Anti-PD-1 therapy plus chemotherapy versus anti-PD-1 therapy alone in patients with high-risk chemorefractory or relapsed gestational trophoblastic neoplasia: a multicenter, retrospective studyResearch in context
Summary: Background: Synergistic antitumor effects of immunotherapy and chemotherapy have been demonstrated in several solid tumors. However, this combination strategy has not been addressed in gestational trophoblastic neoplasia (GTN) cases. We therefore compared the safety and therapeutic effect...
| Main Authors: | , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-05-01
|
| Series: | EClinicalMedicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589537023001517 |
| _version_ | 1797837684744388608 |
|---|---|
| author | Xiaoyu Wang Wei Cang Xiaomei Liu Yu Cheng Xirun Wan Fengzhi Feng Tong Ren Jun Zhao Fang Jiang Hongyan Cheng Yu Gu Lihua Chen Chen Li Xiuqin Li Junjun Yang Xin Lu Yang Xiang |
| author_facet | Xiaoyu Wang Wei Cang Xiaomei Liu Yu Cheng Xirun Wan Fengzhi Feng Tong Ren Jun Zhao Fang Jiang Hongyan Cheng Yu Gu Lihua Chen Chen Li Xiuqin Li Junjun Yang Xin Lu Yang Xiang |
| author_sort | Xiaoyu Wang |
| collection | DOAJ |
| description | Summary: Background: Synergistic antitumor effects of immunotherapy and chemotherapy have been demonstrated in several solid tumors. However, this combination strategy has not been addressed in gestational trophoblastic neoplasia (GTN) cases. We therefore compared the safety and therapeutic effect of anti-programmed cell death 1 (PD-1) therapy combined with chemotherapy versus anti-PD-1 monotherapy among high-risk chemorefractory or relapsed GTN patients. Methods: This retrospective cohort study was conducted at three teaching hospitals in China. Chemorefractory or relapsed GTN cases receiving anti-PD-1 therapy combined with chemotherapy or anti-PD-1 monotherapy were selected from each center between August 2018 and March 2022. Study endpoints included objective response rate (ORR), treatment duration, overall survival (OS) and progression-free survival (PFS). The nature, prevalence and severity of treatment-related adverse events (TRAEs) were evaluated. Findings: This work enrolled 66 cases. Thirty-five and 31 patients received anti-PD-1 therapy alone and combined with chemotherapy, respectively. The combined treatment dramatically increased the objective response rate from 62.9% (22/35) to 96.8% (30/31) (p < 0.001). The median durations until complete response were 2.2 (interquartile range [IQR], 1.4–4.2) and 2.8 (IQR, 1.8–2.8) months in the anti-PD-1 monotherapy and combined treatment cohorts, respectively (P = 0.299). The complete response rate (CRR) for anti-PD-1-refractory patients to salvage chemotherapy was 84.6% (11/13). No significant difference in OS [HR 0.50 (95% CI 0.07–3.24), p = 0.499] was detected between anti-PD-1 cohort and anti-PD-1 plus chemotherapy cohort. The PFS in combined group was significantly longer than in anti-PD-1 group [HR 0.06 (95% CI 0.02–0.16), p < 0.001]. TRAEs were observed in 27 (77.1%) and 25 (80.6%) patients receiving anti-PD-1 therapy monotherapy and combined therapy, respectively (p = 0.729). Interpretation: Anti-PD-1 therapy combined with chemotherapy exhibits sustainably improved antitumor effect and tolerable toxic effects among high-risk chemorefractory or relapsed GTN cases. Patients not responding to PD-1 inhibitors can be effectively rescued with salvage chemotherapy. Funding: The study was supported by National Natural Science Foundation of China (81971475 and 81972451), and the National High Level Hospital Clinical Research Funding (2022-PUMCH-B-083 and 2022-PUMCH-B-084). |
| first_indexed | 2024-04-09T15:29:44Z |
| format | Article |
| id | doaj.art-1068d68eb7ad463a80875bfff149b0b4 |
| institution | Directory Open Access Journal |
| issn | 2589-5370 |
| language | English |
| last_indexed | 2024-04-09T15:29:44Z |
| publishDate | 2023-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EClinicalMedicine |
| spelling | doaj.art-1068d68eb7ad463a80875bfff149b0b42023-04-28T08:56:15ZengElsevierEClinicalMedicine2589-53702023-05-0159101974Anti-PD-1 therapy plus chemotherapy versus anti-PD-1 therapy alone in patients with high-risk chemorefractory or relapsed gestational trophoblastic neoplasia: a multicenter, retrospective studyResearch in contextXiaoyu Wang0Wei Cang1Xiaomei Liu2Yu Cheng3Xirun Wan4Fengzhi Feng5Tong Ren6Jun Zhao7Fang Jiang8Hongyan Cheng9Yu Gu10Lihua Chen11Chen Li12Xiuqin Li13Junjun Yang14Xin Lu15Yang Xiang16Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Peking Union Medical College, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, ChinaDepartment of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Peking Union Medical College, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, ChinaDepartment of Obstetrics and Gynecology, Shengjing Hospital of China Medical University, Shenyang, ChinaDepartment of Gynecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, ChinaDepartment of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Peking Union Medical College, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, ChinaDepartment of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Peking Union Medical College, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, ChinaDepartment of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Peking Union Medical College, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, ChinaDepartment of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Peking Union Medical College, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, ChinaDepartment of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Peking Union Medical College, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, ChinaDepartment of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Peking Union Medical College, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, ChinaDepartment of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Peking Union Medical College, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, ChinaDepartment of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Peking Union Medical College, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, ChinaDepartment of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Peking Union Medical College, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, ChinaDepartment of Obstetrics and Gynecology, Shengjing Hospital of China Medical University, Shenyang, ChinaDepartment of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Peking Union Medical College, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, China; Corresponding author. Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, No. 1 Shuaifuyuan Road, Dongcheng District, Beijing 100730, China.Department of Gynecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China; Corresponding author. Department of Gynecology, Obstetrics and Gynecology Hospital, Fudan University, No.419 Fangxie Road, Shanghai 200011, China.Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Peking Union Medical College, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, China; Corresponding author. Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, No. 1 Shuaifuyuan Road, Dongcheng District, Beijing 100730, China.Summary: Background: Synergistic antitumor effects of immunotherapy and chemotherapy have been demonstrated in several solid tumors. However, this combination strategy has not been addressed in gestational trophoblastic neoplasia (GTN) cases. We therefore compared the safety and therapeutic effect of anti-programmed cell death 1 (PD-1) therapy combined with chemotherapy versus anti-PD-1 monotherapy among high-risk chemorefractory or relapsed GTN patients. Methods: This retrospective cohort study was conducted at three teaching hospitals in China. Chemorefractory or relapsed GTN cases receiving anti-PD-1 therapy combined with chemotherapy or anti-PD-1 monotherapy were selected from each center between August 2018 and March 2022. Study endpoints included objective response rate (ORR), treatment duration, overall survival (OS) and progression-free survival (PFS). The nature, prevalence and severity of treatment-related adverse events (TRAEs) were evaluated. Findings: This work enrolled 66 cases. Thirty-five and 31 patients received anti-PD-1 therapy alone and combined with chemotherapy, respectively. The combined treatment dramatically increased the objective response rate from 62.9% (22/35) to 96.8% (30/31) (p < 0.001). The median durations until complete response were 2.2 (interquartile range [IQR], 1.4–4.2) and 2.8 (IQR, 1.8–2.8) months in the anti-PD-1 monotherapy and combined treatment cohorts, respectively (P = 0.299). The complete response rate (CRR) for anti-PD-1-refractory patients to salvage chemotherapy was 84.6% (11/13). No significant difference in OS [HR 0.50 (95% CI 0.07–3.24), p = 0.499] was detected between anti-PD-1 cohort and anti-PD-1 plus chemotherapy cohort. The PFS in combined group was significantly longer than in anti-PD-1 group [HR 0.06 (95% CI 0.02–0.16), p < 0.001]. TRAEs were observed in 27 (77.1%) and 25 (80.6%) patients receiving anti-PD-1 therapy monotherapy and combined therapy, respectively (p = 0.729). Interpretation: Anti-PD-1 therapy combined with chemotherapy exhibits sustainably improved antitumor effect and tolerable toxic effects among high-risk chemorefractory or relapsed GTN cases. Patients not responding to PD-1 inhibitors can be effectively rescued with salvage chemotherapy. Funding: The study was supported by National Natural Science Foundation of China (81971475 and 81972451), and the National High Level Hospital Clinical Research Funding (2022-PUMCH-B-083 and 2022-PUMCH-B-084).http://www.sciencedirect.com/science/article/pii/S2589537023001517PD-1 inhibitorsGestational trophoblastic neoplasiaCombination therapyChemotherapy |
| spellingShingle | Xiaoyu Wang Wei Cang Xiaomei Liu Yu Cheng Xirun Wan Fengzhi Feng Tong Ren Jun Zhao Fang Jiang Hongyan Cheng Yu Gu Lihua Chen Chen Li Xiuqin Li Junjun Yang Xin Lu Yang Xiang Anti-PD-1 therapy plus chemotherapy versus anti-PD-1 therapy alone in patients with high-risk chemorefractory or relapsed gestational trophoblastic neoplasia: a multicenter, retrospective studyResearch in context EClinicalMedicine PD-1 inhibitors Gestational trophoblastic neoplasia Combination therapy Chemotherapy |
| title | Anti-PD-1 therapy plus chemotherapy versus anti-PD-1 therapy alone in patients with high-risk chemorefractory or relapsed gestational trophoblastic neoplasia: a multicenter, retrospective studyResearch in context |
| title_full | Anti-PD-1 therapy plus chemotherapy versus anti-PD-1 therapy alone in patients with high-risk chemorefractory or relapsed gestational trophoblastic neoplasia: a multicenter, retrospective studyResearch in context |
| title_fullStr | Anti-PD-1 therapy plus chemotherapy versus anti-PD-1 therapy alone in patients with high-risk chemorefractory or relapsed gestational trophoblastic neoplasia: a multicenter, retrospective studyResearch in context |
| title_full_unstemmed | Anti-PD-1 therapy plus chemotherapy versus anti-PD-1 therapy alone in patients with high-risk chemorefractory or relapsed gestational trophoblastic neoplasia: a multicenter, retrospective studyResearch in context |
| title_short | Anti-PD-1 therapy plus chemotherapy versus anti-PD-1 therapy alone in patients with high-risk chemorefractory or relapsed gestational trophoblastic neoplasia: a multicenter, retrospective studyResearch in context |
| title_sort | anti pd 1 therapy plus chemotherapy versus anti pd 1 therapy alone in patients with high risk chemorefractory or relapsed gestational trophoblastic neoplasia a multicenter retrospective studyresearch in context |
| topic | PD-1 inhibitors Gestational trophoblastic neoplasia Combination therapy Chemotherapy |
| url | http://www.sciencedirect.com/science/article/pii/S2589537023001517 |
| work_keys_str_mv | AT xiaoyuwang antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT weicang antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT xiaomeiliu antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT yucheng antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT xirunwan antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT fengzhifeng antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT tongren antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT junzhao antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT fangjiang antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT hongyancheng antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT yugu antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT lihuachen antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT chenli antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT xiuqinli antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT junjunyang antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT xinlu antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext AT yangxiang antipd1therapypluschemotherapyversusantipd1therapyaloneinpatientswithhighriskchemorefractoryorrelapsedgestationaltrophoblasticneoplasiaamulticenterretrospectivestudyresearchincontext |