PMID- 31912796 OWN - NLM STAT- MEDLINE DCOM- 20210106 LR - 20220531 IS - 1569-8041 (Electronic) IS - 0923-7534 (Linking) VI - 31 IP - 1 DP - 2020 Jan TI - Adverse event profile for immunotherapy agents compared with chemotherapy in solid organ tumors: a systematic review and meta-analysis of randomized clinical trials. PG - 50-60 LID - S0923-7534(19)35463-8 [pii] LID - 10.1016/j.annonc.2019.10.008 [doi] AB - BACKGROUND: Immunotherapy agents are an innovative oncological treatment modality and as a result their use has expanded widely. Understanding the treatment-related adverse events (AEs) of these drugs compared with traditional chemotherapy is crucial for clinical practice. DESIGN: A systematic review of studies indexed in Medline (PubMed), Embase, Web of Science, and the Cochrane Databases from January 2000 to 14 February 2019 was conducted. Randomized clinical trials comparing immunotherapy [cytotoxic T-lymphocyte protein-4 (CTLA-4), programmed cell death protein 1 (PD-1), or programmed death-ligand 1 (PD-L1)] with standard-of-care chemotherapy in the treatment of advanced solid-organ neoplasms were included if AEs were reported as an outcome. Primary outcome was AEs >/= grade 3 in severity. Secondary outcomes were proportion of overall AEs, treatment discontinuation due to AEs, deaths due to AEs, and specific AEs [fatigue, diarrhea, acute kidney injury (AKI), colitis, pneumonitis, and hypothyroidism]. Paule-Mandel pooling and a random effects model were used to produce odds ratios (ORs) for measures of effects. RESULTS: Among 10 598 abstracts screened, we included 22 studies involving 12 727 patients. In the immunotherapy group, 16.5% of patients developed an AE >/= grade 3 in severity, compared with 41.09% in the chemotherapy arm [OR = 0.26, 95% confidence interval (CI) 0.19-0.35, I(2) = 92%]. Patients receiving immunotherapy also had lower odds of developing an AE overall (OR = 0.35, 95% CI 0.28-0.44; I(2) = 77%), terminating therapy due to an AE (OR = 0.55, 95% CI 0.39-0.78, I(2) = 80%), or dying from a treatment-related AE (OR = 0.67, 95% CI 0.46-0.98, I(2) = 0%). When treated with chemotherapy versus immunotherapy, patients more frequently experienced fatigue (25.10% versus 15.83%), diarrhea (14.97% versus 11.13%), and AKI (1.79% versus 1.31%). However, colitis (1.02% versus 0.26%), pneumonitis (3.36% versus 0.36%), and hypothyroidism (6.82% versus 0.37%) were more common in those treated with immunotherapy. CONCLUSIONS: Treatment of advanced solid-organ malignancies with immunotherapy compared with traditional chemotherapy is associated with a lower risk of AEs. CI - Copyright (c) 2019 European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved. FAU - Magee, D E AU - Magee DE AD - Division of Urology, Department of Surgery, University of Toronto, Toronto, Canada. FAU - Hird, A E AU - Hird AE AD - Division of Urology, Department of Surgery, University of Toronto, Toronto, Canada. FAU - Klaassen, Z AU - Klaassen Z AD - Division of Urology, Department of Surgery, Medical College of Georgia-Augusta University, Augusta, USA. FAU - Sridhar, S S AU - Sridhar SS AD - Division of Medical Oncology, Department of Internal Medicine, University Health Network, University of Toronto, Toronto, Canada. FAU - Nam, R K AU - Nam RK AD - Division of Urology, Department of Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada. FAU - Wallis, C J D AU - Wallis CJD AD - Division of Urology, Department of Surgery, University of Toronto, Toronto, Canada; Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, USA. FAU - Kulkarni, G S AU - Kulkarni GS AD - Division of Urology, Department of Surgery, University Health Network, University of Toronto, Toronto, Canada. Electronic address: Girish.Kulkarni@uhn.ca. LA - eng PT - Journal Article PT - Meta-Analysis PT - Systematic Review PL - England TA - Ann Oncol JT - Annals of oncology : official journal of the European Society for Medical Oncology JID - 9007735 RN - 0 (Antineoplastic Agents) RN - 0 (Immunologic Factors) SB - IM MH - *Antineoplastic Agents/therapeutic use MH - Humans MH - Immunologic Factors/therapeutic use MH - Immunotherapy/adverse effects MH - *Neoplasms/drug therapy MH - Randomized Controlled Trials as Topic OTO - NOTNLM OT - adverse events OT - chemotherapy OT - immunotherapy OT - meta-analysis OT - neoplasm EDAT- 2020/01/09 06:00 MHDA- 2021/01/07 06:00 CRDT- 2020/01/09 06:00 PHST- 2019/07/18 00:00 [received] PHST- 2019/10/15 00:00 [revised] PHST- 2019/10/17 00:00 [accepted] PHST- 2020/01/09 06:00 [entrez] PHST- 2020/01/09 06:00 [pubmed] PHST- 2021/01/07 06:00 [medline] AID - S0923-7534(19)35463-8 [pii] AID - 10.1016/j.annonc.2019.10.008 [doi] PST - ppublish SO - Ann Oncol. 2020 Jan;31(1):50-60. doi: 10.1016/j.annonc.2019.10.008.