National Quality Measure Compliance for Palliative Bone Radiation Among Patients With Metastatic Non-Small Cell Lung Cancer.

BACKGROUND: There exists wide practice variability in palliative treatment schedules for bone metastases. In an effort to reduce variation and promote high-quality, cost-conscious care, the National Quality Forum (NQF) endorsed measure 1822 in 2012. This measure recommends the use of 30 Gy in 10 fractions, 24 Gy in 6 fractions, 20 Gy in 5 fractions, or 8 Gy in a single fraction for palliative radiation for bone metastases. We report on longitudinal compliance with this measure. METHODS: Using the National Cancer Database, patients with metastatic thoracic non-small cell lung cancer diagnosed between 2004 and 2016 who received radiation therapy for bony sites of metastatic disease were identified. Treatment courses fitting 1 of the 4 recommended schedules under NQF 1822 were coded as compliant. Rates of compliance by patient, tumor, and treatment characteristics were analyzed. RESULTS: A total of 42,685 patients met the criteria for inclusion. Among all patients, 60.2% of treatment courses were compliant according to NQF 1822. Compliance increased over time and was highest for treatments to the extremity (69.8%), lowest for treatments to the skull or head (48.8%), and higher for academic practice (67.1%) compared with community (56.0%) or integrated network facilities (61.2%). On multivariable analysis, predictors of NQF 1822 compliance included year of diagnosis after 2011, treatment to an extremity, or treatment at an academic facility. Of noncompliant treatment courses, extended fractionation (≥11 fractions) occurred in 62.6% and was more common before 2012, in community practice, and for treatments of the skull or head. CONCLUSIONS: Among patients treated for metastatic non-small cell lung cancer, compliance with NQF 1822 increased over time. Although extended fractionation constituted a majority of noncompliant treatment courses, a substantial proportion also involved shorter courses.

Does a Custom Electronic Health Record Alert System Improve Physician Compliance With National Quality Measures for Palliative Bone Metastasis Radiotherapy?

PURPOSE: In an effort to promote cost-conscious, high-quality, and patient-centered care in the palliative radiation of painful bone metastases, the National Quality Forum (NQF) formed measure 1822 in 2012, which recommends the use of one of the four dose-fractionation schemes (30 Gy in 10 fractions, 24 Gy in 6 fractions, 20 Gy in 5 fractions, or 8 Gy in a single fraction). We investigated whether a custom electronic health record (EHR) alert system improved quality measure compliance among 88 physicians at a large academic center and institutional network. METHODS: In March 2018, a multiphase alert system was embedded in a custom web-based EHR. Prior to a course of palliative bone radiation, the alert system notified the user of NQF 1822 recommendations and, once prescription was completed, either affirmed compliance or advised a change in treatment schedule. Rates of compliance were evaluated before and after implementation of alert system. RESULTS: Of 2,399 treatment courses, 86.5% were compliant with NQF 1822 recommendations. There was no difference in rates of NQF 1822 compliance before or after implementation of the custom EHR alert (86.0% before March 2018 v 86.9% during and after March 2018, P = .551). CONCLUSION: There was no change in rates of compliance following implementation of a custom EHR alert system designed to make treatment recommendations based on national quality measure guidelines. To be of most benefit, future palliative bone metastasis decision aids should leverage peer review, target a clear practice deficiency, center upon high-quality practice guidelines, and allow flexibility to reflect the diversity of clinical scenarios.

A Dosimetric Comparison of Oral Cavity Sparing in the Unilateral Treatment of Early Stage Tonsil Cancer: IMRT, IMPT, and Tongue-Deviating Oral Stents.

INTRODUCTION: Tongue-deviating oral stents (TDOS) are commonly used during unilateral neck radiation therapy to reduce unnecessary dose to nontarget oral structures. Their benefit in the setting of highly conformal treatment techniques, however, is not defined. The goal of this study was to investigate the potential benefit of TDOS use on dosimetric parameters in unilateral intensity modulated radiation therapy (IMRT) and intensity modulated proton therapy (IMPT). METHODS: A total of 16 patients with T1-2 tonsil cancer treated at a single institution were selected, of which 8 were simulated/treated with a TDOS and 8 without a TDOS. All received definitive unilateral IMRT to a dose of 66 Gy in 30 fx. IMPT plans were generated for each patient for study purposes and optimized according to standard institutional practice. RESULTS: For IMRT plans, the presence of a TDOS (vs without) was associated with a significantly lower oral mucosa mean dose (31.4 vs 35.3 Gy; P = .020) and V30 (42.7% vs 57.1%; P = .025). For IMPT plans, the presence of TDOS (vs without) was not associated with any improvement in oral mucosa mean dose (18.3 vs 19.9 Gy; P = .274) or V30 (25.0% vs 26.2%; P = .655). IMPT plans without TDOS compared with IMRT plans with TDOS demonstrated reduced oral mucosa mean dose (P < .001) and V30 (P < .001). CONCLUSION: The use of a TDOS for the unilateral treatment of well-lateralized tonsil cancers was associated with oral mucosa sparing for IMRT, but not for IMPT. Moreover, mucosa sparing was improved for IMPT plans without a TDOS compared to IMRT plans with a TDOS.

Racial and Ethnic Disparities Among Participants in US-Based Phase 3 Randomized Cancer Clinical Trials.

Although improving representation of racial and ethnic groups in United States clinical trials has been a focus of federal initiatives for nearly 3 decades, the status of racial and ethnic minority enrollment on cancer trials is largely unknown. We used a broad collection of phase 3 cancer trials derived from ClinicalTrials.gov to evaluate racial and ethnic enrollment among US cancer trials. The difference in incidence by race and ethnicity was the median absolute difference between trial and corresponding Surveillance, Epidemiology, and End Results data. All statistical tests were 2-sided. Using a cohort of 168 eligible trials, median difference in incidence by race and ethnicity was +6.8% for Whites (interquartile range [IQR] = +1.8% to +10.1%; P < .001 by Wilcoxon signed-rank test comparing median difference in incidence by race and ethnicity to a value of 0), -2.6% for Blacks (IQR = -5.1% to +1.2%; P = .004), -4.7% for Hispanics (IQR = -7.5% to -0.3%; P < .001), and -4.7% for Asians (IQR = -5.7% to -3.3%; P < .001). These data demonstrate overrepresentation of Whites, with continued underrepresentation of racial and ethnic minority subgroups.

Stereotactic Body Radiation Therapy for the Definitive Treatment of Early Stage Kidney Cancer: A Survival Comparison With Surgery, Tumor Ablation, and Observation.

PURPOSE: Partial nephrectomy is the preferred definitive treatment for early stage kidney cancer, with tumor ablative techniques or active surveillance reserved for patients not undergoing surgery. Stereotactic body radiation therapy (SBRT) has emerged as a potential noninvasive alternative for patients with early stage kidney cancer not amenable to surgery, with early reports suggesting excellent rates of local control and limited toxicity. METHODS AND MATERIALS: The national cancer database from 2004 to 2014 was queried for patients who received a diagnosis of T1N0M0 kidney cancer. Treatments were categorized as surgery (partial or total nephrectomy), tumor ablation (cryoablation or thermal ablation), SBRT (radiation therapy in 5 fractions or less to a total biological effective dose [BED10] of 72 or more), or observation. A propensity score was generated by multinomial logistic regression. A Cox proportional hazards model was fit to determine association between overall survival and treatment group with propensity score adjustments for patient, demographic, and treatment characteristics. RESULTS: A total of 165,298 received surgery, 17,196 underwent tumor ablation, 104 underwent SBRT, and 18,241 were observed. Median follow-up was 51 months. On multivariable analysis, surgery, tumor ablation, and SBRT were associated with a decreased risk of death compared with observation, with hazard ratios of 0.25 (95% confidence interval, 0.24-0.26, P < .001), 0.36 (0.35-0.38, P < .001), and 0.56 (0.39-0.79, P < .001), respectively. When stratifying by BED10 and compared with observation, hazard ratio for risk of death for patients treated with SBRT to a BED10 ≥100 (n = 62) and a BED10 <100 (n = 42) was 0.34 (0.19-0.60, P < .001) and 0.90 (0.58-1.4, P = .64), respectively. CONCLUSIONS: In this population-based cohort, patients undergoing high-dose SBRT (BED10 ≥100) for early stage kidney cancer demonstrated longer survival compared with patients undergoing observation. This may be a promising noninvasive treatment option for nonsurgical candidates with prospective efficacy and safety assessments meriting study in future clinical trials.

Prospective longitudinal patient-reported outcomes of swallowing following intensity modulated proton therapy for oropharyngeal cancer.

BACKGROUND AND PURPOSE: With an enlarging population of long-term oropharyngeal cancer survivors, dysphagia is an increasingly important toxicity following oropharynx cancer treatment. While lower doses to normal surrounding structures may be achieved with intensity modulated proton therapy (IMPT) compared to photon-based radiation, the clinical benefit is uncertain. METHODS AND MATERIALS: Seventy-one patients with stage III/IV oropharyngeal cancer (AJCC 7th edition) undergoing definitive IMPT on a longitudinal prospective cohort study who had completed the MD Anderson Dysphagia Inventory (MDADI) at pre-specified time points were included. RESULTS: The majority of patients had HPV-positive tumors (85.9%) and received bilateral neck radiation (81.4%) with concurrent systemic therapy (61.8%). Mean composite MDADI scores decreased from 88.2 at baseline to 59.6 at treatment week 6, and then increased to 74.4 by follow up week 10, 77.0 by 6 months follow up, 80.5 by 12 months follow up, and 80.1 by 24 months follow up. At baseline, only 5.6% of patients recording a poor composite score (lower than 60), compared to 61.2% at treatment week 6, 19.1% at follow up week 10, 13.0% at 6 months follow up, 13.5% at 1 year follow up, and 11.1% at 2 years follow up. CONCLUSIONS: Patient reported outcomes following IMPT for oropharyngeal cancer demonstrates decreased swallowing function at completion of treatment with relatively rapid recovery by 10 weeks follow up and steady improvement through 2 years. The results are comparable to similar longitudinal studies of photon-based radiotherapy for oropharynx cancer, and suggest that IMPT confers no additional excess toxicity related to swallowing.

Seed, soil, and spine stereotactic radiosurgery: A unique case of metastatic dissemination.

A 52 year-old gentleman with metastatic pheochromocytoma received single fraction spine stereotactic radiosurgery (SSRS) to an isolated L3 metastasis. Two years later, he developed widespread osseous metastatic disease involving nearly every vertebral body level with the striking exception of the treated L3 vertebrae. The "seed and soil" hypothesis of metastatic dissemination was developed over a century ago and states that tumors cells (the "seed") preferentially grow in select host tissue microenvironments (the "soil"). The high-dose radiation delivered by SSRS may have altered the microenvironment "soil" of the treated L3 vertebrae, rendering it inhospitable to the growth of future metastases. With emerging evidence in support of high-dose stereotactic radiation for oligometastatic disease, there will likely be increasing opportunity to observe and understand treatment changes in the tissue microenvironment and how it relates to the potential for metastatic seeding.

Non-English language validation of patient-reported outcome measures in cancer clinical trials.

Patient-reported outcome measures (PROMs) are increasingly incorporated as endpoints in oncology clinical trials but are often only validated in English. ClinicalTrials.gov was queried for cancer-specific randomized control trials (RCTs) addressing a therapeutic intervention and enrolling primarily in the USA. Peer-reviewed validation of Spanish and Chinese versions of each PROM was assessed. Of 103 eligible trials, a PROM was used as a primary endpoint in 25 RCTs (24.3%) and as a secondary endpoint in 78 RCTs (75.7%). A total of 61 of the 103 eligible trials (59.2%) and 17 of the 25 trials with a PROM primary endpoint (68.0%) used a PROM with either no Spanish or Chinese validation. The absence of validated PROM translations may diminish the voices of non-English language speaking trial participants. With an increasingly diverse US population, validation of non-English PROM translations may decrease disparities in trial participation and improve generalizability of study results.

Dose Escalation for Prostate Adenocarcinoma: A Long-Term Update on the Outcomes of a Phase 3, Single Institution Randomized Clinical Trial.

PURPOSE: To determine the long-term outcomes for prostate adenocarcinoma when escalating radiation dose from 70 Gy to 78 Gy. METHODS AND MATERIALS: Between 1993 and 1998, 301 patients with biopsy-proven clinical stage T1b-T3 prostate adenocarcinoma, any prostate-specific antigen level, and any Gleason score were randomized to 70 Gy in 35 fractions versus 78 Gy in 39 fractions of photon radiation therapy using a 4-field box technique without hormone deprivation therapy. The primary outcome was powered to detect a 15% difference in biochemical or clinical failure. Secondary outcomes included survival, prostate cancer mortality, biochemical failure, local failure, nodal failure, distant failure, and secondary malignancy rates. RESULTS: With a median follow-up of 14.3 years, the cumulative incidence of 15-year biochemical or clinical failure was 18.9% versus 12.0% in the 70 Gy versus 78 Gy arms, respectively (subhazard ratio [sHR], 0.61; 95% confidence interval [CI], 0.38-0.98; Fine-Gray P = .042). The 15-year cumulative incidence of distant metastasis was 3.4% versus 1.1%, respectively (sHR, 0.33; 95% CI, 0.13-0.82; Fine-Gray P = .018). The 15-year cumulative incidence of prostate cancer-specific mortality was 6.2% versus 3.2%, respectively, (sHR, 0.52; 95% CI, 0.27-0.98; Fine-Gray P = .045). There were no differences in overall survival (HR, 1.10; 95% CI, 0.84-1.45; log rank P = .469) or other-cause survival (sHR, 1.33; 95% CI, 0.99-1.79; Fine-Gray P = .061). Salvage therapy was more common in the 70 Gy arm, at 38.7% versus 21.9% in the 78 Gy arm (P = .002). There was a 2.3% secondary solid malignancy rate (1 bladder, 6 rectal) within the radiation treatment field, which was not significantly different between treatment arms. CONCLUSIONS: Dose escalation by 8 Gy (78 Gy vs 70 Gy) provided a sustained improvement in biochemical and clinical failure, which translated into lower salvage rates and improved prostate cancer-specific mortality, but not overall survival. Long-term follow-up demonstrated a low incidence of potential solid tumor secondary malignancies.

Provider variability in intensity modulated radiation therapy utilization among Medicare beneficiaries in the United States.

BACKGROUND: In this study, we sought to examine the variation in intensity modulated radiation therapy (IMRT) use among radiation oncology providers. METHODS AND MATERIALS: The Medicare Physician and Other Supplier Public Use File was queried for radiation oncologists practicing during 2014. Healthcare Common Procedural Coding System code 77301 was designated as IMRT planning with metrics including number of total IMRT plans, rate of IMRT utilization, and number of IMRT plans per distinct beneficiary. RESULTS: Of 2759 radiation oncologists, the median number of total IMRT plans was 26 (mean, 33.4; standard deviation, 26.2; range, 11-321) with a median IMRT utilization rate of 36% (mean, 43%; standard deviation, 25%; range, 4% to 100%) and a median number of IMRT plans per beneficiary of 1.02 (mean, 1.07; range, 1.00-3.73). On multivariable analysis, increased IMRT utilization was associated with male sex, academic practice, technical fee billing, freestanding practice, practice in a county with 21 or more radiation oncologists, and practice in the southern United States (P < .05). The top 1% of users (28 providers) billed a mean 181 IMRT plans with an IMRT utilization rate of 66% and 1.52 IMRT plans per beneficiary. Of these 28 providers, 24 had billed technical fees, 25 practiced in freestanding clinics, and 20 practiced in the South. CONCLUSIONS: Technical fee billing, freestanding practice, male sex, and location in the South were associated with increased IMRT use. A small group of outliers shared several common demographic and practice-based characteristics.

Insurance Status and Racial Disparities in Cancer-Specific Mortality in the United States: A Population-Based Analysis.

Background: Cancer-specific mortality (CSM) is known to be higher among blacks and lower among Hispanics compared with whites. Private insurance confers CSM benefit, but few studies have examined the relationship between insurance status and racial disparities. We sought to determine differences in CSM between races within insurance subgroups.Methods: A population-based cohort of 577,716 patients age 18 to 64 years diagnosed with one of the 10 solid malignancies causing the greatest mortality over 2007 to 2012 were obtained from Surveillance, Epidemiology, and End Results. A Cox proportional hazards model for CSM was constructed to adjust for known prognostic factors, and interaction analysis between race and insurance was performed to generate stratum-specific HRs.Results: Blacks had similar CSM to whites among the uninsured [HR = 1.01; 95% confidence interval (CI), 0.96-1.05], but higher CSM among the Medicaid (HR = 1.04; 95% CI, 0.01-1.07) and non-Medicaid (HR = 1.14; 95% CI, 1.12-1.16) strata. Hispanics had lower CSM compared with whites among uninsured (HR = 0.80; 95% CI, 0.76-0.85) and Medicaid (HR = 0.88; 95% CI, 0.85-0.91) patients, but there was no difference among non-Medicaid patients (HR = 0.99; 95% CI, 0.97-1.01). Asians had lower CSM compared with whites among all insurance types: uninsured (HR = 0.80; 95% CI, 0.76-0.85), Medicaid (HR = 0.81; 95% CI, 0.77-0.85), and non-Medicaid (HR = 0.85; 95% CI, 0.83-0.87).Conclusions: The disparity between blacks and whites was largest, and the advantage of Hispanic race was absent within the non-Medicaid subgroup.Impact: These findings suggest that whites derive greater benefit from private insurance than blacks and Hispanics. Further research is necessary to determine why this differential exists and how disparities can be improved. Cancer Epidemiol Biomarkers Prev; 26(6); 869-75. ©2017 AACR.

A brighter future? The impact of insurance and socioeconomic status on cancer outcomes in the USA: a review.

Uninsured and Medicaid-insured cancer patients have been shown to present with more advanced disease, less often receive cancer-directed therapy and suffer higher rates of mortality than those with private insurance. The Patient Protection and Affordable Care Act was signed into law in March of 2010 and seeks to increase rates of public and private health insurance. Although several provisions will in particular benefit those with chronic and high-cost medical conditions such as cancer, the extent to which disparities in cancer care will be eliminated is uncertain. Further legislative changes may be needed to ensure equal and adequate cancer care for all patients regardless of insurance or socioeconomic status.

Impact of Insurance Status on Radiation Treatment Modality Selection Among Potential Candidates for Prostate, Breast, or Gynecologic Brachytherapy.

PURPOSE: The Patient Protection and Affordable Care Act looks to expand both private and Medicaid insurance. To evaluate how these changes may affect the field of radiation oncology, we evaluated the association of insurance status with the use of brachytherapy in cancers for which this treatment technique is used. METHODS AND MATERIALS: A total of 190,467 patients met the inclusion criteria, of whom 95,292 (50.0%) had breast cancer, 61,096 (32.1%) had prostate cancer, 28,194 (14.8%) had endometrial cancer, and 5885 (3.1%) had cervical cancer. A multivariate logistic regression model was used to determine the association between insurance status and receipt of brachytherapy among patients treated definitively for prostate and cervical cancer or postoperatively for breast and endometrial cancer. RESULTS: The rates of non-Medicaid insurance were 49.9% (cervical), 85.3% (endometrial), 87.4% (breast), and 90.9% (prostate) (P<.001). In a logistic regression, patients who received radiation therapy were less likely to receive brachytherapy if they had Medicaid coverage (odds ratio [OR] 0.57, 95% confidence interval [CI] 0.53-0.61, P<.001) or did not have insurance coverage (OR 0.50, 95% CI 0.45-0.56, P<.001) compared with those with non-Medicaid insurance. On subset analysis, patients with Medicaid coverage or without insurance coverage were significantly less likely to receive brachytherapy than were those with non-Medicaid insurance for all 4 sites, except for patients with endometrial cancer. CONCLUSIONS: Despite being a cost-effective treatment modality, brachytherapy is less often used in the definitive or postoperative management of cancer in patients with Medicaid coverage or without insurance. Upcoming health policy changes resulting in the expansion of private insurance and Medicaid will likely increase access to and demand for brachytherapy.

Proton versus conventional radiotherapy for pediatric salivary gland tumors: Acute toxicity and dosimetric characteristics.

PURPOSE: We evaluated acute toxicity profiles and dosimetric data for children with salivary gland tumors treated with adjuvant photon/electron-based radiation therapy (X/E RT) or proton therapy (PRT). METHODS AND MATERIALS: We identified 24 patients who had received adjuvant radiotherapy for salivary gland tumors. Data were extracted from the medical records and the treatment planning systems. Toxicity was scored according to the Common Terminology Criteria for Adverse Effects 4.0. RESULTS: Eleven patients received X/E RT and 13 PRT, with a median prescribed dose of 60 Gy in each group. In the X/E RT group, 54% of patients developed acute grade II/III dermatitis, 27% grade II/III dysphagia, and 91% grade II/III mucositis, and the median weight loss was 5.3% with one patient requiring feeding tube placement. In the PRT group, 53% had acute grade II/III dermatitis, 0% grade II/III dysphagia, and 46% grade II/III mucositis, with a median weight gain of 1.2%. Additionally, PRT was associated with lower mean doses to several normal surrounding midline and contralateral structures. CONCLUSION: In this retrospective study of pediatric salivary tumors, PRT was associated with a favorable acute toxicity and dosimetric profile. Continued follow-up is needed to identify long-term toxicity and survival data.

Variation in insurance status by patient demographics and tumor site among nonelderly adult patients with cancer.

BACKGROUND: In the United States, an estimated 48 million individuals live without health insurance. The purpose of the current study was to explore the Variation in insurance status by patient demographics and tumor site among nonelderly adult patients with cancer. METHODS: A total of 688,794 patients aged 18 to 64 years who were diagnosed with one of the top 25 incident cancers (representing 95% of all cancer diagnoses) between 2007 and 2010 in the Surveillance, Epidemiology, and End Results (SEER) database were analyzed. Patient characteristics included age, race, sex, marital status, and rural or urban residence. County-level demographics included percent poverty level. Insurance status was defined as having non-Medicaid insurance, Medicaid coverage, or no insurance. RESULTS: On multivariate logistic regression analyses, younger age, male sex, nonwhite race, being unmarried, residence in counties with higher levels of poverty, and rural residence were associated with being uninsured versus having non-Medicaid insurance (all P <.001). The highest rates of non-Medicaid insurance were noted among patients with prostate cancer (92.3%), melanoma of the skin (92.5%), and thyroid cancer (89.5%), whereas the lowest rates of non-Medicaid insurance were observed among patients with cervical cancer (64.2%), liver cancer (67.9%), and stomach cancer (70.9%) (P <.001). Among uninsured individuals, the most prevalent cancers were lung cancer (14.9%), colorectal cancer (12.1%), and breast cancer (10.2%) (P <.001). Lung cancer caused the majority of cancer mortality in all insurance groups. CONCLUSIONS: Rates of insurance coverage vary greatly by demographics and by cancer type. The expansion of health insurance coverage would be expected to disproportionally benefit certain demographic populations and cancer types.

Disparities in stage at diagnosis, treatment, and survival in nonelderly adult patients with cancer according to insurance status.

PURPOSE: The purpose of this study was to determine the association of insurance status with disease stage at presentation, treatment, and survival among the top 10 most deadly cancers using the SEER database. PATIENTS AND METHODS: A total of 473,722 patients age 18 to 64 years who were diagnosed with one of the 10 most deadly cancers in the SEER database from 2007 to 2010 were analyzed. A Cox proportional hazards model was used for multivariable analyses to assess the effect of patient and tumor characteristics on cause-specific death. RESULTS: Overall, patients with non-Medicaid insurance were less likely to present with distant disease (16.9%) than those with Medicaid coverage (29.1%) or without insurance coverage (34.7%; P < .001). Patients with non-Medicaid insurance were more likely to receive cancer-directed surgery and/or radiation therapy (79.6%) compared with those with Medicaid coverage (67.9%) or without insurance coverage (62.1%; P < .001). In a Cox regression that adjusted for age, race, sex, marital status, residence, percent of county below federal poverty level, site, stage, and receipt of cancer-directed surgery and/or radiation therapy, patients were more likely to die as a result of their disease if they had Medicaid coverage (hazard ratio [HR], 1.44; 95% CI, 1.41 to 1.47; P < .001) or no insurance (HR, 1.47; 95% CI, 1.42 to 1.51; P < .001) compared with non-Medicaid insurance. CONCLUSION: Among patients with the 10 most deadly cancers, those with Medicaid coverage or without insurance were more likely to present with advanced disease, were less likely to receive cancer-directed surgery and/or radiation therapy, and experienced worse survival.