Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study
Background: Pembrolizumab is approved for patients with metastatic urothelial carcinoma (UC) who progressed under platinum therapy. The aim of this study was to assess the efficacy and safety of pembrolizumab in a cohort of real-life UC patients. Methods: This retrospective, observational study incl...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2022-02-01
|
| Series: | Current Oncology |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1718-7729/29/2/80 |
| _version_ | 1797481363779092480 |
|---|---|
| author | Elodie Dang Alexandre Vallée Coralie Lepage-Seydoux Karine Sejean Brigitte Bonan Christine Abraham Philippe Beuzeboc Raffaele Ratta |
| author_facet | Elodie Dang Alexandre Vallée Coralie Lepage-Seydoux Karine Sejean Brigitte Bonan Christine Abraham Philippe Beuzeboc Raffaele Ratta |
| author_sort | Elodie Dang |
| collection | DOAJ |
| description | Background: Pembrolizumab is approved for patients with metastatic urothelial carcinoma (UC) who progressed under platinum therapy. The aim of this study was to assess the efficacy and safety of pembrolizumab in a cohort of real-life UC patients. Methods: This retrospective, observational study included advanced UC patients treated with pembrolizumab in a single institution in France. The co-primary endpoints were overall survival (OS) and progression-free survival (PFS) at 6 months. Secondary endpoints were objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety. Results: 78 patients were included in the study. The median OS was 7.3 months (3.8–12.2). The estimated OS rate at 6 months was 61.5% (50.5–72.6). The median PFS was 3.1 months (1.4–7.2). The estimated PFS rate at 6 months was 42.3% (31.1–53.5). The best ORR was 35.9%. The mean DOR was 95.5 days. The DCR was 30.8%. The most common treatment-related adverse events (AEs) of any grade were fatigue (46.2%), diarrhea (11.5%), pruritus (10.3%) and nausea (9.0%). There were no grade 3 AEs that occurred with an incidence of 5% or more. Conclusion: Our results confirmed those of randomized clinical trials concerning the treatment with pembrolizumab in patients with advanced UC that progressed after platinum-based chemotherapy. |
| first_indexed | 2024-03-09T22:13:31Z |
| format | Article |
| id | doaj.art-907969c2e6ca4fffa5a9b6c1602994d1 |
| institution | Directory Open Access Journal |
| issn | 1198-0052 1718-7729 |
| language | English |
| last_indexed | 2024-03-09T22:13:31Z |
| publishDate | 2022-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Current Oncology |
| spelling | doaj.art-907969c2e6ca4fffa5a9b6c1602994d12023-11-23T19:27:07ZengMDPI AGCurrent Oncology1198-00521718-77292022-02-0129294595510.3390/curroncol29020080Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric StudyElodie Dang0Alexandre Vallée1Coralie Lepage-Seydoux2Karine Sejean3Brigitte Bonan4Christine Abraham5Philippe Beuzeboc6Raffaele Ratta7Pharmacy Department, Foch Hospital, 92150 Suresnes, FranceClinical Research and Innovation Department, Foch Hospital, 92150 Suresnes, FrancePharmacy Department, Foch Hospital, 92150 Suresnes, FrancePharmacy Department, Foch Hospital, 92150 Suresnes, FrancePharmacy Department, Foch Hospital, 92150 Suresnes, FranceMedical Oncology Department, Foch Hospital, 92150 Suresnes, FranceMedical Oncology Department, Foch Hospital, 92150 Suresnes, FranceMedical Oncology Department, Foch Hospital, 92150 Suresnes, FranceBackground: Pembrolizumab is approved for patients with metastatic urothelial carcinoma (UC) who progressed under platinum therapy. The aim of this study was to assess the efficacy and safety of pembrolizumab in a cohort of real-life UC patients. Methods: This retrospective, observational study included advanced UC patients treated with pembrolizumab in a single institution in France. The co-primary endpoints were overall survival (OS) and progression-free survival (PFS) at 6 months. Secondary endpoints were objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety. Results: 78 patients were included in the study. The median OS was 7.3 months (3.8–12.2). The estimated OS rate at 6 months was 61.5% (50.5–72.6). The median PFS was 3.1 months (1.4–7.2). The estimated PFS rate at 6 months was 42.3% (31.1–53.5). The best ORR was 35.9%. The mean DOR was 95.5 days. The DCR was 30.8%. The most common treatment-related adverse events (AEs) of any grade were fatigue (46.2%), diarrhea (11.5%), pruritus (10.3%) and nausea (9.0%). There were no grade 3 AEs that occurred with an incidence of 5% or more. Conclusion: Our results confirmed those of randomized clinical trials concerning the treatment with pembrolizumab in patients with advanced UC that progressed after platinum-based chemotherapy.https://www.mdpi.com/1718-7729/29/2/80immune checkpoint inhibitorsimmunotherapypembrolizumabprogrammed cell death 1 receptorurinary bladder neoplasms |
| spellingShingle | Elodie Dang Alexandre Vallée Coralie Lepage-Seydoux Karine Sejean Brigitte Bonan Christine Abraham Philippe Beuzeboc Raffaele Ratta Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study Current Oncology immune checkpoint inhibitors immunotherapy pembrolizumab programmed cell death 1 receptor urinary bladder neoplasms |
| title | Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study |
| title_full | Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study |
| title_fullStr | Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study |
| title_full_unstemmed | Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study |
| title_short | Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study |
| title_sort | clinical benefit of pembrolizumab in advanced urothelial cancer patients in real life setting an efficacy and safety monocentric study |
| topic | immune checkpoint inhibitors immunotherapy pembrolizumab programmed cell death 1 receptor urinary bladder neoplasms |
| url | https://www.mdpi.com/1718-7729/29/2/80 |
| work_keys_str_mv | AT elodiedang clinicalbenefitofpembrolizumabinadvancedurothelialcancerpatientsinreallifesettinganefficacyandsafetymonocentricstudy AT alexandrevallee clinicalbenefitofpembrolizumabinadvancedurothelialcancerpatientsinreallifesettinganefficacyandsafetymonocentricstudy AT coralielepageseydoux clinicalbenefitofpembrolizumabinadvancedurothelialcancerpatientsinreallifesettinganefficacyandsafetymonocentricstudy AT karinesejean clinicalbenefitofpembrolizumabinadvancedurothelialcancerpatientsinreallifesettinganefficacyandsafetymonocentricstudy AT brigittebonan clinicalbenefitofpembrolizumabinadvancedurothelialcancerpatientsinreallifesettinganefficacyandsafetymonocentricstudy AT christineabraham clinicalbenefitofpembrolizumabinadvancedurothelialcancerpatientsinreallifesettinganefficacyandsafetymonocentricstudy AT philippebeuzeboc clinicalbenefitofpembrolizumabinadvancedurothelialcancerpatientsinreallifesettinganefficacyandsafetymonocentricstudy AT raffaeleratta clinicalbenefitofpembrolizumabinadvancedurothelialcancerpatientsinreallifesettinganefficacyandsafetymonocentricstudy |