USA - Proton beam radiation therapy

Proton beam radiation therapy involves directing a beam of accelerated subatomic, electrically charged particles to tumor targets. Proton beam radiation therapy can be used alone or in combination with traditional photon beam radiation therapy to treat malignancies in the abdomen, central nervous system, eye, lung, head and neck, and prostate and some noncancerous conditions (i.e., arteriovenous malformations, macular degeneration, circulatory system defects of the brain).

The purported advantages of protons over photons in radiation therapy include the following:

-       More accurate dosing of targets

-       Reduction of the acute side effects of radiation therapy

-       Lower radiation dose to nontargeted tissue

-       Safer treatment for pediatric patients who are especially vulnerable to radiation side effects

Many radiation oncologists believe that these combined potential advantages will lead to safer overall treatment. However, our searches identified no appropriately designed studies comparing the efficacy of proton therapy to other modes of radiation therapy. Furthermore, a Technical Brief onParticle Beam Radiation Therapies for Cancerpublished by the U.S. Agency for Healthcare Research and Quality in 2009 concluded that systematic review of the clinical literature on the technology would not likely enable conclusions on the effectiveness of proton beam therapy at this time.

Some researchers have expressed reluctance to pursue randomized controlled trials, saying it would be unethical to withhold this more precise method of radiation delivery from patients. However, ECRI Institute's perspective is that the claimed superiority of proton beam therapy has not been demonstrated, and thus the only type of research that can definitively answer the key questions about relative benefits is through randomized controlled trials.

ECRI Institute searches of clinicaltrials.gov identified 47 ongoing trials of proton beam therapy, alone or in combination with other treatment modalities (2 randomized controlled trials and 45 nonrandomized studies) on many types of cancer. Most of these trials, even the randomized clinical trials, will not address the unanswered key questions because they do not make head-to-head comparisons between proton therapy and other radiation therapy modalities. They compare protons to other treatment modalities.

Possible disadvantages of proton beam therapy are acute side effects that can occur during the treatment phase, including fatigue, skin reactions (redness and irritation similar to sunburn), diarrhea, nausea, hair loss, and vomiting. Secondary malignancies can occur following both photon therapy and proton therapy.

Because offering proton therapy requires substantial personnel and financial resources, facilities planning to adopt this technology must first consider the demographics, the number of cancer patients and characteristics (i.e., cancer types) of patients in their service area. Facilities may need to augment staff with clinicians who have expertise in several areas, including radiation oncologists, medical dosimetrists, immobilization specialists, radiation therapists, and medical physicists. Administrators may experience difficulty staffing these centers because of the specialized qualifications of experts in the field.

Planning and maintaining a proton therapy center is costly. Traditional proton therapy systems consist of large multiroom facilities that cost from $100 million to $225 million to build and equip and up to $25 million annually to maintain. Experts predict that proton therapy costs will likely decrease due to competition among design firms, reengineering, and cost sharing among more patients as the technology diffuses. Also, facility cost will decrease as procedures become more efficient. These trends may decrease the cost difference between proton and photon radiation therapy over time.

In the United States, 9 proton therapy centers are operational and 20 more are in the construction or planning stage. Several factors have generated interest in proton therapy, including the following:

-       Development of next-generation smaller systems that are more affordable

-       Advances in proton therapy technology

-       Coding to facilitate reimbursement

-       Designation as a research priority by the U.S. Centers for Medicare & Medicaid Services

-       An increase in the number of clinical applications, especially for pediatric cancers

-       Patient demand

Recent discussions about rising healthcare costs and the cost-effectiveness of proton therapy have raised questions about the technology's value.

Despite these concerns, by 2013, experts predict that 15 proton therapy centers will be operational in the United States, and the number of proton therapy centers worldwide is expected to grow at a similar rate.

NOTE: This excerpt is from ECRI Institute's 2011Emerging Technology Evidence Report onProton beam radiation therapy, a component of ECRI Institute's Health Technology Assessment Information Service.

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