Contemporary Statewide Practice Pattern Assessment of the Palliative Treatment of Bone Metastasis.

PURPOSE: Palliative radiation therapy for bone metastases is often viewed as a single entity, despite national guidelines providing input principally only for painful uncomplicated bone metastases. Data surrounding the treatment of bone metastases are often gleaned from questionnaires of what providers would theoretically do in practice or from population-based data lacking critical granular information. We investigated the real-world treatment of bone metastases with radiation therapy. METHODS AND MATERIALS: Twenty diverse institutions across the state of Michigan had data extracted for their 10 most recent cases of radiation therapy delivered for the treatment of bone metastases at their institution between January and February 2017. Uni- and multivariable binary logistic regression was used to assess the use of single fraction (8 Gy × 1) radiation therapy. RESULTS: A total of 196 cases were eligible for inclusion. Twenty-eight different fractionation schedules were identified. The most common schedule was 3 Gy × 10 fractions (n = 100; 51.0%), 4 Gy × 5 fractions (n = 32; 16.3%), and 8 Gy × 1 (n = 15; 7.7%). The significant predictors for the use of single fraction radiation therapy were the presence of oligometastatic disease (P = .008), previous overlapping radiation therapy (P = .050), and academic practice type (P = .039). Twenty-nine cases (14.8%) received >10 fractions (median 15, range 11-20). Intensity modulated radiation therapy was used in 14 cases (7.1%), stereotactic body radiation therapy in 11 (5.6%), and image guidance with cone beam computed tomography in 11 (5.6%). Of the cases of simple painful bone metastases (no previous surgery, spinal cord compression, fracture, soft tissue extension, or overlapping previous radiation therapy; n = 70), only 12.9% were treated with 8 Gy × 1. CONCLUSIONS: Bone metastases represent a heterogeneous disease, and radiation therapy for bone metastases is similarly diverse. Future work is needed to understand the barriers to single fraction use, and clinical trials are necessary to establish appropriate guidelines for the breadth of this complex disease.

Investigation of the diffusion abnormality index as a new imaging biomarker for early assessment of brain tumor response to radiation therapy.

BACKGROUND: Diffusion MRI, although having the potential to be a biomarker for early assessment of tumor response to therapy, could be confounded by edema and necrosis in or near the brain tumors. This study aimed to develop and investigate the ability of the diffusion abnormality index (DAI) to be a new imaging biomarker for early assessment of brain metastasis response to radiation therapy (RT). METHODS: Patients with either radiosensitive or radioresistant brain metastases that were treated by whole brain RT alone or combined with bortezomib as a radiation sensitizer had diffusion-weighted (DW) MRI pre-RT and 2 weeks (2W) after starting RT. A patient-specific diffusion abnormality probability function (DAProF) was created to account for abnormal low and high apparent diffusion coefficients differently, reflecting respective high cellularity and edema/necrosis. The DAI of a lesion was then calculated by the integral of DAProF-weighted tumor apparent diffusion coefficient histogram. The changes in DAI from pre-RT to 2W were evaluated for differentiating the responsive, stable, and progressive tumors and compared with the changes in gross tumor volume and conventional diffusion metrics during the same time interval. RESULTS: In lesions treated with whole brain RT, the DAI performed the best among all metrics in predicting the posttreatment response of brain metastases to RT. In lesions treated with whole brain RT + bortezomib, although DAI was the best predictor, the performance of all metrics worsened compared with the first group. CONCLUSIONS: The ability of DAI for early assessment of brain metastasis response to RT depends upon treatment regimes.

Adoption of intensity-modulated radiation therapy for breast cancer in the United States.

BACKGROUND: Although intensity modulation of the radiation beam has been shown to lower toxic effects for patients receiving whole-breast irradiation, relatively simple techniques may suffice. It is thus controversial whether such treatment justifies billing for intensity-modulated radiation therapy (IMRT). METHODS: We used the claims data to determine billing for IMRT from Surveillance, Epidemiology, and End Results-Medicare records from 2001 to 2005 for 26,163 women aged 66 years or older with nonmetastatic breast cancer treated with surgery and radiotherapy. The impact of individual covariates (demographic, health services, tumor, and treatment factors) on cost of treatment was assessed using the Wilcoxon two-sample test. Two-sided multivariable logistic regression was used to identify predictors for IMRT use. Cost of radiation was calculated in 2005 dollars. All statistical tests were two-sided. RESULTS: The number of patients with IMRT billing claims increased from 0.9% (49 of 5196) of patients diagnosed in 2001 to 11.2% (564 of 5020) in 2005. In multivariable analysis, IMRT billing was more likely for patients with left-sided tumors (odds ratio [OR] = 1.30, 95% confidence interval [CI] = 1.16 to 1.45), for those residing in a health service area with high radiation oncologist density (OR = 2.32, 95% CI = 1.47 to 3.68), for those treated at freestanding radiation centers (OR = 1.36, 95% CI = 1.20 to 1.53), or for those residing in regions where the Medicare intermediary allowed breast IMRT (OR = 10.87, 95% CI = 9.26 to 12.76, all P < .001). The mean cost of radiation was $7179 without IMRT and $15 230 with IMRT. IMRT adoption contributed to an increase in the mean cost of breast radiation from $6334 in 2001 to $8473 in 2005. CONCLUSIONS: IMRT billing increased 10-fold from 2001 through 2005, contributing to a 33% increase in the cost of breast radiation. These findings suggest that reimbursement policy and practice setting strongly influenced adoption of IMRT billing for breast cancer.

Assessing the benefit of radiation therapy after breast-conserving surgery for ductal carcinoma-in-situ.

PURPOSE: To assess women's preferences regarding the trade-off between the risks and benefits of treatment with radiation therapy (RT) after breast-conserving surgery (BCS) for ductal carcinoma-in-situ (DCIS). PATIENTS AND METHODS: Utilities were obtained from 120 patients and 210 nonpatients for eight relevant health states using standard gambles. RESULTS: Differences in utilities obtained from patient and nonpatient participants between health states were relatively similar. Reduction in the likelihood of local recurrence associated with RT did not result in higher utilities. Utilities for noninvasive recurrence were only lower after initial treatment with RT. Patient and nonpatient participants had the lowest utilities for invasive local recurrence, regardless of initial treatment or manner of salvage therapy. When comparing patient and nonpatient utilities directly, patients had higher utility for being without recurrence after initial RT and lower utility for invasive recurrence salvaged by mastectomy after initial BCS alone. None of the clinical or sociodemographic factors examined explained more than 5% of the variability in the patients' or nonpatients' utilities or their differences. CONCLUSION: The principal benefit associated with adding RT to BCS for DCIS seems to be its ability to reduce invasive recurrences.

A cost comparison analysis of partial versus whole-breast irradiation after breast-conserving surgery for early-stage breast cancer.

PURPOSE: To assess, if and for whom, there are cost savings associated with alternate breast radiotherapy (RT) techniques when compared with the conventional external beam-based whole-breast RT with a boost (WBRT-B). METHODS AND MATERIALS: Treatment planning and delivery utilization data were modeled for eight different breast RT techniques: (1) WBRT-B: 60 Gy in 30 fractions; (2) WBRT: 50 Gy in 25 fractions; (3) WBRT-accelerated (AC): 42.5 Gy in 16 fractions; (4) WBRT-intensity-modulated RT (IMRT): 60 Gy in 30 fractions; (5) accelerated partial breast irradiation (APBI)-IC, MammoSite: 34 Gy in 10 twice-daily fractions; (6) APBI-IT, HDR interstitial: 34 Gy in 10 twice-daily fractions; (7) APBI three-dimensional conformal RT (3D-CRT): 38.5 Gy in 10 twice-daily fractions; or (8) APBI-IMRT: 38.5 Gy in 10 twice-daily fractions. Costs incurred by payer (i.e., direct medical costs; 2003 Medicare Fee Schedule) and patient (i.e., direct nonmedical costs; time and travel) were estimated. Total societal costs were then calculated for each treatment approach. RESULTS: Not all efforts to reduce overall treatment time result in total cost savings. The least expensive partial breast-based RT approaches were the external beam techniques (APBI-3D-CRT, APBI-IMRT). Any reduced cost to patients for the HDR brachytherapy-based APBI regimens were overshadowed by substantial increases in cost to payers, resulting in higher total societal costs; the cost of HDR treatment delivery was primarily responsible for the increased direct medical cost. For the whole breast-based RT approaches, treating without a boost (WBRT) or with WBRT-AC reduced total costs. Overall, WBRT-AC was the least costly of all the regimens, in terms of costs to society; APBI approaches, in general, were favored over whole-breast techniques when only considering costs to patients. CONCLUSIONS: Based on societal cost considerations, WBRT-AC appears to be the preferred approach. If one were to pursue a partial-breast RT regimen to minimize patient costs, it would be more advantageous from a societal perspective to pursue external beam-based approaches such as APBI-3D-CRT or APBI-IMRT in lieu of the brachytherapy-based regimens.

Cost-effectiveness of radiation therapy following conservative surgery for ductal carcinoma in situ of the breast.

PURPOSE: To assess the cost-effectiveness of radiation therapy (RT) in patients with ductal carcinoma in situ (DCIS) after breast-conserving surgery (BCS). METHODS AND MATERIALS: A Markov model was constructed for a theoretical cohort of 55-year-old women with DCIS over a life-time horizon. Probability estimates for local noninvasive (N-INV), local invasive (INV), and distant recurrences were obtained from National Surgical Adjuvant Breast and Bowel Project (NSABP) B-17. Utilities for eight nonmetastatic health states were collected from both healthy women and DCIS patients. Direct medical (2002 Medicare fee schedule) and nonmedical costs (time and transportation) of RT were ascertained. RESULTS: For BCS + RT vs. BCS alone, the estimated N-INV and INV rates at 12 years were 9% and 8% vs. 16% and 18%, respectively. The incremental cost of adding RT was 3300 US dollars despite an initial RT cost of 8700 US dollars due to higher local recurrence-related salvage costs incurred with the BCS alone strategy. An increase of 0.09 quality-adjusted life-years (QALYs) primarily reflected the lower risk of INV with RT, resulting in an incremental cost-effectiveness ratio (ICER) of 36,700 US dollars/QALY. Sensitivity analyses revealed the ICER to be affected by baseline probability of a local recurrence, relative efficacy of RT in preventing INV, negative impact of an INV on quality of life, and cost of initial RT. Cost of salvage BCS + RT and source of utilities (healthy women vs. DCIS patients) influenced the ICER albeit to a lesser degree. CONCLUSIONS: Addition of RT following BCS for patients with DCIS should not be withheld because of concerns regarding its cost-effectiveness.

Prospective quality-of-life assessment in patients receiving concurrent gemcitabine and radiotherapy as a bladder preservation strategy.

OBJECTIVES: To assess, in a Phase I study, whether bladder preservation with concurrent gemcitabine and radiotherapy (RT) influenced patient-reported quality of life (QOL) as determined by the Functional Assessment of Cancer Therapy-Bladder (FACT-BL). METHODS: Between January 1998 and March 2002, 24 patients with urothelial carcinoma of the bladder were enrolled, and 23 patients underwent transuretheral resection of bladder tumor, followed by twice-weekly gemcitabine with concurrent RT. The initial dose was 10 mg/m2 given twice weekly and increased as tolerated. To assess treatment-related QOL, patients completed the FACT-BL questionnaire. RESULTS: Of the 24 patients enrolled, 23 (96%) were assessed for toxicity and response. The FACT-generic (G) QOL assessment was obtained from 22 (92%) of 23 patients. No statistically significant difference was found in the FACT-G or FACT-BL or the combination before, during, or after treatment. The FACT-BL values were lower in patients who received higher doses of gemcitabine (greater than 20 mg/m2 versus 20 mg/m2 or less). At least one dose-limiting toxicity (DLT) was experienced by 5 (23%) of 22 patients. The FACT-G values were lower for those patients who experienced DLT (difference of -13.1, P = 0.07). The physical well-being scores for patients who experienced DLT were lower after treatment (difference of -5.2, P = 0.03) compared with those without DLT. CONCLUSIONS: Concurrent RT and gemcitabine failed to statistically influence patient-reported QOL, although patients who received higher doses reported lower FACT-BL scores. The results of this study suggest that concurrent gemcitabine with conformal RT is a tolerable treatment regimen for bladder preservation, as demonstrated by the excellent treatment compliance and similar FACT measurements.

Out-of-pocket health-care expenditures among older Americans with cancer.

OBJECTIVE: There is currently limited information regarding the out-of-pocket expenditures (OOPE) for medical care made by elderly individuals with cancer. We sought to quantify OOPE for community-dwelling individuals age 70 or older with: 1) no cancer (No CA), 2) a history of cancer, not undergoing current treatment (CA/No Tx), and 3) a history of cancer, undergoing current treatment (CA/Tx). METHODS: We used data from the 1995 Asset and Health Dynamics Study, a nationally representative survey of community-dwelling elderly individuals. Respondents identified their cancer status and reported OOPE for the prior 2 years for: 1) hospital and nursing home stays, 2) outpatient services, 3) home care, and 4) prescription medications. Using a multivariable two-part regression model to control for differences in sociodemographics, living situation, functional limitations, comorbid chronic conditions, and insurance coverage, the additional cancer-related OOPE were estimated. RESULTS: Of the 6370 respondents, 5382 (84%) reported No CA, 812 (13%) reported CA/No Tx, and 176 (3%) reported CA/Tx. The adjusted mean annual OOPE for the No CA, CA/No Tx, and CA/Tx groups were 1210 dollars, 1450 dollars, and 1880 dollars, respectively (P < .01). Prescription medications (1120 dollars per year) and home care services (250 dollars) accounted for most of the additional OOPE associated with cancer treatment. Low-income individuals undergoing cancer treatment spent about 27% of their yearly income on OOPE compared to only 5% of yearly income for high-income individuals with no cancer history (P < .01). CONCLUSIONS: Cancer treatment in older individuals results in significant OOPE, mainly for prescription medications and home care services. Economic evaluations and public policies aimed at cancer prevention and treatment should take note of the significant OOPE made by older Americans with cancer.

Estimating the costs of caring for the older breast cancer patient.

As the population ages, it is expected that more and more elderly women will be diagnosed with breast cancer. Relatively little is known about the cost of caring for this group of patients. The goals of this article will be to introduce the relevant types of costs, to review the available data on these costs and to conclude with some thoughts regarding areas for future research.

Decision-analytic model and cost-effectiveness evaluation of postmastectomy radiation therapy in high-risk premenopausal breast cancer patients.

PURPOSE: To present a decision model that describes the clinical and economic outcomes of node-positive breast cancer with and without postmastectomy radiation therapy (PMRT). METHODS: A Markov process was constructed to project the natural history of breast cancer following mastectomy in premenopausal node-positive women. Biannual hazards of local and distant recurrence without PMRT were derived from a large meta-analysis of adjuvant systemic therapy trials for breast cancer. The addition of PMRT reduced the risk of disease relapse by an odds ratio of 0.69. Costs of PMRT ($11,600) and recurrent breast cancer ($4,250 to 16,200/year) were estimated from available literature. The model projected number of recurrences, relapse-free and overall survival, and costs to 15 years, using a discount rate of 3%. Cost-effectiveness ratios were calculated per incremental year of life and quality-adjusted year of life gained. One- and two-way sensitivity analyses were performed to determine the sensitivity of results to clinical and economic assumptions. RESULTS: The model projected 15-year relapse-free survival of 52% and 43% with and without PMRT, respectively. Overall survival was increased from 48% to 55% with PMRT, resulting in an incremental 0.29 years of life gained per subject. PMRT increased 15-year costs from $40,800 to $48,100. Cost per year of life gained was $24,900, or $22,600 when survival was adjusted for quality of life. Results of the model were relatively sensitive to radiation therapy cost and breast cancer relapse risk. CONCLUSION: This analysis suggests that PMRT offers substantial clinical benefits achieved in a cost-effective manner, with an average cost per year of life gained of $24,900. Results of the model were robust under a wide range of clinical and economic parameters.

Comparing the costs of radiation therapy and radical prostatectomy for the initial treatment of early-stage prostate cancer.

PURPOSE: Radical prostatectomy and external-beam radiation are the most common treatments for localized prostate cancer. Given the absence of clinical consensus in favor of one treatment or the other, relative costs may be a significant factor. This study compares the direct medical costs during the month before and 9 months after diagnosis for patients treated primarily with external-beam radiation or radical prostatectomy for early-stage prostate cancer. METHODS: Patients age 65 or older and coded by the Surveillance, Epidemiology, and End Results (SEER) registry as having been diagnosed with adenocarcinoma of the prostate treated primarily with external-beam radiation or radical prostatectomy during 1992 and 1993 were identified. The initial treatment costs, as measured by Medicare-approved payment amounts, for each strategy were analyzed using linked SEER-Medicare claims data after adjusting for differences in comorbidity and age. An intent-to-treat analysis was also performed to adjust for differences in staging between the two groups. RESULTS: For patients in the treatment-received analysis, the average costs were significantly different; $14,048 (95% confidence interval [CI], $13,765 to $14,330) for radiation therapy and $17,226 (95% CI, $16,891 to $17,560) for radical prostatectomy (P <.001). The average costs for patients in the intent-to-treat analysis were also significantly less for radiation therapy patients ($14,048; 95% CI, $13,765 to $14,330) than for those who underwent radical prostatectomy ($17,516; 95% CI, $17,195 to $17,837; P <.001). CONCLUSION: For patients with early-stage prostate cancer, average costs during the initial treatment interval were at least 23% greater for radical prostatectomy than for external-beam radiation. Major limitations of the research include not studying costs after the initial treatment interval and questionable current applicability, given changes in management of early prostate cancer.