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• W1570481054 abstract "Construction of new proton therapy facilities is expanding rapidly, despite the order-of-magnitude higher expense of building them compared to conventional radiotherapy. Despite this, many have argued that proton therapy is cost effective, at least for some types of cancer and some populations of patients. In this month's Point/Counterpoint, we debate the claim that proton therapy is the most cost-effective modality for partial breast irradiation (PBI). Proton beam irradiation has become the modality of choice for tumors difficult to treat with other modalities. Among those clearly supported by the literature are the treatment of intraocular melanoma, tumors near or at the base of skull, and those requiring treatment with craniospinal irradiation.1 Proton therapy value—meaning benefit as a function of cost—in the treatment of other diseases is more difficult to show. The case of prostate cancer has become the center of a growing discussion on the cost-effectiveness of protons in terms of clinically meaningful gains of expensive new technologies. In this context, it is not intuitive that using protons for accelerated partial breast irradiation (APBI) would be a good value. Yet the data show that proton APBI compares favorably to all the external beam and brachytherapy alternatives.2–5 The dose is very homogeneous within the target region and delivers negligible dose to nontarget breast, heart, and lung. The initial clinical outcomes of proton APBI have been reported from three institutions, and additional Phase II studies are ongoing. Two of these experiences have been updated recently with up to five years of follow-up showing excellent local control rates and high patient satisfaction.6,7 The group at Loma Linda University has the largest published experience with proton beam APBI showing good to excellent cosmetic outcomes in 90% of patients. Problems seen with other types of APBI—high infection rates, declining cosmesis with time, and fat necrosis—have not been seen with proton therapy. In particular, the poor cosmesis seen in the TARGIT-A and RAPID trials suggests that Linac-based APBI may not be a favorable option.8,9 Because of this promising clinical role for protons in the treatment of early stage breast cancer, cost becomes relevant. Only one cost analysis comparing proton APBI to other breast irradiation techniques has been published to date.5 In 2006, Taghian et al. found protons to be more costly than 3D-conformal partial breast irradiation with photons and classic whole breast irradiation (WBI) with a boost. At PTCOG-NA, Ovalle et al. presented their analysis of current costs of proton APBI compared to seven other partial- and whole breast irradiation techniques.10 Using 2014 Medicare reimbursement rates, proton APBI costs were similar to six weeks of whole breast irradiation including a boost, and less costly than APBI with interstitial brachytherapy using a multilumen device or IMRT whole breast treatments. The key factors in these unexpected results are that (1) the small number of treatments required by proton APBI offsets the higher costs per fraction and that (2) reimbursement rates for the various options have significantly changed in the last decade. With lower costs than multilumen brachytherapy APBI or whole breast IMRT, proton APBI appears to be an appealing alternative for the treatment of early stage breast cancer and deserves further investigation. In general, one would not dispute the proposition that with protons one should be able to design a dosimetrically superior treatment plan compared to external beam Linac-based treatments. What may be surprising is the notion that a marvelous physics-rich modality as proton therapy can be considered a less expensive alternative to conventional photon-based treatments for PBI. In 2014, the Alberta Health Services11 issued a report on referral of patients for proton beam therapy (PBT). In this report, they constructed a framework for determining which situations were most likely to benefit from a referral for treatment with protons, recognizing the premium placed on this expensive resource. They estimated the average cost of each referral to be $200,000. Additionally, the report summarized national guidelines for England, Denmark, and the Netherlands, none of which lists breast irradiation as a standard indication for protons. Similarly in 2014, ASTRO released its model policy for PBT12 detailing the indications for insurance coverage based upon medical necessity and adequate clinical data. They state that (1) it is necessary to understand and document the associated clinical benefits of PBT and (2) PBT should not be considered in lieu of a photon-based schema that delivers quality clinical care with low normal tissue toxicities. PBI did not meet their criteria. Recently, Loeffler13 laid out the current and future landscape for particle beam therapy and reviewed sites of proven clinical benefit and sites of ongoing investigation such as breast. He reminds us that dosimetric advantage does not necessarily correlate with a clinical advantage and that a definitive advantage needs to be established for PBT to become common treatment. He lists sites with the highest priority, acknowledging that the data are not yet available to warrant inclusion for breast treatment. There are a few published clinical trials with protons6,7 supplemented with dosimetric studies.2 An early Phase I trial testing the feasibility of proton PBI reported more late skin toxicities compared to photon-based PBI,6 a consequence, they postulated, of limiting daily delivery to a single proton treatment field due to machine time availability. Five-year results for a proton PBI phase 2 trial were reported by Bush et al.7 demonstrating very good results with 5-yr disease-free survival and overall survival rates of 94% and 95% and excellent cosmesis using 40 Gy over two weeks. In comparison, Formenti et al.14 reported 5-yr results on 100 PBI patients treated with photons with one recurrence out of the 100 patients (1%) with 95% disease-free survival. Updated results (private communication) with 397 patients and median follow-up of 40 months indicate a predicted 5-yr recurrence rate of 0.4% and overall survival rate of 98.2% using daily fractions of 6 Gy over five consecutive days. Of course, cost-effectiveness is not based solely on either the expense of a treatment or even a Medicare-based reimbursement analysis but also upon nonmedical costs, weighting factors for normal tissue toxicities, outcomes, and costs of salvage treatments. Shah et al.15 reviewed the cost-effectiveness of accelerated PBI compared with WBI using 2011 Medicare schedules with costs ranging from $8500 (3D planning), $12,500 (IMRT), up to $18,400 for multilumen brachytherapy. Their analysis included estimates of incremental cost-effectiveness ratios and costs per quality adjusted life year. For protons to be considered cost-effective, we need to demonstrate low costs or improved outcomes. Indeed, for protons to be considered cost-effective, they must be proven to be of lower cost than the alternatives, or to have improved outcomes, or both. In the absence of cost-effectiveness analysis, one can analyze these separately. Costs. Costs of therapy can be classified as medical and indirect costs. As previously mentioned, there are two available reports on APBI costs in the USA. The first one used the 2006 Standard Medicare Payments Schedule for professional and technical charges to estimate costs of proton APBI and compare them to a mixed-modality 3D-conformal external APBI schedule and a six-week WBI technique. Protons had higher medical costs than the alternatives but the lowest patient related costs. Today, many other treatment options are utilized for patients with early stage breast cancer. These include APBI with brachytherapy devices and partial- or whole breast irradiation with IMRT. Using current Medicare reimbursement rates, Ovalle et al. compared these treatments (amongst others) to proton APBI.10 The cost of protons was lower than APBI with a brachytherapy device and whole breast IMRT, and very similar to a 6-week WBI schedule with a boost. Effectiveness. One of the most common and probably the most relevant way of comparing treatment effects is survival. Other outcomes specifically significant to radiotherapy are local and local-regional recurrence. Published data on proton APBI on all these fronts are promising, with a 5-yr overall survival of up to 95% and an ipsilateral breast tumor recurrence-free survival of 97%. Assessments of toxicity have been erratic and will be a vital factor when determining the role of proton APBI. Ongoing trials will aid in answering these questions. Finally, according to ASTRO's proton beam therapy model policy (2014),12 coverage with evidence development is suggested for disease sites such as breast as long as the patient is enrolled in a clinical trial. Hopefully, this will facilitate generating more clinical data and cost-effectiveness analysis will likely follow. A driving principle for initiating APBI protocols and certainly one of the major justifications for exploring APBI was an expansion of women's access to breast conserving therapy (BCT). It was noted that access to BCT was particularly an issue in areas underserved by radiation oncology, where traveling long distances for up to 30 daily visits pushed women toward mastectomies and away from BCT. The number of proton facilities, although increasing, remains small and they are largely situated in high population areas, a situation that may not address this original motivation and may increase the costs for those women who feel a pressure to seek out proton therapy but who live very far from a proton center. Thus, although the use of protons provides an alternative for BCT, it may not expand access for the population pools seeking an alternative to mastectomy. As noted in my opening statement, acute and late effects following proton treatment are dependent upon regimen and technique similar to photon-based treatments, suggesting that protons are not inherently superior. They demand attention to dose-fractionation regimens and planning and treatment specifics just as photon-based APBI.6 The APBI toolbox is already crowded and confusing, at least for the patient. Perhaps, the addition of protons will trigger a review of available protocols to determine which techniques are competitive on both a cost and outcome basis since both of these vary substantially. Protons and multicatheter brachytherapy represent the high end of costs, and five-fraction external beam the simpler, low-cost alternative.14 Dr. Ovalle wishes to acknowledge the assistance of her mentor Eric A. Strom, M.D." @default.
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• W1570481054 title "Proton therapy is the most cost-effective modality for partial breast irradiation" @default.
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