Teraźniejszość i przyszłość leków biologicznych w terapii nowotworów głowy i szyi

• Authors: Ewa Pawłowska , Rafał Dziadziuszko , Waldemar Narożny

Title variants

EN

Biological agents in head and neck cancer: current and future considerations

• Languages of publication: PL EN

Abstracts

EN

According to European Medicines Agency’s definition, biological agents are pharmaceuticals whose active substance is made by a living organism. Biologics modulate immunological response by mimicking endogenous proteins or interacting with signaling pathways. The vast majority of biologics used in oncology are monoclonal antibodies. Use of four biologics in treatment of head and neck cancers - cetuximab, afatinib, pembrolizumab, nivolumab, is supported by National Comprehensive Cancer Network (NCCN) and National Institute for Health and Care Excellence (NICE) guidelines. In Poland only cetuximab can be applied in everyday practice, with some limitations. Cetuximab should be administered concurrently with radical radiotherapy to patients with contraindications for cisplatin. Due to rapid development of immunotherapy and biologics in the last decades there are currently hundreds of clinical trials conducted, seeking for most optimal regimens of biological drugs in head and neck cancer treatment, both in radical treatment (neoadjuvant and adjuvant therapy or in combination with radiotherapy) and in paliative treatment (in monotherapy, in combination with chemotherapeutic agents or other biological agents).

PL

Zgodnie z definicją Europejskiej Agencji Leków leki biologiczne są farmaceutykami, których substancja aktywna wytwarzana jest przez żyjący organizm. Mechanizm ich działania polega na modulacji reakcji immunologicznych poprzez naśladowanie naturalnie występujących cząsteczek lub interakcji z ich szlakiem molekularnym. Największą grupę leków biologicznych stanowią przeciwciała monoklonalne. Cztery leki biologiczne zostały zaaprobowane przez zagraniczne towarzystwa onkologiczne (amerykańską Narodową Sieć Ośrodków Onkologicznych NCCN oraz Narodowy Instytut Zdrowia i Doskonałości Klinicznej Wielkiej Brytanii NICE) do terapii nowotworów płaskonabłonkowych głowy i szyi – cetuksymab, afatynib, pembrolizumab i niwolumab. W Polsce tylko pierwszy z nich jest dostępny w codziennej praktyce klinicznej, we wskazaniach ograniczonych ministerialnym programem lekowym. Kwalifikują się do niego chorzy poddawani radykalnej radioterapii, z przeciwwskazaniami do cisplatyny. Gwałtowny rozwój immunoterapii i leczenia celowanego w ostatnich dekadach sprawił, że obecnie toczą się setki badań klinicznych oceniających skuteczność leków biologicznych w terapii nowotworów rejonu głowy i szyi zarówno w leczeniu radykalnym (neoadjuwantowo, adjuwantowo lub w skojarzeniu z radioterapią) jak i paliatywnym (w monoterapii, skojarzeniu z chemioterapeutykami lub innymi lekami biologicznymi).

Keywords

EN

inhibitory kinaz; leki biologiczne; nowotwory głowy i szyi; przeciwciała monoklonalne

Discipline

• MEDICINE: MEDICINE

• Journal: Otorynolaryngologia - przegląd kliniczny
• Year: 2018
• Volume: 17
• Issue: 1
• Pages: 1-14

Contributors

author

Ewa Pawłowska

author

Rafał Dziadziuszko

author

Waldemar Narożny

References

• 1. Decker WK, da Silva RF, Sanabria MH, et al. Cancer immunotherapy: historical perspective of a clinical revolution and emerging preclinical animal models. Front Immunol 2017; 8: 829.
• 2. DeVita Vincent T Jr. Cancer: Principles and Practice of Oncology, 10th ed. Wolters Kluwer Health / Lippincott Williams & Wilkins, Philadelphia 2015.
• 3. Kim ES, Khuri FR, Herbst RS. Epidermal growth factor receptor biology (IMC-C225). Curr Opin Oncol 2001; 13: 506-13.
• 4. Perrotte P, Matsumoto T, Inoue K, et al. Anti-epidermal growth factor receptor antibody C225 inhibits angiogenesis in human transitional cell carcinoma growing orthotopically in nude mice. Clin Cancer Res 1999; 5: 257-65.
• 5. Cortes-Reynosa P. Epidermal growth factor promotes epidermal growth factor receptor nuclear accumulation by a pathway dependent on cytoskeleton integrity in human breast cancer cells. Arch Med Res 2009; 40(5): 331-8. Roskoski R Jr. The ErbB/HER family of protein-tyrosine kinases and cancer. Pharmacol Res 2014; 79: 34-74.
• 6. Lin SY. Nucelar localization of EGF receptor and its potential new role as transcription factor. Nat Cell Biol 2001; 3(9): 802-8.
• 7. Hadari YR, Doody JF, Wang Y, et al. The IgG1 monoclonal antibody cetuximab induces degradation of the epidermal growth factor receptor. J Clin Oncol 2004; 22 (abstract 234).
• 8. http://www.mz.gov.pl/leki/refundacja/programy-lekowe/
• 9. https://www.nccn.org/professionals/physician_gls/pdf/ head-and-neck.pdf.
• 10. https://www.nice.org.uk/guidance/ta473/chapter/1- Recommendations.
• 11. https://www.nice.org.uk/guidance/ta145.
• 12. Burtness B, Goldwasser MA, Flood W, et al. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol 2005; 23: 8646-54.Yarden Y, Sliwkowski MX. Untangling the ErbB signaling network. Nat Rev Mol Cell Biol 2001; 2: 127-37.
• 13. Bonner JA, Harari PM, Giralt J, et al. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomized trial, and relation between cetuximab-induced rash and survival; Lancet Oncol 2010; 11: 21-8.
• 14. Bonner JA, Harari PM, Giralt J, et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med 2006; 354: 567-78.
• 15. Ang KK, Zhang Q, Rosenthal DI, et al. Randomized phase III trial of concurrent celebrated radiation plus cisplatin with or without cetuximab for stage III and IV head and neck carcinoma: RTOG 0522; J Clin Oncol 2014; 27: 2940-50.
• 16. Awan MJ, Nedzi L, Wang D, et al. Final results of a multiinstitutional phase II trial of reirradiation with weekly cisplatin and cetuximab for recurrent or second primary squamous cell carcinoma of the head and neck. Ann Oncol 2018; 29(4): 998-1003.
• 17. Peyrade F, Righini Ch, Gal J, et al. Adjuvant radiotherapy (RDT) plus cisplatinum (Cis) and cetuximab (Cet) in resected head and neck squamous cell carcinoma. J Clin Oncol 2014; 15 (suppl): 6042.
• 18. Vermorken JB, Mesia R, Rivera F, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med 2008; 359: 1116-27.
• 19. Adkins D, Ley J, Atiq O, et al. Multicenter phase 2 trial of cis/carboplatin, nAb-paclitaxel, and CeTUXimab (CACTUX) as first-line therapy for recurrent/metastatic head and neck squamous cell carcinoma. 2018 Multidisciplinary Head and Neck Cancers Symposium. http://headandnecksymposium.org/uploadedFiles/ Head_and_Neck_Symposium/2018_Head_and_Neck_ Symposium/Abstracts/CompleteHeadNeckPapers.pdf.
• 20. Guigay J, Fayette J, Dillies A-F, et al. Cetuximab, docetaxel, and cisplatin as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, phase II GORTEC study. Ann Oncol 2015; 26: 1941-7.
• 21. Hitt R. Phase II study of the combination of cetuximabmab and weekly paclitaxel in the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of head and neck. Ann Oncol 2012; 23: 1016-22.
• 22. Chan AT, Hsu MM, Goh BC, et al. Multicenter, phase II study of cetuximab in combination with carboplatin in patients with recurrent or metastatic nasopharyngeal carcinoma. J Clin Oncol 2005; 23: 3568-76.
• 23. Vermorken JB, Trigo J, Hitt R, et al. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol 2007; 25: 2171-7.
• 24. Fürstenberger G, Senn HJ. Insuline-like growth factors and cancer. Lancet Oncol 2002; 3(5): 298-302.
• 25. Chow LQM, Morishima C, Eaton KD, et al. Phase 1b trial of the Toll-like receptor 8 agonist, motolimod (VTX-2337), combined with cetuximab in patients with recurrent or metastatic SCCHN. Clin Cancer Res 2017; 23(10): 2442-50.
• 26. Kotla V, Goel S, Nischal S, et al. Mechanism of action of lenalidomide in hematological malignancies. J Hematol Oncol 2009; 2: 36.
• 27. Tham T, White TG, Chakraborty S i wsp. Intra-arterial cetuximab for the treatment of recurrent unresectable head and neck squamous cell carcinoma. J Exp There Oncol 2016; 11(4): 293-301.
• 28. Machiels JP, Haddad RI, Fayette J, et al. Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial. Lancet Oncol 2015; 16: 583-94.
• 29. Seiwert TY, Fayette J, Cupissol D, et al. A randomized, phase II study of afatinib versus cetuximab in metastatic or recurrent squamous cell carcinoma of the head and neck. Ann Oncol 2014; 25: 1813-20.
• 30. Machiels JP, Bossi P, Menis J, et al. Activity and safety of afatinib in a window pre-operative EORTC study in patients with squamous cell carcinoma of the head and neck (SCCHN). Ann Oncol 2018; 29(4): 985-91.
• 31. Borden KLB, Culijkovic-Kraljacic B. Ribavirin as an anticancer therapy: Acute Myeloid Leukomie and beyond? Leuk Lymphoma 2010; 51(10): 1805-15.
• 32. Seiwert TY, Burtness B, Mehra R, et al. Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial. Lancet Oncol 2016; 17: 956-65.
• 33. Chow LQ, Haddad R, Gupta S, et al. Antitumor activity of pembrolizumab in biomarker-unselected patients with recurrent and/or metastatic head and neck squamous cell carcinoma: results from the phase Ib KEYNOTE-012 expansion cohort. J Clin Oncol 2016; 34: 3838-45.
• 34. Haddad R, Seiwert Y, Pfister DG, et al. Pembrolizumab after progres- sion on platinum and cetuximab in head and neck squamous cell carcinoma (HNSCC): results from KEYNOTE-055. Ann Oncol 2016; 27: 328-35.
• 35. Hsu C, Lee SH, Ejadi S, et al. Safety and antitumor activity of pembrolizumab in patients with programmed deathligand 1-positive nasopharyngeal carcinoma: results of the KEYNOTE-028 study. J Clin Oncol 2017; 35: 4050-6.
• 36. Moon YW, Hajjar J, Hwu P, et al. Targeting the indoleamine 2,3-dioxygenase pathway in cancer. J Immunother Cancer 2015; 3: 51.
• 37. Palackdharry S, Gillison M, Worden F, et al. Neoadjuvant pembrolizumab is active in surgically resected head and neck cancer. 2018 Multidisciplimnary Head and Neck Cancers Symposium. http://headandnecksymposium. org/uploadedFiles/Head_and_Neck_Symposium/2018_ Head_and_Neck_Symposium/Abstracts/ CompleteHeadNeckPapers.pdf.
• 38. Ahmed H, AlSadek DMM. Galectin-3 as a potential target to prevent cancer metastasis. Clin Med Insights Oncol 2015; 9: 113-21.
• 39. Richon VM. Cancer biology: mechanism of antitumour action of vorinostat (suberoylanilide hydroxamic acid), a novel histone deacetylase inhibitor. Br J Cancer 2006; 95(Suppl 1): S2-S6.
• 40. Thomsen LL, Miles DW, Happerfield L, et al. Nitric oxide synthase activity in human breast cancer. Br J Cancer 1995; 72: 41-4.
• 41. Bronte V, Kasic T, Gri G i wsp. Boosting antitumor responses of T lymphocytes infiltrating human prostate cancers. J Exp Med 2005; 201(8): 1257-68.
• 42. Hatcher JM, Weisberg E, Sim T, et al. Discovery of a highly potent and selective indenoindolone type 1 pan-flt3 inhibitor. ACS Med Chem Lett 2016; 7(5): 476-81.
• 43. Mok S, Koya RC, Tsui C, et al. Inhibition of CSF1 receptor improves the anti-tumor efficacy of adoptive cell transfer immunetherapy. Cancer Res 2014; 74(1): 153-61.
• 44. Chen Y, Zhang H, Zhang Y. Targeting receptor tyrosine kinase EphB4 in cancer therapy. Semin Cancer Biol 2017; S1044-579X(17)30162-1.
• 45. Rehman H, Silk AW, Kane MP, et al. Into the clinic: Talimogene laherparepvec (T-VEC), a first-in-class intratumoral oncolytic viral therapy. J Immunother Cancer 2016; 4: 53.
• 46. Ferris R, Blumenschein G, Fayette J, et al. Nivolumab for recurrent squamous cell carcinoma of the head and neck. N Engl J Med 2016; 375: 1856-67.
• 47. Ferris RL, Blumenschein GR, Fayette J, et al. Two-year update from CheckMate 141: outcomes with nivolumab (nivo) vs. investigator’s choice (IC) in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) in the overall population and PD-L1 subgroups. 2018 Multidisciplinary Head and Neck Cancers Symposium. http://headandnecksymposium.org/uploadedFiles/ Head_and_Neck_Symposium/2018_Head_and_Neck_ Symposium/Abstracts/CompleteHeadNeckPapers.pdf.
• 48. https://www.nice.org.uk/guidance/ta490.
• 49. Gillison M. Safety evaluation of Nivolumab concomitant with platinum-based chemoradiation therapy for intermediate and high-risk local-regionally advanced head and neck squamous cell carcinoma: RTOG Foundation 3504; 2018 Multidisciplinary Head and Neck Cancers Symposium, http://headandnecksymposium.org/uploadedFiles/ Head_and_Neck_Symposium/2018_Head_and_Neck_ Symposium/Abstracts/CompleteHeadNeckPapers.pdf.
• 50. Kaczmar J, Kompelli A, Graboyes E, et al. Phase 2 trial of nivolumab, an anti-PD-1 monoclonal antibody, as a novel neoadjuvant pre-surgical therapy for locally advanced oral cavity cancer. 2018 Multidisciplinary Head and Neck Cancers Symposium. http:// headandnecksymposium.org/uploadedFiles/Head_and_ Neck_Symposium/2018_Head_and_Neck_Symposium/ Abstracts/CompleteHeadNeckPapers.pdf.
• 51. Weed DT, Vella JL, Reis IM, et al. Tadalafil reduces myeloid-derived suppressor cells and regulatory T cells and promotes tumor immunity in patients with head and neck squamous cell carcinoma. Clin Cancer Res 2015; 12(1): 39-48.
• 52. Holbrook EK, Thielens A, Marabelle A, et al. Anti-KIR antibody enhancement of anti-lymphoma activity of natural killer cells as monotherapy and in combination with anti-CD20 antibody. Blood 2014; 123(5): 678-86.
• 53. Illingworth S, Di Y, Bauzon M, et al. Preclinical safety studies of enadenotucirev, a chimeric group B humanspecific oncolytic adenovirus. Mol Ther Oncolytics 2017; 5: 62-74.
• 54. Lam B, Arikawa Y, Cramlett J i wsp. Discovery of TAK- 659 an orally available investigational inhibitor of Spleen tyrosine kinase (SYK). Bioorg Med Chem Lett 2016; 26(24): 5947-50.
• 55. Brahmer J, Rasco D, Chen M, et al. A phase 1a/1b study of FPA008 in combination with nivolumab in patients with selected advanced cancers. Cancer Immun Res 2016; 4(1): B143.
• 56. Van de Ven K, Borst J. Targeting the T-cell co-stimulatory CD27/CD70 pathway in cancer immunotherapy: rationale and potential. Immunotherapy 2015; 7(6): 655-67.
• 57. Ebbers HC, Chamberlain P. Controversies in establishing biosimilarity: extrapolation of indications and global labeling practices. BioDrugs 2016; 30: 1-8.

• Document Type: article