Pamela R. Soulos

Re: Proton vs Intensity-Modulated Radiotherapy for Prostate Cancer: Patterns of Care and Early Toxicity

Over the past decade, intensity modulated radiotherapy (IMRT) has become the standard form of radiotherapy for the treatment of prostate cancer, accounting for more than 80% of all radiotherapy (1). Even as IMRT has been widely adopted, other radiotherapy modalities have come to market, most notably proton radiotherapy (PRT). Although PRT predates IMRT, dissemination of PRT has been increasing rapidly in recent years. In part because of its high capital cost, Medicare is reported to reimburse PRT at a rate 1.4 to 2.5 times that of IMRT (2–4), despite many unexplored questions. First, there is a lack of data regarding national patterns of use and the true cost of PRT among Medicare beneficiaries. Currently, there are only nine PRT centers in operation in the United States (5), and this relatively low treatment capacity limits costs. However, eight other centers are in development (5), along with smaller and more affordable proton machines (6), conceivably opening the door to more widespread adoption of PRT across the country. Second, the Institute for Clinical and Economic Review concluded unanimously that the state of current knowledge of comparative clinical effectiveness was “insufficient” (7,8). Because differences in cancer cure rates and survival from prostate cancer treatment often take many years to become evident, it has been suggested that initial study of prostate cancer treatments should focus on treatment-related toxicity (8). Proponents of PRT argue that the physical properties of protons may decrease the most common side effects associated with prostate radiotherapy—gastrointestinal and genitourinary toxicity (9). Early outcomes from single-arm, prospective trials investigating PRT are forthcoming, indicating low levels of radiation-induced toxicity with early follow-up (10,11). However, IMRT itself has a robust literature describing excellent efficacy and low toxicity in the treatment of prostate cancer (12). Therefore, it is unclear that PRT offers a statistically significant benefit beyond IMRT. Prior studies investigating PRT in Medicare beneficiaries using the Surveillance, Epidemiology, and End Results–Medicare database have been single-institution studies (13,14) and, therefore, are not of the whole country. These studies (13,14) noted a statistically significant reduction of gastrointestinal toxicity for patients undergoing IMRT compared with PRT. A comprehensive comparison of PRT with IMRT requires examination of the entire country for the most recent years available. As more PRT centers become operational, it will be crucial for patients, providers, and policy makers to understand the cost and national pattern of adoption of PRT and the incidence of treatment-related toxicity compared with IMRT. Therefore, we used a national sample of Medicare beneficiaries with prostate cancer to investigate the patterns and cost of PRT delivery, as well as the early treatment-related toxicity associated with PRT compared with IMRT.

Stereotactic Body Radiation Therapy Versus Intensity-Modulated Radiation Therapy for Prostate Cancer: Comparison of Toxicity

PURPOSE Stereotactic body radiation therapy (SBRT) is a technically demanding prostate cancer treatment that may be less expensive than intensity-modulated radiation therapy (IMRT). Because SBRT may deliver a greater biologic dose of radiation than IMRT, toxicity could be increased. Studies comparing treatment cost to the Medicare program and toxicity are needed. METHODS We performed a retrospective study by using a national sample of Medicare beneficiaries age ≥ 66 years who received SBRT or IMRT as primary treatment for prostate cancer from 2008 to 2011. Each SBRT patient was matched to two IMRT patients with similar follow-up (6, 12, or 24 months). We calculated the cost of radiation therapy treatment to the Medicare program and toxicity as measured by Medicare claims; we used a random effects model to compare genitourinary (GU), GI, and other toxicity between matched patients. RESULTS The study sample consisted of 1,335 SBRT patients matched to 2,670 IMRT patients. The mean treatment cost was

Assessing the Impact of a Cooperative Group Trial on Breast Cancer Care in the Medicare Population

13,645 for SBRT versus

Patterns of Use and Short-Term Complications of Breast Brachytherapy in the National Medicare Population From 2008-2009

21,023 for IMRT. In the 6 months after treatment initiation, 15.6% of SBRT versus 12.6% of IMRT patients experienced GU toxicity (odds ratio [OR], 1.29; 95% CI, 1.05 to 1.53; P = .009). At 24 months after treatment initiation, 43.9% of SBRT versus 36.3% of IMRT patients had GU toxicity (OR, 1.38; 95% CI, 1.12 to 1.63; P = .001). The increase in GU toxicity was due to claims indicative of urethritis, urinary incontinence, and/or obstruction. CONCLUSION Although SBRT was associated with lower treatment costs, there appears to be a greater rate of GU toxicity for patients undergoing SBRT compared with IMRT, and prospective correlation with randomized trials is needed.

Adoption of hypofractionated whole-breast irradiation for early-stage breast cancer: a National Cancer Data Base analysis.

PURPOSE The Cancer and Leukemia Group B (CALGB) C9343 trial found that adjuvant radiation therapy (RT) provided minimal benefits for older women with breast cancer. Although treatment guidelines were changed to indicate that some women could forego RT, the impact of the C9343 results on clinical practice is unclear. PATIENTS AND METHODS We used the Surveillance, Epidemiology, and End Results (SEER) -Medicare data set to assess the use of adjuvant RT in a sample of women ≥ 70 years old diagnosed with stage I breast cancer from 2001 to 2007 who fulfilled the C9343 inclusion criteria. We used log-binomial regression to estimate the relation between publication of C9343 and use of RT in the full sample and across strata of patient and health system characteristics. RESULTS Of the 12,925 Medicare beneficiaries in our sample (mean age, 77.7 years), 76.5% received RT. Approximately 79% of women received RT before study publication compared with 75% after (adjusted relative risk of receiving RT postpublication v prepublication: 0.97; 95% CI, 0.95 to 0.98). Although use of RT was lower after the trial within all strata of age and life expectancy, the magnitude of this decrease did not differ significantly by strata. For instance, among patients with life expectancy less than 5 years, RT use decreased by 3.7%, from 44.4% prepublication to 40.7% postpublication. Among patients with life expectancy ≥ 10 years, RT use decreased by 3.0%, from 92.0% to 89.0%. CONCLUSION The C9343 trial had minimal impact on the use of RT among older women in the Medicare population, even among the oldest women and those with shorter life expectancies.

Anesthesiologist Involvement in Screening Colonoscopy: Temporal Trends and Cost Implications in the Medicare Population

PURPOSE Brachytherapy has disseminated into clinical practice as an alternative to whole-breast irradiation (WBI) for early-stage breast cancer; however, current national treatment patterns and associated complications remain unknown. PATIENTS AND METHODS We constructed a national sample of Medicare beneficiaries ages 66 to 94 years who underwent breast-conserving surgery from 2008 to 2009 and were treated with brachytherapy or WBI. We used hospital referral regions (HRRs) to assess national treatment variation and an instrumental variable analysis to compare complication rates between treatment groups, adjusting for patient and clinical characteristics. We compared overall, wound and skin, and deep-tissue and bone complications between brachytherapy and WBI at 1 year of follow-up. RESULTS Of 29,648 women in our sample, 4,671 (15.8%) received brachytherapy. The percent of patients receiving brachytherapy varied substantially across HRRs, ranging from 0% to over 70% (interquartile range, 7.5% to 23.3%). Of women treated with brachytherapy, 34.3% had a complication compared with 27.3% of women undergoing WBI (P < .001). After adjusting for patient and clinical characteristics, 35.2% of women treated with brachytherapy (95% CI, 28.6 to 41.9) had a complication compared with 18.4% treated with WBI (95% CI, 15.5 to 21.3; P value for difference, <.001). Brachytherapy was associated with a 16.9% higher rate of wound and skin complications compared with WBI (95% CI, 10.0 to 23.9; P < .001), but there was no difference in deep-tissue and bone complications. CONCLUSION Brachytherapy is commonly used among Medicare beneficiaries and varies substantially across regions. After 1 year, wound and skin complications were significantly higher among women receiving brachytherapy compared with those receiving WBI.

Estimating the magnitude of colorectal cancers prevented during the era of screening: 1976 to 2009

PURPOSE To evaluate the relationship of patient, hospital, and cancer characteristics with the adoption of hypofractionation in a national sample of patients diagnosed with early-stage breast cancer. METHODS AND MATERIALS We performed a retrospective study of breast cancer patients in the National Cancer Data Base from 2004-2011 who were treated with radiation therapy and met eligibility criteria for hypofractionation. We used logistic regression to identify factors associated with receipt of hypofractionation (vs conventional fractionation). RESULTS We identified 13,271 women (11.7%) and 99,996 women (88.3%) with early-stage breast cancer who were treated with hypofractionation and conventional fractionation, respectively. The use of hypofractionation increased significantly, with 5.4% of patients receiving it in 2004 compared with 22.8% in 2011 (P<.001 for trend). Patients living ≥50 miles from the cancer reporting facility had increased odds of receiving hypofractionation (odds ratio 1.57 [95% confidence interval 1.44-1.72], P<.001). Adoption of hypofractionation was associated with treatment at an academic center (P<.001) and living in an area with high median income (P<.001). Hypofractionation was less likely to be used in patients with high-risk disease, such as increased tumor size (P<.001) or poorly differentiated histologic grade (P<.001). CONCLUSIONS The use of hypofractionation is rising and is associated with increased travel distance and treatment at an academic center. Further adoption of hypofractionation may be tempered by both clinical and nonclinical concerns.

Comparative effectiveness of surgery and radiosurgery for stage I non–small cell lung cancer

BACKGROUND & AIMS Colonoscopy is a recommended component of screening for colorectal cancer. We conducted a retrospective study of Medicare data to determine the frequency of anesthesiologist involvement and to identify patient and provider characteristics and cost implications associated with anesthesiologist involvement. METHODS We used the linked Surveillance, Epidemiology, and End Results Medicare dataset to identify patients without cancer who received a screening colonoscopy examination from July 2001 through 2006 (n = 16,268). The outcome variable was anesthesiologist involvement, which was identified by searching Medicare claims. Logistic regression was used to explore the association between patient and provider characteristics and anesthesiologist involvement. Costs associated with the use of an anesthesiologist were derived based on a cost assessment by the Agency for Healthcare Research and Quality. RESULTS Of the screening colonoscopies assessed, 17.2% involved an anesthesiologist. The screening colonoscopy rate more than doubled during the study period. The frequency of anesthesiologist involvement increased from 11.0% of screening colonoscopies in 2001 to 23.4% in 2006. Surgeons involved an anesthesiologist in 24.2% of colonoscopies, compared with 18.0% of gastroenterologists and 11.3% of primary care providers. The percentage of colonoscopies that involved an anesthesiologist varied among regions, ranging from 1.6% in San Francisco to 57.8% in New Jersey. Anesthesiologist involvement increased the cost by approximately 20% per screening colonoscopy. CONCLUSIONS An increase in the involvement of anesthesiologists has significantly increased the cost of screening colonoscopies. Studies are needed to assess the effects of anesthesiologists on risks and benefits of colonoscopy, to determine the most safe and cost-effective approaches.

The cost implications of prostate cancer screening in the Medicare population

Ideally, screening detects cancer at a more curable stage and, as a result, decreases the rate of subsequent diagnosis at a late stage. Although it is suggested that some cancer screening tests have led to substantial increases in early‐stage incidence with only marginal reductions in late‐stage incidence (eg mammography), the association between temporal trends in colorectal cancer screening and its cumulative impact on colorectal cancer incidence is unknown.

The adoption of new adjuvant radiation therapy modalities among Medicare beneficiaries with breast cancer: clinical correlates and cost implications.

Although surgery is the standard treatment for early‐stage non–small cell lung cancer (NSCLC), stereotactic body radiotherapy (SBRT) has been disseminated as an alternative therapy. The comparative mortalities and toxicities of these treatments for patients of different life expectancies are unknown.