Japanese Journal of Clinical Oncology 32:497-505 (2002)
© 2002 Foundation for Promotion of Cancer Research
Quality Assurance of Radiotherapy and its Clinical Assessment
Division of Multidisciplinary Radiotherapy, Osaka University Graduate School of Medicine, Suita, Osaka, Japan
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONHISTORY OF JAPANESE PCSPCS SURVEYSTRUCTURE, PROCESS AND OUTCOME...STRUCTURE, PROCESS AND OUTCOME...DISSEMINATION OF POSITIVE...COMPARISON OF STRUCTURE AND...COMPARISON OF PROCESS BETWEEN...ESTIMATED NUMBER OF CANCER...CONCLUSIONSAcknowledgmentsREFERENCES |
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Background: We investigated the clinical quality assurance (QA) of radiotherapy in Japan since 1981. The aim of this study was to establish the QA of a radiotherapy system and its clinical assessment in Japan.
Methods: We introduced the Patterns of Care Study (PCS) into Japan to perform this study in 1996. The PCS is a retrospective study designed to establish the national practice for cancer patients during a specific period and should be a complementary study to a prospective randomized controlled study. We collected precise data for 4399 patients with carcinomas of the breast, cervix, esophagus, lung and prostate by means of external audits for 96 institutes from 1998 through 2001. Patients were randomly sampled with two-stage cluster sampling. We stratified 556 institutes into four categories according to the academic condition and annual number of radiotherapy patients. National and regional averages of various factors of radiotherapy could be calculated and were used to measure QA of radiotherapy.
Results: Using a standard score, we could compare the process of individual institutions with national averages and feed back the evaluation score to each institution. With a PCS process survey, we could observe the dissemination of the treatment method under evidence-based medicine from the prospective randomized controlled study. We proposed future prediction of the number of radiotherapy patients and a counter plan for equipment and personnel. The first US–Japan PCS Workshop was held at San Francisco in 2001.
Conclusion: We could establish QA of a radiotherapy system using PCS 1995–97 in Japan.
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONHISTORY OF JAPANESE PCSPCS SURVEYSTRUCTURE, PROCESS AND OUTCOME...STRUCTURE, PROCESS AND OUTCOME...DISSEMINATION OF POSITIVE...COMPARISON OF STRUCTURE AND...COMPARISON OF PROCESS BETWEEN...ESTIMATED NUMBER OF CANCER...CONCLUSIONSAcknowledgmentsREFERENCES |
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The Patterns of Care Study (PCS) of the American College of Radiology (ACR) was originally developed in 1973 to study the structure, process and outcome of radiation therapy care in the USA by Kramer and co-workers (1–6). They used the Donabedian model of quality of care assessment. The survey has been performed every 5 years.
The PCS is a retrospective study designed to establish the national practice process for cancer patients during a specific period. The PCS should be the complementary study to the prospective randomized clinical trials where oncologists search for a new standard of care for cancer patients. The PCS has provided enormous evidence that even elementary radiotherapy techniques have improved the nationwide outcomes for various cancer sites. The PCS can serve as a model for other cancer-directed disciplines so that ultimately a system for the comprehensive evaluation of cancer care can be established (2).
In the early 1970s, we received a request for a structure survey of radiotherapy in Japan from the American Society for Therapeutic Radiology and Oncology (ASTRO) Board members. At that time, we had no scientific society for radiation oncology specialists or a database of structure of radiotherapy in Japan, so we could not comply with their request. However, this event later resulted in the motivation for planned research (56–27) by the late Professor Shigematsu in 1982. The Japanese Society for Therapeutic Radiology and Oncology (JASTRO) was established in February 1988. A structure survey was started in 1990 and has been performed by the Data Base Committee of JASTRO since 1993. This report describes the clinical quality assurance (QA) study in Japan with the support of a Ministry of Health, Labour and Welfare Cancer Research Grant-in-Aid over the past 20 years (7).
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HISTORY OF JAPANESE PCS |
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TOPABSTRACTINTRODUCTIONHISTORY OF JAPANESE PCSPCS SURVEYSTRUCTURE, PROCESS AND OUTCOME...STRUCTURE, PROCESS AND OUTCOME...DISSEMINATION OF POSITIVE...COMPARISON OF STRUCTURE AND...COMPARISON OF PROCESS BETWEEN...ESTIMATED NUMBER OF CANCER...CONCLUSIONSAcknowledgmentsREFERENCES |
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In the fiscal years 1981–82, Shigematsu as a principal investigator (P.I.) performed a planned research study (56–27) on ‘Establishment of standard and assessment of radiotherapy for cancer patients’. A working group surveyed the structure of equipment and personnel and radiation treatment methods (8,9). Subsequently, they proposed the clinical assessment of radiotherapy for specific disease sites (10,11).
In the fiscal years 1992–93, Inoue (P.I.) carried out a planned research study (4–20) on ‘Promotion of precision radiotherapy and efficacious nationwide data acquisition in clinical radiotherapy trials’. A preliminary investigation was performed concerning the PCS to improve the QA of radiotherapy in national practice using a retrospective study (5). We published the ‘Blue book’ in Japanese with the permission of the chief editor to improve the structure of radiotherapy in Japan (12).
In the fiscal years 1994–95, Inoue (P.I.) carried out a planned research study (6–13) on ‘The role and efficiency of radiotherapy in the multidisciplinary treatment of cancer’. We published a radiotherapy manual to improve the standard of radiotherapy processes and translated the American Association of Physicists in Medicine (AAPM) Report No. 40 to establish a QA system for radiotherapy in Japan (13,14). Teshima, a member of our working group, studied under the supervision of Hanks in Philadelphia in 1995 and acquired the know-how for PCS surveys.
In the fiscal years 1996–97, Abe (P.I.) carried out a planned research study (8–27) on ‘Indication of radiotherapy and QA of various radiotherapies’ and Ikeda (P.I.) performed another planned research study (8–29) on ‘Indication of radiotherapy for aged patients with cancer’. Official requests for an extramural PCS audit by two principal investigators of two different cancer research groups were mailed to 22 members of four different radiation oncology research groups. Fifteen of them agreed to participate in this audit (15,16).
In the fiscal years 1998–2001, Inoue (P.I.) carried out a planned research study (10–17) on ‘Research on QA of radiotherapy systems and its clinical assessment’. We intended to establish clinical QA of radiotherapy through PCS in Japan. By means of an extramural audit, we collected precise data for 4399 patients. The national averages (NAs) and regional averages (RAs) of the process of radiation therapy were calculated (17,18). We showed the actual state of radiotherapy nationwide in Japan during 1995 and 1997 by a preliminary outcome survey.
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PCS SURVEY |
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TOPABSTRACTINTRODUCTIONHISTORY OF JAPANESE PCSPCS SURVEYSTRUCTURE, PROCESS AND OUTCOME...STRUCTURE, PROCESS AND OUTCOME...DISSEMINATION OF POSITIVE...COMPARISON OF STRUCTURE AND...COMPARISON OF PROCESS BETWEEN...ESTIMATED NUMBER OF CANCER...CONCLUSIONSAcknowledgmentsREFERENCES |
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During the fiscal years 1998 and 2001, we undertook the development of the data format for a PCS survey, training of auditors, extramural audit, follow-up study, semiannual meeting and data analysis, US–Japan cancer seminar and opening of a web home page, which are shown in a timetable for the PCS 1995–97 working group in Fig. 1.
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In 1998, we decided the data format for the PCS database of four disease sites, breast, cervix, esophagus and lung, through consensus panel discussions to establish the best current management. One year later we added the data format for prostate cancer.
An external audit team of 23 radiation oncologists was organized from 10 academic institutions by nationwide selection. In September 1998, one-day training was performed for auditors at the Department of Medical Engineering, Osaka University School of Allied Health Sciences. They entered the data format for the survey in their own personal computer to reduce erroneous data entries (Fig. 2) (18,19). External audits were performed during September 1998 and January 2001. For each institution, one radiation oncologist visited and surveyed data by reviewing patients’ charts. An Internet mailing list including all members in the PCS research group kept the data entries accurate and uniform by the audit team (20). In situ real time checks and adjustments of the data input were available between each surveyor and the PCS committee (21). The working time was 5460 h in total, i.e. ~420 days, when every auditor worked 13 h per day.
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We stratified 556 institutions into four categories according to the facility master survey by Tsunemoto (22). A1 is academic institutions, i.e. cancer centers or university hospitals where 300 or more patients are treated per year, A2 is the same academic institutions where less than 300 patients are treated per year, B1 is non-academic institutions, i.e. national hospitals, public general hospitals and private hospitals, where 120 or more patients are treated per year, and B2 is non-academic institutions where less than 120 patients are treated per year (20). This stratification of institutions by academic conditions and annual number of patients treated with radiotherapy was sufficiently adapted for this PCS survey (23).
Patients with five disease sites were randomly sampled using two-stage cluster sampling that consists of sampling of institutions from four institutional strata in the first stage and sampling of patients from the institutions in the second stage (18). In general, this PCS survey revealed that breast cancer patients in Japan were younger than those in Western countries. A comparative study between the USA and Japan also indicated this phenomenon. Accordingly, this two-stage cluster sampling method functioned properly.
Permission for the PCS survey was obtained from the President or Director of each institution. The eligibility criteria for the PCS survey included (a) absence of distant metastases, (b) absence of prior or concurrent malignancies and (c) absence of prior history of radiotherapy for the relevant cancer.
Extramural audits of 96 participating institutes in total were conducted from 1998 through 2001. We accumulated precise data for 4399 patients with carcinoma of the breast, cervix, esophagus and lung who underwent radiotherapy during 1995 through 1997 and of prostate during 1996 through 1998 (Table 1).
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National averages (NAs) and regional averages (RAs) of the various factors of radiotherapy could be calculated from the collected PCS data (18). These numerical values themselves are used to measure the QA of radiotherapy in Japan. Using the standard score, we could compare the processes of an individual institution with national averages and feed back the evaluation score to each institution (20).
Concerning the dose for the spinal cord of patients with lung cancer treated with radiotherapy, we could calculate the national averages and also institutional averages and standard score for each institution. For example, extremely high institutional averages and standard scores have been shown (20). Subsequently, we could inform the corresponding institute of the standard score to improve such a poor process. In other words, we could not only propose comprehensive QA planning by institutional strata to the government, but also inform individual institutions about the comprehensive necessary structure for technical upgrading.
Follow-up studies were performed at the time of the second audit and with mail to the corresponding institute.
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STRUCTURE, PROCESS AND OUTCOME OF UTERINE CERVICAL CANCER |
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TOPABSTRACTINTRODUCTIONHISTORY OF JAPANESE PCSPCS SURVEYSTRUCTURE, PROCESS AND OUTCOME...STRUCTURE, PROCESS AND OUTCOME...DISSEMINATION OF POSITIVE...COMPARISON OF STRUCTURE AND...COMPARISON OF PROCESS BETWEEN...ESTIMATED NUMBER OF CANCER...CONCLUSIONSAcknowledgmentsREFERENCES |
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The structure survey was started in 1990 and has been performed in the Data Base Committee of JASTRO every other year since 1993 (24). The number of linear accelerators has doubled in the past 10 years; in contrast, the number of telecobalt units has decreased from 170 to 103. High-dose-rate cobalt-60 afterloading machines were replaced with iridium-192 micro-sources year by year. The numbers of X-ray simulators or CT simulators and also radiotherapy planning (RTP) computers installed seem to be sufficient (Table 2).
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A survey of structure for equipment and personnel by institution group is shown in Table 3. Equipment data were derived from the JASTRO structure survey in 1995 (25) and personnel data from PCS 1995–97. High-dose-rate (HDR) brachytherapy units were installed in more than 70% of A1 and A2 institutions, but in 42% of B1 and in only 4% of B2 institutions. Median values of full-time equivalent (FTE) radiation oncologists were (devoting 40 h per week to radiation oncology services) were 2.4 and 1.1 for A1 and A2 institutions, respectively. However, there were only 0.6 and 0.2 radiation oncologists for B1 and B2 institutions, respectively.
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The data for 1066 patients with carcinoma of the uterine cervix were collected from the PCS survey 1995–97. Of 592 patients with uterine cervical cancer who were treated without surgery, i.e. mainly treated with radiotherapy, 76% underwent brachytherapy. This figure means that gynecological radiotherapy processes in Japan seem to be in a favorable condition. About 80% of the patients underwent brachytherapy in A1 and A2 institutions, but only 50% of the patients in B2 institutions received brachytherapy (26). Since only 4% of the B2 institutions could utilize the own brachytherapy unit, most of the Japanese radiation oncologists in B2 institutions sent their patients to an appropriate facility in the neighborhood. However, there was still a 30% difference in the utilization of brachytherapy between A1 and B2 institutions. This difference was closely related to the small number of FTE radiation oncologists and medical appliances unable to be renewed because of poor financial resources. At the present time, it is necessary to upgrade not only the quality of structure but also of radiation oncologists in B2 institutions.
One of the most important prognostic factors associated with improved survival for carcinoma of the uterine cervix was the use of intracavitary brachytherapy. Patients who received brachytherapy showed significantly better survival curves than those without brachytherapy. Three-year overall survivals were 78 and 48% for patients with and without brachytherapy, respectively (P = 0.0001) (26). More than 90% of patients were treated with a high-dose-rate remote afterloader.
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STRUCTURE, PROCESS AND OUTCOME OF ESOPHAGEAL CANCER |
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TOPABSTRACTINTRODUCTIONHISTORY OF JAPANESE PCSPCS SURVEYSTRUCTURE, PROCESS AND OUTCOME...STRUCTURE, PROCESS AND OUTCOME...DISSEMINATION OF POSITIVE...COMPARISON OF STRUCTURE AND...COMPARISON OF PROCESS BETWEEN...ESTIMATED NUMBER OF CANCER...CONCLUSIONSAcknowledgmentsREFERENCES |
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Data on 776 patients with esophageal cancer were collected for the PCS survey 1995–97.
Based on the JASTRO structure survey in 1995 (25), the mean numbers of linear accelerators were 1.75, 1.35, 1.05 and 0.78 for A1, A2, B1 and B2 institutions, respectively (Table 2). According to the PCS process for esophageal cancer in the non-surgery group, the applied photon beam energy of the treatment machine was significantly different among institutional strata. Although only 1% of patients were treated with lower beam energies of 4 MV or less in A1 institutions, 61% of patients underwent external radiotherapy of 4 MV or less in B2 institutions. On the other hand, 35 and 25% of patients were treated with lower photon beam energies of 4 MV or less in A2 and B1 institutions, respectively. There were no patients treated with a telecobalt unit in A1 and B1 institutions, whereas 7 and 22% of patients underwent telecobalt therapy in A2 and B2 institutions, respectively (27).
The interim outcome survey revealed that survival rates of patients who received radiotherapy for esophageal cancer were 36, 35, 19 and 15% in A1, A2, B1 and B2 institutions, respectively. (A vs B, P = 0.001) (27). Concerning radiotherapy for thoracic esophageal cancer, the utilization of a higher photon beam energy was recommended and resulted in an improvement in survival rates. Such a treatment process of using a lower photon beam energy for esophageal cancer should be improved by means of the installation of a higher energy linear accelerator. According to an earlier survey in the USA, the PCS also identified specific areas for improvement in the structure, such as higher energy photon beams and dedicated treatment simulators (28).
According to the above-described interim analysis of the treatment results of esophageal cancer by radiotherapy, it seemed that there was a significant difference among the four institutional strata. However, we could not reach a definite conclusion because of the shortage of follow-up data. We need much more time to state the exact results of radiotherapy for cancer patients among the stratification of the hospitals with PCS in Japan. We must continue the Japanese PCS, just as PCS in the USA of 30 years or more, to evaluate and to make the appropriate proposals to the government concerning comprehensive cancer care in Japan.
It is significantly indicated that institutional stratification may help to assure the quality level of radiation oncology facilities. In the clinical trial setting, the quality level of participants must be certified more strictly in future studies (21).
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DISSEMINATION OF POSITIVE CLINICAL TRIAL OF LUNG CANCER |
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TOPABSTRACTINTRODUCTIONHISTORY OF JAPANESE PCSPCS SURVEYSTRUCTURE, PROCESS AND OUTCOME...STRUCTURE, PROCESS AND OUTCOME...DISSEMINATION OF POSITIVE...COMPARISON OF STRUCTURE AND...COMPARISON OF PROCESS BETWEEN...ESTIMATED NUMBER OF CANCER...CONCLUSIONSAcknowledgmentsREFERENCES |
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Data on 1099 patients with lung cancer, consisting of 920 patients with non-small cell lung cancer (NSCLC) and 179 with small cell lung cancer (SCLC), were collected from the PCS survey 1995–97.
Using the PCS process survey, we could observe the dissemination of the treatment method under evidence-based medicine from a prospective randomized controlled study. The protocol study of the Japan Clinical Oncology Group (JCOG) is one of the most active and well-known multi-institutional cooperative studies in Japan. They have tested newly developed chemotherapeutic drugs and their combinations.
Eligibility criteria for stage, chemotherapy regimen and its sequence with radiotherapy were grossly matched. As for lung cancer, the 1993 regimen for NSCLC (29) was performed in only 14%. In the 1991 regimen for SCLC (30), concurrent chemo-radiotherapy was used in only 16% and even in 1995–97. The sequential regimen for SCLC was standard in this time period (31). Therefore, PCS could monitor nicely the dissemination of positive clinical trials nationwide (Fig. 3). The results of clinical studies on SCLC had favorably penetrated into clinical practice (21). The earlier trial was usually more frequently disseminated into national practice than the latest trial.
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COMPARISON OF STRUCTURE AND PROCESS BETWEEN THE USA AND JAPAN: BREAST CANCER |
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TOPABSTRACTINTRODUCTIONHISTORY OF JAPANESE PCSPCS SURVEYSTRUCTURE, PROCESS AND OUTCOME...STRUCTURE, PROCESS AND OUTCOME...DISSEMINATION OF POSITIVE...COMPARISON OF STRUCTURE AND...COMPARISON OF PROCESS BETWEEN...ESTIMATED NUMBER OF CANCER...CONCLUSIONSAcknowledgmentsREFERENCES |
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Of 1147 patients with breast cancer who were collected from the PCS survey 1995–97, 866 underwent breast-conserving therapy.
The first US–Japan PCS Workshop was held in San Francisco in November 2001. A comparative study of five diseases has been already agreed between the US and Japan PCS working groups in 2000. The Workshop was supported by grants from the US National Institutes of Health (NIH) and the Japan Society for the Promotion of Science. We discussed the history and purpose of PCS in both countries, staging, medical care systems, structure, epidemiology, PCS of each disease site, statistics, data management and future collaboration at this Workshop.
There were significant differences in structure between the USA and Japan (25,32). The US population was about double the Japanese population. According to the comparison of structures between Japan and the USA, the number of new cancer patients treated with radiotherapy in the USA was eight times more than in Japan (20). The cover rates of radiotherapy were 15 and 49% in Japan and the USA, respectively. The number of radiation oncologists in Japan was about one third of those in the USA, but, one-seventh in full time equivalents. The number of medical physicists showed a substantial difference between Japan and the USA (Table 4).
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We compared the data from the Japanese PCS 1995–97 and the US PCS 1993–94 on breast conservation therapy. Quadrantectomy was the most commonly used breast-conserving surgery (47%) in Japan. In contrast, it was used in less than 4% of the cases in the USA. Accordingly, boost irradiation to the tumor bed was used in only 12% of the cases in Japan compared with 84% in the USA (Fig. 4). We expect the extent of surgical treatment in Japan to be smaller, i.e. from quadrantectomy to lumpectomy, in near future. Accordingly, the practice of radiation treatment should be improved as to individualization by the status of the surgical margin. Similar evidence was also indicated in the early PCS survey in the USA (28).
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COMPARISON OF PROCESS BETWEEN THE USA AND JAPAN: PROSTATE CANCER |
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TOPABSTRACTINTRODUCTIONHISTORY OF JAPANESE PCSPCS SURVEYSTRUCTURE, PROCESS AND OUTCOME...STRUCTURE, PROCESS AND OUTCOME...DISSEMINATION OF POSITIVE...COMPARISON OF STRUCTURE AND...COMPARISON OF PROCESS BETWEEN...ESTIMATED NUMBER OF CANCER...CONCLUSIONSAcknowledgmentsREFERENCES |
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Data on 311 patients with prostate cancer were collected from the PCS survey 1996–98.
There are significant differences in cultural, racial and social backgrounds between Japan and the USA. Based on the small number of 162 patients radically treated with photon beams between 1996 and 1998, 80% of the patients had high-risk diseases defined as T3–4 tumors, a pretreatment prostate-specific antigen (PSA) of more than 20 ng/ml or poorly differentiated adenocarcinoma (33). Androgen ablation was performed in 86% of patients and the median duration of hormonal therapy before and after radiation therapy was 5 and 21 months, respectively. The median treatment dose was 65 Gy. The 3-year overall and biochemical relapse-free survivals were 87 and 86%, respectively. Toxicity was mild. In contrast, most of the patients in the USA were reported to have localized prostate adenocarcinoma with moderate differentiation. The radiation doses employed in Japan were lower than those typically used in the USA. PCS studies in the USA revealed that the median dose employed increased from 66 to 68.4 Gy between 1978 and 1994 (34). The PCS studies in the USA also indicated the striking effect that the number of T3 patients who underwent a definitive radiotherapeutic dose of 60 Gy or less decreased from 16 to only 1% during the same period. There was a dramatic decrease in the use of adjuvant hormonal therapy, from 59% in 1978 to 9% in 1994, in the USA. However, in Japan hormonal therapy was commonly utilized, because of the considerable number of patients with advanced disease or poorly differentiated tumors. One of the reasons for such a difference in the usage of hormonal therapy was the variations in the medical care systems between the two countries.
In Japan, the government developed a social insurance system for the protection of workers during the rapid growth of industry at the end of the 19th century. After the Second World War, the government established the Council of Social Services in 1949. The New National Health Insurance Act was passed in 1958. All persons were covered by some kind of insurance by April 1961 (35). The cover rate of health insurance for Japanese people is as high as those in Sweden and the UK. In contrast, that in the USA is extremely low (Table 5) (36).
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ESTIMATED NUMBER OF CANCER PATIENTS |
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TOPABSTRACTINTRODUCTIONHISTORY OF JAPANESE PCSPCS SURVEYSTRUCTURE, PROCESS AND OUTCOME...STRUCTURE, PROCESS AND OUTCOME...DISSEMINATION OF POSITIVE...COMPARISON OF STRUCTURE AND...COMPARISON OF PROCESS BETWEEN...ESTIMATED NUMBER OF CANCER...CONCLUSIONSAcknowledgmentsREFERENCES |
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Until the middle of the 20th century, deaths caused by infectious diseases such as pneumonia, tuberculosis and gastroenteritis prevailed in Japan. However, since the late 1940s, these diseases have rapidly decreased and have been replaced by so-called lifestyle-related diseases such as malignant neoplasms, heart disease and cerebrovascular disease. Cancer has ranked first in the causes of deaths since 1981. The number of cancer deaths in 2000 was 295 399 and the death rate per 100 000 was 235.2, accounting for 30.7% of the total number of deaths (37). The number of cancer incident cases in 1999 was 554 000. Around 107 000 patients, i.e. 19% of cancer patients, are being treated with radiation therapy.
Using the Osaka Cancer Registry, the incidence of cancer in Japan up to 2015 has been projected according to age, gender and the primary site of the cancer. The incidence of cancer in Japan in 2015 is estimated to be 890 000, which is a 2.1-fold increase over that in 1993. Further, 61% of the cancer patients will be 70 years or older. In 2015, the first rank of the site of cancer incidence is estimated to be lung, the second stomach and the third colon, and these are followed by liver, gallbladder/biliary tract, pancreas, rectum and breast (38).
According to the Osaka Cancer Registry, the 5-year relative survival rates at all sites significantly improved from 30% in 1975–77 to 41% in 1990 (39). For carcinomas of the esophagus, lung, breast and uterus, the 5-year relative survival rates showed marked improvements. Although survival from prostate cancer had not improved up to 1990, this rate was obtained in the pre-PSA era.
We now well understand the remarkable changes in treatment policy of carcinomas of the breast and prostate over the past 10 years. Concerning breast cancer, breast conservation therapy has become more popular, and now nearly half of the patients undergo breast conservation therapy in Japan. This has resulted in a rapid increase in the number of cancer patients treated with radiation over the past 5 years. Since the PSA era, we can detect earlier stages of prostate cancer and have a better chance to treat middle-aged patients with prostate cancer than before. However, we cannot detect the intrinsic changes of the process and outcome in the PCS so far, because we collected the clinical data on the patients treated with radiation during 1995 and 1997 in the first PCS in Japan. These patients received a second-time follow-up in 2002 by the new PCS group (P.I. T. Teshima). We will be able to indicate the changes in process and outcome based on such a change in the structure in the near future.
The lifespan of the Japanese has increased rapidly during the past four decades, and we will face serious problems derived from the rapid aging of society in the near future. Such a rapid change has not been encountered in any other countries so far (Table 6) (36).
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By 2015, number of cancer patients treated with radiation will reach 190 000 according to the prediction based on the extrapolation from the number of new patients in the last 5 years (40). The cover rate of radiotherapy is estimated as 21%.
The number of the FTE radiation oncologists is currently 497. When the changes in the distribution of cancers, widening of application or indication of radiotherapy and the introduction of new sophisticated treatments are taken into account, 936 FTE radiation oncologists will be needed to maintain the current patient load per FTE radiation oncologist. If the number of patients treated with radiotherapy increases as per our estimate, at least 26 FTE radiation oncologists will have to be added every year to maintain the patient load per FTE radiation oncologist (40).
How to increase the number of new radiation oncologists is a major problem in Japan. We have made some efforts in the Educational Committee of JASTRO during the past 7 years. Since 1995, JASTRO has provided financial support of 2 000 000 Japanese yen to those who are going to hold a Radiotherapy Summer Seminar for medical students across the country with the intention of stimulating their interest in radiation oncology. About 30 medical students participate in this two-day seminar every year. Since 1999, a Radiation Oncology Summer Seminar has been held for young radiation oncologists.
Based on the JASTRO structure survey in 1995 (25), the number of medical physicists was surprisingly small, only 60 in Japan. The ultimate objective of Medical Radiation Physics activities is to assure the delivery of high-quality radiation therapy. The QA program in Medical Radiation Physics must be developed and monitored by a qualified medical radiation physicist. The success of radiation therapy is dependent on the accuracy of delivery of specified doses to selected targets, both tumors and normal tissues. The margin for prevention of serious error may be slight. Therefore, the Medical Radiation Physicist must be provided with adequate personnel and equipment to accomplish these important tasks (12). However, in Japan, radiation oncologists and technologists had great difficulty in playing a critical role in the QA field of radiotherapy because of the shortage of medical physicists. Accordingly, the level of QA is not satisfactory at the present time. We need a sufficient number of medical physicists for the introduction of advanced technology into routine clinical work and to upgrade the QA level of radiotherapy in Japan.
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CONCLUSIONS |
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TOPABSTRACTINTRODUCTIONHISTORY OF JAPANESE PCSPCS SURVEYSTRUCTURE, PROCESS AND OUTCOME...STRUCTURE, PROCESS AND OUTCOME...DISSEMINATION OF POSITIVE...COMPARISON OF STRUCTURE AND...COMPARISON OF PROCESS BETWEEN...ESTIMATED NUMBER OF CANCER...CONCLUSIONSAcknowledgmentsREFERENCES |
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The clinical QA of radiotherapy was investigated over the past 20 years in Japan. A survey of the structure, process and outcome of radiotherapy has been performed by the group study since 1982. PCS was introduced completely for the first time in Japan in 1996.
QA of radiotherapy systems was established through evaluation of clinical cases by PCS. An audit of 96 domestic institutions was conducted between 1998 and 2001 and data on 4399 patients were accumulated. The quantitative evaluation data for each institution were computed by a standard score that compared NAs with RAs and fed back to each institution. NAs and RAs for factors involved the process and preliminary outcome through PCS are useful as QA measurements in Japan. We have proposed a future prediction of the number of radiotherapy patients and a counter plan. The first US–Japan PCS Workshop was held in San Francisco in November 2001.
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Acknowledgments |
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TOPABSTRACTINTRODUCTIONHISTORY OF JAPANESE PCSPCS SURVEYSTRUCTURE, PROCESS AND OUTCOME...STRUCTURE, PROCESS AND OUTCOME...DISSEMINATION OF POSITIVE...COMPARISON OF STRUCTURE AND...COMPARISON OF PROCESS BETWEEN...ESTIMATED NUMBER OF CANCER...CONCLUSIONSAcknowledgmentsREFERENCES |
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The author thanks all radiation oncologists and staff who participated in this study. Their cooperation in providing information made these surveys possible. This work was supported in part by a Grant-in-Aid for Cancer Research Groups from the Ministry of Health, Labor and Welfare (Nos 56–27, 6–13, 8–27, 8–29, 10–17, 14–6).
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FOOTNOTES |
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+ For reprints and all correspondence: Toshihiko Inoue, Division of Multidisciplinary Radiotherapy, Osaka University Graduate School of Medicine, Yamadaoka, Suita 565-0871, Japan. E-mail: toinoue@radono.med.osaka-u.ac.jp
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REFERENCES |
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TOPABSTRACTINTRODUCTIONHISTORY OF JAPANESE PCSPCS SURVEYSTRUCTURE, PROCESS AND OUTCOME...STRUCTURE, PROCESS AND OUTCOME...DISSEMINATION OF POSITIVE...COMPARISON OF STRUCTURE AND...COMPARISON OF PROCESS BETWEEN...ESTIMATED NUMBER OF CANCER...CONCLUSIONSAcknowledgmentsREFERENCES |
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Received July 12, 2002; accepted August 20, 2002
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