverse events of special interest(Until September 30, 2019)
- Time to progression(Until September 30, 2019)
- Duration of response(Until September 30, 2019)