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Journal of Clinical Oncology, Vol 23, No 10 (April 1), 2005: pp. 2437-2438 © 2005 American Society of Clinical Oncology. DOI: 10.1200/JCO.2005.99.145
Rationing and Decision MakingDepartment of Radiation Oncology, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa To the Editor: Doctors at a proton therapy center reported their decision not to accept a young child with an ependymoma of the posterior cranial fossa into their proton therapy program.1 There was a possibility that proton therapy might have an advantage over standard conformal therapy, as there would be a lower integral dose of irradiation to the brain. This is for a technical reason—if the "Bragg peak" portion of the proton beam is used, the dose falls off rapidly, distally to the beam. The case is used to dramatically illustrate the principles of rationing of resources. Rationing applies whenever some commodity, essential or otherwise, is in short supply. It is often associated with a shortage of goods (such as foodstuffs or fuel) that might arise from natural disasters or conflict. Rationing is therefore an emotive word. Is its use justified in the case presented? Sound decision making is a process that begins with evidence or facts, followed by the logical selection from different options with the help of objective criteria.2 Evidence-based medicine is widely advocated because of possible bias, even among those who are fully sincere. In medical therapy, bias may be present because of enthusiasm for a particular mode of therapy. The significance of different types of evidence varies.3 In one such system, level-1 evidence is the most compelling and is derived from randomized clinical trials or the observation of dramatic effects. Level 2 includes systemic review of cohorts of patients; level 3 includes case-control studies; and level 4 includes case series. The lowest level of evidence is 5, which includes deductions from basic principles. Ependymomas of the posterior cranial fossa do not have a good prognosis. This depends largely on the completeness of surgical excision, though they are also treated to substantial doses of irradiation.4-6 It is indeed desirable in principle to reduce the integral dose of irradiation to the developing brain. However, these tumors are usually sizable, in the order of 4 cm, and are in a confined space. A margin of 1 cm to the tumor bed is recommended.4 There are many uncertainties associated with proton therapy. It is not clear how much the dose to the brain would be reduced with proton therapy as compared with stereotactic irradiation, which is widely available.5 The administered dose in the base of the skull region may be uncertain because of technical factors, and the relative biologic effect of the irradiation in the Bragg peak region is debated. Hyperfractionated radiation, to reduce normal tissue complications, and dose escalation, has unfortunately not improved the prognosis.6 The only reference to the value of proton therapy in the article is a 1989 article describing a series of patients who were treated for chordomas and chondrosarcomas of the base of the skull.7 There is therefore a presumption of clinical benefit of proton therapy in this case, which is not justified on the facts presented—level 5 evidence or extrapolation from basic principles. Future clinical reports evaluating the benefit of proton therapy in this situation, with the help of modeling of physical parameters of cases, will be most useful. The selection of patient for a program or the evaluation of eligibility criteria for a formalized study would be more apt contexts for decision making regarding therapies of uncertain gain. Patients, or their relatives, who are given to understand that they will not receive a form of treatment because of rationing will understand that they are deprived, which may not be factual. There are gentler phrases, such as "resource allocation" or "priority setting," though these may have very much the same meaning. These terms should be used with circumspection when the evidence indicates that the benefits are only potentially present or clinically insignificant when compared with other widely available modalities. Author's Disclosures of Potential Conflicts of Interest The author indicated no potential conflicts of interest. REFERENCES
1. Jagsi RJ, DeLaney TF, Donelan K, et al: Real-time rationing of scarce resources: The Northeast Proton Therapy Center Experience. J Clin Oncol 22:2246-2250, 2004
2. Daniels N: Accountability for reasonableness: Establishing a fair process for priority setting is easier than agreeing on principles. BMJ 321:1300-1301, 2000 3. Djulbegovic B, Lyman G, Ruckdeschel JC: Why evidence-based oncology? Evidence Based Oncol 1:2-5, 2000[CrossRef] 4. Taylor RE: Review of radiotherapy dose and volume for intracranial ependymoma. Pediatr Blood Cancer 42:457-460, 2004[Medline] 5. Mansur DB, Drzymala RE, Rich KM, et al: The efficacy of stereotactic radiosurgery in the management of intracranial ependymoma. J Neurooncol 66:187-190, 2004[Medline] 6. Massimino M, Gandola L, Giangaspero F, et al: Hyperfractionated radiotherapy and chemotherapy for childhood ependymoma: Final results of the first prospective AIEOP (Associazione Italiana di Ematologia-Oncologia Pediatrica) study. Int J Radiat Oncol Biol Phys 58:1336-1345, 2004[CrossRef][Medline] 7. Austin-Seymour M, Munzenrider J, Goitein M, et al: Fractionated proton radiation therapy of chordoma and low-grade chondrosarcoma of the base of the skull. J Neurosurg 70:13-17, 1989[Medline]
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Copyright © 2005 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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