Original Articles

Impatto sul PDTA di cancro della prostata dei dispositivi medici fiducial markers ed ExacTrac® X-Ray 6D valutati con mini report HTA

DOI 10.23753/htafocus2017.03.018

Giorgio Lusiani, Matteo Sepulcri, Massimo Castoro, Massimo Rugge, Laura Evangelista


Introduction Prostate cancer represents the tumor with the highest incidence on male. Actually, the primary treatment using external beam radiation therapy (EBRT) needs high doses and many fractions of therapy, that means a great use of resources. The introduction of two medical devices (MD) (“Fiducial markers” and “ExacTrac® X-Ray 6D”) could optimize the diagnostic and therapeutic pathway for prostate cancer.
Material and Methods A systematic review of literature from 2007 to 2015 has been made for the assessment on safe and efficacy of fiducial markers (FM) and ExacTrac (ET). The same aspects have been evaluated by an internal, mono-institutional experience, comparing the outcomes of 38 consecutive patients treated with EBRT using MDs vs 39 patients treated without MDs. The rate-related medical service of Veneto and the use of resources produce the economic evaluation.
Results The use of MDs is suitable in terms of efficacy. In terms of safe, the use of MDs shows a higher incidence of rectal and urinary toxicity at the end of EBRT, while toxicity is lower at 3 and 9 months from the last fraction comparing with patients treated without MDs. The economy evaluation demonstrates that economic and social savings are due to decreased number of fractions, in spite of a great cost of the MDs (especially for one of them).
Conclusions The use of MDs is recommended for the optimisation of the diagnostic and therapeutic pathway for prostate cancer, safeguarding efficacy, safe, good use of resources, social saving and low cost.

Key words: medical devices, prostate cancer, radiotherapy, cost-analysis