Original Title: État des connaissances: mise à jour des indications de la protonthérapie en oncologie

Authors' objectives: PrT is not available in Québec. There is a centre in Vancouver that specializes in the treatment of ocular tumours, and worldwide, there are more than 60 facilities. Québec patients in whom PrT is indicated are treated in the United States after their case is evaluated by an expert committee of the Régie de l’assurance maladie du Québec (RAMQ). Since 2010, 76 patients have been treated with PrT, at a cost of more than $15 million to the RAMQ. Since the cost of a PrT treatment has doubled in the past 5 years, the Direction générale de cancérologie asked INESSS to update the clinical indications for PrT and to then estimate the annual number of patients who might be treated with this modality.

Authors' results and conclusions: RESULTS: This information brief summarizes the recent evidence from assessment reports and systematic reviews comparing the efficacy and safety of PrT with those of PhT in the treatment of several types of cancer. Although they are of fairly good quality, the synthesis documents considered include studies that vary widely in terms of their designs, the types of tumours, the clinical indicators examined, the PhT and PrT techniques used, and the types of analyses. Furthermore, the methodological biases inherent in retrospective studies and non-controlled prospective studies limit the scope of the conclusions. As well, the most relevant clinical indicators are not systematically reported in all the studies. For all these reasons, it is difficult to rule on the net health benefit of PrT in comparison to PhT. Indeed, the evidence does not provide any proof in favour of PrT for the indications recognized by most organizations and experts worldwide, with the exception of ocular cancer, pediatric cancers and central nervous system cancers. Furthermore, the level of evidence is weak for the potential indications, which are presently not recognized in Québec. The recommendations in several countries differ with regard to hepatocellular carcinoma, non-small-cell lung cancer, prostate cancer and other clinical situations, such as re-irradiation. However, esophageal and breast cancers are not indications recognized in current practice. CONCUSION: In conclusion, since the quality of the existing data is inadequate, it is presently not relevant to propose treatment with PrT for: • Non-small-cell lung cancer; • Hepatocellular carcinoma; • Prostate cancer; • Esophageal cancer; • Breast cancer; • Re-irradiation cases.

Authors' recommendations: For the indications recognized in Québec, the following principles should be applied when evaluating treatment requests: • PrT should confer to the patient a significant benefit over the latest PhT techniques available in Québec, such as image-guided radiotherapy (IGRT), volumetric-modulated arc therapy (VMAT), 4-dimensional radiotherapy or radiosurgery. • Approved PrT treatments should: o be curative in intent; o be for patients with a good performance score (0 to 2); o be for patients with a life expectancy greater than 5 years. • The patient's ability and willingness to travel should be taken into consideration. • Whether PrT is to be used as first- or second-line treatment, all cases involving patients likely to receive PrT should be discussed within a committee specializing in cancer diagnosis and treatment. • Every request for PrT treatment should be submitted to the Comité provincial de protonthérapie by a radiation oncologist who has evaluated the patient concerned. Research in the area of PrT is growing rapidly, which suggests that the clinical indications for this treatment modality might be broadened in the more or less long term. Within the next 3 years, the current phase III studies will provide new efficacy and safety data for better assessing the actual role of PrT in the treatment of several types of cancer.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/mise-a-jour-des-indications-de-la-protontherapie-en-oncologie.html

Year Published: 2017

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/mise-a-jour-des-indications-de-la-protontherapie-en-oncologie.html

English language abstract: An English language summary is available

Publication Type: Other

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: Gouvernement du Québec