Immunotherapy in patients with metastatic castration-resistant prostate cancer: a meta-analysis of data from 7 phase III studies and 3 phase II studies
Abstract Background Immunotherapies have emerged as potential treatments for metastatic castration-resistant prostate cancer (mCRPC). However, it is still unclear to identify the efficacy and safety of immunotherapy in large-scale samples. We performed a meta-analysis of 7 phase III randomized trial...
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BMC
2022-09-01
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Series: | Experimental Hematology & Oncology |
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Online Access: | https://doi.org/10.1186/s40164-022-00312-y |
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author | Anqiang Zhang Dali Tong |
author_facet | Anqiang Zhang Dali Tong |
author_sort | Anqiang Zhang |
collection | DOAJ |
description | Abstract Background Immunotherapies have emerged as potential treatments for metastatic castration-resistant prostate cancer (mCRPC). However, it is still unclear to identify the efficacy and safety of immunotherapy in large-scale samples. We performed a meta-analysis of 7 phase III randomized trials and 3 phase II trials comparing immunotherapy to placebo in mCRPC. Methods Searching the PubMed, ClinicalTrials and Cochrane Library, completed III/IV phase trials were identified. Data extraction was conducted according to the PRISMA statement. The measured outcomes were OS, PFS, ORR and AE. Based on the results of phase III randomized trials, 3 II phase trials with results were identified. Results A total of 4185 patients were available for evaluation of OS, and 3320 for PFS. Compared to placebo, immunotherapies were not able to improve OS (HR = 0.90; 95%CI 0.79–1.03; p = 0.13). However, immunotherapies, especially ICBs were able to decrease the risk of progression over placebo by 18% (HR = 0.82; 95%CI 0.68–1.00; p = 0.04). Significant ORR improvement was found in patients treated in ICBs (RR = 1.90; 95%CI 1.30–2.78; p < 0.001). Immunotherapies (OR = 1.01, 95% CI = 0.40–2.56; OR = 1.27, 95% CI = 0.72–2.25) were not associated with significant any grade TRAEs and 3–4 grade TRAEs. However, in subgroup analysis, ICBs (OR = 2.85, 95% CI = 2.27–3.57) and vaccines (OR = 0.78, 95% CI = 0.64–0.53) were associated with significant 3–4 grade TRAEs respectively. Moreover, ICBs alone induced positive PSA response [OR = 2.43(1.09–5.43), P = 0.03(I2 = 0%, P = 0.83)] and was effective in advanced PC even without classical therapies based on three phase II clinical trials about ICBs. Conclusions Immunotherapies are not able to improve OS, but significantly improve PFS and ORR especially in ICBs treatment. Immunotherapies were not associated with significant TRAEs. However, in subgroup analysis, ICBs and vaccines were associated with significant 3–4 grade TRAEs. |
first_indexed | 2024-04-11T10:46:01Z |
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institution | Directory Open Access Journal |
issn | 2162-3619 |
language | English |
last_indexed | 2024-04-11T10:46:01Z |
publishDate | 2022-09-01 |
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series | Experimental Hematology & Oncology |
spelling | doaj.art-d9905db9462d4da39c1411df11b32db22022-12-22T04:29:03ZengBMCExperimental Hematology & Oncology2162-36192022-09-011111510.1186/s40164-022-00312-yImmunotherapy in patients with metastatic castration-resistant prostate cancer: a meta-analysis of data from 7 phase III studies and 3 phase II studiesAnqiang Zhang0Dali Tong1State Key Laboratory of Trauma, Burns and Combined Injury, Wound Trauma Medical Center, Institute of Surgery Research, Daping Hospital, Army Medical UniversityDepartment of Urology, Daping Hospital, Army Medical UniversityAbstract Background Immunotherapies have emerged as potential treatments for metastatic castration-resistant prostate cancer (mCRPC). However, it is still unclear to identify the efficacy and safety of immunotherapy in large-scale samples. We performed a meta-analysis of 7 phase III randomized trials and 3 phase II trials comparing immunotherapy to placebo in mCRPC. Methods Searching the PubMed, ClinicalTrials and Cochrane Library, completed III/IV phase trials were identified. Data extraction was conducted according to the PRISMA statement. The measured outcomes were OS, PFS, ORR and AE. Based on the results of phase III randomized trials, 3 II phase trials with results were identified. Results A total of 4185 patients were available for evaluation of OS, and 3320 for PFS. Compared to placebo, immunotherapies were not able to improve OS (HR = 0.90; 95%CI 0.79–1.03; p = 0.13). However, immunotherapies, especially ICBs were able to decrease the risk of progression over placebo by 18% (HR = 0.82; 95%CI 0.68–1.00; p = 0.04). Significant ORR improvement was found in patients treated in ICBs (RR = 1.90; 95%CI 1.30–2.78; p < 0.001). Immunotherapies (OR = 1.01, 95% CI = 0.40–2.56; OR = 1.27, 95% CI = 0.72–2.25) were not associated with significant any grade TRAEs and 3–4 grade TRAEs. However, in subgroup analysis, ICBs (OR = 2.85, 95% CI = 2.27–3.57) and vaccines (OR = 0.78, 95% CI = 0.64–0.53) were associated with significant 3–4 grade TRAEs respectively. Moreover, ICBs alone induced positive PSA response [OR = 2.43(1.09–5.43), P = 0.03(I2 = 0%, P = 0.83)] and was effective in advanced PC even without classical therapies based on three phase II clinical trials about ICBs. Conclusions Immunotherapies are not able to improve OS, but significantly improve PFS and ORR especially in ICBs treatment. Immunotherapies were not associated with significant TRAEs. However, in subgroup analysis, ICBs and vaccines were associated with significant 3–4 grade TRAEs.https://doi.org/10.1186/s40164-022-00312-yImmunotherapiesICBsVaccinesmCRPCOSPFS |
spellingShingle | Anqiang Zhang Dali Tong Immunotherapy in patients with metastatic castration-resistant prostate cancer: a meta-analysis of data from 7 phase III studies and 3 phase II studies Experimental Hematology & Oncology Immunotherapies ICBs Vaccines mCRPC OS PFS |
title | Immunotherapy in patients with metastatic castration-resistant prostate cancer: a meta-analysis of data from 7 phase III studies and 3 phase II studies |
title_full | Immunotherapy in patients with metastatic castration-resistant prostate cancer: a meta-analysis of data from 7 phase III studies and 3 phase II studies |
title_fullStr | Immunotherapy in patients with metastatic castration-resistant prostate cancer: a meta-analysis of data from 7 phase III studies and 3 phase II studies |
title_full_unstemmed | Immunotherapy in patients with metastatic castration-resistant prostate cancer: a meta-analysis of data from 7 phase III studies and 3 phase II studies |
title_short | Immunotherapy in patients with metastatic castration-resistant prostate cancer: a meta-analysis of data from 7 phase III studies and 3 phase II studies |
title_sort | immunotherapy in patients with metastatic castration resistant prostate cancer a meta analysis of data from 7 phase iii studies and 3 phase ii studies |
topic | Immunotherapies ICBs Vaccines mCRPC OS PFS |
url | https://doi.org/10.1186/s40164-022-00312-y |
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