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Perspective

Position paper: new insights into the immunobiology and dynamics of tumor–host interactions require adaptations of clinical studies

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Pages 639-646 | Received 04 May 2020, Accepted 18 Jun 2020, Published online: 30 Jun 2020

References

  • Sackett DL, Rosenberg WM, Gray JA, et al. Evidence based medicine: what it is and what it isn’t. BMJ. 1996;312(7023):71–72..
  • Deaton A, Cartwright N. Understanding and misunderstanding randomized controlled trials. Soc Sci Med. 2018;210:2–21..
  • Johnson N, Bryant A, Miles T, et al. Adjuvant chemotherapy for endometrial cancer after hysterectomy. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD003175.
  • Ioannidis JPA, Stuart ME, Brownlee S, et al. How to survive the medical misinformation mess. Eur J Clin Invest. 2017;47:795–802.
  • Chakraborty S, Hosen MI, Ahmed M, et al. Onco-multi-OMICS approach: a new frontier in cancer research. Biomed Res Int. 2018;2018:9836256..
  • Krzyszczyk P, Acevedo A, Davidoff EJ, et al. The growing role of precision and personalized medicine for cancer treatment. Technology (Singap World Sci). 2018;6:79–100.
  • Harvey Turner J. An introduction to the clinical practice of theranostics in oncology. Br J Radiol. 2018 Nov;91(1091):20180440.
  • Janku F. Tumour heterogeneity in the clinic: is it a real problem? Ther Adv Med Oncol. 2014;6:43–51.
  • Schirrmacher V, Lorenzen D, Van Gool SW, et al. A new strategy of cancer immunotherapy combining hyperthermia/oncolytic virus pretreatment with specific autologous anti-tumour vaccination - a Review. Austin Oncol Case Rep. 2017;2(1):1006.
  • Van Gool SW, Makalowski J, Feyen O, et al. The induction of immunogenic cell death (ICD) during maintenance chemotherapy and subsequent multimodal immunotherapy for glioblastoma (GBM). Austin Oncol Case Rep. 2018;3:1010.
  • Schirrmacher V, van Gool S, Stuecker W. Breaking therapy resistance: an update on oncolytic newcastle disease virus for improvements of cancer therapy. Biomedicines. 2019;7:66.
  • Horak P, Klink B, Heining C, et al. Precision oncology based on omics data: the NCT Heidelberg experience. Int J Cancer. 2017;141(5):877–886..
  • Zardavas D, Piccart-Gebhart M. Clinical trials of precision medicine through molecular profiling: focus on breast cancer. Am Soc Clin Oncol Educ Book. 2015;e183–90. DOI:10.14694/EdBook_AM.2015.35.e183
  • Pitt JM, Vetizou M, Daillere R, et al. Resistance mechanisms to immune-checkpoint blockade in cancer: tumour-intrinsic and -extrinsic factors. Immunity. 2016;44:1255–1269.
  • Tannock IF, Amir E, Booth CM, et al. Relevance of randomised controlled trials in oncology. Lancet Oncol. 2016;17:e560–e7.
  • Oncology TL. Are results from clinical trials reliable? Lancet Oncol. 2019;20:1035.
  • Del Paggio JC, Tannock IF. The fragility of phase 3 trials supporting FDA-approved anticancer medicines: a retrospective analysis. Lancet Oncol. 2019;20(8):1065–1069..
  • Tibau A, Molto C, Borrell M, et al. Magnitude of clinical benefit of cancer drugs approved by the US food and drug administration based on single-arm trials. JAMA Oncol. 2018;4:1610–1611.
  • Booth CM, Del Paggio JC. Approvals in 2016: questioning the clinical benefit of anticancer therapies. Nat Rev Clin Oncol. 2017;14:135–136.
  • Davis C, Naci H, Gurpinar E, et al. Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009–13. BMJ. 2017;359:j4530.
  • Gauging the validity of cancer drug trials: a call for collaboration. Comment and opinion from The BMJ’s international community of readers, authors, and editors; 2019 Sept 18 [cited 2020 Apr 29]. Available from: https://blogs.bmj.com/bmj/2019/09/18/gauging-the-validity-of-cancer-drug-trials-a-call-for-collaboration/
  • Naci H, Davis C, Savovic J, et al. Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014–16: cross sectional analysis. BMJ. 2019;366:l5221.
  • Schirrmacher V. From chemotherapy to biological therapy: A review of novel concepts to reduce the side effects of systemic cancer treatment (Review). Int J Oncol. 2019;54(2):407–419.
  • Postel-Vinay S, Aspeslagh S, Lanoy E, et al. Challenges of phase 1 clinical trials evaluating immune checkpoint-targeted antibodies. Ann Oncol. 2016;27:214–224.
  • Collette L, Bogaerts J, Suciu S. Statistical methodology for personalized medicine. New developments at EORTC headquarters since the turn of the 21st century. Eur J Cancer Suppl. 2012;10:13–19.
  • Rodon J, Soria JC, Berger R, et al. Challenges in initiating and conducting personalized cancer therapy trials: perspectives from WINTHER, a Worldwide Innovative Network (WIN) Consortium trial. Ann Oncol. 2015;26:1791–1798.
  • Rödiger T, Müller AC, Graamann J, et al. Genauere Evidenz für Präzisionsmedizin notwendig. Dtsch Arztebl. 2019;116:A1708–12.
  • Golan T, Milella M, Ackerstein A, et al. The changing face of clinical trials in the personalized medicine and immuno-oncology era: report from the international congress on clinical trials in Oncology & Hemato-Oncology (ICTO 2017). J Exp Clin Cancer Res. 2017;36:192.
  • Catani JPP, Riechelmann RP, Adjemian S, et al. Near future of tumour immunology: anticipating resistance mechanisms to immunotherapies, a big challenge for clinical trials. Hum Vaccin Immunother. 2017;13:1109–1111.
  • Park JJH, Siden E, Zoratti MJ, et al. Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols. Trials. 2019;20:572.
  • Collette L, Tombal B. N-of-1 trials in oncology. Lancet Oncol. 2015;16(8):885–886.
  • Fountzilas E, Tsimberidou AM. Overview of precision oncology trials: challenges and opportunities. Expert Rev Clin Pharmacol. 2018;11(8):797–804.
  • Schork NJ. Personalized medicine: time for one-person trials. Nature. 2015;520(7549):609–611.
  • Design and implementation of N-of-1 Trials: a user’s guide. AHRQ publication No. 13 (14)-EHC122-EF. Rockville, MD: Agency for Healthcare Research and Quality; 2014 Feb. [cited 2020 Jun 24]. Available from: www.effectivehealthcare.ahrq.gov/N-1-Trials.cfm.
  • Mullin R. Cost to develop new pharmaceutical drug now exceed $2.5 b. Sci Am. 2014;24. Available from: https://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now-exceeds-2-5b/
  • DiMasi JA, Reichert JM, Feldman L, et al. Clinical approval success rates for investigational cancer drugs. Clin Pharmacol Ther. 2013;94(3):329–335.
  • Hay M, Thomas DW, Craighead JL, et al. Clinical development success rates for investigational drugs. Nat Biotechnol. 2014;32(1):40–51.
  • Jonsson B, Hofmarcher T, Lindgren P, et al. The cost and burden of cancer in the European Union 1995–2014. Eur J Cancer. 2016;66:162–170.
  • Vivot A, Jacot J, Zeitoun JD, et al. Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000–2015. Ann Oncol. 2017;28:1111–1116.
  • Mailankody S, Prasad V. Comparative effectiveness questions in oncology. N Engl J Med. 2014;370(16):1478–1481.
  • Al-Badriyeh D, Alameri M, Al-Okka R. Cost-effectiveness research in cancer therapy: a systematic review of literature trends, methods and the influence of funding. BMJ Open. 2017;7:e012648.
  • Sinclair U. I, candidate for governor: and how I got licked. New York: Farrar and Rinehart; 1935.
  • Cosgrove L, Shaughnessy AF, Wheeler EE, et al. From caveat emptor to caveat venditor: time to stop the influence of money on practice guideline development. J Eval Clin Pract. 2014;20:809–812.
  • Packer M. Absence of an ideal observer II: the agonizing search for experts without a conflict of interest. Circulation. 2017;136:2400–2402.
  • Liu X, Tang LL, Mao YP, et al. Evidence underlying recommendations and payments from industry to authors of the national comprehensive cancer network guidelines. Oncologist. 2019;24:498–504.
  • Packer M. The absence of an ideal observer: why some clinical trials may not be what we think they are. Circulation. 2017;136:1085–1086.
  • Polyzos NP, Mauri D, Ioannidis JP. Guidelines on chemotherapy in advanced stage gynecological malignancies: an evaluation of 224 professional societies and organizations. PLoS One. 2011;6:e20106.
  • FDA 2019; 2019 [cited 2020 Apr 29]. Available from: https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance.
  • EMA 2020; 2020 [cited 29 Apr 2020]. Available from: https://www.ema.europa.eu/en/about-us/how-we-work/governance-documents/funding
  • Pham-Kanter G. Revisiting financial conflicts of interest in FDA advisory committees. Milbank Q. 2014;92:446–470.
  • Lieb K, Klemperer D, Ludwig WD. Interessenkonflikte in der Medizin. Heidelberg New York: Springer Verlag Berlin; 2011.
  • Niraula S, Seruga B, Ocana A, et al. The price we pay for progress: a meta-analysis of harms of newly approved anticancer drugs. J Clin Oncol. 2012;30:3012–3019.
  • Niraula S, Amir E, Vera-Badillo F, et al. Risk of incremental toxicities and associated costs of new anticancer drugs: a meta-analysis. J Clin Oncol. 2014;32:3634–3642.
  • Thakkar JP, Dolecek TA, Horbinski C, et al. Epidemiologic and molecular prognostic review of glioblastoma. Cancer Epidemiol Biomarkers Prev. 2014;23:1985–1996.
  • Louis DN, Perry A, Reifenberger G, et al. The 2016 World Health Organization classification of tumours of the central nervous system: a summary. Acta Neuropathol. 2016;131:803–820.
  • Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Eng J Med. 2005;352:987–996.
  • Stupp R, Hegi ME, Mason WP, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009;10:459–466.
  • Hegi ME, Diserens AC, Gorlia T, et al. MGMT gene silencing and benefit from temozolomide in glioblastoma. N Engl J Med. 2005;352:997–1003.
  • Sturm D, Witt H, Hovestadt V, et al. Hotspot mutations in H3F3A and IDH1 define distinct epigenetic and biological subgroups of glioblastoma. Cancer Cell. 2012;22:425–437.
  • Sathornsumetee S, Rich JN. Designer therapies for glioblastoma multiforme. Ann N Y Acad Sci. 2008;1142:108–132.
  • Chen R, Cohen AL, Colman H. Targeted therapeutics in patients with high-grade gliomas: past, present, and future. Curr Treat Options Oncol. 2016;17:42.
  • Dos Santos MA, Pignon JP, Blanchard P, et al. Systematic review and meta-analysis of phase I/II targeted therapy combined with radiotherapy in patients with glioblastoma multiforme: quality of report, toxicity, and survival. J Neurooncol. 2015;123:307–314.
  • Su J, Cai M, Li W, et al. Molecularly targeted drugs plus radiotherapy and temozolomide treatment for newly diagnosed glioblastoma: a meta-analysis and systematic review. Oncol Res. 2016;24:117–128.
  • Cihoric N, Tsikkinis A, Minniti G, et al. Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov. Radiat Oncol. 2017;12:1.
  • Sim HW, Morgan ER, Mason WP. Contemporary management of high-grade gliomas. CNS Oncol. 2018;7:51–65.
  • Aldape K, Brindle KM, Chesler L, et al. Challenges to curing primary brain tumours. Nat Rev Clin Oncol. 2019;16(8):509–520..
  • Halabi S, Michiels S. Textbook of clinical trials in oncology: a statistical perspective. Chapman and Hall/CRC: Boca Raton; 2019.
  • McGranahan T, Li G, Nagpal S. History and current state of immunotherapy in glioma and brain metastasis. Ther Adv Med Oncol. 2017;9(5):347–368.
  • Reardon DA, Freeman G, Wu C, et al. Immunotherapy advances for glioblastoma. Neuro Oncol. 2014;16(11):1441–1458..
  • Srinivasan VM, Ferguson SD, Lee S, et al. Tumour vaccines for malignant gliomas. Neurotherapeutics. 2017;14:345–357.
  • Desai R, Suryadevara CM, Batich KA, et al. Emerging immunotherapies for glioblastoma. Expert Opin Emerg Drugs. 2016;21:133–145.
  • Carlsson SK, Brothers SP, Wahlestedt C. Emerging treatment strategies for glioblastoma multiforme. EMBO Mol Med. 2014;6:1359–1370.
  • Sharma P, Debinski W. Receptor-targeted glial brain tumour therapies. Int J Mol Sci. 2018;19:3326.
  • Huang J, Liu F, Liu Z, et al. Immune checkpoint in glioblastoma: promising and challenging. Front Pharmacol. 2017;8:242.
  • Wang X, Guo G, Guan H, et al. Challenges and potential of PD-1/PD-L1 checkpoint blockade immunotherapy for glioblastoma. J Exp Clin Cancer Res. 2019;38:87.
  • Ameratunga M, Coleman N, Welsh L, et al. CNS cancer immunity cycle and strategies to target this for glioblastoma. Oncotarget. 2018;9:22802–22816.
  • Pellegatta S, Di Ianni N, Pessina S, et al. ABCC3 expressed by CD56(dim) CD16(+) NK cells predicts response in glioblastoma patients treated with combined chemotherapy and dendritic cell immunotherapy. Int J Mol Sci. 2019;20:5886.
  • Liau LM, Ashkan K, Tran DD, et al. First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma. J Transl Med. 2018;16:142.
  • Ioannidis JPA, Kim BYS, Trounson A. How to design preclinical studies in nanomedicine and cell therapy to maximize the prospects of clinical translation. Nat Biomed Eng. 2018;2:797–809.
  • Schirrmacher V. Cancer vaccines and oncolytic viruses exert profoundly lower side effects in cancer patients than other systemic therapies: a comparative analysis. Biomedicines. 2020;8(3):61.
  • Schirrmacher V. New insights into mechanisms of long-term protective anti-tumour immunity induced by cancer vaccines modified by virus infection. Biomedicines. 2020;8:55.
  • Ivan Illich (medical historian), on Swiss television, Lugano, 1975; 1975. [cited 2020 Jun 24]. Available from: https://ivu.org/people/quotes/health.html

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