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Comparing the Costs of Radiation Therapy and Radical Prostatectomy for the Initial Treatment of Early-Stage Prostate Cancer

From the Research Department, American College of Radiology, Reston; Direct Research, LLC, Vienna, VA; Departments of Urology and Health Services, University of California, Los Angeles; Providence St Joseph Medical Center, Burbank, CA; Section of Urology, Virginia Mason Medical Center, Seattle, WA; Department of Radiation Oncology, University of Michigan, Ann Arbor, MI; and Department of Health Services Administration, University of Alabama at Birmingham, Birmingham, AL.

Address reprint to Jeffrey H. Burkhardt, PhD, Assistant Professor, University of Alabama at Birmingham, Webb 552, 1530 3rd Ave S, Birmingham, AL 35294-3361; email: jburkhar{at}uab.edu

	ABSTRACT

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PURPOSE: Radical prostatectomy and external-beam radiation are the most common treatments for localized prostate cancer. Given the absence of clinical consensus in favor of one treatment or the other, relative costs may be a significant factor. This study compares the direct medical costs during the month before and 9 months after diagnosis for patients treated primarily with external-beam radiation or radical prostatectomy for early-stage prostate cancer.

METHODS: Patients age 65 or older and coded by the Surveillance, Epidemiology, and End Results (SEER) registry as having been diagnosed with adenocarcinoma of the prostate treated primarily with external-beam radiation or radical prostatectomy during 1992 and 1993 were identified. The initial treatment costs, as measured by Medicare-approved payment amounts, for each strategy were analyzed using linked SEER-Medicare claims data after adjusting for differences in comorbidity and age. An intent-to-treat analysis was also performed to adjust for differences in staging between the two groups.

RESULTS: For patients in the treatment-received analysis, the average costs were significantly different; $14,048 (95% confidence interval [CI], $13,765 to $14,330) for radiation therapy and $17,226 (95% CI, $16,891 to $17,560) for radical prostatectomy (P < .001). The average costs for patients in the intent-to-treat analysis were also significantly less for radiation therapy patients ($14,048; 95% CI, $13,765 to $14,330) than for those who underwent radical prostatectomy ($17,516; 95% CI, $17,195 to $17,837; P < .001).

CONCLUSION: For patients with early-stage prostate cancer, average costs during the initial treatment interval were at least 23% greater for radical prostatectomy than for external-beam radiation. Major limitations of the research include not studying costs after the initial treatment interval and questionable current applicability, given changes in management of early prostate cancer.

	INTRODUCTION

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DURING THE PAST decade, prostate cancer has surpassed lung cancer to become the most commonly diagnosed cancer among men in the United States.¹ Fortunately, the vast majority of these cancers are clinically confined to the prostate at diagnosis. Considerable controversy exists regarding the optimal treatment for these early-stage prostate cancers.^2,3 Currently, accepted treatment options for such patients include radical prostatectomy, external-beam radiation therapy, brachytherapy, and watchful waiting. Unfortunately, the clinical data required to resolve the controversy do not currently exist, and therefore, the decision regarding which treatment to pursue is usually based on patient and/or physician preference. Not surprisingly, urologists tend to recommend surgical treatment for patients with localized prostate cancer, whereas radiation oncologists are more likely to recommend radiation therapy.⁴

Although the use of brachytherapy is growing in popularity, radical prostatectomy and external-beam radiation therapy remain the most common treatments for localized prostate cancer. It has been estimated that more than 60,000 men with early-stage prostate cancer receive external-beam radiation therapy each year,⁵ whereas nearly 75,000 men undergo radical prostatectomy. To date, most studies comparing external-beam radiation therapy and radical prostatectomy have focused primarily on efficacy,^6-12 health-related quality of life,^13-17 and cost of treating patients either without regard to the type of treatment or with one specific type of treatment.^18,19 However, very few studies have examined the difference in cost between the two treatment strategies.²⁰

Given the absence of a clinical consensus in favor of one treatment, cost factors become more important in the type of treatment decision, with over $1.7 billion spent in the United States for prostate cancer treatment in 1995.²¹ This study examined the cost of treatment by comparing direct medical costs during the initial treatment interval period, from 1 month before diagnosis to 9 months after diagnosis, for men treated with external-beam radiation therapy or radical prostatectomy for early-stage prostate cancer.

	METHODS

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Data Sources
Data for this study come from the Surveillance, Epidemiology and End Results (SEER)-Medicare linked data set, which was created by researchers at the National Cancer Institute (NCI) and the Health Care Financing Administration to provide information about costs, utilization, and medical outcomes among elderly patients diagnosed with cancer.²² Using a deterministic matching algorithm, clinical data for 93% of the incident cases in the NCI’s 11 SEER tumor registries were linked to their Medicare claims data. These registries cover six metropolitan areas (San Francisco/Oakland, San Jose/Monterey, Detroit, Atlanta, Los Angeles, and Seattle/Puget Sound) and five states (Connecticut, Utah, New Mexico, Iowa, and Hawaii) and include approximately 14% of the United States population.²³ Using well-defined procedures, trained abstractors collect clinical and sociodemographic data on all incident cancer cases within their region. Data collected by SEER include primary tumor site, histology, SEER stage (localized, regional, distant, and unstaged), treatment (eg, surgery, radiation therapy) planned or given within the first 4 months after diagnosis, age at diagnosis, and race. Abstractors are required to use all available information, both clinical and pathologic, when determining a patient’s SEER stage. Prostate cancer patients must have disease confined to the prostate to be categorized as localized; extracapsular spread or seminal vesicle, bladder, rectum, or pelvic lymph node involvement to be categorized as regional; and involvement of other distant sites to be categorized as distant. The SEER data set also includes information on which procedures that were classified as cancer-directed surgery (eg, radical prostatectomy with or without lymph node dissection, lymph node dissection alone) and radiation procedures (eg, external-beam radiation therapy, brachytherapy, or both) were performed.

The cost data in the linked data set were extracted from the Health Care Financing Administration’s Medicare Statistical System and National Claims History files and include claims data from both Medicare Part A and Part B. These data include Medicare claims for inpatient care in hospitals and skilled nursing facilities, home health services, hospice services, physician services, and outpatient services. At the time of this analysis, complete claims data were only available for the years 1991 through 1994. The measure of cost used in this article is the total amount Medicare deemed payable—defined as the amount that Medicare itself paid for the service plus the coinsurance and deductible amounts due from the patient and/or his other insurance under Medicare payment rules. This equals, for all practical purposes, total payments received by hospitals, physicians, and other providers.

Study Populations
The study population for all analyses consisted of men age 65 and over who were coded by SEER as having been diagnosed with adenocarcinoma of the prostate during 1992 and 1993. This time period was chosen because of the limitations of the claims data available at the time of our analysis (ie, complete claims data were only available for 1991 through 1994) and the period for which data were required—7 months before diagnosis (including 6 months for a comorbidity adjustment discussed later) and 9 months after diagnosis.

Patients were excluded from all analyses for several reasons. First, to increase the likelihood that complete claims were available, patients who were not enrolled in Medicare Part A and Part B or were members of a health maintenance organization during any portion of the assessment period were excluded. (Medicare pays a monthly fee for health maintenance organization enrollees and, in general, does not receive claims for their care.) Second, patients who did not survive the initial treatment interval were excluded. Only patients with complete data for the entire initial treatment interval were included. Third, because only small numbers of patients were found to have undergone brachytherapy alone, or external-beam radiation and brachytherapy, these patients were excluded. Fourth, patients undergoing cystoprostatectomy were excluded. Finally, to avoid confounding, patients with a history of a prior malignancy were also excluded.

As noted by Lu-Yao and Yao,²⁴ SEER uses the best available evidence when assigning a stage for patients with prostate cancer. Although pathologic evidence is available to stage patients who underwent radical prostatectomy, only clinical evidence is generally available for staging those treated with external-beam radiation. Because some patients in the surgery group were thought to have disease localized to the prostate before surgery but were subsequently found to have regional or distant disease at the time of surgery, limiting the study population for the surgery group to those patients who were classified as having undergone radical prostatectomy and having localized disease would result in differential staging and could bias our results. Accordingly, like Lu-Yao and Yao, for our treatment-received analysis, we included in the surgery group all patients undergoing radical prostatectomy, regardless of SEER stage, whereas patients were assigned to the radiation group only if they were coded as having localized disease and external-beam radiation therapy with or without lymph node dissection. Lu-Yao and Yao²⁴ also noted that intraoperative discovery of lymph node involvement usually results in a decision not to proceed with the radical prostatectomy because the surgery would no longer be curative. Exclusion of these patients from the surgery group could also bias our results. To address this issue, in addition to our primary analysis of the treatment received, we also performed an intent-to-treat analysis²⁴ in which patients were assigned to the surgery group if it was documented that they had undergone a radical prostatectomy or a lymph node dissection, regardless of stage. The criteria for inclusion in the radiation group remained the same for both analyses.

Assessment Period
We measured costs of all health care during the initial treatment interval, defining initial treatment interval as the period from 1 calendar month before diagnosis to 9 calendar months after diagnosis (including the calendar month of diagnosis), for a total period of 10 calendar months. Although 6 months has generally been used as the time period corresponding to the time for the diagnostic work-up and the initial course of treatment,²⁵ we included an additional 3 months to allow for possible delay in the commencement of treatment as sometimes occurs among patients with prostate cancer. As part of one of the methods used to adjust for differences in comorbidity (see below), costs during the 6 calendar months before the initial treatment interval were also estimated.

Comorbidity and Age Adjustments
Patients who undergo treatment with external-beam radiation therapy are generally older and sicker than those who undergo radical prostatectomy.^14,26 Because we examined total health care costs, not prostate cancer–specific costs, these differences could potentially bias the analysis (ie, total costs associated with radiation patients could be higher than those for surgery due in part to the additional cost of caring for the radiation patients’ other illnesses). Accordingly, we attempted to adjust for differences in comorbidity between the two groups.

One of the earliest methods described in the literature for controlling for comorbid diseases is the Charlson index, which was originally developed to predict mortality.²⁷ In this index, as with many of its variants,^28,29 individual disease categories are identified through sets of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9 CM) codes. The original Charlson index grouped the ICD-9 CM codes into 17 relevant disease categories, with each disease category assigned a weight based on severity. Each patient’s comorbid disease weight was based on the presence or absence of each disease category. Klabunde et al³⁰ recently published a methodology for computing the Charlson index using inpatient and outpatient claims data rather than hospital inpatient information only, as was done in the original Charlson index. We computed two comorbidity indices of this type. Both were based on inpatient and outpatient claims in the 6 months preceding the initial treatment interval. One index used the disease categories and weights used by the original Charlson index; the other used the disease categories and weights Klabunde et al³⁰ developed.

As an alternative technique, we controlled for comorbid diseases and other differences between radiation and surgical patients by subtracting the average monthly health care expenditures for the 6-month period before the initial treatment interval from the average monthly health care expenditures during the initial treatment interval. By subtracting in this fashion, we estimated health care spending attributable to prostate cancer treatment only, after removing the expenditures for noncancer care. This method should control not only for comorbid conditions but also for other factors likely to affect expenditures, such as age or regional differences in utilization of health care.

The results of the analyses were, in addition, adjusted for differences in patient age by using weights to make the age distribution in each treatment category (radiation therapy or surgery) match the age distribution of the entire population under study. Age categories used in weighting were 65 to 69, 70 to 74, 75 to 79, 80 to 84, and 85 years and over.

Statistical Analysis
Mean payment per case was used as the resource measure throughout the analysis. Means correctly reflect the financial implications of treatment, appropriately weighting high- and low-cost cases in proportion to their impact on total spending. Medians or other measures of central tendency typically underweight high-cost cases that account for the preponderance of spending and may give a substantially distorted view of spending. For example, inpatient care accounts for approximately 40% of total Medicare spending, but median annual inpatient spending for all Medicare beneficiaries is zero (because far fewer than half of beneficiaries are hospitalized each year).

Statistical tests are two-tailed t tests for differences between groups, using the means and standard errors of payment per case. In theory, because spending data are approximately lognormal, small-sample tests and P values based on this normal approximation may be somewhat overstated. This might have been a concern if sample size had been small or P values for key payment contrasts had been near .05. In practice, however, averages are based on thousands of cases and P values for key measures grossly exceed traditional thresholds of statistical significance. In this situation, a simple t test with symmetric confidence intervals is adequate to screen out potentially statistically insignificant results.

	RESULTS

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Patients
During 1992 and 1993, 34,432 men 65 years old and over were identified by SEER as having been diagnosed with adenocarcinoma of the prostate. After removing those patients not eligible, based on the exclusion criteria described above, 10,255 patients met the criteria for inclusion in the study (Table 1). Of these patients, 4,956 were assigned to the external-beam radiation group and 4,847 patients were assigned to the surgery group for the treatment-received analysis using the criteria outlined above. For the intent-to-treat analysis, 452 additional patients who underwent lymph node dissection without radical prostatectomy were added to the surgery group. Of note, to assess the accuracy of the SEER treatment coding, we compared the SEER codes with the Current Procedural Terminology (CPT) codes in the Medicare claims files and found complete agreement 88% of the time.

Intent-to-Treat Analysis
The Klabunde-adjusted average cost during the initial treatment period was greater for the 452 patients who were added to the surgery group for the intent-to-treat analysis ($19,492) than for those in the treatment-received surgery group ($17,226). When these 452 patients were added to the surgery group, the average adjusted cost for the new group rose to $17,516, resulting in a difference of $3,471 or 25% (P < .001) from the radiation group (Table 4). Depending on the method of adjustment, the difference between the surgery and radiation groups widened, from a low of $2,869, or 20%, without any adjustment, to a high of $3,828, or 34% (P < .001), using our method of subtracting the preceding 6 months’ costs.

	DISCUSSION

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Even without adjusting for differences between radiation and surgery patients, the costs among patients undergoing external-beam radiation therapy were significantly less than for those patients undergoing radical prostatectomy. However, because radiation patients were older and had higher comorbidity than radical prostatectomy patients, we adjusted for these differences using a number of different methodologies. In every case, the difference in cost associated with the two treatments was larger than without adjustment.

Although other studies have compared the costs associated with different treatments for prostate cancer, almost all of these analyses are single-institution studies that report the initial costs or charges associated with different treatment strategies solely within their own institution.^31-35 If one limits the comparison of our results to those studies that also used large administrative data sets, they are similar and consistent. Both Brandeis et al²⁰ and Penberthy et al³⁶ reported that the initial treatment period costs were approximately 20% greater for patients undergoing surgery compared with external-beam radiation therapy.

The principal strengths of this research are the quality of the data; the large sample size from the population-based, linked SEER-Medicare data set; and the inclusion of both radiation oncologists and urologists on the research team. However, our data and analyses have several limitations. First, the initial treatment interval costs represent the expenses associated with the diagnosis and initial treatment of prostate cancer. They do not reflect the longer-term treatment costs or the lifetime medical costs for patients with prostate cancer. Further, they do not include nonmedical costs, such as the cost of time lost while undergoing and recovering from treatment, costs of informal care giving, transportation, or costs associated with impaired ability to work or to enjoy leisure activities.

Second, the data are from 1992 and 1993 and practice patterns (including pretreatment imaging studies ordered), for both urologists and radiation oncologists, may have changed since that time. The average length of hospital stay after a radical prostatectomy has been decreasing;^21,37 thus, although average costs per inpatient hospital day have increased, the cost of a radical prostatectomy may have decreased. Conversely, the increasing use of dose escalation via conformal three-dimensional treatment techniques^38-41 and neoadjuvant and adjuvant hormonal therapy^42,43 may have led to an increase in the costs associated with external-beam radiation therapy. Further, relative payments for surgical versus radiation procedures or inpatient versus outpatient care may have changed.

Third, although the SEER-Medicare linked data set is the most comprehensive available, it may not be representative of all prostate carcinoma patients. Its population is limited to patients who are at least age 65, so it does not include the younger, healthier patients who are more likely to undergo radical prostatectomy with less morbidity.²⁰ The SEER data comprise all patients diagnosed with prostate cancer from the 11 SEER regions, which are spread across the country. Nonetheless, this sample may not fully reflect regional differences in treatment.

Fourth, this study does not include patients treated by brachytherapy, which has become increasingly more common as a treatment option. Our data set did not include sufficient numbers of patients treated by brachytherapy to permit accurate measurement of its cost relative to radical prostatectomy or external-beam radiation therapy.

Because of the limitations noted, further analyses are appropriate as more current data become available, both to compare the changes in practice over time and to analyze the longer-term costs of the different treatments.

The cost of health care in the United States continues to be a major concern of policy makers and healthcare payers. Because prostate cancer is the most commonly diagnosed malignancy in American men age 65 years and older, the costs associated with its treatment are of particular interest. Issues other than cost are probably of more importance to individual patients when deciding which strategy to pursue for treatment of their prostate cancer. However, to the degree that society focuses on the cost of health care and because controversy remains about the optimal treatment for men with early-stage prostate cancer, these results, indicating that external-beam radiation therapy is the less expensive treatment initially, remain important. The generalizability of these results to current practice is, however, limited by changes in the management of early-stage prostate cancer since 1992 and 1993, changes such as the growth of three-dimensional conformational radiotherapy and brachytherapy as well as shortened postoperative inpatient stays. Also, our study does not include costs beyond the initial treatment period, and these would be expected to differ if one treatment approach generates more long-term side effects than the other.

	ACKNOWLEDGMENTS

 
Supported in part by the American College of Radiology, Reston, VA (C.H.).

We thank Arnold Potosky, PhD, for his comments on our methods and in development of the data set. We also appreciate Howard Sandler, MD, for his helpful comments during the preparation of the manuscript.

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Submitted November 27, 2002; accepted March 19, 2002.

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