Ascertainment of postprostatectomy radiotherapy for prostate cancer in the Surveillance, Epidemiology, and End Results database.

BACKGROUND: Surveillance, Epidemiology, and End Results (SEER) data are frequently used to examine receipt of adjuvant radiotherapy (RT), but to the authors' knowledge the accuracy of data regarding second-course treatments is unknown. METHODS: Using SEER-Medicare-linked data, the authors identified a cohort of men who underwent radical prostatectomy for localized prostate cancer with indications for RT due to adverse pathologic risk factors. Receipt of RT was compared between the SEER database and Medicare claims, with the latter considered to be the "gold standard." Multivariable logistic regression was used to assess factors associated with ascertainment of RT in SEER. RESULTS: A total of 3842 men were analyzed, 749 of whom were found to have Medicare claims for RT within 1 year of undergoing prostatectomy. SEER ascertainment of postprostatectomy RT was 56% overall: 76% among patients who received RT within 2 months of prostatectomy, 73% among patients who received RT between 2 to 4 months after prostatectomy, 63% among patients who received RT between 4 to 6 months after prostatectomy, 44% among patients who received RT between 6 to 8 months after prostatectomy, and 21% among patients who received RT between 8 to 12 months after prostatectomy. On multivariable analysis, increasing time from prostatectomy to RT was found to be significantly associated with decreased SEER ascertainment (odds ratio, 0.70 per month; P<.001). There also was variation noted by SEER region and urban/rural locale. CONCLUSIONS: SEER underascertains the receipt of postprostatectomy RT compared with Medicare claims, and the magnitude of the underascertainment increases with longer time between prostatectomy and RT. These findings have direct implications for the use of SEER data alone to assess patterns of care and guideline concordance for second-course treatment. Cancer 2016;122:3069-3074. © 2016 American Cancer Society.

Trends in the use of postprostatectomy therapies for patients with prostate cancer: a surveillance, epidemiology, and end results Medicare analysis.

BACKGROUND: For patients with adverse pathologic factors (positive surgical margins, extracapsular extension, or seminal vesicle invasion) on prostatectomy pathology, the use and timing of postsurgical treatments are controversial. The goal of the current study was to examine patterns of care in patients with a pathologic indication for postprostatectomy radiotherapy (RT) using the Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked database. METHODS: A total of 3460 men treated with radical prostatectomy for localized prostate cancer between 2000 and 2006 with at least 1 adverse pathologic factor and at least 3 years of claims data after surgery were included. Medicare claims through December 31, 2009 were examined. Rates of postprostatectomy hormonal therapy, RT, or both were examined. Logistic regression analysis examined potential factors associated with the receipt and timing of RT. RESULTS: Within 3 years after surgery, 1076 patients (31%) received some form of further therapy, including 850 (25%) who received RT. Receipt of RT was < 35% in all subgroups including every year of study. Fewer than one-half of patients who received RT (43%) did so within 6 months of surgery. On multivariate analysis, pathologic T classification and tumor grade were associated with receipt of RT within 6 months or 3 years of surgery, as were younger age, geographic region, and population density. CONCLUSIONS: Rates of postprostatectomy RT remain low and the timing of RT has not appreciably changed since the publication of the randomized trials supporting the use of adjuvant RT. The use of hormone therapy is almost as common as RT, despite a relative lack of evidence supporting its use in this setting.

Intensity-modulated radiation therapy, proton therapy, or conformal radiation therapy and morbidity and disease control in localized prostate cancer.

CONTEXT: There has been rapid adoption of newer radiation treatments such as intensity-modulated radiation therapy (IMRT) and proton therapy despite greater cost and limited demonstrated benefit compared with previous technologies. OBJECTIVE: To determine the comparative morbidity and disease control of IMRT, proton therapy, and conformal radiation therapy for primary prostate cancer treatment. DESIGN, SETTING, AND PATIENTS: Population-based study using Surveillance, Epidemiology, and End Results-Medicare-linked data from 2000 through 2009 for patients with nonmetastatic prostate cancer. MAIN OUTCOME MEASURES: Rates of gastrointestinal and urinary morbidity, erectile dysfunction, hip fractures, and additional cancer therapy. RESULTS: Use of IMRT vs conformal radiation therapy increased from 0.15% in 2000 to 95.9% in 2008. In propensity score-adjusted analyses (N = 12,976), men who received IMRT vs conformal radiation therapy were less likely to receive a diagnosis of gastrointestinal morbidities (absolute risk, 13.4 vs 14.7 per 100 person-years; relative risk [RR], 0.91; 95% CI, 0.86-0.96) and hip fractures (absolute risk, 0.8 vs 1.0 per 100 person-years; RR, 0.78; 95% CI, 0.65-0.93) but more likely to receive a diagnosis of erectile dysfunction (absolute risk, 5.9 vs 5.3 per 100 person-years; RR, 1.12; 95% CI, 1.03-1.20). Intensity-modulated radiation therapy patients were less likely to receive additional cancer therapy (absolute risk, 2.5 vs 3.1 per 100 person-years; RR, 0.81; 95% CI, 0.73-0.89). In a propensity score-matched comparison between IMRT and proton therapy (n = 1368), IMRT patients had a lower rate of gastrointestinal morbidity (absolute risk, 12.2 vs 17.8 per 100 person-years; RR, 0.66; 95% CI, 0.55-0.79). There were no significant differences in rates of other morbidities or additional therapies between IMRT and proton therapy. CONCLUSIONS: Among patients with nonmetastatic prostate cancer, the use of IMRT compared with conformal radiation therapy was associated with less gastrointestinal morbidity and fewer hip fractures but more erectile dysfunction; IMRT compared with proton therapy was associated with less gastrointestinal morbidity.

Prostate Stereotactic Body Radiation Therapy: An Overview of Toxicity and Dose Response.

PURPOSE: Ultrahypofractionationed radiation therapy for prostate cancer is increasingly studied and adopted. The American Association of Physicists in Medicine Working Group on Biological Effects of Hypofractionated Radiotherapy therefore aimed to review studies examining toxicity and quality of life after stereotactic body radiation therapy (SBRT) for prostate cancer and model its effect. METHODS AND MATERIALS: We performed a systematic PubMed search of prostate SBRT studies published between 2001 and 2018. Those that analyzed factors associated with late urinary, bowel, or sexual toxicity and/or quality of life were included and reviewed. Normal tissue complication probability modelling was performed on studies that contained detailed dose/volume and outcome data. RESULTS: We found 13 studies that examined urinary effects, 6 that examined bowel effects, and 4 that examined sexual effects. Most studies included patients with low-intermediate risk prostate cancer treated to 35-40 Gy. Most patients were treated with 5 fractions, with several centers using 4 fractions. Endpoints were heterogeneous and included both physician-scored toxicity and patient-reported quality of life. Most toxicities were mild-moderate (eg, grade 1-2) with a very low overall incidence of severe toxicity (eg, grade 3 or higher, usually <3%). Side effects were associated with both dosimetric and non-dosimetric factors. CONCLUSIONS: Prostate SBRT appears to be overall well tolerated, with determinants of toxicity that include dosimetric factors and patient factors. Suggested dose constraints include bladder V(Rx Dose)Gy <5-10 cc, urethra Dmax <38-42 Gy, and rectum Dmax <35-38 Gy, though current data do not offer firm guidance on tolerance doses. Several areas for future research are suggested.

Tumor Control Probability Modeling and Systematic Review of the Literature of Stereotactic Body Radiation Therapy for Prostate Cancer.

PURPOSE: Dose escalation improves localized prostate cancer disease control, and moderately hypofractionated external beam radiation is noninferior to conventional fractionation. The evolving treatment approach of ultrahypofractionation with stereotactic body radiation therapy (SBRT) allows possible further biological dose escalation (biologically equivalent dose [BED]) and shortened treatment time. METHODS AND MATERIALS: The American Association of Physicists in Medicine Working Group on Biological Effects of Hypofractionated Radiation Therapy/SBRT included a subgroup to study the prostate tumor control probability (TCP) with SBRT. We performed a systematic review of the available literature and created a dose-response TCP model for the endpoint of freedom from biochemical relapse. Results were stratified by prostate cancer risk group. RESULTS: Twenty-five published cohorts were identified for inclusion, with a total of 4821 patients (2235 with low-risk, 1894 with intermediate-risk, and 446 with high-risk disease, when reported) treated with a variety of dose/fractionation schemes, permitting dose-response modeling. Five studies had a median follow-up of more than 5 years. Dosing regimens ranged from 32 to 50 Gy in 4 to 5 fractions, with total BED (α/ß = 1.5 Gy) between 183.1 and 383.3 Gy. At 5 years, we found that in patients with low-intermediate risk disease, an equivalent doses of 2 Gy per fraction (EQD2) of 71 Gy (31.7 Gy in 5 fractions) achieved a TCP of 90% and an EQD2 of 90 Gy (36.1 Gy in 5 fractions) achieved a TCP of 95%. In patients with high-risk disease, an EQD2 of 97 Gy (37.6 Gy in 5 fractions) can achieve a TCP of 90% and an EQD2 of 102 Gy (38.7 Gy in 5 fractions) can achieve a TCP of 95%. CONCLUSIONS: We found significant variation in the published literature on target delineation, margins used, dose/fractionation, and treatment schedule. Despite this variation, TCP was excellent. Most prescription doses range from 35 to 40 Gy, delivered in 4 to 5 fractions. The literature did not provide detailed dose-volume data, and our dosimetric analysis was constrained to prescription doses. There are many areas in need of continued research as SBRT continues to evolve as a treatment modality for prostate cancer, including the durability of local control with longer follow-up across risk groups, the efficacy and safety of SBRT as a boost to intensity modulated radiation therapy (IMRT), and the impact of incorporating novel imaging techniques into treatment planning.

PIK3CA Mutation in HPV-Associated OPSCC Patients Receiving Deintensified Chemoradiation.

PIK3CA is the most frequently mutated gene in human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC). Prognostic implications of such mutations remain unknown. We sought to elucidate the clinical significance of PIK3CA mutations in HPV-associated OPSCC patients treated with definitive chemoradiation (CRT). Seventy-seven patients with HPV-associated OPSCC were enrolled on two phase II clinical trials of deintensified CRT (60 Gy intensity-modulated radiotherapy with concurrent weekly cisplatin). Targeted next-generation sequencing was performed. Of the 77 patients, nine had disease recurrence (two regional, four distant, three regional and distant). Thirty-four patients had mutation(s) identified; 16 had PIK3CA mutations. Patients with wild-type-PIK3CA had statistically significantly higher 3-year disease-free survival than PIK3CA-mutant patients (93.4%, 95% confidence interval [CI] = 85.0% to 99.9% vs 68.8%, 95% CI = 26.7% to 89.8%; P = .004). On multivariate analysis, PIK3CA mutation was the only variable statistically significantly associated with disease recurrence (hazard ratio = 5.71, 95% CI = 1.53 to 21.3; P = .01). PIK3CA mutation is associated with worse disease-free survival in a prospective cohort of newly diagnosed HPV-associated OPSCC patients treated with deintensified CRT.

Shoulder symptoms and quality of life impact of limited neck dissection after de-intensified chemoradiotherapy: Secondary analysis of two prospective trials.

BACKGROUND: We investigated the quality of life (QOL) impact of post-radiation therapy (RT) superselective/selective neck dissection after de-intensified chemoradiation for human papillomavirus-associated oropharynx cancer. METHODS: A total of 147 patients received 60 Gy and weekly low-dose cisplatin on two phase 2 trials with planned post-RT neck dissection or surveillance positron emission tomography with neck dissection reserved for salvage. UW-QOL Shoulder Score, EORTC H&N-35, and EAT-10 were assessed. RESULTS: In all, 48 of 147 patients had post-RT neck dissection. At 2 years, 37% and 13% of patients receiving post-RT neck dissection had Shoulder Score ≥ 1 (any shoulder symptoms) and ≥ 2 (symptoms affecting work/hobbies), respectively, versus only 16% and 3% of patients not receiving post-RT neck dissection. Post-RT neck dissection was associated with Shoulder Score ≥ 1 (P = 0.005) and Shoulder Score ≥ 2 (P = 0.03) at 2 years, but not H&N-35 or EAT-10 scores. CONCLUSIONS: Post-RT superselective/selective neck dissection was associated with modest but persistent shoulder symptoms. These toxicities should be weighed against the probability of persistent disease when evaluating patients for post-RT neck dissection.

Prospective Assessment of Patient-Reported Dry Eye Syndrome After Whole Brain Radiation.

PURPOSE: Dry eye is not typically considered a toxicity of whole brain radiation therapy (WBRT). We analyzed dry eye syndrome as part of a prospective study of patient-reported outcomes after WBRT. METHODS AND MATERIALS: Patients receiving WBRT to 25 to 40 Gy were enrolled on a study with dry mouth as the primary endpoint and dry eye syndrome as a secondary endpoint. Patients received 3-dimensional WBRT using opposed lateral fields. Per standard practice, lacrimal glands were not prospectively delineated. Patients completed the Subjective Evaluation of Symptom of Dryness (SESoD, scored 0-4, with higher scores representing worse dry eye symptoms) at baseline, immediately after WBRT (EndRT), and at 1 month (1M), 3 months, and 6 months. Patients with baseline SESoD ≥3 (moderate dry eye) were excluded. The endpoints analyzed were ≥1-point and ≥2-point increase in SESoD score at 1M. Lacrimal glands were retrospectively delineated with fused magnetic resonance imaging scans. RESULTS: One hundred patients were enrolled, 70 were eligible for analysis, and 54 were evaluable at 1M. Median bilateral lacrimal V20Gy was 79%. At 1M, 17 patients (32%) had a ≥1-point increase in SESoD score, and 13 (24%) a ≥2-point increase. Lacrimal doses appeared to be associated with an increase in SESoD score of both ≥1 point (V10Gy: P = .042, odds ratio [OR] 1.09/%; V20Gy: P = .071, OR 1.03/%) and ≥2 points (V10Gy: P = .038, OR 1.15/%; V20Gy: P = .063, OR 1.04/%). The proportion with increase in dry eye symptoms at 1M for lacrimal V20Gy ≥79% versus <79% was 46% versus 15%, respectively, for ≥1 point SESoD increase (P = .02) and 36% versus 12%, respectively, for ≥2 point SESoD increase (P = .056). CONCLUSIONS: Dry eye appears to be a relatively common, dose/volume-dependent acute toxicity of WBRT. Minimization of lacrimal gland dose may reduce this toxicity, and patients should be counseled regarding the existence of this potential side effect and treatments for dry eye.

Assessment of Risk of Xerostomia After Whole-Brain Radiation Therapy and Association With Parotid Dose.

Importance: Whole-brain radiation therapy (WBRT) delivers a substantial radiation dose to the parotid glands, but the parotid glands are not delineated for avoidance and xerostomia has never been reported as an adverse effect. Minimizing the toxic effects in patients receiving palliative treatments, such as WBRT, is crucial. Objective: To assess whether xerostomia is a toxic effect of WBRT. Design, Setting, and Participants: This observational cohort study enrolled patients from November 2, 2015, to March 20, 2018, at 1 academic center (University of North Carolina Hospitals) and 2 affiliated community hospitals (High Point Regional Hospital and University of North Carolina Rex Hospital). Adult patients (n = 100) receiving WBRT for the treatment or prophylaxis of brain metastases were enrolled. Patients who had substantial baseline xerostomia or did not complete WBRT or at least 1 postbaseline questionnaire were prospectively excluded from analysis and follow-up. Patients received 3-dimensional WBRT using opposed lateral fields covering the skull and the C1 or C2 vertebra. Per standard practice, the parotid glands were not prospectively delineated. Main Outcomes and Measures: Patients completed the University of Michigan Xerostomia Questionnaire and a 4-point bother score at baseline, immediately after WBRT, at 1 month, at 3 months, and at 6 months. The primary end point was the 1-month xerostomia score, with a hypothesized worsening score of 10 points from baseline. Results: Of the 100 patients enrolled, 73 (73%) were eligible for analysis and 55 (55%) were evaluable at 1 month. The 73 patients included 43 women (59%) and 30 men (41%) with a median (range) age of 61 (23-88) years. The median volume of parotid receiving at least 20 Gy (V20Gy) was 47%. The mean xerostomia score was 7 points at baseline and was statistically significantly higher at each assessment period, including 21 points immediately after WBRT (95% CI, 16-26; P < .001), 23 points (95% CI, 16-30; P < .001) at 1 month, 21 points (95% CI, 13-28; P < .001) at 3 months, and 14 points (95% CI, 7-21; P = .03) at 6 months. At 1 month, the xerostomia score increased by 20 points or more in 19 patients (35%). The xerostomia score at 1 month was associated with parotid dose as a continuous variable and was 35 points in patients with parotid V20Gy of 47% or greater, compared with only 9 points in patients with parotid V20Gy less than 47% (P < .001). The proportion of patients who self-reported to be bothered quite a bit or bothered very much by xerostomia at 1 month was 50% in those with parotid V20Gy of 47% or greater, compared with only 4% in those with parotid V20Gy less than 47% (P < .001). At 3 months, this difference was 50% vs 0% (P = .001). Xerostomia was not associated with medication use. Conclusions and Relevance: Clinically significant xerostomia occurred by the end of WBRT, appeared to be persistent, and appeared to be associated with parotid dose. The findings from this study suggest that the parotid glands should be delineated for avoidance to minimize these toxic effects in patients who undergo WBRT and often do not survive long enough for salivary recovery.

Pitfalls of post-treatment PET after de-intensified chemoradiotherapy for HPV-associated oropharynx cancer: Secondary analysis of a phase 2 trial.

OBJECTIVES: We evaluated patterns of nodal response and positive predictive value (PPV) of 3 month post-treatment PET in patients with HPV-associated oropharyngeal cancer treated on a multi-institutional de-intensification trial. MATERIALS AND METHODS: Eligibility criteria included: (1) T0-3, N0-2c, M0, (2) HPV+/p16+ oropharyngeal squamous cell carcinoma, and (3) ≤10 pack-years smoking or ≤30 pack-years and abstinent ≥5 years. Patients received 60 Gy radiation alone (T0-2, N0-1) or with concurrent weekly cisplatin 30 mg/m2 and surveillance PET three months post-radiation. Nodal responses were categorized as complete (CR), equivocal (ER), or incomplete (IR) using both local and central radiographic review. A "true positive" was ER/IR with clinical/radiographic progression or positive pathology. RESULTS: 79 node-positive pts (84% N2) were analyzed. Distribution of nodal CR, ER, and IR was 44 (56%), 27 (34%), and 8 (10%), respectively. 29 (37%) had ER/IR in pre-treatment node-positive neck levels, whereas 14 (18%) had ER/IR in pre-treatment node-negative levels. Of patients with ER/IR, 5 were observed clinically, 19 received repeat imaging, and 11 received either biopsy (1) or neck dissection (10). The PPV was 9% for ER/IR and 13% for IR, with 3 patients found to have persistent disease on neck dissection. There was no difference in nodal relapse rate in patients with nodal CR vs. nodal ER/IR. CONCLUSION: Post-treatment PET may not accurately predict the presence of persistent disease in patients with favorable-risk oropharynx cancer. These results support close surveillance rather than surgical evaluation in most favorable-risk patients.

Comparison of Patient Report and Medical Records of Comorbidities: Results From a Population-Based Cohort of Patients With Prostate Cancer.

IMPORTANCE: The comorbid conditions of patients with cancer affect treatment decisions, which in turn affect survival and health-related quality-of-life outcomes. Comparative effectiveness research studies must account for these conditions via medical record abstraction or patient report. OBJECTIVE: To examine the agreement between medical records and patient reports in assessing comorbidities. DESIGN, SETTING, AND PARTICIPANTS: Patient-reported information and medical records were prospectively collected as part of the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study, a population-based cohort of 881 patients with newly diagnosed localized prostate cancer enrolled in the North Carolina Central Cancer Registry from January 1, 2011, through June 30, 2013. The presence or absence of 20 medical conditions was compared based on patient report vs abstraction of medical records. MAIN OUTCOMES AND MEASURES: Agreement between patient reports and medical records for each condition was assessed using the κ statistic. Subgroup analyses examined differences in κ statistics based on age, race, marital status, educational level, and income. Logistic regression models for each condition examined factors associated with higher agreement. RESULTS: A total of 881 patients participated in the study (median age, 65 years; age range, 41-80 years; 633 white [71.9%]). In 16 of 20 conditions, there was agreement between patient reports and medical records for more than 90% of patients; agreement was lowest for hyperlipidemia (68%; κ = 0.36) and arthritis (66%; κ = 0.14). On multivariable analysis, older age (≥70 years old) was significantly associated with lower agreement for myocardial infarction (odds ratio [OR], 0.31; 95% CI, 0.12-0.80), cerebrovascular disease (OR, 0.10; 95% CI, 0.01-0.78), coronary artery disease (OR, 0.37; 95% CI, 0.20-0.67), arrhythmia (OR, 0.44; 95% CI, 0.25-0.79), and kidney disease (OR, 0.18; 95% CI, 0.06-0.52). Race and educational level were not significantly associated with κ in 18 of 19 modeled conditions. CONCLUSIONS AND RELEVANCE: Overall, patient reporting provides information similar to medical record abstraction without significant differences by patient race or educational level. Use of patient reports, which are less costly than medical record audits, is a reasonable approach for observational comparative effectiveness research.

Racial Differences in Diffusion of Intensity-Modulated Radiation Therapy for Localized Prostate Cancer.

Intensity-modulated radiation therapy (IMRT), an innovative treatment option for prostate cancer, has rapidly diffused over the past decade. To inform our understanding of racial disparities in prostate cancer treatment and outcomes, this study compared diffusion of IMRT in African American (AA) and Caucasian American (CA) prostate cancer patients during the early years of IMRT diffusion using the Surveillance, Epidemiology and End Results (SEER)-Medicare linked database. A retrospective cohort of 947 AA and 10,028 CA patients diagnosed with localized prostate cancer from 2002 through 2006, who were treated with either IMRT or non-IMRT as primary treatment within 1 year of diagnoses was constructed. Logistic regression was used to examine potential differences in diffusion of IMRT in AA and CA patients, while adjusting for socioeconomic and clinical covariates. A significantly smaller proportion of AA compared with CA patients received IMRT for localized prostate cancer (45% vs. 53%, p < .0001). Racial differences were apparent in multivariable analysis though did not achieve statistical significance, as time and factors associated with race (socioeconomic, geographic, and tumor related factors) explained the preponderance of variance in use of IMRT. Further research examining improved access to innovative cancer treatment and technologies is essential to reducing racial disparities in cancer care.

Costs of care in a matched pair comparison of intensity-modulated radiation therapy (IMRT) versus conventional radiation therapy (CRT) for the treatment of head and neck cancer.

OBJECTIVES: Intensity-modulated radiation therapy (IMRT) has been rapidly adopted for the treatment of head and neck cancer. Limited comparative effectiveness data suggest that IMRT reduces the incidence of xerostomia and improves quality of life. We assess the cost of IMRT versus the older conventional radiation therapy (CRT) relative to other potential drivers of cost in patients with head and neck cancer. METHODS: We compared patients treated with definitive radiation with or without chemotherapy for squamous cell carcinoma of the head and neck treated between 2000 and 2009. IMRT-treated patients were matched to CRT-treated patients by site, stage, and smoking status. Itemized billing charges were obtained for each patient and used to estimate cost using the Medicare fee schedule. Multivariate analysis was used to assess the influence of demographic, clinical, and treatment variables on total, pretreatment, during treatment, and follow-up costs. RESULTS: Models indicate that compared with CRT, IMRT was associated with, on average, a $5881 increase in total costs (P=0.043), a $1700 decrease in pretreatment costs (P=0.014), a $4768 increase in costs during treatment (P=0.004), and no significant difference in follow-up costs. Positron emission tomography scans, cancer recurrence, and comorbidity were also associated with higher total costs in this sample. CONCLUSIONS: Use of IMRT relative to CRT was strongly correlated with higher total costs, but disease control, patient comorbidity, and use of positron emission tomography also had significant effects on overall costs. Cost-effectiveness models should be developed to assess whether the potential benefits of IMRT are worth the associated investment.

Two-year and lifetime cost-effectiveness of intensity modulated radiation therapy versus 3-dimensional conformal radiation therapy for head-and-neck cancer.

PURPOSE: To assess the cost-effectiveness of intensity modulated radiation therapy (IMRT) versus 3-dimensional conformal radiation therapy (3D-CRT) in the treatment of head-and neck-cancer (HNC). METHODS AND MATERIALS: We used a Markov model to simulate radiation therapy-induced xerostomia and dysphagia in a hypothetical cohort of 65-year-old HNC patients. Model input parameters were derived from PARSPORT (CRUK/03/005) patient-level trial data and quality-of-life and Medicare cost data from published literature. We calculated average incremental cost-effectiveness ratios (ICERs) from the US health care perspective as cost per quality-adjusted life-year (QALY) gained and compared our ICERs with current cost-effectiveness standards whereby treatment comparators less than $50,000 per QALY gained are considered cost-effective. RESULTS: In the first 2 years after initial treatment, IMRT is not cost-effective compared with 3D-CRT, given an average ICER of $101,100 per QALY gained. However, over 15 years (remaining lifetime on the basis of average life expectancy of a 65-year-old), IMRT is more cost-effective at $34,523 per QALY gained. CONCLUSION: Although HNC patients receiving IMRT will likely experience reduced xerostomia and dysphagia symptoms, the small quality-of-life benefit associated with IMRT is not cost-effective in the short term but may be cost-effective over a patient's lifetime, assuming benefits persist over time and patients are healthy and likely to live for a sustained period. Additional data quantifying the long-term benefits of IMRT, however, are needed.

Comparative effectiveness of intensity-modulated radiotherapy and conventional conformal radiotherapy in the treatment of prostate cancer after radical prostatectomy.

IMPORTANCE: Comparative effectiveness research of prostate cancer therapies is needed because of the development and rapid clinical adoption of newer and costlier treatments without proven clinical benefit. Radiotherapy is indicated after prostatectomy in select patients who have adverse pathologic features and in those with recurrent disease. OBJECTIVES: To examine the patterns of use of intensity-modulated radiotherapy (IMRT), a newer, more expensive technology that may reduce radiation dose to adjacent organs compared with the older conformal radiotherapy (CRT) in the postprostatectomy setting, and to compare disease control and morbidity outcomes of these treatments. DESIGN AND SETTING: Data from the Surveillance, Epidemiology, and End Results-Medicare-linked database were used to identify patients with a diagnosis of prostate cancer who had received radiotherapy within 3 years after prostatectomy. PARTICIPANTS: Patients who received IMRT or CRT. MAIN OUTCOMES AND MEASURES: The outcomes of 457 IMRT and 557 CRT patients who received radiotherapy between 2002 and 2007 were compared using their claims through 2009. We used propensity score methods to balance baseline characteristics and estimate adjusted incidence rate ratios (RRs) and their 95% CIs for measured outcomes. RESULTS: Use of IMRT increased from zero in 2000 to 82.1% in 2009. Men who received IMRT vs CRT showed no significant difference in rates of long-term gastrointestinal morbidity (RR, 0.95; 95% CI, 0.66-1.37), urinary nonincontinent morbidity (0.93; 0.66-1.33), urinary incontinence (0.98; 0.71-1.35), or erectile dysfunction (0.85; 0.61-1.19). There was no significant difference in subsequent treatment for recurrent disease (RR, 1.31; 95% CI, 0.90-1.92). CONCLUSIONS AND RELEVANCE: Postprostatectomy IMRT and CRT achieved similar morbidity and cancer control outcomes. The potential clinical benefit of IMRT in this setting is unclear. Given that IMRT is more expensive, its use for postprostatectomy radiotherapy may not be cost-effective compared with CRT, although formal analysis is needed.

The use of radiation therapy appears to improve outcome in patients with malignant primary tracheal tumors: a SEER-based analysis.

PURPOSE: To conduct a matched pair analysis assessing the impact of radiotherapy (RT) in patients with resectable and unresectable primary malignant tracheal tumors using Surveillance, Epidemiology and End Results (SEER) database. PATIENTS AND METHODS: The SEER registry was used to identify every patient (or "case") who received RT between 1988 and 2007 for primary malignant tracheal tumors, and to search for corresponding "controls" (not treated with RT), with the same prognostic and treatment factors (surgery on the trachea, disease extension, histology, and gender). Overall survival (OS) was calculated with the Kaplan-Meier methods. Results of OS and cumulative incidence of death from tracheal cancer in the cases and controls, and in various subsets, were compared using log-rank and Gray's tests. RESULTS: Two hundred fifty-eight patients who received RT were identified, and 78 of these had appropriate matched controls identified, forming the basis of this analysis. In the 78 (+RT) cases, the median follow-up was 60 months (range, 10-192) in the survivors vs. 55 months (range, 2-187) in the controls (no-RT group). Patients in RT group had significantly better OS, and a lower cumulative incidence of death from tracheal cancer than no-RT patients (p < 0.05). Treatment with radiation was associated with improved survival in patients with squamous cell histology [p < 0.0001], regional disease extension [p = 0.030], or those that did not undergo resection [p = 0.038]. There were four deaths in RT group and three in no-RT group attributed to cardiac and respiratory causes. CONCLUSION: Our data suggest a survival benefit for the use of RT broadly for all patients with tracheal cancer. Nevertheless, the retrospective nature of this observational study limits its interpretation.