Safety and effectiveness of pembrolizumab monotherapy in Japanese patients with unresectable urothelial carcinoma: a nation-wide post-marketing surveillance
Abstract Background This study was conducted to identify factors associated with the safety and effectiveness of pembrolizumab in Japanese patients with unresectable urothelial carcinoma and to confirm the real-world safety and effectiveness of pembrolizumab in Japanese patients. Methods This multic...
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| Format: | Article |
| Language: | English |
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BMC
2023-06-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-023-10930-2 |
| _version_ | 1797795682831040512 |
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| author | Hiroyuki Nishiyama Yu Tanaka Masahiro Hamada Masahiko Ozaki Toshihiko Minegishi Yuichiro Ito Shinichiroh Maekawa Nobuyuki Yamamoto |
| author_facet | Hiroyuki Nishiyama Yu Tanaka Masahiro Hamada Masahiko Ozaki Toshihiko Minegishi Yuichiro Ito Shinichiroh Maekawa Nobuyuki Yamamoto |
| author_sort | Hiroyuki Nishiyama |
| collection | DOAJ |
| description | Abstract Background This study was conducted to identify factors associated with the safety and effectiveness of pembrolizumab in Japanese patients with unresectable urothelial carcinoma and to confirm the real-world safety and effectiveness of pembrolizumab in Japanese patients. Methods This multicenter, observational, post-marketing surveillance was conducted over a 1-year observation period starting at pembrolizumab initiation (200-mg pembrolizumab every 3 weeks); data were collected from case report forms (3 months and 1 year). Safety measures included treatment-related adverse events and adverse events of special interest (AEOSI). Effectiveness assessments included tumor response, objective response rate (ORR), and disease control rate (DCR). Results Overall, 1293 patients were evaluated for safety and 1136 for effectiveness. At 12 months, the treatment-related adverse event incidence was 53.8% (n = 696) and that of AEOSI was 25.0% (n = 323). The most frequent AEOSI of any grade were endocrinological disorder (10.4%, n = 134), interstitial lung disease (ILD) (7.2%, n = 93), and hepatic function disorder (4.9%, n = 64). Multivariate analysis demonstrated that the risk of developing ILD was almost seven times greater (odds ratio 6.60) in patients with a comorbidity of ILD, and approximately twice as high in patients aged ≥ 65 years (odds ratio 2.24) and with smoking history (odds ratio 1.79). The ORR was 26.1% and the DCR was 50.7%. The ORR was 46.4% in patients with a Bellmunt risk score of 0 and decreased as the Bellmunt risk score increased. Conclusions This post-marketing surveillance confirmed the safety and effectiveness of pembrolizumab in Japanese patients with unresectable urothelial carcinoma in the real-world setting. |
| first_indexed | 2024-03-13T03:21:42Z |
| format | Article |
| id | doaj.art-e9e970c9534e430ba327aa4b8b5ff89f |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-03-13T03:21:42Z |
| publishDate | 2023-06-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-e9e970c9534e430ba327aa4b8b5ff89f2023-06-25T11:19:51ZengBMCBMC Cancer1471-24072023-06-0123111110.1186/s12885-023-10930-2Safety and effectiveness of pembrolizumab monotherapy in Japanese patients with unresectable urothelial carcinoma: a nation-wide post-marketing surveillanceHiroyuki Nishiyama0Yu Tanaka1Masahiro Hamada2Masahiko Ozaki3Toshihiko Minegishi4Yuichiro Ito5Shinichiroh Maekawa6Nobuyuki Yamamoto7Department of Urology, Faculty of Medicine, University of TsukubaJapan Pharmacovigilance, MSD K.K.Japan Pharmacovigilance, MSD K.K.Japan Pharmacovigilance, MSD K.K.Oncology Medical Affairs, MSD K.K.Oncology Medical Affairs, MSD K.K.Japan Pharmacovigilance, MSD K.K.Respiratory Medicine and Medical Oncology, Wakayama Medical UniversityAbstract Background This study was conducted to identify factors associated with the safety and effectiveness of pembrolizumab in Japanese patients with unresectable urothelial carcinoma and to confirm the real-world safety and effectiveness of pembrolizumab in Japanese patients. Methods This multicenter, observational, post-marketing surveillance was conducted over a 1-year observation period starting at pembrolizumab initiation (200-mg pembrolizumab every 3 weeks); data were collected from case report forms (3 months and 1 year). Safety measures included treatment-related adverse events and adverse events of special interest (AEOSI). Effectiveness assessments included tumor response, objective response rate (ORR), and disease control rate (DCR). Results Overall, 1293 patients were evaluated for safety and 1136 for effectiveness. At 12 months, the treatment-related adverse event incidence was 53.8% (n = 696) and that of AEOSI was 25.0% (n = 323). The most frequent AEOSI of any grade were endocrinological disorder (10.4%, n = 134), interstitial lung disease (ILD) (7.2%, n = 93), and hepatic function disorder (4.9%, n = 64). Multivariate analysis demonstrated that the risk of developing ILD was almost seven times greater (odds ratio 6.60) in patients with a comorbidity of ILD, and approximately twice as high in patients aged ≥ 65 years (odds ratio 2.24) and with smoking history (odds ratio 1.79). The ORR was 26.1% and the DCR was 50.7%. The ORR was 46.4% in patients with a Bellmunt risk score of 0 and decreased as the Bellmunt risk score increased. Conclusions This post-marketing surveillance confirmed the safety and effectiveness of pembrolizumab in Japanese patients with unresectable urothelial carcinoma in the real-world setting.https://doi.org/10.1186/s12885-023-10930-2Japanese patientsPembrolizumabPost-marketing surveillanceUnresectable urothelial carcinoma |
| spellingShingle | Hiroyuki Nishiyama Yu Tanaka Masahiro Hamada Masahiko Ozaki Toshihiko Minegishi Yuichiro Ito Shinichiroh Maekawa Nobuyuki Yamamoto Safety and effectiveness of pembrolizumab monotherapy in Japanese patients with unresectable urothelial carcinoma: a nation-wide post-marketing surveillance BMC Cancer Japanese patients Pembrolizumab Post-marketing surveillance Unresectable urothelial carcinoma |
| title | Safety and effectiveness of pembrolizumab monotherapy in Japanese patients with unresectable urothelial carcinoma: a nation-wide post-marketing surveillance |
| title_full | Safety and effectiveness of pembrolizumab monotherapy in Japanese patients with unresectable urothelial carcinoma: a nation-wide post-marketing surveillance |
| title_fullStr | Safety and effectiveness of pembrolizumab monotherapy in Japanese patients with unresectable urothelial carcinoma: a nation-wide post-marketing surveillance |
| title_full_unstemmed | Safety and effectiveness of pembrolizumab monotherapy in Japanese patients with unresectable urothelial carcinoma: a nation-wide post-marketing surveillance |
| title_short | Safety and effectiveness of pembrolizumab monotherapy in Japanese patients with unresectable urothelial carcinoma: a nation-wide post-marketing surveillance |
| title_sort | safety and effectiveness of pembrolizumab monotherapy in japanese patients with unresectable urothelial carcinoma a nation wide post marketing surveillance |
| topic | Japanese patients Pembrolizumab Post-marketing surveillance Unresectable urothelial carcinoma |
| url | https://doi.org/10.1186/s12885-023-10930-2 |
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