Camrelizumab plus platinum-irinotecan followed by maintenance camrelizumab plus apatinib in untreated extensive-stage small-cell lung cancer: a nonrandomized clinical trial
BackgroundProgrammed cell death-ligand 1 (PD-L1) inhibitors plus chemotherapy have made substantial progress in extensive-stage small-cell lung cancer (ES-SCLC), but the survival benefit is still limited. This study aimed to evaluate the preliminary efficacy and safety of camrelizumab plus platinum-...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2023-04-01
|
| Series: | Frontiers in Immunology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2023.1168879/full |
| _version_ | 1797849238808297472 |
|---|---|
| author | Jun Ni Jun Ni Xiaoyan Si Hanping Wang Xiaotong Zhang Li Zhang |
| author_facet | Jun Ni Jun Ni Xiaoyan Si Hanping Wang Xiaotong Zhang Li Zhang |
| author_sort | Jun Ni |
| collection | DOAJ |
| description | BackgroundProgrammed cell death-ligand 1 (PD-L1) inhibitors plus chemotherapy have made substantial progress in extensive-stage small-cell lung cancer (ES-SCLC), but the survival benefit is still limited. This study aimed to evaluate the preliminary efficacy and safety of camrelizumab plus platinum-irinotecan (IP/IC) followed by maintenance camrelizumab plus apatinib in patients with untreated ES-SCLC.MethodsIn this non-randomized clinical trial (NCT04453930), eligible patients with untreated ES-SCLC received 4-6 cycles of camrelizumab plus IP/IC, followed by maintenance with camrelizumab plus apatinib until disease progression or unmanageable toxicity. The primary endpoint was progression-free survival (PFS). Patients who received PD-L1 inhibitors (atezolizumab or durvalumab) plus platinum-etoposide (EP/EC) were selected as the historical control.ResultsNineteen patients received IP/IC plus camrelizumab and 34 patients received EP/EC plus PD-L1 inhibitor. At a median follow-up time of 12.1 months, the median PFS was 10.25 months (95% CI: 9.40-NA) in the IP/IC plus camrelizumab group and 7.10 months (95% CI 5.79-8.40) in the EP/EC plus PD-L1 inhibitor group, respectively (HR=0.58, 95% CI 0.42-0.81). The objective response rate of IP/IC plus camrelizumab and EP/EC plus PD-L1 inhibitor was 89.6% and 82.4%, respectively. The most common treatment-related adverse events in the IP/IC plus camrelizumab group was neutropenia, followed by reactive cutaneous capillary endothelial proliferation (RCCEP) and diarrhea. The occurrence of immune-related adverse event was found to be associated with a prolonged PFS (HR=4.64, 95% CI 1.92-11.18).ConclusionsIP/IC plus camrelizumab followed by maintenance camrelizumab plus apatinib showed preliminary efficacy and acceptable safety profile in patients with untreated ES-SCLC. |
| first_indexed | 2024-04-09T18:40:40Z |
| format | Article |
| id | doaj.art-67924a8ae3224d5d9a4eb59d2540093a |
| institution | Directory Open Access Journal |
| issn | 1664-3224 |
| language | English |
| last_indexed | 2024-04-09T18:40:40Z |
| publishDate | 2023-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Immunology |
| spelling | doaj.art-67924a8ae3224d5d9a4eb59d2540093a2023-04-11T05:27:06ZengFrontiers Media S.A.Frontiers in Immunology1664-32242023-04-011410.3389/fimmu.2023.11688791168879Camrelizumab plus platinum-irinotecan followed by maintenance camrelizumab plus apatinib in untreated extensive-stage small-cell lung cancer: a nonrandomized clinical trialJun Ni0Jun Ni1Xiaoyan Si2Hanping Wang3Xiaotong Zhang4Li Zhang5Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences & Peking Union Medical College, Beijing, ChinaDepartment of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, ChinaDepartment of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences & Peking Union Medical College, Beijing, ChinaDepartment of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences & Peking Union Medical College, Beijing, ChinaDepartment of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences & Peking Union Medical College, Beijing, ChinaDepartment of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences & Peking Union Medical College, Beijing, ChinaBackgroundProgrammed cell death-ligand 1 (PD-L1) inhibitors plus chemotherapy have made substantial progress in extensive-stage small-cell lung cancer (ES-SCLC), but the survival benefit is still limited. This study aimed to evaluate the preliminary efficacy and safety of camrelizumab plus platinum-irinotecan (IP/IC) followed by maintenance camrelizumab plus apatinib in patients with untreated ES-SCLC.MethodsIn this non-randomized clinical trial (NCT04453930), eligible patients with untreated ES-SCLC received 4-6 cycles of camrelizumab plus IP/IC, followed by maintenance with camrelizumab plus apatinib until disease progression or unmanageable toxicity. The primary endpoint was progression-free survival (PFS). Patients who received PD-L1 inhibitors (atezolizumab or durvalumab) plus platinum-etoposide (EP/EC) were selected as the historical control.ResultsNineteen patients received IP/IC plus camrelizumab and 34 patients received EP/EC plus PD-L1 inhibitor. At a median follow-up time of 12.1 months, the median PFS was 10.25 months (95% CI: 9.40-NA) in the IP/IC plus camrelizumab group and 7.10 months (95% CI 5.79-8.40) in the EP/EC plus PD-L1 inhibitor group, respectively (HR=0.58, 95% CI 0.42-0.81). The objective response rate of IP/IC plus camrelizumab and EP/EC plus PD-L1 inhibitor was 89.6% and 82.4%, respectively. The most common treatment-related adverse events in the IP/IC plus camrelizumab group was neutropenia, followed by reactive cutaneous capillary endothelial proliferation (RCCEP) and diarrhea. The occurrence of immune-related adverse event was found to be associated with a prolonged PFS (HR=4.64, 95% CI 1.92-11.18).ConclusionsIP/IC plus camrelizumab followed by maintenance camrelizumab plus apatinib showed preliminary efficacy and acceptable safety profile in patients with untreated ES-SCLC.https://www.frontiersin.org/articles/10.3389/fimmu.2023.1168879/fullsmall cell lung carcinoma (SCLC)platinumirinotecancamrelizumabimmune checkpoint inhibitors |
| spellingShingle | Jun Ni Jun Ni Xiaoyan Si Hanping Wang Xiaotong Zhang Li Zhang Camrelizumab plus platinum-irinotecan followed by maintenance camrelizumab plus apatinib in untreated extensive-stage small-cell lung cancer: a nonrandomized clinical trial Frontiers in Immunology small cell lung carcinoma (SCLC) platinum irinotecan camrelizumab immune checkpoint inhibitors |
| title | Camrelizumab plus platinum-irinotecan followed by maintenance camrelizumab plus apatinib in untreated extensive-stage small-cell lung cancer: a nonrandomized clinical trial |
| title_full | Camrelizumab plus platinum-irinotecan followed by maintenance camrelizumab plus apatinib in untreated extensive-stage small-cell lung cancer: a nonrandomized clinical trial |
| title_fullStr | Camrelizumab plus platinum-irinotecan followed by maintenance camrelizumab plus apatinib in untreated extensive-stage small-cell lung cancer: a nonrandomized clinical trial |
| title_full_unstemmed | Camrelizumab plus platinum-irinotecan followed by maintenance camrelizumab plus apatinib in untreated extensive-stage small-cell lung cancer: a nonrandomized clinical trial |
| title_short | Camrelizumab plus platinum-irinotecan followed by maintenance camrelizumab plus apatinib in untreated extensive-stage small-cell lung cancer: a nonrandomized clinical trial |
| title_sort | camrelizumab plus platinum irinotecan followed by maintenance camrelizumab plus apatinib in untreated extensive stage small cell lung cancer a nonrandomized clinical trial |
| topic | small cell lung carcinoma (SCLC) platinum irinotecan camrelizumab immune checkpoint inhibitors |
| url | https://www.frontiersin.org/articles/10.3389/fimmu.2023.1168879/full |
| work_keys_str_mv | AT junni camrelizumabplusplatinumirinotecanfollowedbymaintenancecamrelizumabplusapatinibinuntreatedextensivestagesmallcelllungcanceranonrandomizedclinicaltrial AT junni camrelizumabplusplatinumirinotecanfollowedbymaintenancecamrelizumabplusapatinibinuntreatedextensivestagesmallcelllungcanceranonrandomizedclinicaltrial AT xiaoyansi camrelizumabplusplatinumirinotecanfollowedbymaintenancecamrelizumabplusapatinibinuntreatedextensivestagesmallcelllungcanceranonrandomizedclinicaltrial AT hanpingwang camrelizumabplusplatinumirinotecanfollowedbymaintenancecamrelizumabplusapatinibinuntreatedextensivestagesmallcelllungcanceranonrandomizedclinicaltrial AT xiaotongzhang camrelizumabplusplatinumirinotecanfollowedbymaintenancecamrelizumabplusapatinibinuntreatedextensivestagesmallcelllungcanceranonrandomizedclinicaltrial AT lizhang camrelizumabplusplatinumirinotecanfollowedbymaintenancecamrelizumabplusapatinibinuntreatedextensivestagesmallcelllungcanceranonrandomizedclinicaltrial |