Real-world efficacy and safety of low-dose pembrolizumab in patients with advanced and refractory gynecologic cancers
Objective: The approved standard dose of pembrolizumab (200 mg administrated every 3 weeks) for cancer treatment imposes a significant financial burden on patients. However, no study has analyzed the clinical outcomes of low-dose pembrolizumab among individuals diagnosed with gynecologic cancer. The...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2024-04-01
|
| Series: | Journal of the Formosan Medical Association |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S0929664623003996 |
| _version_ | 1797215976171765760 |
|---|---|
| author | Chien-Hsiang Kao Hao Lin Chien-Ting Liu Yu-Che Ou Hung-Chun Fu Chia-Che Wu Chen-Hsuan Wu |
| author_facet | Chien-Hsiang Kao Hao Lin Chien-Ting Liu Yu-Che Ou Hung-Chun Fu Chia-Che Wu Chen-Hsuan Wu |
| author_sort | Chien-Hsiang Kao |
| collection | DOAJ |
| description | Objective: The approved standard dose of pembrolizumab (200 mg administrated every 3 weeks) for cancer treatment imposes a significant financial burden on patients. However, no study has analyzed the clinical outcomes of low-dose pembrolizumab among individuals diagnosed with gynecologic cancer. The primary objective of this study was to assess the effectiveness and safety of a low-dose pembrolizumab regimen in real-world clinical practice. Methods: We retrospectively assessed the efficacy and safety data of patients with gynecologic malignancies who received pembrolizumab between 2017 and 2022 at Kaohsiung Chang Gung Memorial Hospital. Furthermore, we conducted a comparative analysis of the objective response rate (ORR) and progression-free survival (PFS) between patients with deficient mismatch repair (dMMR) and proficient MMR (pMMR). Results: A total of thirty-nine patients were included and received pembrolizumab at fixed dosages of 50 mg (5.1%), 100 mg (84.6%) and 200 mg (10.3%) per cycle. Compared to the pMMR group, the dMMR group exhibited a tendency toward improved ORR (45.5% vs. 13.0%, p = 0.074), and notably, the median duration of response remained unreached. There was no significant difference in PFS between the dMMR and pMMR groups; however, the patients with dMMR in tumor tissue had a trend of better survival (p = 0.079). Incidence of immune-related adverse events (irAEs) of any grade was observed in 13 patients (33.3%), with 3 individuals (7.7%) experiencing grade 3 or 4 events. Conclusion: Low-dose pembrolizumab may be a cost-effective and safe treatment option without compromising clinical outcomes in patients with refractory gynecologic cancers. |
| first_indexed | 2024-04-24T11:38:37Z |
| format | Article |
| id | doaj.art-a2abae5253b54e6086ca3e2369c58eef |
| institution | Directory Open Access Journal |
| issn | 0929-6646 |
| language | English |
| last_indexed | 2024-04-24T11:38:37Z |
| publishDate | 2024-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of the Formosan Medical Association |
| spelling | doaj.art-a2abae5253b54e6086ca3e2369c58eef2024-04-10T04:28:32ZengElsevierJournal of the Formosan Medical Association0929-66462024-04-011234487495Real-world efficacy and safety of low-dose pembrolizumab in patients with advanced and refractory gynecologic cancersChien-Hsiang Kao0Hao Lin1Chien-Ting Liu2Yu-Che Ou3Hung-Chun Fu4Chia-Che Wu5Chen-Hsuan Wu6Department of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, TaiwanDepartment of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, TaiwanDivision of Hematology-Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University, College of Medicine, Kaohsiung, TaiwanDepartment of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, TaiwanDepartment of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, TaiwanDivision of Hematology-Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University, College of Medicine, Kaohsiung, TaiwanDepartment of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan; Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taoyuan 33302, Taiwan; Corresponding author. Department of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital, No. 123, Dapi Rd., Niaosong Dist., Kaohsiung City 83301, Taiwan, R.O.C.Objective: The approved standard dose of pembrolizumab (200 mg administrated every 3 weeks) for cancer treatment imposes a significant financial burden on patients. However, no study has analyzed the clinical outcomes of low-dose pembrolizumab among individuals diagnosed with gynecologic cancer. The primary objective of this study was to assess the effectiveness and safety of a low-dose pembrolizumab regimen in real-world clinical practice. Methods: We retrospectively assessed the efficacy and safety data of patients with gynecologic malignancies who received pembrolizumab between 2017 and 2022 at Kaohsiung Chang Gung Memorial Hospital. Furthermore, we conducted a comparative analysis of the objective response rate (ORR) and progression-free survival (PFS) between patients with deficient mismatch repair (dMMR) and proficient MMR (pMMR). Results: A total of thirty-nine patients were included and received pembrolizumab at fixed dosages of 50 mg (5.1%), 100 mg (84.6%) and 200 mg (10.3%) per cycle. Compared to the pMMR group, the dMMR group exhibited a tendency toward improved ORR (45.5% vs. 13.0%, p = 0.074), and notably, the median duration of response remained unreached. There was no significant difference in PFS between the dMMR and pMMR groups; however, the patients with dMMR in tumor tissue had a trend of better survival (p = 0.079). Incidence of immune-related adverse events (irAEs) of any grade was observed in 13 patients (33.3%), with 3 individuals (7.7%) experiencing grade 3 or 4 events. Conclusion: Low-dose pembrolizumab may be a cost-effective and safe treatment option without compromising clinical outcomes in patients with refractory gynecologic cancers.http://www.sciencedirect.com/science/article/pii/S0929664623003996ImmunotherapyImmune checkpoint inhibitorsPembrolizumabDNA mismatch repairAdverse effects |
| spellingShingle | Chien-Hsiang Kao Hao Lin Chien-Ting Liu Yu-Che Ou Hung-Chun Fu Chia-Che Wu Chen-Hsuan Wu Real-world efficacy and safety of low-dose pembrolizumab in patients with advanced and refractory gynecologic cancers Journal of the Formosan Medical Association Immunotherapy Immune checkpoint inhibitors Pembrolizumab DNA mismatch repair Adverse effects |
| title | Real-world efficacy and safety of low-dose pembrolizumab in patients with advanced and refractory gynecologic cancers |
| title_full | Real-world efficacy and safety of low-dose pembrolizumab in patients with advanced and refractory gynecologic cancers |
| title_fullStr | Real-world efficacy and safety of low-dose pembrolizumab in patients with advanced and refractory gynecologic cancers |
| title_full_unstemmed | Real-world efficacy and safety of low-dose pembrolizumab in patients with advanced and refractory gynecologic cancers |
| title_short | Real-world efficacy and safety of low-dose pembrolizumab in patients with advanced and refractory gynecologic cancers |
| title_sort | real world efficacy and safety of low dose pembrolizumab in patients with advanced and refractory gynecologic cancers |
| topic | Immunotherapy Immune checkpoint inhibitors Pembrolizumab DNA mismatch repair Adverse effects |
| url | http://www.sciencedirect.com/science/article/pii/S0929664623003996 |
| work_keys_str_mv | AT chienhsiangkao realworldefficacyandsafetyoflowdosepembrolizumabinpatientswithadvancedandrefractorygynecologiccancers AT haolin realworldefficacyandsafetyoflowdosepembrolizumabinpatientswithadvancedandrefractorygynecologiccancers AT chientingliu realworldefficacyandsafetyoflowdosepembrolizumabinpatientswithadvancedandrefractorygynecologiccancers AT yucheou realworldefficacyandsafetyoflowdosepembrolizumabinpatientswithadvancedandrefractorygynecologiccancers AT hungchunfu realworldefficacyandsafetyoflowdosepembrolizumabinpatientswithadvancedandrefractorygynecologiccancers AT chiachewu realworldefficacyandsafetyoflowdosepembrolizumabinpatientswithadvancedandrefractorygynecologiccancers AT chenhsuanwu realworldefficacyandsafetyoflowdosepembrolizumabinpatientswithadvancedandrefractorygynecologiccancers |