N.C. Sheets

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.

Phase 2 Trial of De-intensified Chemoradiation Therapy for Favorable-Risk Human Papillomavirus–Associated Oropharyngeal Squamous Cell Carcinoma

PURPOSE To perform a prospective, multi-institutional, phase 2 study of a substantial decrease in concurrent chemoradiation therapy (CRT) intensity as primary treatment for favorable-risk, human papillomavirus-associated oropharyngeal squamous cell carcinoma. METHODS AND MATERIALS The major inclusion criteria were: (1) T0 to T3, N0 to N2c, M0; (2) human papillomavirus or p16 positive; and (3) minimal/remote smoking history. Treatment was limited to 60 Gy intensity modulated radiation therapy with concurrent weekly intravenous cisplatinum (30 mg/m(2)). The primary study endpoint was pathologic complete response (pCR) rate based on required biopsy of the primary site and dissection of pretreatment positive lymph node regions, regardless of radiographic response. Power computations were performed for the null hypothesis that the pCR rate is 87% and n=40, resulting in a type 1 error of 14.2%. Secondary endpoint measures included physician-reported toxicity (Common Toxicity Terminology for Adverse Events, CTCAE), patient-reported symptoms (PRO-CTCAE), and modified barium swallow studies. RESULTS The study population was 43 patients. The pCR rate was 86% (37 of 43). The incidence of CTCAE grade 3/4 toxicity and PRO-CTCAE severe/very severe symptoms was as follows: mucositis 34%/45%, general pain 5%/48%, nausea 18%/52%, vomiting 5%/34%, dysphagia 39%/55%, and xerostomia 2%/75%. Grade 3/4 hematologic toxicities were 11%. Thirty-nine percent of patients required a feeding tube for a median of 15 weeks (range, 5-22 weeks). There were no significant differences in modified barium swallow studies before and after CRT. CONCLUSIONS The pCR rate with decreased intensity of therapy with 60 Gy of IMRT and weekly low-dose cisplatinum is very high in favorable-risk oropharyngeal squamous cell carcinoma, with evidence of decreased toxicity compared with standard therapies. ClinicalTrials.gov ID: NCT01530997.

Trends in the use of postprostatectomy therapies for patients with prostate cancer: A Surveillance, Epidemiology, and End Results Medicare analysis

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.

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.

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

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.

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

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

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

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

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 patients 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 radiation therapy (IMRT), proton therapy (PT), and conformal radiation therapy (CRT) in the treatment of localized prostate 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

Preservation of swallowing function with de-intensified chemoradiation therapy for HPV-associated oropharyngeal squamous cell carcinoma

5881 increase in total costs (P=0.043), a