Abstract
PURPOSE:
Guidelines recommend short-course (≤10 fractions) external-beam radiotherapy (EBRT) for bone metastases. Stereotactic body radiotherapy (SBRT) may also improve outcomes; however, routine use is not recommended outside clinical trials. We assess national radiotherapy trends in complex techniques for bone metastases and associated expenditures.
METHODS:
Using a claims-based Medicare dataset covering 84% of beneficiaries, we assessed the relative proportion of all radiation episodes represented by bone metastases. We then evaluated use of short-course and long-course (>10 fractions) EBRT, intensity-modulated radiotherapy (IMRT), and SBRT for bone metastases in hospital-affiliated outpatient (OPD) or freestanding (FREE) facilities. We assessed differences using chi-squared or Wilcoxon rank-sum tests for categorical and continuous variables, respectively. We identified associations with modality, fractionation, and expenditures using multivariable logistic/linear regression.
RESULTS:
Among 467,781 radiation episodes for 17 cancer diagnoses, the overall proportion of episodes dedicated to bone metastases (9.4%) was stable from 2015–2017, though treatments were increasing in the hospital-affiliated outpatient setting (P<0.005). We identified 40,993 episodes for bone metastases, of which 63% were short-course EBRT, 24% long-course EBRT, 7% SBRT, and 6% IMRT. Techniques more common in the hospital-affiliated outpatient setting included short-course EBRT (OPD, 69% vs. FREE, 56%) and SBRT (OPD, 9% vs. FREE, 5%). Techniques more common among freestanding centers included long-course EBRT (OPD, 19% vs. FREE, 31%) and IMRT (OPD, 4% vs. FREE, 9%). From 2015–2017, long-course EBRT decreased by an absolute 8%; short-course EBRT, SBRT, and IMRT increased by 4%, 2.5%, and 1%, respectively. SBRT/IMRT uptake did not differ by setting (P=0.4). Differences in expenditures between SBRT and short-course EBRT decreased by a relative 8% in professional and 12% in technical fees.
CONCLUSION:
Approximately 1-in-4 patients received long-course EBRT, with small reductions in use largely replaced by complex treatment modalities. However, expenditures for complex modalities also decreased over time. As alternative payment models take effect, quality metrics are needed to ensure appropriate, effective, and safe delivery of complex technologies.
Keywords: Bone metastases, Stereotactic body radiotherapy, End-of-life, Palliative care
INTRODUCTION
In patients with advanced cancer, bone metastases are a common cause of skeletal-related events, including pain and fracture, which can increase morbidity and decrease quality-of-life. Although the relative incidence of bone metastases varies by histology, recent estimates suggest a 10-year cumulative incidence of 28% across all cancer types (1). For decades, radiotherapy (RT) has been the mainstay for effective palliation of bone metastases, providing pain relief in up to 85% of patients, with at least 50% reporting complete pain response at 1–2 weeks (2). In particular, stereotactic body radiotherapy (SBRT)—a technique that delivers highly conformal radiation in ≤5 fractions to small targets throughout the body—is emerging as a safe, effective treatment for bone metastases (3). Recent prospective randomized trials report benefit with SBRT in terms of short-term palliation of pain (4,5) and progression-free survival for oligometastatic disease (6–8).
In 2013, the American Society of Radiation Oncology (ASTRO) released their Choosing Wisely guidelines, which specify avoidance of long-course (>10 fractions) external beam radiotherapy (EBRT) for bone metastases, and instead, advocate for short-course (≤10 fractions) regimens (9). In 2017, ASTRO updated their consensus guidelines further specifying that SBRT should only be employed in the setting of a clinical trial or prospective registry (10). Accordingly, use of long-course regimens decreased from 34% to 20% among patients receiving EBRT from 2011–2014 (11); at this time, SBRT comprised 4% of all treatments. A more recent analysis of Medicare claims data from 2016–2018 found that long-course regimens comprised 23% of EBRT treatments, suggesting limited improvement (12). However, neither study evaluated factors associated with use of complex modalities, including SBRT or IMRT, nor assessed trends over time including differences in expenditures by modality. Meanwhile, potential cost-effective solutions to delivering SBRT have been reported (13). Therefore, an updated comparative analysis of trends in practice and associated expenditures is warranted.
In July 2019, the Centers for Medicare and Medicaid Services (CMS) introduced the Radiation Oncology Alternative Payment Model (RO-APM), which proposes bundled reimbursements for radiation treatments, in part to discourage use of extended fractionation and control costs (14). As part of this announcement, CMS released a limited claims-based dataset of Medicare beneficiaries who received RT between 2015–2017. With promising prospective data available for SBRT in bone metastases (3), and the first randomized trial reporting a progression-free survival benefit for SBRT in oligometastatic disease published in 2016 (15), we sought to evaluate early trends in uptake of complex modalities for bone metastases and associated expenditures over time using this dataset. We hypothesize that during the study period, the proportion of radiation oncology practice dedicated to bone metastases increased, thereby accompanying an increase in use of complex modalities (primarily among hospital-affiliated outpatient centers) and a decrease in associated expenditures.
PATIENTS AND METHODS
Study cohort
The CMS dataset released as part of the RO-APM proposal includes a total of 517,988 radiation treatment episodes among Medicare beneficiaries, including 17 different cancer diagnoses (including bone metastases), representative of 84% of radiation treatments from 2015–2017. Episodes among Medicare beneficiaries under the age of 65 were excluded. For detailed analysis of bone metastases episodes, proton therapy, brachytherapy, intraoperative RT, and/or episodes involving >1 modality were excluded (Figure 1). This study was approved by the Institutional Review Board at Memorial Sloan Kettering Cancer Center.
Figure 1. Episode Cohort Breakdown.
The Centers for Medicaid and Medicare Services (CMS) Radiation Oncology database consists of over 517,988 90-day episodes representative of 84% of Medicare beneficiaries who received radiation for treatment of one of 17 cancer diagnoses from 2015–2017. Our final study cohort was limited to episodes for patients aged 65 and older, who received radiation in the form of EBRT, IMRT, or SBRT for the treatment of bone metastases. Patients who received >1 radiation modality or were treated with PBT, brachytherapy or IORT were excluded from the study.
Abbreviations: EBRT, external beam radiotherapy; IMRT, intensity-modulated radiotherapy; IORT, intraoperative radiotherapy; PBT, proton beam therapy; SBRT, stereotactic body radiotherapy.
Covariables
In addition to diagnosis and modality, available covariables included gender, age group (i.e. 65–74, 75–84, ≥85), major procedures (yes/no), chemotherapy (yes/no), and treatment setting. While a list of all possible major procedures and chemotherapy regimens given is available online (16), no specific, episode-level information is available. Mortality was classified by time period (i.e. death within 1–30 days, 31–60 days, or 61–90 days of treatment; or no death within 90 days).
Outcomes
Primary outcomes were receipt of any radiation for bone metastases (compared to all episodes), as well as use of short-course (≤10 fractions) EBRT, long-course (>10 fractions) EBRT, IMRT, or SBRT among bone metastases episodes only. Secondary outcomes were winsorized payments for professional (PRO) and technical (TECH) fees. These expenditures were adjusted for inflation using the medical component of the Consumer Price Index.
Statistical Analysis
With a baseline rate of SBRT use at 5% (from prior studies), we deemed an absolute 1% increase to be clinically meaningful (as this represents a relative 20% increase in use). With approximately 14,000 bone metastases episodes per year and an alpha of 0.05, we had a 95.6% power to detect this difference between 2015–2017. Episodes were further grouped by treatment setting (hospital-affiliated outpatient, OPD, or freestanding centers, FREE), with baseline differences between groups assessed using Pearson’s chi-squared or Wilcoxon rank-sum tests for categorical and continuous variables, respectively. Time trends were depicted using stacked bar charts, stratified by treatment setting. Multivariable logistic regression models adjusting for select covariables were used to identify factors associated with short-course (vs. long-course RT) and SBRT (vs. EBRT/IMRT). Similarly, multivariable linear regression models were used to identify factors associated with treatment-related expenditures. All models tested the interaction between year and facility type to determine whether time trends varied by treatment setting. P-values <0.01 indicated statistical significance. All statistics were performed using R version 3.6.1 (R Foundation for Statistical Computing, Vienna, Austria).
RESULTS
Bone metastases as a component of routine radiation oncology practice
Among all 467,781 eligible episodes of radiation delivered between 2015–2017 among Medicare beneficiaries age ≥65 years old, 43,196 episodes were for the treatment of bone metastases. Although the total number of episodes for bone metastases increased slightly during the study period (Figure 2), the proportion of episodes for bone metastases relative to all cancer diagnoses remained stable, comprising 9.4% of all radiation episodes (OR 0.97, 95% CI: 0.93–1.01 in both years, P=0.2). On multivariable analysis comparing episodes for bone metastases to episodes for all cancer diagnoses (controlling for gender, age, major procedures, chemotherapy, and treatment year), treatment for bone metastases was more likely to be performed in freestanding centers compared to hospital-based facilities (OR 0.73, 95% CI: 0.70–0.75). However, there was an increasing trend over time in the proportion of bone metastases treated in hospital-affiliated outpatient facilities relative to freestanding (OR 1.06, 95% CI: 1.01–1.11 in 2016 and 1.09, 1.03–1.14 in 2017; P=0.005 for the interaction between year and facility type; Supplementary Table 4).
Figure 2. Radiotherapy Trends by Cancer Diagnosis, 2015–2017†.
† Note: Please refer to Supplementary Tables 5a–c for exact numbers and percentages by year.
Bone metastases cohort characteristics
In total, 40,993 episodes met criteria for study inclusion, including 58% of episodes occurring in hospital-affiliated outpatient centers and 42% in freestanding centers. Cohort characteristics by treatment setting are summarized in Table 1. Overall, 43% of patients were female, 52% of patients were in the youngest age category (65–74 years) and 74% had received chemotherapy within the 90-day episode, with statistically significant but small (and likely not clinically meaningful) differences based on facility type. There was also no significant difference in overall rate of death within 90 days of treatment between facility types (P=0.6).
Table 1.
Cohort Characteristics, All Bone Metastases
| Statistic* | ALL N=40,993 | FREE N=17,307 | OPD N=23,686 | P-value† | |
|---|---|---|---|---|---|
| Demographics | |||||
| Gender | |||||
| Female | N (%) | 17480 (43%) | 7190 (42%) | 10290 (43%) | <0.001 |
| Male | N (%) | 23513 (57%) | 10117 (58%) | 13396 (57%) | |
| Age group | |||||
| 65–74 | N (%) | 21193 (52%) | 8739 (50%) | 12454 (53%) | <0.001 |
| 75–84 | N (%) | 14963 (37%) | 6459 (37%) | 8504 (36%) | |
| 85+ | N (%) | 4837 (12%) | 2109 (12%) | 2728 (12%) | |
| Treatment Characteristics | |||||
| Major procedure(s) | |||||
| Yes | N (%) | 12010 (29%) | 4872 (28%) | 7138 (30%) | <0.001 |
| No | N (%) | 28,983 (71%) | 12,435 (72%) | 16,548 (70%) | |
| Chemotherapy | |||||
| Yes | N (%) | 30,492 (74%) | 13188 (76%) | 17304 (73%) | <0.001 |
| No | N (%) | 1,0501 (26%) | 4,119 (24%) | 6,382 (27%) | |
| Radiation modality | |||||
| SBRT | N (%) | 2840 (7%) | 818 (5%) | 2022 (9%) | <0.001 |
| EBRT | N (%) | 35697 (87%) | 14986 (87%) | 20711 (87%) | |
| IMRT | N (%) | 2456 (6%) | 1503 (9%) | 953 (4%) | |
| Course length | |||||
| 1–10 services | N (%) | 29,939 (73%) | 11118 (64%) | 18821 (79%) | <0.001 |
| 11+ services | N (%) | 11,054 (27%) | 6189 (36%) | 4865 (21%) | |
| Expenditures | |||||
| Provider fees (USD, $) | Median (IQR) | 1234 (948, 1655) | 1348 (1025, 1785) | 1158 (900, 1554) | <0.001 |
| Technology fees (USD, $) | Median (IQR) | 4429 (3245, 6094) | 4528 (3522, 6268) | 4332 (3104, 5942) | <0.001 |
| Clinical Outcomes | |||||
| Death during 90-day episode | |||||
| No death | N (%) | 32382 (79%) | 13705 (79%) | 18677 (79%) | 0.6 |
| Within 1–30 days | N (%) | 1993 (5%) | 846 (5%) | 1147 (5%) | |
| Within 31–60 days | N (%) | 3586 (9%) | 1477 (9%) | 2109 (9%) | |
| Within 61–90 days | N (%) | 3032 (7%) | 1279 (7%) | 1753 (7%) | |
Abbreviations: 95% CI, 95% confidence interval; EBRT, external beam radiotherapy; FREE, freestanding; IMRT, intensity modulated radiotherapy; OPD, hospital-affiliated outpatient; OR, odds ratio; SBRT, stereotactic body radiotherapy.
Statistics presented: N (%); Median (IQR)
Statistical tests performed: chi-square test of independence; Wilcoxon rank-sum test
Trends in radiation fractionation and modality for bone metastases
Trends in RT for bone metastases are summarized in Figure 3. EBRT accounted for 87% of all treatments, with short-course and long-course EBRT comprising 63% and 24% of these episodes, respectively. From 2015–2017, long-course EBRT decreased by an absolute 8% (from 28% to 20%) and was more common among freestanding facilities (OPD, 19% vs. FREE, 31%). Meanwhile, short-course EBRT increased by an absolute 4% (from 61% to 65%) and was more common in hospital-affiliated outpatient facilities (OPD, 69% vs. FREE, 56%). On multivariable logistic regression, patient characteristics associated with higher odds of receiving short-course RT included being older (age >75), not undergoing major procedures, and death within 90 days of treatment (all P<0.01; Table 2).
Figure 3. Radiotherapy Trends by Provider Type, 2015–2017 *.
Abbreviations: EBRT, external beam radiotherapy; IMRT, intensity-modulated radiotherapy; Long, 11+ fractions; SBRT, stereotactic body radiotherapy; Short, 1–10 fractions.
* Note: Please refer to Supplementary Table 1a–c for exact numbers and percentages by year.
Table 2.
Multivariable Logistic Regression, Probability of ≤10 fractions *
| Observations used: All bone metastases (subset ≤10 fractions) = 40,993 (29,939) | |||
|---|---|---|---|
| OR | 95% CI | P-value | |
| Demographics | |||
| Gender | |||
| Female | — | — | 0.2 |
| Male | 1.03 | 0.98, 1.08 | |
| Age group | |||
| 65–74 | — | — | <0.001 |
| 75–84 | 1.08 | 1.03, 1.14 | |
| 85+ | 1.32 | 1.22, 1.43 | |
| Treatment Characteristics | |||
| Major procedure(s) | |||
| No | — | — | 0.007 |
| Yes | 0.93 | 0.89, 0.98 | |
| Chemotherapy | |||
| No | — | — | 0.016 |
| Yes | 1.07 | 1.01, 1.13 | |
| Radiation modality | |||
| SBRT | — | — | <0.001 |
| EBRT | 0.01 | 0.01, 0.02 | |
| IMRT | 0.00 | 0.00, 0.01 | |
| Year | |||
| 2015 | — | — | <0.001 |
| 2016 | 1.20 | 1.11, 1.30 | |
| 2017 | 1.37 | 1.27, 1.49 | |
| Facility Type | |||
| FREE | — | — | <0.001 |
| OPD | 1.93 | 1.79, 2.09 | |
| Year * Provider type | |||
| 2016 * OPD | 1.03 | 0.92, 1.15 | 0.10 |
| 2017 * OPD | 1.13 | 1.01, 1.26 | |
| Clinical Outcomes | |||
| Death during 90-Day episode | |||
| Did not die within 90 days | — | — | <0.001 |
| Death within 1–30 days | 14.4 | 11.3, 18.7 | |
| Death within 31–60 days | 2.06 | 1.88, 2.26 | |
| Death within 61–90 days | 1.31 | 1.20, 1.43 | |
Abbreviations: EBRT, external beam radiotherapy; FREE, freestanding; IMRT, intensity-modulated radiotherapy; OPD, hospital-affiliated outpatient; OR, odds ratio; SBRT, stereotactic body radiotherapy.
Versus long-course RT (11+ fractions)
The remaining 13% of episodes involved complex radiation modalities: 7% SBRT and 6% IMRT. From 2015–2017, there was an absolute 3.5% increase in the collective use of complex modalities (from 12% to 15%), representative of an absolute 2.5% and 1% increase in SBRT and IMRT, respectively, as well as a significant association between later years and higher odds of complex radiation modality use compared to 2015 (SBRT and IMRT: P<0.001 and P=0.033, respectively; Table 3). Notably, 52% of IMRT episodes were long-course (>10 fractions), compared to 27% of EBRT episodes. Similar to EBRT, long-course regimens accounted for a larger percentage of IMRT episodes in the freestanding setting (OPD, 40% vs. FREE, 59%).
Table 3.
Multivariable Logistic Regression, Probability of Complex Radiation Modalities
| SBRT1 | IMRT2 | |||||
|---|---|---|---|---|---|---|
| Observations used: | All episodes (SBRT) = 40,993 (2,835) | All episodes (IMRT) = 40,993 (2,456) | ||||
| OR | 95% CI | P-value | OR | 95% CI | P-value | |
| Demographics | ||||||
| Gender | ||||||
| Female | — | — | 0.001 | — | — | 0.02 |
| Male | 1.14 | 1.05, 1.23 | 1.10 | 1.02, 1.20 | ||
| Age group | ||||||
| 65–74 | — | — | <0.001 | — | — | 0.3 |
| 75–84 | 0.88 | 0.81, 0.95 | 0.94 | 0.86, 1.03 | ||
| 85+ | 0.60 | 0.52, 0.69 | 0.91 | 0.80, 1.04 | ||
| Treatment characteristics | ||||||
| Major procedure(s) | ||||||
| No | — | — | <0.001 | — | — | <0.001 |
| Yes | 1.22 | 1.13, 1.33 | 0.74 | 0.67, 0.81 | ||
| Chemotherapy | ||||||
| No | — | — | <0.001 | — | — | 0.5 |
| Yes | 0.58 | 0.53, 0.63 | 0.97 | 0.88, 1.07 | ||
| Year | ||||||
| 2015 | — | — | <0.001 | — | — | 0.03 |
| 2016 | 1.30 | 1.08, 1.56 | 1.01 | 0.88, 1.15 | ||
| 2017 | 1.56 | 1.31, 1.86 | 1.17 | 1.02, 1.33 | ||
| Facility Type | ||||||
| FREE | — | — | <0.001 | — | — | <0.001 |
| OPD | 2.01 | 1.71, 2.36 | 0.44 | 0.38, 0.51 | ||
| Year * Provider type | ||||||
| 2016 * OPD | 0.86 | 0.69, 1.07 | 0.4 | 0.96 | 0.77, 1.19 | 0.8 |
| 2017 * OPD | 0.90 | 0.73, 1.11 | 1.03 | 0.84, 1.26 | ||
| Clinical outcomes | ||||||
| Death during 90-Day episode | ||||||
| Did not die within 90 days | — | — | <0.001 | — | — | <0.001 |
| Death within 1–30 days | 0.23 | 0.17, 0.31 | 0.62 | 0.49, 0.77 | ||
| Death within 31–60 days | 0.28 | 0.23, 0.35 | 0.78 | 0.66, 0.91 | ||
| Death within 61–90 days | 0.37 | 0.30, 0.45 | 0.72 | 0.60, 0.86 | ||
Abbreviations: 95% CI, 95% confidence interval; EBRT, external beam radiotherapy; FREE, freestanding; IMRT, intensity modulated radiotherapy; OPD, hospital-affiliated outpatient; OR, odds ratio; SBRT, stereotactic body radiotherapy.
Probability of SBRT (versus EBRT or IMRT alone)
Probability of IMRT (versus EBRT or SBRT alone).
On multivariable logistic regression, treatment in hospital-affiliated outpatient facilities was associated with higher odds of SBRT (OPD, 9% vs. FREE, 5%; OR 2.01, 95% CI: 1.71–2.36) and lower odds of IMRT (OPD, 4% vs. FREE 9%; OR 0.44, 95% CI: 0.38–0.51; both P<0.001). Although SBRT was increasing at a slower rate among hospital-affiliated outpatient facilities compared to freestanding facilities, this difference was not statistically significant (Interaction test: Year*Facility Type, P=0.4). Patient characteristics associated with higher odds of SBRT included being male and younger (age <75), while lower odds of SBRT were associated with receipt of chemotherapy and death within 90 days of treatment (all P<0.001). Similar characteristics were associated with receipt of IMRT (Table 3).
Trends in radiation treatment expenditures for bone metastases
Compared to 2015, overall expenditures significantly increased in 2016 and 2017, both in terms of professional fees and technical fees (both P<0.001). On multivariable linear regression, EBRT and IMRT were significantly associated with lower expenditures compared to SBRT (both P<0.001; Supplementary Table 2). Other factors associated with increased expenditures included long-course (>10 fractions) regimens and treatment in freestanding facilities (both P<0.001). For episodes with ≤10 fractions, SBRT averaged $1,755 in professional and $10,240 in technical fees; IMRT averaged $1,708 in professional and $5,991 in technical fees; and EBRT averaged $1,151 in professional and $3,538 in technical fees.
Notably, from 2015 to 2017, the differences in expenditures between complex modalities and short-course EBRT were decreasing. For SBRT and short-course EBRT, differences in expenditures decreased by a relative 8% in professional fees (from $721 to $664) and 12% in technical fees (from $7,026 to $6,168). For IMRT and short-course EBRT, differences in expenditures decreased by a relative 19% in professional fees (from $591 to $479) and 28% in technical fees (from $2,908 to $2,095). Further details characterizing expenditure trends by modality, fractionation, and treatment setting are summarized in Supplementary Table 3.
Lastly, while technical fees did not differ by setting (P=0.5), they were increasing at a significantly faster rate over time among hospital-affiliated outpatient facilities on multivariable analysis controlling for both modality and fractionation (Interaction test: Year*Facility Type, P<0.001; Supplementary Table 2).
DISCUSSION
To our knowledge, this nationally comprehensive, claims-based analysis of >40,000 radiation episodes for bone metastases from 2015–2017 is the largest contemporary study evaluating national trends in use of complex radiation technologies and associated expenditures. Collectively, our results demonstrate that long-course EBRT for bone metastases decreased over time (from 28% in 2015 to 20% in 2017), in accordance with Choosing Wisely recommendations, potentially demonstrating an improvement from prior estimates ranging from 24–36% (11,12,17). However, while there has been a small concomitant increase in the adoption of short-course EBRT (from 61% to 65%), a nearly equal rise in the use of complex modalities was also observed (from 12% to 15%). Expenditures associated with complex treatments did, nonetheless, decrease over time.
Importantly, there was no difference in rates of SBRT uptake between hospital-affiliated (more often academic) centers and freestanding (more often community-based) clinics, thus suggesting increasing use in routine practice, despite ASTRO guidelines specifying that highly conformal modalities should be limited to clinical trials and prospective registries (18). This may be supported by randomized trial data available as early as 2016, which at the time, suggested potentially improved outcomes with SBRT in well-selected patients (15), and have since become more robust between 2018–2020 (4,7,19). Without detailed clinical information in the current study, we cannot assess the appropriateness of increasing use nationally, but can draw attention to a potential gap between contemporary practice patterns and the availability of clinical practice guidelines for complex technologies.
Although the overall incidence of cancer in the U.S. has remained stable over time, cancer spending continues to account for approximately 10% of total healthcare expenditures (20), with current estimates suggesting that cancer-related expenditures are projected to continue their disproportionate increase compared to other health expenditures in the next decade (21). Our results show that although expenditures for radiation of bone metastases are increasing overall, absolute differences in expenditures between conventional (short-course EBRT) and complex (SBRT or IMRT) treatments are decreasing over time. This finding could reflect both decreasing reimbursement as well as more efficient processes within radiation clinics. In a recent prospective study, STAT RAD, an expedited workflow for single-fraction SBRT actually reduced expenditures compared to 10-fraction conventional RT for bone metastases (13).
Meanwhile, in 2014, the American Society for Clinical Oncology (ASCO) recommended moving toward bundled payments in an effort to standardize high-quality, value-based cancer care (22). Then, in 2019, with radiation oncology identified as a specialty exceeding the sustainable growth rate (23), the CMS proposed a new bundled payment model (RO-APM) (14). Of note, while bundled payments may decrease expenditures by reducing persistent use of extended fractionation schemes that are unsupported by evidence, they may also reduce use of complex radiation modalities which may, in select circumstances, improve patient outcomes. To combat this, the Final Rule announced by CMS mandates reporting of patient characteristics and established quality metrics. First, all episodes of bone metastases will require reporting of Clinical Data Elements including ECOG Performance Status, prior radiation to the site (yes/no), and spinal location (yes/no) (24), which is consistent with prior reports (Gillespie et al, submitted), though may warrant greater specification in national guidelines. Second, quality measures will include a plan of care for pain (CMW Quality ID #144), communication of the radiation treatment summary, and documentation of an advanced care plan (CMS Quality ID #47) (16). To further optimize outcomes in the setting of bundled payments, research is needed to establish benchmarks for appropriate use of complex treatments (especially SBRT) and identify patient-centered outcomes (such as skeletal-related events and toxicity) that could ensure avoidance of under-treatment.
There are several limitations to this study. First, our cohort includes Medicare recipients age ≥65, thereby excluding younger patients, those with private insurance, and those who pay out-of-pocket, thus limiting generalizability. Second, the dataset lacks clinical details which may have influenced choice of modality and fractionation including performance status, number of metastases, life expectancy, history of prior radiation, and the presence of complicated bone metastases, i.e. lesions with impending or existing pathologic fracture, neurologic compromise, and/or retreatment (25). Third, we could not account for the potential dependence between episodes from the same patient because the dataset does not include a patient identifier. Fourth, hospital-based outpatient facilities can encompass both tertiary centers and hospital-affiliated satellite sites (26). As such, we are unable to evaluate practice patterns at satellite centers separately, though such an investigation may be of future interest given their expanding role in cancer care (27). Lastly, the dataset does not specify the exact number of fractions delivered, thereby precluding assessment of single-fraction RT.
CONCLUSION
Despite multiple published guidelines, still 1-in-4 patients treated for bone metastases from 2015–2017 received long-course conventional EBRT. Fortunately, long-course EBRT is decreasing, though it is largely being replaced by complex treatments. This is occurring in both hospital-affiliated outpatient and freestanding settings, and therefore, likely reflects increasing use in routine practice rather than strictly on-trial, as current guidelines specify. As evidence emerges in support of complex radiation technologies, guidance on appropriate use in routine care is needed. Meanwhile, with systems-level changes in reimbursement forthcoming, metrics to better evaluate appropriate use and sustain high quality care are also needed.
Supplementary Material
Acknowledgments
FUNDING:
Dr. Bekelman reports funding from UnitedHealth Group and Pfizer, during the conduct of the study. Dr. Gillespie reports funding from the National Cancer Care Network/Pfizer EMBRACE. Dr. Yang reports funding from AstraZeneca and Kazia Therapeutics. The funders/sponsors had no role in the design and conduct of this study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Footnotes
CONFLICT OF INTEREST DISCLOSURES:
Dr. Bekelman reports personal fees from Optum, personal fees from CVS Health and personal fees in 2017 and 2018 from Actuarial Research Corporation as a consultant on radiation oncology to the Center for Medicare and Medicaid Services, Center for Medicare and Medicaid Innovation Center, unrelated to the submitted work. Dr. Gillespie is a co-founder of the educational website, eContour.org. Dr. Tsai reports fees as a consultant for Varian Medical, Inc. Dr. Yang reports fees as a consultant for Debiopharm, Galera Therapeutics, and ResTorBio.
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REFERENCES
- 1.Hernandez RK, Wade SW, Reich A, et al. Incidence of bone metastases in patients with solid tumors: Analysis of oncology electronic medical records in the united states. BMC Cancer 2018;18:44. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Chow E, Harris K, Fan G, et al. Palliative radiotherapy trials for bone metastases: A systematic review. J Clin Oncol 2007;25:1423–36. [DOI] [PubMed] [Google Scholar]
- 3.Spencer KL, van der Velden JM, Wong E, et al. Systematic review of the role of stereotactic radiotherapy for bone metastases. J Natl Cancer Inst 2019;111:1023–1032. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.Nguyen QN, Chun SG, Chow E, et al. Single-fraction stereotactic vs conventional multifraction radiotherapy for pain relief in patients with predominantly nonspine bone metastases: A randomized phase 2 trial. JAMA Oncol 2019;5:872–878. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Sprave T, Verma V, Forster R, et al. Randomized phase ii trial evaluating pain response in patients with spinal metastases following stereotactic body radiotherapy versus three-dimensional conformal radiotherapy. Radiother Oncol 2018;128:274–282. [DOI] [PubMed] [Google Scholar]
- 6.Gomez DR, Tang C, Zhang J, et al. Local consolidative therapy vs. Maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer: Long-term results of a multi-institutional, phase ii, randomized study. J Clin Oncol 2019;37:1558–1565. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Palma DA, Olson R, Harrow S, et al. Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): A randomised, phase 2, open-label trial. Lancet 2019;393:2051–2058. [DOI] [PubMed] [Google Scholar]
- 8.Phillips R, Shi WY, Deek M, et al. Outcomes of observation vs stereotactic ablative radiation for oligometastatic prostate cancer: The oriole phase 2 randomized clinical trial. JAMA Oncol 2020. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9.Hahn C, Kavanagh B, Bhatnagar A, et al. Choosing wisely: The american society for radiation oncology’s top 5 list. Pract Radiat Oncol 2014;4:349–55. [DOI] [PubMed] [Google Scholar]
- 10.Lutz ST, Jones J, Chow E. Role of radiation therapy in palliative care of the patient with cancer. J Clin Oncol 2014;32:2913–9. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Logan JK, Jiang J, Shih YT, et al. Trends in radiation for bone metastasis during a period of multiple national quality improvement initiatives. J Oncol Pract 2019;15:e356–e368. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.Gupta A, Wang P, Sedhom R, et al. Physician practice variability in the use of extended-fraction radiation therapy for bone metastases: Are we choosing wisely? JCO Oncol Pract 2020:JOP1900633. [DOI] [PubMed] [Google Scholar]
- 13.Muller DA, Wages NA, Statistician, et al. Stat rad: A prospective dose escalation clinical trial of single fraction scan-plan-qa-treat sbrt for painful osseous metastases. Pract Radiat Oncol 2020. [DOI] [PubMed] [Google Scholar]
- 14.. CMS. Medicare program; specialty care models to improve quality of care and reduce expenditures. In: Editor, editorêditors. Book Medicare program; specialty care models to improve quality of care and reduce expenditures, July 19 ed. Federal Register; 2019. [Google Scholar]
- 15.Gomez DR, Blumenschein GR Jr., Lee JJ, et al. Local consolidative therapy versus maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer without progression after first-line systemic therapy: A multicentre, randomised, controlled, phase 2 study. Lancet Oncol 2016;17:1672–1682. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16.CMS. Radiation oncology model. https://innovationcmsgov/innovation-models/radiation-oncology-model 2020.
- 17.Wallace AS, Fiveash JB, Williams CP, et al. Choosing wisely at the end of life: Use of shorter courses of palliative radiation therapy for bone metastasis. Int J Radiat Oncol Biol Phys 2018;102:320–324. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 18.Lutz S, Balboni T, Jones J, et al. Palliative radiation therapy for bone metastases: Update of an Astro evidence-based guideline. Pract Radiat Oncol 2017;7:4–12. [DOI] [PubMed] [Google Scholar]
- 19.Palma DA, Olson R, Harrow S, et al. Stereotactic ablative radiotherapy for the comprehensive treatment of oligometastatic cancers: Long-term results of the sabr-comet phase ii randomized trial. J Clin Oncol 2020:JCO2000818. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.CMS. Centers for medicare & medicaid services: National health expenditure data. https://wwwcmsgov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData 2019, December 17.
- 21.Cancer facts & figures 2020. https://wwwcancerorg/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2020html 2020.
- 22.Gill BS, Beriwal S, Rajagopalan MS, et al. Quantitative evaluation of radiation oncologists’ adaptability to lower reimbursing treatment programs. Pract Radiat Oncol 2015;5:267–73. [DOI] [PubMed] [Google Scholar]
- 23.Alhassani A, Chandra A, Chernew ME. The sources of the sgr “hole”. N Engl J Med 2012;366:289–91. [DOI] [PubMed] [Google Scholar]
- 24.CMS. Innovation for high-value radiotherapy: An informal request for information on radiation oncology model clinical data elements (cdes) from the center for medicare and medicaid innovation. https://innovationcmsgov/media/document/ro-clin-data-elements-rfi 2020.
- 25.Cheon PM, Wong E, Thavarajah N, et al. A definition of “uncomplicated bone metastases” based on previous bone metastases radiation trials comparing single-fraction and multi-fraction radiation therapy. J Bone Oncol 2015;4:13–7. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 26.CMS. Cms manual system pub. 100–07 state operations provider certification transmittal 57. https://wwwcmsgov/Regulations-and-Guidance/Guidance/Transmittals 2010.
- 27.Onega T, Alford-Teaster J, Wang F. Population-based geographic access to parent and satellite national cancer institute cancer center facilities. Cancer 2017;123:3305–3311. [DOI] [PubMed] [Google Scholar]
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