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Regulatory Actions in Radiotherapy

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Regulatory Actions in Radiotherapy August 10, 2017 CONSIDERATIONS ON POTENTIAL REGULATORY ACTIONS FOR RADIATION PROTECTION IN RADIOTHERAPY: MONITORING UNWANTED RADIATION EXPOSURE IN RADIOTHERAPY A proposal for further discussion drafted by Autoridad Regulatoria Nuclear of Argentina and the Secretariat of the International Atomic Energy Agency (Product from the Practical Arrangements between the International Atomic Energy Agency and the Autoridad Regulatoria Nuclear of Argentina on cooperation in the area of radiation safety and monitoring) Interim Document I. INTRODUCTION BACKGROUND (1) On September 18, 2015, the Autoridad Regulatoria Nuclear (ARN) 1 of Argentina and the Secretariat of the International Atomic Energy Agency (IAEA)2, hereinafter termed ‘the Parties’, agreed on ‘Practical Arrangements’ setting forth the framework for non-exclusive cooperation between the Parties in the area of radiation safety and monitoring. The agreement was reconfirmed and partially enhanced during ceremony presided by the Chairman of ARN, Néstor Masriera, and the Deputy Director General of the IAEA, Juan Carlos Lentijo, with the presence of the Argentine Ambassador, Rafael Mariano Grossi, in the framework of the 60th Annual Regular Session of the IAEA General Conference, in Vienna, on September 30, 2016. (2) The Practical Arrangements identify activities in which cooperation between the Parties may be pursued subject to their respective mandates, governing regulations, rules, policies and procedures. A relevant activity agreed to be pursued is the ‘development of regulatory guidance on radiological protection in radiotherapy, addressing in particular the potential increase in the risk of second cancers’. The proposal described herein is a result of such activity. (3) Two major international endeavours have confirmed that there is scope for reducing radiological risks associated to both diagnostic and therapeutic uses of 1 The ARN is the Argentinean national body competent in the regulation of nuclear and radiological safety, safeguards and physical security, therefore regulating various sources of radiation exposure. As a national regulator it succeeds the National Nuclear Regulatory Entity (1994-1997) and the regulatory branch of the National Atomic Energy Commission (1950-1994). It was created in 1997 by National Law No. 24,804, as an autarchic entity in the jurisdiction of the Presidency of Argentina. It is charged of regulating those activities in order to, inter alia, protect people, the environment and future generations of the harmful effects of ionizing radiation. It also has the function of advising the Argentine government in matters within its competence and being proactive in meeting the needs of the stakeholders. 2 The IAEA was created in 1957 in response to the deep fears and expectations generated by the discoveries and diverse uses of nuclear technology. A relevant statutory function of the IAEA is to establish standards of safety and to provide for their application. The IAEA has established international radiation protection standards, including standards for the protection of patients, in co-sponsorship with other relevant international organizations of the UN family. 1 radiation without reducing the medical benefits: the International Conference on the Radiological Protection of Patients in Diagnostic and Interventional Radiology, Nuclear Medicine and Radiotherapy, held in Málaga in 2001 (the Málaga Conference)3, and the follow up International Conference on Radiation Protection in Medicine: Setting the Scene for the Next Decade’, which took place in Bonn, Germany in 2012 (the Bonn Conference) 4. (4) Overall the recommendations from the Málaga and Bonn Conferences concluded that the relevant international organizations should convene expert groups, including experts from professional societies and regulatory bodies, to formulate action plans for future work relating to the radiological protection of patients. There was recognition that everyone in the health care community has a role to play in improving radiation protection of patients undergoing radio-diagnosis or radiotherapy. (5) Following the Málaga and Bonn Conferences great advances were achieved in the radiation protection of patients undergoing radio-diagnostic procedures. These include the establishment of international standards under the aegis of the IAEA (see hereinafter, ‘international standards’). However, regulatory advancements for radiation protection in radiotherapy have been more limited. (6) There have also been vast advances in radiotherapy treatment modalities. These have allowed for a significant reduction of the normal tissue volumes receiving relatively high doses. However, in many cases these modalities may lead to the irradiation of larger volumes of the body to low doses. (7) It is important to note that advances in radiotherapy techniques, together with improvements in the early detection of cancer and also in supportive care, have contributed to steady gains in the expectation of survival of patients suffering cancers. As a result, the prospective risk of long-term surviving patients to incur ‘second primary cancers’ attributable to radiotherapy is becoming an important issue particularly for paediatric patients. (8) The prospective risk of such ‘second primary cancers’ is associated to the radiation exposure incurred in the course of radiotherapy procedures. Most of this exposure is therapeutic but some adventitious exposures are unavoidable. Regulatory requirements for monitoring these exposures are very limited. (9) This document explores relevant radiation protection issues in radiotherapy and presents some considerations on potential regulatory actions for monitoring and recording exposures incurred in radiotherapy procedures. The document particularly addresses unwanted radiation exposure in radiotherapy, namely not wished or desired exposures that however are incurred unavoidably and unintentionally during 3 INTERNATIONAL ATOMIC ENERGY AGENCY. Radiological Protection of Patients in Diagnostic and Interventional Radiology, Nuclear Medicine and Radiotherapy. Proceedings of an international Conference held in Málaga, Spain, 26–30 March 2001 / organized by the International Atomic Energy Agency...[et al.]. Proceedings series, ISSN 0074–1884. STI/PUB/1113. ISBN 92–0–101401–5. IAEA, Vienna, 2001. 4 INTERNATIONAL ATOMIC ENERGY AGENCY. Radiation Protection in Medicine: Setting the Scene for the Next Decade. Proceedings of an International Conference, Bonn, 3–7 December 2012. IAEA, Vienna, 2015. Proceedings series, ISSN 0074–1884. STI/PUB/1663. ISBN 978–92–0–103914–9 2 radiotherapy procedures; these will be identified hereinafter with the acronym URER 5. URERs can be monitored and recorded, either by measurement or estimation, through the use of dosimetric quantities or suitable proxies. (10) URERs may be associated with prospective increases in the incidence of those ‘second primary cancers’. These malignancies will be more precisely termed ‘prospective increase of primary malignancies attributable to radiotherapy’ and will be hereinafter identified with the acronym PIPMAR (see hereinafter for a discussion on PIPMAR vis-à-vis ‘second primary cancers’). (11) It is to be noted that, already in 2013, the United Nations Scientific Committee on the Effects of Atomic Radiation had warned the United Nations General Assembly UNGA on the importance to evaluate potential radiation effects on children after cancer radiotherapy6. After that early warning, UNSCEAR addressed the issue of ‘second cancers after radiotherapy’ in its reporting of its sixty-third session to the (UNGA), which took place in Vienna on 27 June-1 July 20167. UNSCEAR then decided to elaborate working material for an in-depth discussion on a proposal for estimating ‘second cancers after radiotherapy’. The UNSCEAR representations of France and Argentina worked in this initiative. More recently, at its sixty-fourth session on 29 May–2 June 2017 UNSCEAR, adopted a report informing UNGA that it discussed plans for a new project on ‘second primary cancers after radiotherapy’ and was fostering the development of an ad hoc project plan and its implementation. Moreover, UNSCEAR is therefore fully engaged in estimating ‘second cancers after radiotherapy’. (12) The UNSCEAR decision to address this issue is extremely significant. The challenge of PIPMAR is real since a very large cohort of latent sufferers is probably being amassed and might potentially manifest in the future. The time seems to be ripe for considering potential regulatory actions for radiation protection in radiotherapy related to this situation. (13) It is underlined that the reporting in this document should be considered as interim, namely the output is transistory until more permanent suggestions are agreed by consensus among all parties concerned, including relevant regulatory bodies of IAEA Member States. AIM (14) The ultimate aim of the document is to suggest exploring the possibility of potential regulatory requirements for monitoring and recording URERs. (15) Additional aims are to facilitate both, understanding and potential quantification of PIPMARs, and also implementing radiation protection recommendations for patients undergoing radiotherapy. Appropriate estimates of URERs seems to be essential for 5 The adjective unwanted, i.e.., not wished or desired, is used as a simplification of the more proper adjective adventitious. The latter derives from the Latin adventus, the past participle of the verb advenire, and it carries the proper meaning
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