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Curated Papers > High-Impact Authoritative Literature on "CAR-T Therapy"

Risks and Benefits of Chimeric Antigen Receptor T-Cell (CAR-T) Therapy in Cancer: A Systematic Review and Meta-Analysis. ​

Literature Information ​

DOI10.1016/j.tmrv.2019.01.005
PMID30948292
JournalTransfusion medicine reviews
Impact Factor2.5
JCR QuartileQ2
Publication Year2019
Times Cited111
KeywordsCAR-T cell therapy, Cancer, Hematologic, Systematic review
Literature TypeJournal Article, Meta-Analysis, Research Support, Non-U.S. Gov't, Systematic Review
ISSN0887-7963
Pages98-110
Issue33(2)
AuthorsEmma J M Grigor, Dean Fergusson, Natasha Kekre, Joshua Montroy, Harold Atkins, Matthew D Seftel, Mads Daugaard, Justin Presseau, Kednapa Thavorn, Brian Hutton, Robert A Holt, Manoj M Lalu

TL;DR ​

This study systematically reviews the efficacy and safety of chimeric antigen receptor (CAR) T-cell therapy in patients with relapsed or refractory hematologic and solid malignancies, finding that 54.4% of patients with CD19+ hematologic cancers achieved a complete response, while only 4.1% of solid tumor patients did. The findings highlight the promise of CAR-T therapy in hematologic malignancies contrasted with its limited efficacy in solid tumors, providing critical insights for patients and healthcare providers regarding the therapeutic potential and associated risks of this treatment.

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CAR-T cell therapy · Cancer · Hematologic · Systematic review

Abstract ​

Promising efficacy results of chimeric antigen receptor (CAR) T-cell therapy have been tempered by safety considerations. Our objective was to comprehensively summarize the efficacy and safety of CAR-T cell therapy in patients with relapsed or refractory hematologic or solid malignancies. MEDLINE, Embase, and the Cochrane Register of Controlled Trials (inception - November 21, 2017). Interventional studies investigating CAR-T cell therapy in patients with malignancies were included. Our primary outcome of interest was complete response (defined as the absence of detectable cancer). Two independent reviewers extracted relevant data, assessed risk of bias, and graded the quality of evidence using established methods. A total of 42 hematological malignancy studies and 18 solid tumor studies met were included (913 participants). Of 486 evaluable hematologic patients, 54.4% [95% CI, 42.5%-65.9%] experienced complete response in 27 CD19 CAR-T cell therapy studies. Of 65 evaluable hematologic patients, 24.4% [95% CI, 9.4%-50.3%] experienced complete response in seven non-CD19 CAR-T cell therapy studies. Cytokine release syndrome was experienced by 55.3% [95% CI, 40.3%-69.4%] of patients and neurotoxicity 37.2% [95% CI, 28.6%-46.8%] of patients with hematologic malignancies. Of 86 evaluable solid tumor patients, 4.1% [95% CI, 1.6%-10.6%] experienced complete response in eight CAR-T cell therapy studies. Limitations include heterogeneity of study populations, as well as high risk of bias of included studies. There was a strong signal for efficacy of CAR-T cell therapy in patients with CD19+ hematologic malignancies and no overall signal in solid tumor trials published to date. These results will help inform patients, physicians, and other stakeholders of the benefits and risks associated with CAR-T cell therapy.

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Primary Questions Addressed ​

  1. What are the specific mechanisms behind the efficacy of CAR-T cell therapy in CD19+ hematologic malignancies compared to solid tumors?
  2. How do the rates of cytokine release syndrome and neurotoxicity in CAR-T therapy differ among various patient demographics or treatment regimens?
  3. What advancements or modifications in CAR-T cell therapy are being explored to improve outcomes in solid tumor patients?
  4. How does the risk of bias in the included studies affect the interpretation of the overall efficacy and safety of CAR-T therapy?
  5. What are the long-term outcomes and potential late-onset side effects associated with CAR-T cell therapy in patients who achieve a complete response?

Key Findings ​

  1. Research Background and Objective:
    Chimeric Antigen Receptor T-cell (CAR-T) therapy has emerged as a groundbreaking treatment for various malignancies, particularly hematologic cancers. While early results have shown promising efficacy, concerns surrounding safety and adverse effects have arisen. The objective of this systematic review and meta-analysis was to provide a comprehensive assessment of the efficacy and safety profile of CAR-T cell therapy in patients with relapsed or refractory hematologic malignancies and solid tumors. By synthesizing data from multiple studies, the authors aimed to clarify the potential benefits and risks associated with this innovative therapy.

  2. Main Methods and Findings:
    The authors conducted a systematic review of interventional studies involving CAR-T cell therapy, searching databases such as MEDLINE, Embase, and the Cochrane Register of Controlled Trials up to November 21, 2017. A total of 60 studies were included, comprising 42 focused on hematologic malignancies and 18 on solid tumors, with a collective participant count of 913. The primary outcome measured was the rate of complete response, defined as the absence of detectable cancer. The findings revealed that 54.4% of evaluable patients with CD19+ hematologic malignancies achieved a complete response, while only 4.1% of evaluable solid tumor patients experienced a complete response. Additionally, safety concerns were highlighted, with 55.3% of hematologic patients experiencing cytokine release syndrome and 37.2% facing neurotoxicity.

  3. Core Conclusions:
    The study concluded that CAR-T cell therapy demonstrates significant efficacy in treating CD19+ hematologic malignancies, with over half of the patients achieving a complete response. However, the response rates for solid tumors were markedly lower, indicating limited effectiveness in this area. Furthermore, the high incidence of adverse effects, particularly cytokine release syndrome and neurotoxicity, underscores the need for careful patient monitoring and management strategies. The findings emphasize the dual nature of CAR-T therapy as a potent but potentially hazardous treatment option.

  4. Research Significance and Impact:
    This systematic review and meta-analysis provide valuable insights into the efficacy and safety of CAR-T cell therapy, guiding healthcare professionals in clinical decision-making. The strong efficacy signal for CD19+ hematologic malignancies supports the continued use and development of CAR-T therapies in these patients. However, the limited effectiveness in solid tumors and the significant safety concerns raise critical questions about the broader application of CAR-T technology. These insights will aid patients, clinicians, and policymakers in understanding the therapeutic landscape of CAR-T therapy, ultimately contributing to improved patient outcomes and informed treatment choices in oncology.

Literatures Citing This Work ​

  1. Integrated cancer tissue engineering models for precision medicine. - Michael E Bregenzer;Eric N Horst;Pooja Mehta;Caymen M Novak;Shreya Raghavan;Catherine S Snyder;Geeta Mehta - PloS one (2019)
  2. Integrative Approaches to Cancer Immunotherapy. - Gregory L Szeto;Stacey D Finley - Trends in cancer (2019)
  3. CAR T-cell product performance in haematological malignancies before and after marketing authorisation. - Magdi Elsallab;Bruce L Levine;Alan S Wayne;Mohamed Abou-El-Enein - The Lancet. Oncology (2020)
  4. Preclinical safety evaluation of chimeric antigen receptor-modified T cells against CD19 in NSG mice. - Hairuo Wen;Zhe Qu;Yujing Yan;Chengfei Pu;Chao Wang;Hua Jiang;Tiantian Hou;Yan Huo - Annals of translational medicine (2019)
  5. Chimeric antigen receptor T-cell therapies: Optimising the dose. - Nathaniel Dasyam;Philip George;Robert Weinkove - British journal of clinical pharmacology (2020)
  6. Biomarkers in individualized management of chimeric antigen receptor T cell therapy. - Mengyi Du;Parameswaran Hari;Yu Hu;Heng Mei - Biomarker research (2020)
  7. The future of cancer immunotherapy: microenvironment-targeting combinations. - Yonina R Murciano-Goroff;Allison Betof Warner;Jedd D Wolchok - Cell research (2020)
  8. Cardiovascular Effects of CAR T Cell Therapy: A Retrospective Study. - Bénédicte Lefebvre;Yu Kang;Amanda M Smith;Noelle V Frey;Joseph R Carver;Marielle Scherrer-Crosbie - JACC. CardioOncology (2020)
  9. CAR T Cell Therapy for Pediatric Brain Tumors. - John D Patterson;Jeffrey C Henson;Rebecca O Breese;Kevin J Bielamowicz;Analiz Rodriguez - Frontiers in oncology (2020)
  10. Partnering with patients to get better outcomes with chimeric antigen receptor T-cell therapy: towards engagement of patients in early phase trials. - Madison Foster;Dean A Fergusson;Terry Hawrysh;Justin Presseau;Natasha Kekre;Stuart Schwartz;Gisell Castillo;Sarah Asad;Grace Fox;Harold Atkins;Kednapa Thavorn;Joshua Montroy;Robert A Holt;Zarah Monfaredi;Manoj M Lalu - Research involvement and engagement (2020)

... (101 more literatures)

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