The Efficacy and Safety of Sintilimab Combined With Nab-Paclitaxel as a Second-Line Treatment for Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Cancer
BackgroundUnresectable advanced or recurrent gastric cancer patients have a poor prognosis. PD-1 monotherapy regimen and PD-1 combined chemotherapy regimen have become the standard third- and first-line treatment for advanced gastric cancer, respectively. However, the status of immune checkpoint inh...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-06-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2022.924149/full |
| _version_ | 1818240253601775616 |
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| author | Jianzheng Wang Yunduan He Baiwen Zhang Huifang Lv Caiyun Nie Beibei Chen Weifeng Xu Jing Zhao Xiaojiao Cheng Qingli Li Shuiping Tu Xiaobing Chen |
| author_facet | Jianzheng Wang Yunduan He Baiwen Zhang Huifang Lv Caiyun Nie Beibei Chen Weifeng Xu Jing Zhao Xiaojiao Cheng Qingli Li Shuiping Tu Xiaobing Chen |
| author_sort | Jianzheng Wang |
| collection | DOAJ |
| description | BackgroundUnresectable advanced or recurrent gastric cancer patients have a poor prognosis. PD-1 monotherapy regimen and PD-1 combined chemotherapy regimen have become the standard third- and first-line treatment for advanced gastric cancer, respectively. However, the status of immune checkpoint inhibitors in the second-line treatment for advanced gastric cancer has not been established. The combination of chemotherapy and anti-PD-1 antibody has been demonstrated to have a synergistic effect. In this study, we aimed to evaluate the efficacy and safety of sintilimab combined with nab-paclitaxel in the second-line treatment for advanced gastric cancer (GC)/gastroesophageal junction (GEJ) cancer patients.Patients and MethodsWe retrospectively analyzed patients with advanced GC/GEJ cancer that progressed after first-line systemic therapies with sintilimab combined with nab-paclitaxel from April 1, 2019 to December 31, 2021. The primary endpoint was progression-free survival (PFS). The secondary endpoints included objective response rate (ORR), disease control rate (DCR), and safety.ResultsThirty-nine patients were enrolled and eligible for response assessment. Complete response (CR) was not observed, 15 patients achieved partial response (PR), 16 patients had stable disease (SD) and 9 patients had progressive disease (PD). The ORR and DCR were 15 (38.5%) and 31 (79.5%), respectively. Median PFS was 5.4 months (95%CI: 3.072-7.728). PFSs between different subgroups were analyzed. The results showed that gender, age, Human epidermal growth factor receptors 2 (HER2) status, PD-L1 expression, primary tumor site and chemotherapy cycles had no significant effect on PFS. Most of the adverse events (AEs) were of grade 1-2 and manageable. The common treatment-related adverse events of grade 3 or 4 included anemia (12.8%), neutropenia (12.8%), leukopenia (10.3%), hand-foot syndrome (7.7%), thrombocytopenia (7.7%). The potential immune-related adverse events (irAEs) were grade 1 pneumonia (1 pts [2.6%]) and grade 4 hepatitis (1 pts [2.6%]). There were no treatment-related deaths.ConclusionThese results indicate that sintilimab combined with nab-paclitaxel exhibits good anti-tumor activity and an acceptable safety profile as a second-line treatment for advanced or metastatic gastric cancer. These results warrant further investigation and evaluation to identify patients who can benefit more from the combined treatment strategy. |
| first_indexed | 2024-12-12T13:10:30Z |
| format | Article |
| id | doaj.art-5e1a7964c11b4d558c60b7c0fa7c7b68 |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-12-12T13:10:30Z |
| publishDate | 2022-06-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Oncology |
| spelling | doaj.art-5e1a7964c11b4d558c60b7c0fa7c7b682022-12-22T00:23:32ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2022-06-011210.3389/fonc.2022.924149924149The Efficacy and Safety of Sintilimab Combined With Nab-Paclitaxel as a Second-Line Treatment for Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction CancerJianzheng Wang0Yunduan He1Baiwen Zhang2Huifang Lv3Caiyun Nie4Beibei Chen5Weifeng Xu6Jing Zhao7Xiaojiao Cheng8Qingli Li9Shuiping Tu10Xiaobing Chen11Department of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou, University and Henan Cancer Hospital, Zhengzhou, ChinaDepartment of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou, University and Henan Cancer Hospital, Zhengzhou, ChinaDepartment of Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaDepartment of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou, University and Henan Cancer Hospital, Zhengzhou, ChinaDepartment of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou, University and Henan Cancer Hospital, Zhengzhou, ChinaDepartment of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou, University and Henan Cancer Hospital, Zhengzhou, ChinaDepartment of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou, University and Henan Cancer Hospital, Zhengzhou, ChinaDepartment of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou, University and Henan Cancer Hospital, Zhengzhou, ChinaDepartment of Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaDepartment of Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaDepartment of Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaDepartment of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou, University and Henan Cancer Hospital, Zhengzhou, ChinaBackgroundUnresectable advanced or recurrent gastric cancer patients have a poor prognosis. PD-1 monotherapy regimen and PD-1 combined chemotherapy regimen have become the standard third- and first-line treatment for advanced gastric cancer, respectively. However, the status of immune checkpoint inhibitors in the second-line treatment for advanced gastric cancer has not been established. The combination of chemotherapy and anti-PD-1 antibody has been demonstrated to have a synergistic effect. In this study, we aimed to evaluate the efficacy and safety of sintilimab combined with nab-paclitaxel in the second-line treatment for advanced gastric cancer (GC)/gastroesophageal junction (GEJ) cancer patients.Patients and MethodsWe retrospectively analyzed patients with advanced GC/GEJ cancer that progressed after first-line systemic therapies with sintilimab combined with nab-paclitaxel from April 1, 2019 to December 31, 2021. The primary endpoint was progression-free survival (PFS). The secondary endpoints included objective response rate (ORR), disease control rate (DCR), and safety.ResultsThirty-nine patients were enrolled and eligible for response assessment. Complete response (CR) was not observed, 15 patients achieved partial response (PR), 16 patients had stable disease (SD) and 9 patients had progressive disease (PD). The ORR and DCR were 15 (38.5%) and 31 (79.5%), respectively. Median PFS was 5.4 months (95%CI: 3.072-7.728). PFSs between different subgroups were analyzed. The results showed that gender, age, Human epidermal growth factor receptors 2 (HER2) status, PD-L1 expression, primary tumor site and chemotherapy cycles had no significant effect on PFS. Most of the adverse events (AEs) were of grade 1-2 and manageable. The common treatment-related adverse events of grade 3 or 4 included anemia (12.8%), neutropenia (12.8%), leukopenia (10.3%), hand-foot syndrome (7.7%), thrombocytopenia (7.7%). The potential immune-related adverse events (irAEs) were grade 1 pneumonia (1 pts [2.6%]) and grade 4 hepatitis (1 pts [2.6%]). There were no treatment-related deaths.ConclusionThese results indicate that sintilimab combined with nab-paclitaxel exhibits good anti-tumor activity and an acceptable safety profile as a second-line treatment for advanced or metastatic gastric cancer. These results warrant further investigation and evaluation to identify patients who can benefit more from the combined treatment strategy.https://www.frontiersin.org/articles/10.3389/fonc.2022.924149/fullgastric cancersintilimabnab-paclitaxelsecond-line treatmentimmunotherapy |
| spellingShingle | Jianzheng Wang Yunduan He Baiwen Zhang Huifang Lv Caiyun Nie Beibei Chen Weifeng Xu Jing Zhao Xiaojiao Cheng Qingli Li Shuiping Tu Xiaobing Chen The Efficacy and Safety of Sintilimab Combined With Nab-Paclitaxel as a Second-Line Treatment for Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Cancer Frontiers in Oncology gastric cancer sintilimab nab-paclitaxel second-line treatment immunotherapy |
| title | The Efficacy and Safety of Sintilimab Combined With Nab-Paclitaxel as a Second-Line Treatment for Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Cancer |
| title_full | The Efficacy and Safety of Sintilimab Combined With Nab-Paclitaxel as a Second-Line Treatment for Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Cancer |
| title_fullStr | The Efficacy and Safety of Sintilimab Combined With Nab-Paclitaxel as a Second-Line Treatment for Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Cancer |
| title_full_unstemmed | The Efficacy and Safety of Sintilimab Combined With Nab-Paclitaxel as a Second-Line Treatment for Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Cancer |
| title_short | The Efficacy and Safety of Sintilimab Combined With Nab-Paclitaxel as a Second-Line Treatment for Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Cancer |
| title_sort | efficacy and safety of sintilimab combined with nab paclitaxel as a second line treatment for advanced or metastatic gastric cancer and gastroesophageal junction cancer |
| topic | gastric cancer sintilimab nab-paclitaxel second-line treatment immunotherapy |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2022.924149/full |
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