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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 study

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-pr...

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Autores principales: Wang, Xiaoyu, Cang, Wei, Liu, Xiaomei, Cheng, Yu, Wan, Xirun, Feng, Fengzhi, Ren, Tong, Zhao, Jun, Jiang, Fang, Cheng, Hongyan, Gu, Yu, Chen, Lihua, Li, Chen, Li, Xiuqin, Yang, Junjun, Lu, Xin, Xiang, Yang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10154962/
https://www.ncbi.nlm.nih.gov/pubmed/37152364
http://dx.doi.org/10.1016/j.eclinm.2023.101974
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author Wang, Xiaoyu
Cang, Wei
Liu, Xiaomei
Cheng, Yu
Wan, Xirun
Feng, Fengzhi
Ren, Tong
Zhao, Jun
Jiang, Fang
Cheng, Hongyan
Gu, Yu
Chen, Lihua
Li, Chen
Li, Xiuqin
Yang, Junjun
Lu, Xin
Xiang, Yang
author_facet Wang, Xiaoyu
Cang, Wei
Liu, Xiaomei
Cheng, Yu
Wan, Xirun
Feng, Fengzhi
Ren, Tong
Zhao, Jun
Jiang, Fang
Cheng, Hongyan
Gu, Yu
Chen, Lihua
Li, Chen
Li, Xiuqin
Yang, Junjun
Lu, Xin
Xiang, Yang
author_sort Wang, Xiaoyu
collection PubMed
description 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 10.13039/501100001809National 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).
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spelling pubmed-101549622023-05-04 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 study Wang, Xiaoyu Cang, Wei Liu, Xiaomei Cheng, Yu Wan, Xirun Feng, Fengzhi Ren, Tong Zhao, Jun Jiang, Fang Cheng, Hongyan Gu, Yu Chen, Lihua Li, Chen Li, Xiuqin Yang, Junjun Lu, Xin Xiang, Yang eClinicalMedicine Articles 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 10.13039/501100001809National 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). Elsevier 2023-04-27 /pmc/articles/PMC10154962/ /pubmed/37152364 http://dx.doi.org/10.1016/j.eclinm.2023.101974 Text en © 2023 The Author(s) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Articles
Wang, Xiaoyu
Cang, Wei
Liu, Xiaomei
Cheng, Yu
Wan, Xirun
Feng, Fengzhi
Ren, Tong
Zhao, Jun
Jiang, Fang
Cheng, Hongyan
Gu, Yu
Chen, Lihua
Li, Chen
Li, Xiuqin
Yang, Junjun
Lu, Xin
Xiang, Yang
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 study
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 study
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 study
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 study
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 study
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 study
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 study
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10154962/
https://www.ncbi.nlm.nih.gov/pubmed/37152364
http://dx.doi.org/10.1016/j.eclinm.2023.101974
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