Japanese Journal of Clinical Oncology 33:518-521 (2003)
© 2003 Foundation for Promotion of Cancer Research
Patterns of Care Study: Comparison of Process of Post-mastectomy Radiotherapy (PMRT) in Japan and the USA
1 Japanese PCS Working Subgroup of Breast Cancer, Japan and 2 Breast Subcommittee of PCS, American College of Radiology, Philadelphia, PA, USA
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONCONCLUSIONSACKNOWLEDGMENTSREFERENCES |
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Background: The Patterns of Care Study (USPCS) by the American College of Radiology (ACR) has made significant contributions to improvements in the procedures of care for patients with breast cancer in the USA. The purpose of this study was to identify problems associated with the process of care for patients undergoing post-mastectomy radiotherapy (PMRT) in Japan compared with those in the USA.
Methods: The Japanese Patterns of Care Study Subgroup (JPCS) conducted a national survey in 1998–2000, involving 79 institutions and using two-stage cluster sampling of institutions and patients, which showed that between 1995 and 1997 PMRT was performed on 258 patients. The survey of the USPCS, involving 55 institutions, found that 407 patients received PMRT between 1998 and 1999.
Results: More than three axillary positive nodes were detected in 54% of the patients covered by the JPCS and in 46% of those covered by the USPCS. The clinical set-up of radiation treatment was planned without the aid of computed tomography or X-ray simulation for 25% of the JPCS patients and for 6% of the USPCS patients. The chest wall of 31% of the JPCS patients and of 98% of the USPCS patients was irradiated. The JPCS showed that inappropriate radiation techniques such as parallel opposed fields for chest wall irradiation were used for 3% of the patients in academic facilities, but for 25% of those in non-academic facilities (P = 0.0002).
Conclusion: There is ample room for improvement in radiation treatment planning and chest wall irradiation techniques in Japan.
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONCONCLUSIONSACKNOWLEDGMENTSREFERENCES |
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A multidisciplinary approach is crucial for improving treatment results for patients with operable locally advanced breast cancer (1–4). The role of radiotherapy following mastectomy (PMRT) was the subject of long studies during the 1990s (1,5). Two prospective randomized control trials reported in 1997 finally demonstrated that PMRT including chest wall and regional lymph node irradiation was associated not only with a higher loco-regional control rate but also with a higher overall survival rate (6,7). PMRT has since been widely used for patients with locally advanced breast cancer in the USA and other Western countries (1). In 2001, the American Society of Clinical Oncology (ASCO) proposed guidelines for the establishment of treatment procedures for PMRT in clinical practice (3). The first survey of the Japanese Patterns of Care Study (JPCS), covering patients with breast cancer treated between 1995 and 1997, demonstrated that there was a significant difference among the radiation techniques for PMRT employed in various institutions (8). This difference should be reduced in order to improve the national average outcome for procedures of care for patients with locally advanced breast cancers. In addition, some investigators have identified major differences in the structuring and staffing patterns of radiation oncology between Japan and the USA (9). A severe shortage of human resources in the field of radiation oncology, including radiation oncologists, medical physicists and dosimetrists, may prove to be a severe hindrance for improvement in the procedures of care in Japan.
In the USA, the Patterns of Care Study (USPCS) by the American College of Radiology (ACR) has made significant contributions to improvements in the procedures of care for patients with breast cancer (10,11). The JPCS has been collaborating with the USPCS for several years (9). The purpose of the study presented here was to clarify the problems with procedures of care for patients undergoing PMRT and other adjuvant therapies in Japan compared with those in the USA.
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PATIENTS AND METHODS |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONCONCLUSIONSACKNOWLEDGMENTSREFERENCES |
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The first national survey in Japan, carried out in 1998–2000, which involved 79 Japanese institutions and used two-stage cluster sampling of institutions and patients, showed that 1124 patients with breast cancer had been treated with radiotherapy between 1995 and 1997; breast conservation therapy had been administered to 866 patients and mastectomy followed by radiotherapy to 258 patients. The eligibility criteria for the survey were (a) absence of distant metastases, (b) ipsilateral lesions, (c) absence of prior or concurrent malignancies, (d) absence of prior history of radiotherapy for breast cancer and (e) absence of collagen vascular disease.
The survey in the USA, involving 55 institutions, found that 407 patients had been treated with PMRT between 1998 and 1999. It used two-stage cluster sampling of institutions and patients, the same as used in Japan. The exclusion criteria for the survey were (a) bilateral breast cancer, (b) neoadjuvant chemotherapy, (c) prior or concurrent malignancies and (d) previous radiation treatment.
The patients’ clinical records were also reviewed to determine the clinical and pathological stage of the tumors according to the Fifth Classification of the International Union Against Cancer (UICC) (12). Academic facilities were defined as university hospitals or cancer centers and non-academic facilities as other hospitals. Differences between ratios were assessed with the chi-squared test.
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RESULTS |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONCONCLUSIONSACKNOWLEDGMENTSREFERENCES |
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Patients’ Characteristics
The median age of the 258 patients in the JPCS was 53 years and that of the 405 patients in the USPCS 54 years; 41% of the JPCS subjects were postmenopausal compared with 63% in the USPCS. The JPCS included only Japanese patients (100%), whereas the USPCS included Caucasians (82%), African American (10%) and other ethnic groups. Mammography was used for 51% of the JPCS and for 88% of the USPCS subjects at the initial assessment.
Management of the Primary Tumor and Regional Lymph Nodes
T3 or T4, as defined by the UICC Classification, was detected in 31% of the JPCS and T3 in 23% of the USPCS subjects (Table 1). The JPCS found more than three axillary positive nodes in 54% of the patients and one to three positive nodes in 21%. The corresponding rates for the USPCS were 46 and 33%.
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Classical radical mastectomy including resection of the major and minor pectoral muscles was performed for 22% of the patients and modified radical mastectomy for 68% of the patients surveyed by the JPCS. No JPCS data are available regarding breast reconstruction. The USPCS study shows that modified radical mastectomy was performed for 93% of the patients and breast reconstruction for 25%.
Axillary dissection was performed for 98% of the patients in both the JPCS and the USPCS. Complete axillary node dissection that included 10 or more nodes in the specimen was performed for 76% of the JPCS and 84% of the USPCS subjects.
Radiotherapy
The clinical set-up of radiation treatment was planned without the aid of computed tomography (CT) or X-ray simulation for 25% of the JPCS cases and for 6% of cases included in the USPCS. On the other hand, simulations using CT were employed only for 28% of the JPCS cases (academic facilities 39%; non-academic facilities 17%; P = 0.0001). The USPCS found that isodose curves based on CT image or breast contour were obtained for 90% of the patients and isodose curves in the central plane only for 70% and those in the multiple axial planes for 20% of the patients. Wedges, which are useful for modification of dose distribution, were used for 19% of the patients surveyed by the JPCS and for 82% of those covered by the USPCS.
Not including missing data, the chest wall of only 31% of the JPCS patients was irradiated and radiotherapy was administered more frequently at academic than non-academic facilities (41 vs 22%, P = 0.001). Chest wall irradiation was used for 98% of the patients in the USPCS. The median total dose of chest wall irradiation administered to JPCS subjects was 49 Gy and the median fraction size was 2.0 Gy. For USPCS subjects, the corresponding quantities were 50 and 1.88 Gy. Supraclavicular lymph node and internal mammary node irradiation were used for 84 and 73% of the patients in the JPCS survey and for 98 and 19% of those in the USPCS study, respectively. It is worth noting that, according to the JPCS, inappropriate radiation techniques such as parallel opposed fields for chest wall irradiation were used for 3% of the patients at academic facilities, but for 25% of those in non-academic facilities (P = 0.0002). In the USPCS survey, photon beam for chest wall irradiation was used for 87% of the patients and electron beam was used for 11%. However, there were no data regarding the frequency of use of tangential fields among the patients who were treated with a photon beam.
Adjuvant Systemic Therapy
Chemotherapy was used for 68% of the JPCS and 88% of the USPCS subjects. Among the JPCS patients treated with chemotherapy, 53% received PMRT and chemotherapy concurrently and chemotherapy before PMRT was used for 94%.
Hormonal therapy was used for 67% of the JPCS subjects and for 55% of their USPCS counterparts. According to the JPCS, 42% of the patients received hormonal therapy concurrently with PMRT, whereas the figure was 86% for the patients surveyed by the USPCS.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONCONCLUSIONSACKNOWLEDGMENTSREFERENCES |
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PMRT is generally used for patients with more than three positive axillary nodes or locally advanced breast cancers for reduction of chest wall recurrence and improvement of overall survival (1,3,6,7). The ASCO has proposed guidelines for the establishment of treatment procedures for PMRT in clinical practice (3). According to these guidelines, the area irradiated for PMRT should include the chest wall and supraclavicular nodes and/or internal mammary nodes. The JPCS, however, demonstrated that the technical aspects of the delivery of radiation at Japanese institutions differed from those recommended by the ASCO guidelines (3). The JPCS survey showed that chest wall irradiation was performed for only 31% of the patients and that most patients received regional irradiation. We also found that the radiation technique was often inappropriate, because the parallel opposed field technique and clinical set-up were used for chest wall irradiation. Appropriate radiation planning and treatment techniques, such as the tangential field technique with the aid of CT or an X-ray simulator, need to be established to prevent severe complications. At present, there exists no educational system in Japan for radiation oncologists and radiation technologists to improve the quality of their care. In the future, we have to learn from the educational programs of the European Society of Therapeutic Radiation Oncology (ESTRO) and the American Society of Therapeutic Radiation Oncology (ASTRO) for the establishment of such an educational system in Japan. However, we believe that the activity of PCS itself will be educational for the radiation oncologists and technologists who participated in PCS audits. The radiation oncologists and technologists who participated in PCS audits can obtain information that shows the level of their own treatment technique and procedures compared with the national average. This important information will lead to improved quality of treatment techniques and procedures in their institutions.
The USPCS showed that isodose curves based on CT imaging or breast contours were obtained for 90% of the patients, whereas those in multiple axial planes were obtained only for 20%. This could mean that three-dimensional treatment planning for patients with breast cancer is not widely practised in the USA. It should be remembered, however, that there is insufficient evidence to show the potential benefits of three-dimensional treatment planning leading to better results and fewer complications compared with two-dimensional treatment planning (13). In Japan, the clinical set-up and parallel opposed field technique for chest wall irradiation need to be replaced by routine two-dimensional treatment planning with isodose curves in the central plane. Two-dimensional treatment planning for PMRT should be performed routinely at all institutions.
Compared with the USPCS, the JPCS included many patients who underwent more aggressive surgery, such as classical radical mastectomy. This might be one of the reasons why chest wall irradiation has been employed less frequently in Japan. The surgical management of regional nodes reported by the JPCS was almost the same as that for the USPCS, but regional irradiation was more often employed for JPCS subjects. Japanese radiation oncologists may therefore think that the management of regional nodes is important, although current findings indicate that regional irradiation alone has limited value, so that the number of patients treated with regional irradiation alone may decrease in the future (14).
The 7th International Consensus Meeting held in St. Gallen in 2001 recommended that adjuvant systemic therapy should be provided on the basis of risk factors, including menopausal state, tumor bulk, axillary node status and endocrine responsiveness (2). The administration of chemotherapy concurrently with PMRT may enhance adverse effects such as radiation-induced pneumonitis. The ASCO guidelines for PMRT indicate that there is insufficient evidence to recommend the optimal sequencing of chemotherapy and PMRT (3). Colleoni et al. reported, however, that adjuvant chemotherapy followed by radiotherapy was superior to radiotherapy followed by chemotherapy for patients without hormonal responsiveness (15) and the USPCS demonstrated that PMRT was used after chemotherapy for 94% of patients. In Japan, oral 5-fluorouracil has been routinely administered for 2–3 years after surgery, so that radiotherapy followed by chemotherapy might be suitable for Japanese clinical practice. The JPCS showed that more than half of the patients without hormonal responsiveness received inappropriate hormonal therapy. The indication for hormonal therapy should be based on hormonal responsiveness and other risk factors. In addition, a key point for improving the quality of adjuvant therapy for patients with locally advanced breast cancer is collaboration of surgical oncologists, radiation oncologists and medical oncologists.
Finally, it would not be justified to conclude that clinical practice in the USA is superior to that in Japan, because the treatment period covered by the JPCS was different from that covered by the USPCS. Nevertheless, Japanese radiation and other oncologists can learn about some critical issues from the difference between clinical practices in Japan and in the USA. As Japanese radiation oncologists and radiation technologists, we have to identify the weak points of our process of care in order to resolve them as soon as possible and adopt the technical aspects that are applicable and effective for our clinical practice.
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CONCLUSIONS |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONCONCLUSIONSACKNOWLEDGMENTSREFERENCES |
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Chest wall irradiation for PMRT is infrequently used in Japan, but regional node irradiation is employed routinely. There is considerable room for improvement in the techniques including simulation used for chest wall irradiation and for planning.
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ACKNOWLEDGMENTS |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONCONCLUSIONSACKNOWLEDGMENTSREFERENCES |
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This study was supported by Grants-in-Aid for Cancer Research (10-17, 14-6) from the Ministry of Health, Labor and Welfare of Japan and by a Grant from the Japan Society for the Promotion of Science.
Part of this work was presented at the Second Japan/USA PCS Workshop, Tokyo, Japan, February 2003.
We thank all radiation oncologists who participated in this study. Their efforts to provide information for us make surveys such as this possible.
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FOOTNOTES |
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+ For reprints and all correspondence: Naoto Shikama, Department of Radiology, Shinshu University, School of Medicine, 3–1–1 Asahi, Matsumoto 390-8621, Japan. E-mail:shikama{at}hsp.md.shinshu-u.ac.jp
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONCONCLUSIONSACKNOWLEDGMENTSREFERENCES |
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Received April 20, 2003; accepted August 21, 2003
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