Robe, Pierre ; Université de Liège - ULiège > Département des sciences biomédicales et précliniques > Département des sciences biomédicales et précliniques
Mathiesen, Tiit
Broekman, Marike L.
Language :
English
Title :
Ethical difficulties in the innovative surgical treatment of patients with recurrent glioblastoma multiforme.
Publication date :
2017
Journal title :
Journal of Neurosurgery
ISSN :
0022-3085
eISSN :
1933-0693
Publisher :
American Association of Neurological Surgeons, United States - Illinois
Agar M, Ko DN, Sheehan C, Chapman M, Currow DC: Informed consent in palliative care clinical trials: challenging but possible. J Palliat Med 16:485-491, 2013.
Angelos P: Ethical issues of participant recruitment in surgical clinical trials. Ann Surg Oncol 20:3184-3187, 2013.
Appelbaum PS: Clinical practice. Assessment of patients' competence to consent to treatment. N Engl J Med 357:1834-1840, 2007.
Barkun JS, Aronson JK, Feldman LS, Maddern GJ, Strasberg SM, Altman DG, et al: Evaluation and stages of surgical innovations. Lancet 374:1089-1096, 2009.
Beecher HK: Consent in clinical experimentation: myth and reality. JAMA 195:34-35, 1966.
Beecher HK: Ethics and clinical research. N Engl J Med 274:1354-1360, 1966.
Beecher HK: Some guiding principles for clinical investigation. JAMA 195:1135-1136, 1966.
Bender S, Flicker L, Rhodes R: Access for the terminally ill to experimental medical innovations: A three-pronged threat. Am J Bioeth 7:3-6, 2007.
Biffl WL, Spain DA, Reitsma AM, Minter RM, Upperman J, Wilson M, et al: Responsible development and application of surgical innovations: A position statement of the Society of University Surgeons. J Am Coll Surg 206:1204-1209, 2008.
Bohman LE, Gallardo J, Hankinson TC, Waziri AE, Mandigo CE, McKhann GM II, et al: The survival impact of postoperative infection in patients with glioblastoma multiforme. Neurosurgery 64:828-835, 2009.
Bowles AP Jr, Perkins E: Long-Term remission of malignant brain tumors after intracranial infection: A report of four cases. Neurosurgery 44:636-643, 1999.
Brody BA: The Ethics of Biomedical Research: An International Perspective. New York: Oxford University Press, 1998.
Broekman ML, Carrière ME, Bredenoord AL: Surgical innovation: The ethical agenda: A systematic review. Medicine (Baltimore) 95:e3790, 2016.
Buhles WC: Compassionate use: A story of ethics and science in the development of a new drug. Perspect Biol Med 54:304-315, 2011.
Canavero S, Bonicalzi V: Central pain following cord severance for cephalosomatic anastomosis. CNS Neurosci Ther 22:271-274, 2016.
Caplan A: Is it sound public policy to let the terminally ill access experimental medical innovations? Am J Bioeth 7:1-3, 2007.
Caplan A, Bateman-House A: Compassion for each individual's own sake. Am J Bioeth 14:16-17, 2014.
Caplan AL, Bateman-House A: Should patients in need be given access to experimental drugs? Expert Opin Pharmacother 16:1275-1279, 2015.
Caplan AL, Ray A: The ethical challenges of compassionate use. JAMA 315:979-980, 2016.
Casarett DJ, Karlawish JH: Are special ethical guidelines needed for palliative care research? J Pain Symptom Manage 20:130-139, 2000.
Chinot OL, Wick W, Mason W, Henriksson R, Saran F, Nishikawa R, et al: Bevacizumab plus radiotherapy-Temozolomide for newly diagnosed glioblastoma. N Engl J Med 370:709-722, 2014.
Cho DY, Lin SZ, Yang WK, Lee HC, Hsu DM, Lin HL, et al: Targeting cancer stem cells for treatment of glioblastoma multiforme. Cell Transplant 22:731-739, 2013.
Cohen PD, Isaacs T, Willocks P, Herman L, Stamford J, Riggare S, et al: Sham neurosurgical procedures: The patients' perspective. Lancet Neurol 11:1022, 2012.
Craig SE, Wright J, Sloan AE, Brady-Kalnay SM: Fluorescent- guided surgical resection of glioma with targeted molecular imaging agents: A literature review. World Neurosurg 90:154-163, 2016.
De Bonis P, Albanese A, Lofrese G, de Waure C, Mangiola A, Pettorini BL, et al: Postoperative infection may influence survival in patients with glioblastoma: simply a myth? Neurosurgery 69:864-869, 2011.
De Bonis P, Fiorentino A, Anile C, Balducci M, Pompucci A, Chiesa S, et al: The impact of repeated surgery and adjuvant therapy on survival for patients with recurrent glioblastoma. Clin Neurol Neurosurg 115:883-886, 2013.
Dutoit V, Herold-Mende C, Hilf N, Schoor O, Beckhove P, Bucher J, et al: Exploiting the glioblastoma peptidome to discover novel tumour-Associated antigens for immunotherapy. Brain 135:1042-1054, 2012.
Eakin E: Bacteria on the brain. New Yorker. December 7, 2015. (http://www.newyorker.com/magazine/2015/12/07/bacteria-on-The-brain) [Accessed February 14, 2017].
Ellor SV, Pagano-Young TA, Avgeropoulos NG: Glioblastoma: background, standard treatment paradigms, and supportive care considerations. J Law Med Ethics 42:171-182, 2014.
Emanuel EJ, Wendler D, Grady C: What makes clinical research ethical? JAMA 283:2701-2711, 2000.
Eyüpoglu IY, Hore N, Merkel A, Buslei R, Buchfelder M, Savaskan N: Supra-complete surgery via dual intraoperative visualization approach (DiVA) prolongs patient survival in glioblastoma. Oncotarget 7:25755-25768, 2016.
Galpern WR, Corrigan-Curay J, Lang AE, Kahn J, Tagle D, Barker RA, et al: Sham neurosurgical procedures in clinical trials for neurodegenerative diseases: scientific and ethical considerations. Lancet Neurol 11:643-650, 2012.
González-Saldivar G, Rodríguez-Gutiérrez R, Viramontes- Madrid JL, Salcido-Montenegro A, Carlos-Reyna KE, Treviño-Alvarez AM, et al: Participants' perception of pharmaceutical clinical research: A cross-sectional controlled study. Patient Prefer Adherence 10:727-734, 2016.
Grisso T, Appelbaum PS: Assessing Competence to Consent to Treatment. New York: Oxford University Press, 1998.
Hyun I: Allowing innovative stem cell-based therapies outside of clinical trials: Ethical and policy challenges. J Law Med Ethics 38:277-285, 2010.
Kapp JP: Microorganisms as antineoplastic agents in CNS tumors. Arch Neurol 40:637-642, 1983.
Lerner BH: Sins of omission-cancer research without informed consent. N Engl J Med 351:628-630, 2004.
London AJ: Cutting surgical practices at the joints: individuating and assessing surgical procedures, in Reitsma AM, Moreno JD (eds): Ethical Guidelines for Innovative Surgery. Hagerstown, MD: University Publishing Group, 2006.
Meyerson D: Innovative surgery and the precautionary principle. J Med Philos 38:605-624, 2013.
Meyerson D: Is there a right to access innovative surgery? Bioethics 29:342-352, 2015.
Niemansburg SL, van Delden JJ, Dhert WJ, Bredenoord AL: Reconsidering the ethics of sham interventions in an era of emerging technologies. Surgery 157:801-810, 2015.
Nycum G, Reid L: The harm-benefit tradeoff in "bad deal" trials. Kennedy Inst Ethics J 17:321-350, 2007.
Quick-Weller J, Lescher S, Forster MT, Konczalla J, Seifert V, Senft C: Combination of 5-ALA and iMRI in re-resection of recurrent glioblastoma. Br J Neurosurg 30:313-317, 2016.
Ringel F, Pape H, Sabel M, Krex D, Bock HC, Misch M, et al: Clinical benefit from resection of recurrent glioblastomas: Results of a multicenter study including 503 patients with recurrent glioblastomas undergoing surgical resection. Neuro Oncol 18:96-104, 2016.
Romano LV, Jacobson PD: Patient access to unapproved therapies: The leading edge of medicine and law. J Health Life Sci Law 2:45, 47-72, 2009.
Roth-Cline M, Nelson R: FDA implementation of the expanded access program in the United States. Am J Bioeth 14:17-19, 2014.
Roy DJ, MacDonald N: Ethical issues in palliative care, in Doyle D, Hanks GW, MacDonald N (eds): Oxford Textbook of Palliative Medicine. Oxford: Oxford University Press, 1998, pp 97-138.
Sacristán JA, Aguarón A, Avendaño-Solá C, Garrido P, Carrión J, Gutiérrez A, et al: Patient involvement in clinical research: Why, when, and how. Patient Prefer Adherence 10:631-640, 2016.
Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ: Fluorescence-guided surgery with 5-Aminolevulinic acid for resection of malignant glioma: A randomised controlled multicentre phase III trial. Lancet Oncol 7:392- 401, 2006.
Tsou A: Ethical considerations when counseling patients about stem cell tourism. Continuum (Minneap Minn) 21 (1 Spinal Cord Disorders):201-205, 2015.
van Wijmen MP, Pasman HR, Widdershoven GA, Onwuteaka- Philipsen BD: Continuing or forgoing treatment at the end of life? Preferences of the general public and people with an advance directive. J Med Ethics 41:599-606, 2015.
Wait SD, Prabhu RS, Burri SH, Atkins TG, Asher AL: Polymeric drug delivery for the treatment of glioblastoma. Neuro Oncol 17 (Suppl 2):219-223, 2015.
Walker MJ, Rogers WA, Entwistle V: Ethical justifications for access to unapproved medical interventions: An argument for (limited) patient obligations. Am J Bioeth 14:3-15, 2014.