Treatment patterns for prostate cancer: comparison of Medicare claims data to medical record review.

BACKGROUND: As evidence-based guidelines increasingly define standards of care, the accurate reporting of patterns of treatment becomes critical to determine if appropriate care has been provided. We explore the level of agreement between claims and record abstraction for treatment regimens for prostate cancer. METHODS: Medicare claims data were linked to medical records abstraction using data from the Centers for Disease Control and Prevention's National Program of Cancer Registry-funded Breast and Prostate Patterns of Care study. The first course of therapy included surgery, radiation therapy (RT), and hormonal therapy with luteinizing hormone-releasing hormone agonists. RESULTS: The linked sample included 2765 men most (84.7%) of whom had stage II prostate cancer. Agreement was excellent for surgery (κ=0.92) and RT (κ=0.92) and lower for hormonal therapy (κ=0.71); however, most of the discrepancies were due to greater number of patients reported who received hormonal therapy in the claims database than in the medical records database. For some standard multicomponent management strategies sensitivities were high, for example, hormonal therapy with either combination RT (86.9%) or cryosurgery (96.6%). CONCLUSIONS: Medicare claims are sensitive for determining patterns of multicomponent care for prostate cancer and for detecting use of hormonal therapy when not reported in the medical records abstracts.

Imaging evaluation for suspected pulmonary embolism: what do emergency physicians and radiologists say?

OBJECTIVE: The utility of various imaging techniques and strategies for the diagnosis of pulmonary embolism has been studied in randomized control trials and extensively described in the literature. CT and ventilation-perfusion scintigraphy are the mainstays of diagnosis, and MRI is emerging. The purpose of this study was to assess the diagnostic approach to pulmonary embolism practiced by emergency physicians and advised by radiologists. MATERIALS AND METHODS: Questionnaires were sent to emergency physicians and radiologists in Pennsylvania. The questions covered diagnostic strategies for the detection of pulmonary embolism in the usual situations and in clinical circumstances in which the primary imaging technique is considered less desirable. RESULTS: Sixty-two radiologists and 52 emergency physicians completed the survey. Ninety percent of radiologists and 96% of emergency physicians answered that CT was their first-line choice for the diagnosis of pulmonary embolism. The use of ventilation-perfusion scintigraphy increased in the care of patients with renal failure and allergy to iodinated contrast material. MRI was chosen infrequently. CONCLUSION: CT is the overwhelmingly preferred technique for the diagnosis of pulmonary embolism. The role of ventilation-perfusion scintigraphy increases when the use of iodinated contrast material is contraindicated. MRI does not seem to have an important role in practice.

Frequency of use of imaging tests in the diagnosis of pulmonary embolism: effects of physician specialty, patient characteristics, and region.

OBJECTIVE: The purpose of this study was to ascertain whether clinical practice in diagnosing pulmonary embolism is consistent with recommendations in the literature and to explore variations in practice across site of care (e.g., emergency department), physician and patient characteristics, and geographic location. MATERIALS AND METHODS: Medicare 5% research identifiable files were analyzed. The cases of patients with emergency department visits or inpatient stays for a diagnosis of pulmonary embolism or for symptoms related to pulmonary embolism (shortness of breath, chest pain, and syncope) were identified. We determined the number of patients who underwent each type of relevant imaging test and evaluated variations in the first non-chest-radiographic test by site of care and treating physician specialty. Using logistic regression, we studied variations in the use of common imaging tests, exploring variations associated with patient characteristics, physician specialty, site of care, and geographic location. RESULTS: For patients in whom pulmonary embolism might have been suspected, the most common tests were echocardiography (26% of the patients), CT or CT angiography of the chest (11%), cardiac perfusion study (6.9%), and duplex ultrasound (7.3%). For patients with an inpatient diagnosis of pulmonary embolism, the most common tests were chest CT or CT angiography (49%), duplex ultrasound (18%), echocardiography (10.9%), and ventilation-perfusion scintigraphy (10.9%). For patients for whom pulmonary embolism might have been suspected, many large variations were found in practice patterns among physician specialties and geographic locations. There were fewer variations among patients with the inpatient diagnosis of pulmonary embolism. CONCLUSION: Physician practice in the diagnosis of pulmonary embolism is broadly consistent with recommendations. However, variations by physician specialty and geographic location may be evidence of inappropriate imaging.

The actual role of CT and ventilation-perfusion scanning in workup for suspected pulmonary embolism: evidence from hospitals.

OBJECTIVE: Over the past two decades, CT has been found valuable in the diagnosis of pulmonary embolism (PE). We sought to ascertain the relative roles of CT and ventilation-perfusion (V/Q) scanning, the previously preferred technique, in the diagnosis of PE in recent practice and whether there is variation among hospital types. MATERIALS AND METHODS: Using the Medicare anonymized 5% of beneficiaries complete claims file for 2005, we studied the use of relevant CT and V/Q scanning in the evaluation of patients with a diagnosis of PE and of patients with symptoms that might have been due to PE (chest pain, syncope, difficulty breathing). In 2008, we surveyed the radiology departments of Pennsylvania hospitals about the use of CT and V/Q scanning for PE, service availability hours, and what equipment was used. RESULTS: In all data, we found that CT was used approximately six times as frequently as V/Q scanning. In the Medicare data, only small differences in frequency of use of CT and V/Q scanning were associated with hospital characteristics. Academic hospitals did not differ in a major way from other hospitals, nor did small or rural hospitals. In the survey, 97% of radiology departments reported that CT was available for evaluation of PE 24 hours a day 7 days a week. Ninety-three percent of departments reported V/Q scanning was available at some times; 77% reported V/Q available at all times. CONCLUSION: CT was a fully disseminated and dominant technique for the diagnosis of PE by 2005, and it was readily available at small and rural hospitals. The lack of availability of off-hours V/Q scanning at a substantial fraction of hospitals may be a problem for patients with contraindications to CT.

Feasibility of using administrative claims data for cost-effectiveness analysis of a clinical trial.

OBJECTIVE: This study was performed retrospectively to determine if Medicare claims data could be used to evaluate the cost effectiveness, from a payer perspective, of different radiation treatment schedules evaluated in a national clinical trial. METHODS: Medicare costs from all providers and all places of service were obtained from the Centers for Medicare & Medicaid Services for patients treated in the period 1992-1996 on Radiation Therapy Oncology Group 90-03, and combined with data on outcomes from the trial. RESULTS: Of the 1,113 patients entered, Medicare cost data and clinical outcomes were available for 187 patients. Significant differences in tolerance of treatment and outcome were noted between patients with Medicare data included in the study and patients without Medicare data, and non-Medicare patients excluded from it. Ninety-five percent confidence ellipses on the incremental cost-effectiveness scatterplots crossed both axes, indicating non-significant differences in cost effectiveness between radiation treatment schedules. CONCLUSIONS: Claims data permit estimation of cost effectiveness, but Medicare data provide inadequate representation of results applicable to patients from the general population.

An Economic Analysis of Radiation Therapy Oncology Group 94-10: Cost-Efficacy of Concurrent vs. Sequential Chemoradiotherapy.

BACKGROUND: Cost can be a major issue in therapeutic decision-making, and in particular for patients with locally advanced non-small cell lung cancer (LA-NSCLC). METHODS: The specific aim of this analysis was to evaluate the costs and outcomes of patients treated on Radiation Therapy Oncology Group (RTOG) 94-10, Medicare Part A and Part B costs from all for patients treated from 1991 to 1996 on RTOG 94-10, a phase III trial showing a survival benefit for concurrent chemoradiation (STD RT) over sequential (RT day 50) chemoradiation in LA-NSCLC with intermediate outcome for concurrent twice daily radiation and chemotherapy (HFX RT). 26-month expected costs for each arm of the trial in 1996 dollars were determined, with Kaplan Meier sampling average estimates of survival probabilities for each month and mean monthly costs. The analysis was performed from a payer's perspective. Incremental cost-effectiveness ratios were calculated comparing RT on day 50 and HFX RT to the STD RT. RESULTS: Of the 610 patients entered, Medicare cost data and clinical outcomes were available for 92 patients. In this subset, compared to STD RT, RT on day 50 proved less costly but resulted in reduced survival at 1 year. In addition, HFX RT cost slightly more than STD RT but was less effective in this cohort of patients. CONCLUSIONS: In patients with Medicare insurance and with significant toxicity burden, RT on day 50 is the least expensive but also least effective treatment in this subset of patients treated on RTOG 94-10.

Who enrolls onto clinical oncology trials? A radiation Patterns Of Care Study analysis.

PURPOSE: To identify factors significantly influencing accrual to clinical protocols by analyzing radiation Patterns of Care Study (PCS) surveys of 3,047 randomly selected radiotherapy (RT) patients. METHODS AND MATERIALS: Patterns of Care Study surveys from disease sites studied for the periods 1992-1994 and 1996-1999 (breast cancer, n = 1,080; prostate cancer, n = 1,149; esophageal cancer, n = 818) were analyzed. The PCS is a National Cancer Institute-funded national survey of randomly selected RT institutions in the United States. Patients with nonmetastatic disease who received RT as definitive or adjuvant therapy were randomly selected from eligible patients at each institution. To determine national estimates, individual patient records were weighted by the relative contribution of each institution and patients within each institution. Data regarding participation in clinical trials were recorded. The factors age, gender, race, type of insurance, and practice type of treating institution (academic or not) were studied by univariate and multivariate analyses. RESULTS: Overall, only 2.7% of all patients were accrued to clinical protocols. Of these, 57% were enrolled on institutional review board-approved institutional trials, and 43% on National Cancer Institute collaborative group studies. On multivariate analysis, patients treated at academic facilities (p = 0.0001) and white patients (vs. African Americans, p = 0.0002) were significantly more likely to participate in clinical oncology trials. Age, gender, type of cancer, and type of insurance were not predictive. CONCLUSIONS: Practice type and race significantly influence enrollment onto clinical oncology trials. This suggests that increased communication and education regarding protocols, particularly focusing on physicians in nonacademic settings and minority patients, will be essential to enhance accrual.

Outcome results of the 1996-1999 patterns of care survey of the national practice for patients receiving radiation therapy for carcinoma of the esophagus.

PURPOSE: A Patterns of Care Study of patients treated from 1996 to 1999 evaluated the national practice for patients receiving radiation therapy for carcinoma of the esophagus in the United States. METHODS: A national survey was conducted at 59 institutions in a stratified random sample selected from a master list of radiation therapy facilities throughout the United States. Patient, tumor, and treatment characteristics were evaluated. Multivariate comparisons of survival times were made using the Cox proportional hazards model. RESULTS: Adenocarcinoma was diagnosed in 51% of patients and squamous cell carcinoma in 49% of patients. Sixteen percent of patients were clinical stage (CS) I (using the 1983 American Joint Committee on Cancer system), 39% were CS II, and 33% were CS III. Significant variables in the multivariate analysis of survival times included clinical stage, treatment approach, and facility size. Patients with CS III disease had a higher hazard risk of death as compared with CS I patients (hazard ratio [HR], 2.01; P = .001), whereas those treated with chemoradiotherapy followed by surgery (HR, 0.32; P < .0001) had a decreased risk of death compared with chemoradiotherapy-only patients. Patients at small centers had a higher risk of death (HR, 1.32; P = .03) compared with patients treated at larger facilities. CONCLUSION: Concurrent chemoradiotherapy continued to be the most commonly utilized treatment approach during the time period studied. The observation that patients undergoing surgical resection following chemoradiation have a decreased HR or chance of death compared with other treatment schemes supports the need for a randomized trial comparing these strategies.

Clinical and Demographic Factors Associated With Receipt of Non Guideline-concordant Initial Therapy for Nonmetastatic Prostate Cancer.

OBJECTIVES: To determine the extent to which initial therapy for nonmetastatic prostate cancer was concordant with nationally recognized guidelines using supplemented cancer registry data and what factors were associated with receipt of nonguideline-concordant care. METHODS: Initial therapy for 8229 nonmetastatic prostate cancer cases diagnosed in 2004 from cancer registries in 7 states was abstracted as part of the Centers for Disease Control's Patterns of Care Breast and Prostate Cancer study conducted during 2007 to 2009. The National Comprehensive Cancer Network clinical practice guidelines version 1.2002 was used as the standard of care based on recurrence risk group and life expectancy (LE). A multivariable model was used to determine risk factors associated with receipt of nonguideline-concordant care. RESULTS: Nearly 80% with nonmetastatic prostate cancer received guideline-concordant care for initial therapy. Receipt of nonguideline-concordant care (including receiving either less aggressive therapy or more aggressive therapy than indicated) was related to older age, African American race/ethnicity, being unmarried, rural residence, and especially to being in the high recurrence risk group where receiving less aggressive therapy than indicated occurred more often than receiving more aggressive therapy (adjusted OR=4.2; 95% CL, 3.5-5.2 vs. low-risk group). Compared with life table estimates adjusted for comorbidity, physicians tended to underestimate LE. CONCLUSIONS: Receipt of less aggressive therapy than indicated among high-risk group men with >5-year LE based on life table estimates adjusted for comorbidity was a concern. Physicians may tend to underestimate 5-year survival among this group and should be alerted to the importance of recommending aggressive therapy when warranted. However, based on more recent guidelines, among those with low-risk disease, the proportion considered to be receiving less aggressive therapy than indicated may now be lower because active surveillance is now considered appropriate.

Patterns of brachytherapy practice for patients with carcinoma of the cervix (1996-1999): a patterns of care study.

PURPOSE/OBJECTIVE: To analyze the details of brachytherapy practice in patients treated for carcinoma of the cervix in the United States between 1996 and 1999. METHODS AND MATERIALS: Radiation facilities were selected from a stratified random sample. Patients were randomly selected from lists of eligible patients treated at each facility. A total of 442 patients' records were reviewed in 59 facilities to obtain data about patients' characteristics, evaluation, tumor extent, and treatment. National estimates were made using weights that reflected the relative contribution of each institution and of each patient within the sampled institutions. From our survey we estimate that 16,375 patients were treated in the United States during this study period. Unless otherwise specified, brachytherapy practice was based on the 408 patients who had their brachytherapy or all their treatment at the surveyed facility. RESULTS: A total of 91.5% of patients underwent brachytherapy at the initial treating institution; 8.5% were referred to a second site for brachytherapy. Forty-two percent of U.S. facilities referred at least some patients to a second facility for brachytherapy. Of U.S. facilities that treated < or =2 eligible patients per year, 61% referred all of their patients to a second facility for brachytherapy or treated with external RT alone; none of the U.S. facilities with larger experience (>2 eligible patients per year) referred all their patients to a second facility for brachytherapy treatment, but 28% referred some patients to an outside facility for brachytherapy. Overall, 94% of patients who completed treatment with curative intent received brachytherapy. Of these patients who had brachytherapy, 77.8%, 13.3%, and 0.9%, respectively, were treated with low-dose-rate (LDR), high-dose-rate (HDR), or a combination of HDR and LDR brachytherapy; 7.9% had interstitial brachytherapy (5.7% LDR and 1.9% HDR, 0.3% mixed). In facilities that treated >2 patients per year, 15.5% and 9.4% of brachytherapy procedures included HDR or interstitial, respectively; in facilities that treated fewer patients, 3.4% had HDR brachytherapy, and only 1.2% had interstitial brachytherapy. Patients treated with LDR intracavitary radiotherapy had one (23.5%), two (74.1%), or three (2.4%) implants. For patients treated with curative intent who completed radiation therapy with LDR intracavitary radiation therapy without hysterectomy, the median brachytherapy dose to Point A was 40.3 Gy, and the median total dose to Point A was 82.9 Gy. Patients were treated with HDR intracavitary radiation therapy using a variety of treatment schedules using 1-2 fractions (7.5%), 3-4 fractions (17.4%), 5-6 fractions (38.5%), 7-9 fractions (33.5%), or 12 fractions (3%). Fraction sizes were <500 cGy (29.5%), 500-<600 (25.2%), 600 (28.1%), >600 (8%), or unknown (9.2%). For patients treated with HDR, the median total dose to Point A (corrected for fraction size using a alpha/beta = 10) was 85.8 Gy (range: 56.2-116.1 Gy). At institutions treating <500 new patients per year, the percentage of patients receiving a brachytherapy dose <40 Gy was significantly higher than at institutions treating > or =500 new patients per year (p < 0.0001). For LDR intracavitary radiation therapy, 5.8% had neither bladder nor rectal doses recorded for any of their implants, whereas in HDR intracavitary radiation therapy, 73.4% had neither bladder nor rectal doses recorded for any of their implants. The median total duration of radiation therapy was identical for patients who had HDR or LDR intracavitary radiation therapy (57 days). For LDR at institutions treating <500 new patients per year, the percentage of patients with treatment duration >56 days was significantly greater than at institutions > or =500 new patients per year (p = 0.002). Of the patients who had LDR intracavitary radiation therapy implants, 65% were treated using tandem and shielded Fletcher-Suit-Delclos colpostats; other patients had mini ovoids (10.9%), cylinders (3.9%), Henschke (3.7%), or other/mixed applicators (16.5%). In contrast, of patients treated with HDR intracavitary radiation therapy, 68.7% had tandem and rings, 18.2% Fletcher-Suit-Delclos ovoids, 7.5% mini ovoids, 2.3% cylinders, and 3.2% other or mixed applicators. CONCLUSIONS: The median duration of treatment and median Point A dose were very similar for patients treated with HDR or LDR. Patients with HDR were treated using a variety of treatment schedules. Different applicator types were favored for LDR vs. HDR. Of patients treated with HDR, 73.4% had no brachytherapy bladder or rectal doses recorded, suggesting that full dosimetric calculations were performed only for the first fraction in many institutions. Facility size significantly impacted on referral to another institution for brachytherapy, brachytherapy dose, and treatment duration.

1998-1999 patterns of care study process survey of national practice patterns using breast-conserving surgery and radiotherapy in the management of stage I-II breast cancer.

PURPOSE: The Patterns of Care Study survey process evaluation has been an effective means of assessing the evaluation and treatment practices used by radiation oncologists in the United States for Stage I-II breast cancer. The current 1998-1999 report updates the previous 1989 and 1993-1994 analyses and reflects the recent changes in surgery and systemic therapy observed nationally in the management of early-stage disease. METHODS AND MATERIALS: A weighted sample size of 71,877 patient records of women treated with breast-conserving surgery and radiotherapy (RT) was obtained from a stratified two-stage sampling of 353 patient records. These cases were centrally reviewed from academic and private radiation oncology practices across the United States. The data collected included patient characteristics, clinical and pathologic factors, and surgical and RT details. The results were compared with those of previous Patterns of Care Study survey reports. RESULTS: Of the patients in the current survey, 97% had undergone mammography before biopsy. A review of the primary tumor pathologic findings indicated improved quantification of an intraductal component from 7.0% in 1993-1994 to 20.4% in 1998-1999 (p = 0.01). The tumor characteristics were better defined, with estrogen and progesterone receptor measurement performed in 91.4% and 91.3% in the 1998-1999 survey vs. 83.7% and 80.3% in the 1989 survey, respectively (p = 0.03 and p = 0.002, respectively). Axillary dissection was performed in 82.2% in the present survey compared with 93.6% in the 1993-1994 survey (p = 0.0004); sentinel node biopsy was performed in 20.1% of the present cases. The use of CT for planning was increased in the current survey, with 22.9% cases CT planned vs. 9% in 1993-1994 (p = 0.10). In the present survey, 100% had received whole breast RT. When a supraclavicular field was added, the dose was prescribed to a specified depth in 67.5% of cases, most commonly 3 cm. When an axillary field was added, the dose was generally prescribed to the mid-plane. Chemotherapy and tamoxifen was used in 36% and 55.8% of patients, respectively, in the 1998-1999 survey, representing a statistically significant increase compared with the 1993-1994 survey, despite comparable pathologic tumor size and nodal involvement. CONCLUSION: The present results demonstrate a high level of compliance of the sampled radiation oncology practices with current breast conservation standards and continued improvement in many categories compared with prior patterns of care study surveys. The estimates in the current survey after whole breast RT will serve as a benchmark against newer trends in breast cancer RT, such as partial breast RT.

Patterns of care survey (PCS) in lung cancer: how well does current U.S. practice with chemotherapy in the non-metastatic setting follow the literature?

BACKGROUND: In LD-SCLC, combined modality therapy has emerged as the standard of practice in good performance status (PS) patients (pts). Pignon's meta-analysis [N Engl J Med 1992;327:1618-24] showed that combination chemotherapy (CT) and thoracic radiation (XRT) in LD-SCLC yielded an absolute 5.4% increase in 3-year survival versus chemotherapy alone. Concurrent chemoradiation upfront has generated the highest survival rates [Murray. J Clin Oncol 1993;11:336-44; Jeremic. J Clin Oncol 1996;15:893-900; Takada. J Clin Oncol 2002;20:3054-60]. In stage III NSCLC, multiple studies have shown therapeutic superiority for combination chemotherapy and XRT versus RT alone; and recent literature suggests a therapeutic advantage for concurrent chemoradiation versus chemotherapy followed by XRT [Curran. ASCO 2000;19:484a; Furuse. JCO 1999;17:2692-9; Zatloukal. ASCO 2002;A-1159]. Data are less secure regarding the role of chemotherapy in stage I and II NSCLC. MATERIAL AND METHODS: A stratified two-step cluster sampling technique was used for data collection. Five hundred and forty-one individuals diagnosed between 1998 and 1999 with lung cancer, either LD-SCLC or stages I-III NSCLC were sampled from 58 institutions featuring radiotherapy facilities, giving a weighted sample size (wss) of 42,335 patients. All pts had Karnofski performance status (KPS) >or=60. We determined the percentage who received chemotherapy; the nature of chemotherapy and its timing with respect to XRT. SUDAAN statistical software was used to allow the incorporation of the design elements and weights to reflect the relative contribution of each institution and each patient in the analysis RESULTS: Of 72 (wss=6138) pts with LD-SCLC, 100% received XRT and 95% received chemotherapy (CT); 66% received concurrent (con) CT and XRT, of whom 29% also received CT pre XRT; 22% received CT post XRT as well, and 23% received both: 63% received sequential CT-->XRT+/-con CT; and 38% received some CT after XRT. Fifty-two percent received cisplatin (DDP), and 38% received carboplatin (CBDCA); 73% received etoposide (VP-16), while 10% received paclitaxel. Of 469 pts (wss=36,197) with NSCLC, 52% received CT, including 30% with stage I disease, 48% with stage II NSCLC, 60% with stage III NSCLC, and 50% with unknown stage. Thirty-nine percent received sequential CT-->XRT+/-CT, of whom 49% received CT pre XRT only. Seventy-four percent received con CT and XRT; and 27% received posterior CT, of whom 84% also received con CT/XRT. Forty-five received some CT in the pre-op setting and 15% in the post-op setting. Twelve percent received DDP-based therapy, while only 13% and 7% received VP-16 or vincas, respectively; 67% received CBDCA. Seventy-two percent received taxanes, of whom 96% received paclitaxel. Gemcitabine was administered to 3% of NSCLC pts. CONCLUSIONS: Combined modality therapy is typically employed in the therapy of LD-SCLC and LA-NSCLC. The majority of those treated for SCLC receive concurrent CT/XRT, while nearly 3/4 of those treated with CT and XRT for LA-NSCLC received concurrent CT/XRT. Current practice in the US generally matches evidence-based literature, although a significant percentage of practitioners substitute CBDCA for DDP in both venues and use paclitaxel in lieu of vincas or etoposide in NSCLC.

Patterns of radiotherapy practice for patients with carcinoma of the uterine cervix: a patterns of care study.

PURPOSE: To determine the influence of research findings and evolving technology on the practice of radiotherapy in patients with carcinoma of the cervix. METHODS AND MATERIALS: Radiation oncology facilities were randomly selected from two strata: those that treated <500 and those that treated >/=500 new cancer patients annually. Patient records were randomly selected from lists of eligible patients treated between 1996 and 1999 at each institution. A total of 442 patient records were reviewed at 59 facilities (55 with eligible patients). National estimates were made using weights that reflected the relative contribution of each institution and of each patient within the sampled institutions. Most estimates were based on the 383 patients who had received their initial therapy at a surveyed facility (excluding the 59 patients who were referred for brachytherapy only after initial treatment at another facility). The estimates of brachytherapy practice were based on the 408 patients who had received their brachytherapy at a surveyed facility. The data were compared with those obtained from a similar 1992-1994 survey. RESULTS: Overall, 40.5%, 25.4%, and 33.9% of patients had Stage IA-IIA, IIB, or IIIA-IVA disease, respectively. CT was the most common method of nodal evaluation, with surgical evaluation performed in only 12% of patients. Of the 55 facilities with eligible patients, 32 had treated <==8 eligible patients during the 4-year study period. We estimated that 27.5% of patients were treated at facilities that treated <==2 patients with intact cervical cancer annually; 43% were treated at facilities that treated <500 new patients annually. Patients treated at small facilities were significantly more likely to have received a total dose to Point A of <80 Gy, to have had their treatment protracted to >70 days, and to have undergone adjuvant hysterectomy or chemotherapy. In large facilities, radiotherapy was less likely to be protracted to >70 days in the 1996-1999 survey than in the 1992-1994 survey (p < 0.0001); however, in small facilities, treatment was more likely to be protracted than in the earlier survey (p = 0.06), contributing to increasing disparities between the treatments given in large and small facilities. Overall, 92.4% of patients treated with nonpalliative intent were treated with brachytherapy. Of the patients who received brachytherapy, 16.4% had at least part of their brachytherapy delivered at a high dose rate; this was not significantly greater than the proportion treated with high-dose-rate brachytherapy in the 1992-1994 survey (9.1%; p = 0.3). The proportion of patients receiving chemotherapy as part of their initial treatment in 1996-1999 (34.6%) was not significantly different statistically from that in 1992-1994 (25.6%; p = 0.3). However, in 1999, 63% of patients had received chemotherapy compared with 19%, 28%, and 26% in 1996, 1997, and 1998, respectively. The details and confirmation of chemotherapy administration were rarely documented in the radiation oncology clinic notes and hospital records. CONCLUSION: The sharp increase in the use of chemotherapy in 1999 suggested rapid application of the results from randomized trials. However, considerable heterogeneity in practice patterns remains, particularly in the use of brachytherapy. The practice at small facilities appears to differ significantly from that at larger facilities in several respects, with a statistically significantly larger proportion of treatments at small facilities failing to meet current guidelines for optimal treatment.

Status of postmastectomy radiotherapy in the United States: a patterns of care study.

PURPOSE: The Patterns of Care Study performed this first known practice survey to establish a national profile of the delivery of postmastectomy radiotherapy (RT) in operable breast cancer. METHODS AND MATERIALS: A Patterns of Care Study research associate collected data from 55 randomly selected institutions. The survey data included 132 items describing the patient, pathologic features, and treatment course for patients with clinical Stage I, II, and IIIA breast cancer undergoing postmastectomy RT in 1998 and 1999. A multivariate analysis was performed to determine the impact of tumor factors and type of treatment facility on the radiation fields used. RESULTS: A weighted sample size of 13,720 was obtained from a sampling of 405 patient records. The mean tumor size was 3.5 cm, and the mean number of axillary nodal metastases was 4.55. Lymphatic vascular invasion was noted in 34%, microscopic skin or dermal lymphatic invasion in 16%, positive or close margins in 36%, and extracapsular nodal extension in 23%. Radiotherapy included the chest wall in all cases and the regional nodes in 78%. When nodal RT was delivered, it included a supraclavicular field, supplemental axillary field, and/or an internal mammary field in 98%, 46%, and 23% of cases, respectively. Chest wall and supraclavicular RT was delivered in >90% of instances with 6-MV photons to doses between 45 and 50 Gy. More variation was seen in the delivery of the axillary and internal mammary RT. On multivariate analysis, the presence of four or more positive nodes and treatment at a large-volume facility were the factors most frequently associated with the use of regional radiation fields. CONCLUSION: This Patterns of Care Study survey has demonstrated that breast cancer patients undergoing postmastectomy RT in 1998 and 1999 had a high proportion of factors associated with an increased risk of locoregional failure. The practice patterns established in this study provide a baseline for comparison with future survey results.

Changing trends in national practice for external beam radiotherapy for clinically localized prostate cancer: 1999 Patterns of Care survey for prostate cancer.

PURPOSE: To report changing trends in external beam radiotherapy (EBRT) delivery practice for clinically localized prostate cancer as determined from the 1999 survey from the American College of Radiology National Patterns of Care Study. METHODS AND MATERIALS: The 1999 survey included a weighted sample of 36,496 patient records obtained from a stratified two-stage sample of 554 patient records. Patients were surveyed from 58 institutions and were treated between January 1999 and December 1999. Of these, 36% (weighted sample size, 13,293; unweighted sample size, 162) were treated with brachytherapy with or without EBRT and 64% (weighted sample size, 23,203; unweighted sample size, 392) were treated with EBRT only. The latter group is the subject of this report. The following trends in clinical practice were analyzed according to prognostic risk groups and other variables and compared with the results of the prior surveys: use of androgen deprivation therapy (ADT) in combination with EBRT, higher prescription dose levels, and administration of elective whole pelvic RT (WPRT). RESULTS: The incidence of ADT use for favorable, intermediate, and unfavorable-risk groups was 31%, 54%, and 79%, respectively. A multivariate logistic regression analysis revealed a statistically significantly increased likelihood of intermediate (p = 0.001) and unfavorable (p <0.0001) risk groups treated with ADT in conjunction with EBRT compared with favorable-risk patients. ADT use was more prevalent among treated patients in the 1999 survey than in the 1994 survey (51% vs. 8%, p <0.0001). Compared with the prior survey, a greater percentage of patients were treated with higher radiation doses in the 1999 survey (> or =72 Gy, 45% in 1999 vs. 3% in 1994, p <0.0001). In the 1999 survey, the proportion of patients with favorable, intermediate, and unfavorable tumors treated to doses > or =72 Gy was 43%, 38%, and 60%, respectively, compared with 4%, 3%, and 1%, respectively, in the 1994 survey. Compared with the 1994 survey, a large increase in the number of patients treated with brachytherapy (36% vs. 3%, p <0.0001). The frequency of WPRT use decreased from 92% in 1989 to 52% in 1994 to 23% in 1999. For the 1999 survey, a multivariate analysis indicated that unfavorable-risk patients (p = 0.016) and intermediate-risk patients (p = 0.018) were more likely to be treated with WPRT compared with favorable-risk patients. Nevertheless, even among unfavorable-risk patients, a substantial decline had occurred in the use of WPRT for the 1999 survey (70% for the 1994 survey compared with the 31% for the current survey; p = 0.003). CONCLUSION: The significantly increased use of ADT for high-risk patients and higher radiation doses, especially for intermediate- and high-risk patients, reflects the penetration and growing acceptance of clinical trial results that have demonstrated the efficacy of these treatment approaches. The relatively high proportion of favorable-risk patients treated with high radiation dose levels was greater than expected. A large increase in brachytherapy was observed compared with prior surveys. Most treated patients with high-risk disease did not undergo elective WPRT, which likely reflects the influences of prior trials, stage migration, and the commonly held belief that WPRT provides minimal benefit in the setting of higher radiation doses.

The national practice for patients receiving radiation therapy for carcinoma of the esophagus: results of the 1996-1999 Patterns of Care Study.

PURPOSE: A Patterns of Care Study (PCS) was conducted to evaluate the standards of practice for patients receiving radiation therapy for esophageal cancer from 1996 to 1999. This study examined the evaluation and treatment schemes used during this time and compared these results to the PCS data obtained between 1992 and 1994 to identify any fundamental changes in national practice. METHODS: A national survey was conducted using a two-stage cluster sampling technique. Specific information was collected on 414 patients with esophageal cancer who received radiotherapy (RT) as part of definitive or adjuvant management at 59 institutions. Patients were staged according to the 1983 AJCC. Eligibility criteria for case review included RT between 1996 and 1999, no evidence of distant metastasis (including CT evidence of either supraclavicular or celiac nodes >1 cm), squamous cell or adenocarcinoma histology, Karnofsky performance status >60, tumors in the thoracic esophagus with <2 cm extension into the stomach, and no prior malignancies within the last 5 years. Statistical analysis was performed on the database using SUDAAN software to accurately reflect the type of sampling technique used by PCS. For the purpose of this analysis, institutions were stratified as either large or small based on the number of new cases seen each year. For the purposes of comparison, the 1992-1994 PCS esophageal survey results were subjected to the same statistical procedures and tests. RESULTS: The median age of patients was 64 years. Seventy-seven percent were male, and 23% were female. Karnofsky performance status was >or=80% in 85% of patients. The racial profile mirrors the previous survey with 75% Caucasian, 21% African-American, 3% Asian, and <1% Hispanic. A review of the histology revealed a nearly 50:50 split between squamous cell and adenocarcinoma. Sixteen percent were clinical Stage I, 39% clinical Stage II, and 33% clinical Stage III according to the 1983 AJCC system. Workup included endoscopy (96%), CT of the chest (87%), CT of the abdomen (75%), and esophagram (64%). Endoscopic ultrasound (EUS) was used in 18% of cases as compared to <2% in the original survey (p < 0.0001). Patients treated at large centers were more likely to undergo EUS than those treated at small centers (23% vs. 12%, p = 0.047). Fifty-six percent of patients received concurrent chemoradiation as definitive treatment. There was a significant increase in the use of concurrent chemoradiation before planned surgical resection as compared to the original survey (27% vs. 10%, p = 0.007). Other schemes included RT alone (10%), postoperative RT (1%), and postoperative chemoradiation (5%). Forty-six percent of patients with adenocarcinoma underwent trimodality therapy as compared to 19% with squamous cell carcinomas (p = 0.0002). Patients undergoing preoperative chemoradiation were more likely to have had an EUS. The median total dose of external RT was 50.4 Gy, and the median dose per fraction was 1.8 Gy. Brachytherapy was used in 6% of cases. The chemotherapy agents most commonly used included 5-fluorouracil (82%), cisplatin (67%), and paclitaxel (22%). Paclitaxel was more commonly employed as part of a preoperative chemoradiation regimen than in the setting of definitive chemoradiation (46% vs. 12%, p = 0.03). Compared to the original survey, paclitaxel use significantly increased between 1996 and 1999 (0.2% vs. 22%, p = 0.001). CONCLUSIONS: The Patterns of Care Survey confirms the use of concurrent chemoradiation as part of the national standards of practice for the management of esophageal cancer patients. A comparison with the previous study documents the significant rise in the use of EUS, preoperative chemoradiation followed by surgery, and the increasing use of paclitaxel as part of a combined modality regimen.

Patterns of radiation therapy practice for patients treated for intact cervical cancer in 2005 to 2007: a quality research in radiation oncology study.

PURPOSE: To assess practice patterns and compliance with clinical performance measures for radiation therapy (RT) for patients with intact carcinoma of the cervix. METHODS AND MATERIALS: Trained research associates reviewed the records of 261 randomly selected patients who received RT for cervix carcinoma between 2005 and 2007 from 45 facilities randomly selected after stratification by practice type. National estimates of patient and treatment characteristics were calculated from survey data using SUDAAN statistical software. RESULTS: From the survey data, we estimated that only 8% of US facilities treated on average more than 3 eligible patients per year. No small or medium nonacademic facilities in the survey treated more than 3 eligible patients per year. Approximately 65.5% of patients began treatment in a facility that treated 3 or fewer eligible patients per year. Although 87.5% of patients had brachytherapy as part of their treatment, the proportion treated with external beam RT only was about double that estimated from the 1996 to 1999 survey. The use of high-dose-rate brachytherapy sharply increased, particularly in small nonacademic facilities. Overall, patients treated in nonacademic facilities were more likely to have incomplete or protracted treatment; 43% of patients treated in small nonacademic facilities did not have treatment completed within 10 weeks. Also, patients treated in facilities that treated 3 or fewer eligible patients per year were significantly less likely to receive concurrent chemotherapy than were patients treated in other facilities. CONCLUSION: Survey results indicate a disturbingly high rate of noncompliance with established criteria for high-quality care of patients with cervical cancer. Noncompliance rates are particularly high in nonacademic facilities, especially those that treat relatively few patients with intact cervical cancer.

Impact of sociodemographic factors on the radiotherapeutic management of lung cancer: Results of a Quality Research in Radiation Oncology survey.

PURPOSE: The objective of this study is to describe the impact of sociodemographic (SOC) factors on the management of lung cancer patients treated at radiation therapy facilities participating in the Quality Research in Radiation Oncology survey. METHODS AND MATERIALS: A 2-stage stratified random sample of lung cancer patients treated in 2006 to 2007 at 45 facilities yielded 340 stage I-III non-small cell lung cancer (NSCLC) and 144 limited-stage small cell lung cancer (LS-SCLC) cases. Five SOC variables based on data from the 2000 US Census were analyzed for association with the following clinical factors: patients living in urban versus rural settings (U/R); median household income (AHI); % below poverty level (PPV); % unemployed (PUE); and % with college education (PCE). RESULTS: The 340 NSCLC patients were stage I, 16%; stage II, 11%; stage III, 62%; stage unknown, 11%. Histologic subtypes were adenocarcinoma, 31.8%; squamous cell carcinoma, 35.3%; large cell carcinoma, 3.2%; and NSCLC NOS, 27.7%. The median age was 66 years. Median Karnofsky performance status (KPS) was 80. The 144 LS-SCLC had a median age of 63; 73 were male (50.7%). Median KPS was 80. Stereotactic body radiation therapy (SBRT) and modern imaging utilization was associated with treatment at facilities located in higher SOC regions. SBRT was employed in 46.8% stage I NSCLC patients treated in centers where %PUE was below median versus 14.8% in centers where %PUE was above median (P = .02). Four-dimensional computed tomography was utilized in 14.2% of patients treated in centers located in regions with %PPV below median versus 3.7% in centers located in regions with %PPV above median (P < .01). SCLC patients were more likely to receive all of their planned RT when treated at centers located in regions with lower PPV (95.0% vs 79.1%; P = .04). CONCLUSIONS: SOC factors may impact use of modern treatment planning and delivery and multidisciplinary management of NSCLC and SCLC. These results may suggest an impact of these SOC factors on access to health care.

Type and dose of radiotherapy used for initial treatment of non-metastatic prostate cancer.

BACKGROUND: We sought to describe patterns of initial radiotherapy among non-metastatic prostate cancer (PC) patients by recurrence risk groups. METHODS: Medical records were abstracted for a sample of 9017 PC cases diagnosed in 2004 as a part of the Center for Disease Control and Prevention's Prostate and Breast Patterns of Care Study in seven states. Non-metastatic PC cases are categorized as low-risk (LR), intermediate-risk (IR) or high-risk (HR) groups based on pretreatment PSA, tumor stage, and Gleason score per 2002 NCCN guidelines. Univariate and multivariate analyses were employed to determine factors associated with the type and dose of radiotherapy by the risk groups. RESULTS: Of the 9,017 patients, 3153 who received definitive radiotherapy either alone or in combination with hormone therapy (HT) were selected for in-depth analysis. Multivariate models showed that LR patients were more likely to receive seed implant brachytherapy (BT) than those in higher risk groups. Those in the IR group were most likely to receive external beam radiotherapy (EBRT) combined with BT or high-dose radiotherapy. Use of HT in combination with radiotherapy was more common in the IR and HR groups than for LR patients. Intensity modulated radiation treatment (IMRT) was used to treat 32.6% of PC patients treated with EBRT, with the majority (60.6%) treated with high-dose radiotherapy. CONCLUSIONS: Radiotherapy types and dosage utilization varied by PC risk groups. Patients in IR were more likely than those in LR or HR to receive high-dose radiotherapy. IMRT was used in about one third of patients to deliver high-dose radiotherapy.

Can patient comorbidities be included in clinical performance measures for radiation oncology?

PURPOSE: Patient comorbidities may affect the applicability of performance measures that are inherent in multidisciplinary cancer treatment guidelines. This article describes the distribution of common comorbid conditions by disease site and by patient and facility characteristics in patients who received radiation therapy as part of treatment for cancer of the breast, cervix, lung, prostate, and stomach, and investigates the association of comorbidities with treatment decisions. MATERIALS AND METHODS: Stratified two-stage cluster sampling provided a random sample of radiation oncology facilities. Eligible patients were randomly sampled from each participating facility for each disease site, and data were abstracted from medical records. The Adult Comorbidity Evaluation Index (ACE-27) was used to measure comorbid conditions and their severity. National estimates were calculated using SUDAAN statistical software. RESULTS: Multivariable logistic regression models predicted the dependent variable "treatment changed or contraindicated due to comorbidities." The final model showed that ACE-27 was highly associated with change in treatment for patients with severe or moderate index values compared to those with none or mild (P < .001). Two other covariates, age and medical coverage, had no (age) or little (medical coverage) significant contribution to predicting treatment change in the multivariable model. Disease site was associated with treatment change after adjusting for other covariates in the model. CONCLUSIONS: ACE-27 is highly predictive of treatment modifications for patients treated for these cancers who receive radiation as part of their care. A standardized tool identifying patients who should be excluded from clinical performance measures allows more accurate use of these measures.