A post-marketing observational study of ramucirumab in patients with gastric cancer in Japan
Autor: | Soshi Nagaoka, Yongzhe Piao, Kensei Yamaguchi, Hiroya Asou, Taeko Katayose, Yucherng Chen |
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Rok vydání: | 2021 |
Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Paclitaxel Combination therapy Perforation (oil well) Antineoplastic Agents Aspiration pneumonia Neutropenia Antibodies Monoclonal Humanized Ramucirumab Young Adult Japan Stomach Neoplasms Internal medicine Antineoplastic Combined Chemotherapy Protocols Adverse Drug Reaction Reporting Systems Humans Medicine Prospective Studies Adverse effect Aged Aged 80 and over business.industry Gastroenterology Post-marketing surveillance Cancer General Medicine Middle Aged medicine.disease Survival Analysis Clinical trial Oncology Original Article Female Gastric cancer business |
Zdroj: | Gastric Cancer |
ISSN: | 1436-3305 1436-3291 |
Popis: | Background This study evaluated the safety and effectiveness of ramucirumab monotherapy and combination therapy for advanced gastric cancer in the real-world setting. Methods This single-arm, prospective, multicenter, non-interventional, observational, post-marketing study was conducted in Japan from August 2015 to March 2019. Patients with unresectable advanced or recurrent gastric cancer and newly prescribed ramucirumab were followed for up to 12 months after first treatment. Data on adverse events and survival were collected via Electronic Data Capture. Results Of 687 enrolled patients, 658 were eligible for analysis. Most patients received either ramucirumab monotherapy (123/658; 18.7%) or ramucirumab plus paclitaxel combination therapy (528/658; 80.2%). The majority of patients reported ≥ 1 adverse events in both the combination therapy (any grade, 479/528; 90.7%; ≥ Grade 3, 321/528; 60.8%) and monotherapy groups (any grade, 77/123; 62.6%; ≥ Grade 3, 42/123; 34.2%). The most common any grade adverse events were neutropenia (combination: 49.6%; monotherapy: 8.9%), fatigue (combination: 19.5%; monotherapy: 13.8%), and decreased appetite (combination: 18.2%; monotherapy: 10.6%). Grade 5 adverse events were reported in 4 patients, including metastases to meninges, pneumonia aspiration, death, and gastric perforation; of these, gastric perforation was deemed treatment-related. Median survival time was 5.7 months (95% confidence interval: 4.1–6.8 months) following monotherapy and 11.0 months (95% confidence interval: 9.8–12.2 months) following combination therapy. Conclusions This analysis adds to the limited data available on ramucirumab use in a real-world setting, demonstrating similar safety and effectiveness for ramucirumab in treating advanced gastric cancer in routine clinical practice in Japan to that of global clinical trials. |
Databáze: | OpenAIRE |
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