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Erschienen in: Drug Safety 2/2019

01.02.2019 | Review Article

Safety and Tolerability of Adoptive Cell Therapy in Cancer

verfasst von: Benita Wolf, Stefan Zimmermann, Caroline Arber, Melita Irving, Lionel Trueb, George Coukos

Erschienen in: Drug Safety | Ausgabe 2/2019

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Abstract

Adoptive T cell therapy (ACT) is a safe and effective personalized cancer immunotherapy that can comprise naturally occurring ex vivo expanded cells (e.g., tumor-infiltrating lymphocytes [TIL]) or T cells genetically engineered to confer antigen specificity (T-cell receptor [TCR] or chimeric antigen receptor [CAR] engineered T cells) to mediate cancer rejection. In recent years, some ACTs have produced unprecedented breakthrough responses: TIL therapy has moved from melanoma to solid tumor applications, TCR-engineered cells are developed for hematologic and solid tumors, and CAR-engineered T cells have received Food and Drug Administration (FDA) approval for the treatment of patients with certain B-cell malignancies. Although results are encouraging, to date, only a small percentage of patients with advanced malignancies can benefit from ACT. Besides ACT availability and accessibility, treatment-related toxicities represent a major hurdle in the widespread implementation of this therapeutic modality. The large variety of observed toxicities is caused by the infused cell product or as side effects of accompanying medication and chemotherapy. Toxicities can occur immediately or can be delayed. In order to render those highly promising therapeutic approaches safe enough for a wider pool of patients outside of clinical trials, an international consensus for toxicity management needs to be established.
Literatur
5.
Zurück zum Zitat Aoki Y, Takakuwa K, Kodama S, Tanaka K, Takahashi M, Tokunaga A, et al. Use of adoptive transfer of tumor-infiltrating lymphocytes alone or in combination with cisplatin-containing chemotherapy in patients with epithelial ovarian cancer. Cancer Res. 1991;51(7):1934–9.PubMed Aoki Y, Takakuwa K, Kodama S, Tanaka K, Takahashi M, Tokunaga A, et al. Use of adoptive transfer of tumor-infiltrating lymphocytes alone or in combination with cisplatin-containing chemotherapy in patients with epithelial ovarian cancer. Cancer Res. 1991;51(7):1934–9.PubMed
6.
Zurück zum Zitat Freedman RS, Edwards CL, Kavanagh JJ, Kudelka AP, Katz RL, Carrasco CH, et al. Intraperitoneal adoptive immunotherapy of ovarian carcinoma with tumor-infiltrating lymphocytes and low-dose recombinant interleukin-2: a pilot trial. J Immunother Emphas Tumor Immunol. 1994;16(3):198–210.CrossRef Freedman RS, Edwards CL, Kavanagh JJ, Kudelka AP, Katz RL, Carrasco CH, et al. Intraperitoneal adoptive immunotherapy of ovarian carcinoma with tumor-infiltrating lymphocytes and low-dose recombinant interleukin-2: a pilot trial. J Immunother Emphas Tumor Immunol. 1994;16(3):198–210.CrossRef
7.
Zurück zum Zitat Fujita K, Ikarashi H, Takakuwa K, Kodama S, Tokunaga A, Takahashi T, et al. Prolonged disease-free period in patients with advanced epithelial ovarian cancer after adoptive transfer of tumor-infiltrating lymphocytes. Clin Cancer Res. 1995;1(5):501–7.PubMed Fujita K, Ikarashi H, Takakuwa K, Kodama S, Tokunaga A, Takahashi T, et al. Prolonged disease-free period in patients with advanced epithelial ovarian cancer after adoptive transfer of tumor-infiltrating lymphocytes. Clin Cancer Res. 1995;1(5):501–7.PubMed
8.
Zurück zum Zitat Fabbri M, Ridolfi R, Maltoni R, Ridolfi L, Riccobon A, Flamini E, et al. Tumor infiltrating lymphocytes and continuous infusion interleukin-2 after metastasectomy in 61 patients with melanoma, colorectal and renal carcinoma. Tumori. 2000;86(1):46–52.CrossRef Fabbri M, Ridolfi R, Maltoni R, Ridolfi L, Riccobon A, Flamini E, et al. Tumor infiltrating lymphocytes and continuous infusion interleukin-2 after metastasectomy in 61 patients with melanoma, colorectal and renal carcinoma. Tumori. 2000;86(1):46–52.CrossRef
12.
Zurück zum Zitat Eshhar Z, Waks T, Gross G, Schindler DG. Specific activation and targeting of cytotoxic lymphocytes through chimeric single chains consisting of antibody-binding domains and the gamma or zeta subunits of the immunoglobulin and T-cell receptors. Proc Natl Acad Sci USA. 1993;90(2):720–4.CrossRef Eshhar Z, Waks T, Gross G, Schindler DG. Specific activation and targeting of cytotoxic lymphocytes through chimeric single chains consisting of antibody-binding domains and the gamma or zeta subunits of the immunoglobulin and T-cell receptors. Proc Natl Acad Sci USA. 1993;90(2):720–4.CrossRef
14.
Zurück zum Zitat Pinthus JH, Waks T, Kaufman-Francis K, Schindler DG, Harmelin A, Kanety H, et al. Immuno-gene therapy of established prostate tumors using chimeric receptor-redirected human lymphocytes. Cancer Res. 2003;63(10):2470–6.PubMed Pinthus JH, Waks T, Kaufman-Francis K, Schindler DG, Harmelin A, Kanety H, et al. Immuno-gene therapy of established prostate tumors using chimeric receptor-redirected human lymphocytes. Cancer Res. 2003;63(10):2470–6.PubMed
17.
Zurück zum Zitat Antony PA, Piccirillo CA, Akpinarli A, Finkelstein SE, Speiss PJ, Surman DR, et al. CD8 + T cell immunity against a tumor/self-antigen is augmented by CD4 + T helper cells and hindered by naturally occurring T regulatory cells. J Immunol. 2005;174(5):2591–601.CrossRef Antony PA, Piccirillo CA, Akpinarli A, Finkelstein SE, Speiss PJ, Surman DR, et al. CD8 + T cell immunity against a tumor/self-antigen is augmented by CD4 + T helper cells and hindered by naturally occurring T regulatory cells. J Immunol. 2005;174(5):2591–601.CrossRef
19.
Zurück zum Zitat Dudley ME, Wunderlich JR, Yang JC, Hwu P, Schwartzentruber DJ, Topalian SL, et al. A phase I study of nonmyeloablative chemotherapy and adoptive transfer of autologous tumor antigen-specific T lymphocytes in patients with metastatic melanoma. J Immunother. 2002;25(3):243–51.CrossRef Dudley ME, Wunderlich JR, Yang JC, Hwu P, Schwartzentruber DJ, Topalian SL, et al. A phase I study of nonmyeloablative chemotherapy and adoptive transfer of autologous tumor antigen-specific T lymphocytes in patients with metastatic melanoma. J Immunother. 2002;25(3):243–51.CrossRef
22.
Zurück zum Zitat Dudley ME, Wunderlich JR, Shelton TE, Even J, Rosenberg SA. Generation of tumor-infiltrating lymphocyte cultures for use in adoptive transfer therapy for melanoma patients. J Immunother. 2003;26(4):332–42.CrossRef Dudley ME, Wunderlich JR, Shelton TE, Even J, Rosenberg SA. Generation of tumor-infiltrating lymphocyte cultures for use in adoptive transfer therapy for melanoma patients. J Immunother. 2003;26(4):332–42.CrossRef
23.
Zurück zum Zitat Rosenberg SA, Yannelli JR, Yang JC, Topalian SL, Schwartzentruber DJ, Weber JS, et al. Treatment of patients with metastatic melanoma with autologous tumor-infiltrating lymphocytes and interleukin 2. J Natl Cancer Inst. 1994;86(15):1159–66.CrossRef Rosenberg SA, Yannelli JR, Yang JC, Topalian SL, Schwartzentruber DJ, Weber JS, et al. Treatment of patients with metastatic melanoma with autologous tumor-infiltrating lymphocytes and interleukin 2. J Natl Cancer Inst. 1994;86(15):1159–66.CrossRef
32.
Zurück zum Zitat Rosenberg SA, Packard BS, Aebersold PM, Solomon D, Topalian SL, Toy ST et al. Use of tumor-infiltrating lymphocytes and interleukin-2 in the immunotherapy of patients with metastatic melanoma. A preliminary report. N Engl J Med. 1988;319(25):1676–80. https://doi.org/10.1056/nejm198812223192527. Rosenberg SA, Packard BS, Aebersold PM, Solomon D, Topalian SL, Toy ST et al. Use of tumor-infiltrating lymphocytes and interleukin-2 in the immunotherapy of patients with metastatic melanoma. A preliminary report. N Engl J Med. 1988;319(25):1676–80. https://​doi.​org/​10.​1056/​nejm198812223192​527.
33.
Zurück zum Zitat Haanen J, Carbonnel F, Robert C, Kerr KM, Peters S, Larkin J et al. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(suppl_4):iv119–iv42. https://doi.org/10.1093/annonc/mdx225. Haanen J, Carbonnel F, Robert C, Kerr KM, Peters S, Larkin J et al. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(suppl_4):iv119–iv42. https://​doi.​org/​10.​1093/​annonc/​mdx225.
37.
Zurück zum Zitat Rosenberg SA, Lotze MT, Yang JC, Aebersold PM, Linehan WM, Seipp CA, et al. Experience with the use of high-dose interleukin-2 in the treatment of 652 cancer patients. Ann Surg. 1989;210(4):474–84 (discussion 84–5).CrossRef Rosenberg SA, Lotze MT, Yang JC, Aebersold PM, Linehan WM, Seipp CA, et al. Experience with the use of high-dose interleukin-2 in the treatment of 652 cancer patients. Ann Surg. 1989;210(4):474–84 (discussion 84–5).CrossRef
42.
Zurück zum Zitat Schwartzentruber DJ. Interleukin-2: Clinical applications—principles of administration and management of side effects. In: Rosenberg AZ, editor. Principles and Practice of the Biologic Therapy of Cancer. Philadelphia: Lippincott, Williams & Wilkins; 2000. p. 32–50. Schwartzentruber DJ. Interleukin-2: Clinical applications—principles of administration and management of side effects. In: Rosenberg AZ, editor. Principles and Practice of the Biologic Therapy of Cancer. Philadelphia: Lippincott, Williams & Wilkins; 2000. p. 32–50.
43.
Zurück zum Zitat Dutcher JP, Schwartzentruber DJ, Kaufman HL, Agarwala SS, Tarhini AA, Lowder JN, et al. High dose interleukin-2 (Aldesleukin)—expert consensus on best management practices-2014. J ImmunoTher Cancer. 2014;2:26.CrossRef Dutcher JP, Schwartzentruber DJ, Kaufman HL, Agarwala SS, Tarhini AA, Lowder JN, et al. High dose interleukin-2 (Aldesleukin)—expert consensus on best management practices-2014. J ImmunoTher Cancer. 2014;2:26.CrossRef
45.
Zurück zum Zitat Schwartz RN, Stover L, Dutcher JP. Managing toxicities of high-dose interleukin-2. Oncology (Williston Park). 2002;16(11 Suppl 13):11–20.PubMed Schwartz RN, Stover L, Dutcher JP. Managing toxicities of high-dose interleukin-2. Oncology (Williston Park). 2002;16(11 Suppl 13):11–20.PubMed
46.
Zurück zum Zitat Schwartzentruber DJ. Guidelines for the safe administration of high-dose interleukin-2. J Immunother. 2001;24(4):287–93.CrossRef Schwartzentruber DJ. Guidelines for the safe administration of high-dose interleukin-2. J Immunother. 2001;24(4):287–93.CrossRef
47.
Zurück zum Zitat Krouse RS, Royal RE, Heywood G, Weintraub BD, White DE, Steinberg SM, et al. Thyroid dysfunction in 281 patients with metastatic melanoma or renal carcinoma treated with interleukin-2 alone. J Immunother Emphas Tumor Immunol. 1995;18(4):272–8.CrossRef Krouse RS, Royal RE, Heywood G, Weintraub BD, White DE, Steinberg SM, et al. Thyroid dysfunction in 281 patients with metastatic melanoma or renal carcinoma treated with interleukin-2 alone. J Immunother Emphas Tumor Immunol. 1995;18(4):272–8.CrossRef
54.
Zurück zum Zitat Bendle GM, Linnemann C, Hooijkaas AI, Bies L, de Witte MA, Jorritsma A et al. Lethal graft-versus-host disease in mouse models of T cell receptor gene therapy. Nat Med. 2010;16(5):565–70, 1p following 70. https://doi.org/10.1038/nm.2128. Bendle GM, Linnemann C, Hooijkaas AI, Bies L, de Witte MA, Jorritsma A et al. Lethal graft-versus-host disease in mouse models of T cell receptor gene therapy. Nat Med. 2010;16(5):565–70, 1p following 70. https://​doi.​org/​10.​1038/​nm.​2128.
67.
Zurück zum Zitat Janeway CATP, Walport M, Shlomchik MJ. Immunobiology: the immune system in health and disease. Immunobiology, 5th edition. New York: Garland Science; 2001. Janeway CATP, Walport M, Shlomchik MJ. Immunobiology: the immune system in health and disease. Immunobiology, 5th edition. New York: Garland Science; 2001.
95.
Zurück zum Zitat Kochenderfer JN, Dudley ME, Kassim SH, Somerville RP, Carpenter RO, Stetler-Stevenson M, et al. Chemotherapy-refractory diffuse large B-cell lymphoma and indolent B-cell malignancies can be effectively treated with autologous T cells expressing an anti-CD19 chimeric antigen receptor. J Clin Oncol. 2015;33(6):540–9. https://doi.org/10.1200/JCO.2014.56.2025.CrossRefPubMed Kochenderfer JN, Dudley ME, Kassim SH, Somerville RP, Carpenter RO, Stetler-Stevenson M, et al. Chemotherapy-refractory diffuse large B-cell lymphoma and indolent B-cell malignancies can be effectively treated with autologous T cells expressing an anti-CD19 chimeric antigen receptor. J Clin Oncol. 2015;33(6):540–9. https://​doi.​org/​10.​1200/​JCO.​2014.​56.​2025.CrossRefPubMed
104.
Zurück zum Zitat Schuster SJ, Bishop MR, Tam C, Waller EK, Borchmann P, Mcguirk J et al. Global pivotal phase 2 trial of the CD19-targeted therapy CTL019 in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL)—an interim analysis. In: Oncology H, editor. 14th International conference on malignant lymphoma; 07.06.2017; Lugano (Switzerland): Hematological Oncology; 2017. Schuster SJ, Bishop MR, Tam C, Waller EK, Borchmann P, Mcguirk J et al. Global pivotal phase 2 trial of the CD19-targeted therapy CTL019 in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL)—an interim analysis. In: Oncology H, editor. 14th International conference on malignant lymphoma; 07.06.2017; Lugano (Switzerland): Hematological Oncology; 2017.
117.
Zurück zum Zitat Bonini C, Ferrari G, Verzeletti S, Servida P, Zappone E, Ruggieri L, et al. HSV-TK gene transfer into donor lymphocytes for control of allogeneic graft-versus-leukemia. Science. 1997;276(5319):1719–24.CrossRef Bonini C, Ferrari G, Verzeletti S, Servida P, Zappone E, Ruggieri L, et al. HSV-TK gene transfer into donor lymphocytes for control of allogeneic graft-versus-leukemia. Science. 1997;276(5319):1719–24.CrossRef
118.
Zurück zum Zitat Ciceri F, Bonini C, Stanghellini MT, Bondanza A, Traversari C, Salomoni M, et al. Infusion of suicide-gene-engineered donor lymphocytes after family haploidentical haemopoietic stem-cell transplantation for leukaemia (the TK007 trial): a non-randomised phase I-II study. Lancet Oncol. 2009;10(5):489–500. https://doi.org/10.1016/S1470-2045(09)70074-9.CrossRefPubMed Ciceri F, Bonini C, Stanghellini MT, Bondanza A, Traversari C, Salomoni M, et al. Infusion of suicide-gene-engineered donor lymphocytes after family haploidentical haemopoietic stem-cell transplantation for leukaemia (the TK007 trial): a non-randomised phase I-II study. Lancet Oncol. 2009;10(5):489–500. https://​doi.​org/​10.​1016/​S1470-2045(09)70074-9.CrossRefPubMed
Metadaten
Titel
Safety and Tolerability of Adoptive Cell Therapy in Cancer
verfasst von
Benita Wolf
Stefan Zimmermann
Caroline Arber
Melita Irving
Lionel Trueb
George Coukos
Publikationsdatum
01.02.2019
Verlag
Springer International Publishing
Erschienen in
Drug Safety / Ausgabe 2/2019
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI
https://doi.org/10.1007/s40264-018-0779-3

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