Update on the indications for proton and carbon ion therapy by Austrian HTA Institute

On June 16, 2020, HTA Austria – Austrian Institute for Health Technology Assessment (AIHTA) issued an update report on the indications for proton and carbon ion therapy with an overview of confirmed indications, indications that are only recommended under clinical research and excluded indications

The report is an update of the four LBI-HTA reports from 2013, 2015, and 2018. Since 2013, the number of particle therapy centers worldwide has more than doubled, with 82 currently operating particle therapy facilities. In Europe, there are 27 operating centers compare to 14 in 2013. It was assumed that with such a large number of treatment centers, the underlying clinical evidence for patient benefit was convincing.

For the present update, there was only a hand search for HTA reviews and systematic reviews, limited to the period 2018 - June 2020 in three databases: International HTA Database, Medline via PubMed Central®, and Cochrane Collaboration. Two HTA reports and one systematic review, as well as further systematic reviews of individual indications, were identified.

The identified reviews unanimously articulated that the existing - mostly retrospective - studies are of low quality and insufficient to be able to make conclusive statements about the added value of proton or carbon ion therapy. It shows an unchanged picture of the data situation compared to 2013.

Only a few indications are recommended for proton or carbon ion therapy, more for reasons of plausibility than on the basis of convincing data. These are chordomas and chondrosarcomas, uveal melanoma (under conditions), pediatric tumors (skull base, brain, and head and neck tumors) to avoid secondary tumors.

Further indications, with curative intent and not metastatic, are only recommended under conditions of prospective clinical studies:

• Tumors at the base of the skull and in the central nervous system,
• Tumors in the head and neck area (exception oropharynx),
• Inoperable lung carcinomas (NSCLC) stages I to IIIb,
• Lymphomas and sarcomas,
• Some gastrointestinal tumors (esophagus, pancreas),
• Inoperable liver cell carcinoma (HCC),
• Prostate carcinoma (with restrictions).

Clearly excluded indications are operable HCC, operable NSCLC, NSCLC stage IV, rectal cancer (with exceptions), breast cancer (with exception).

Numerous reviews come to the same conclusion that only prospective high-quality primary studies can make statements about the superiority or equivalence of proton and carbon ion therapy with clinical endpoints of effectiveness and superiority with endpoints for acute and late toxicity.

The full details in German can be found here.

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