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Chronic graft-versus-host disease (GVHD) can be associated with significant morbidity, in part because of nonreversible fibrosis, which impacts physical functioning (eye, skin, lung manifestations) and mortality (lung, gastrointestinal manifestations). Progress in preventing severe morbidity and mortality associated with chronic GVHD is limited by a complex and incompletely understood disease biology and a lack of prognostic biomarkers. Likewise, treatment advances for highly morbid manifestations remain hindered by the absence of effective organ-specific approaches targeting "irreversible" fibrotic sequelae and difficulties in conducting clinical trials in a heterogeneous disease with small patient numbers. The purpose of this document is to identify current gaps, to outline a roadmap of research goals for highly morbid forms of chronic GVHD including advanced skin sclerosis, fasciitis, lung, ocular and gastrointestinal involvement, and to propose strategies for effective trial design. The working group made the following recommendations: (1) Phenotype chronic GVHD clinically and biologically in future cohorts, to describe the incidence, prognostic factors, mechanisms of organ damage, and clinical evolution of highly morbid conditions including long-term effects in children; (2) Conduct longitudinal multicenter studies with common definitions and research sample collections; (3) Develop new approaches for early identification and treatment of highly morbid forms of chronic GVHD, especially biologically targeted treatments, with a special focus on fibrotic changes; and (4) Establish primary endpoints for clinical trials addressing each highly morbid manifestation in relationship to the time point of intervention (early versus late). Alternative endpoints, such as lack of progression and improvement in physical functioning or quality of life, may be suitable for clinical trials in patients with highly morbid manifestations. Finally, new approaches for objective response assessment and exploration of novel trial designs for small populations are required., (Copyright © 2021 The American Society for Transplantation and Cellular Therapy. All rights reserved.)

Purpose: To describe the patterns of definitive radiotherapy practice for patients with uterine cervical cancer from 1999 to 2001 in Japan., Methods and Materials: The Japanese Patterns of Care Study (JPCS) working group conducted a third extramural audit survey of 68 institutions and collected specific information on 324 cervical cancer patients treated with definitive radiotherapy., Results: Almost all patients (96%) were treated with whole pelvic radiotherapy using opposing anteroposterior fields (87%). A midline block was used in 70% of the patients. Intracavitary brachytherapy (ICBT) was applied in 82% of cases. Most patients (89%) were treated with high-dose rate (HDR) ICBT. Calculation of doses to organs at risk (ICRU 38) was performed for rectum in 25% of cases and for bladder in 18% of cases. Only 3% of patients were given intravenous conscious sedation during ICBT applicator insertions. The median total biologically effective dose at point A (EBRT+ICBT) was 74 Gy(10) in cases treated with HDR-ICBT. There was no significant difference in total biologically effective dose between stages. The median overall treatment time was 47 days. Concurrent chemoradiation was applied in 17% of patients., Conclusions: This study describes the general patterns of radiotherapy practice for uterine cervical cancer in Japan. Although methods of external radiotherapy seemed to be appropriate, there was room for improvement in ICBT practice, such as pretreatment. A substantial difference in total radiotherapy dose between Japan and the United States was observed.

Optimal management of radiotherapy for prostate cancer patients has become a major concern for physicians in Japan. We reviewed published reports identifying the differences in the patterns of care for prostate cancer patients treated with radical external beam radiotherapy in Japan, Germany, and the United States. The reports indicate that Japanese patients have more advanced primary disease than patients in Germany or the United States. These patient characteristics for Japan and the United States have been almost unchanged for several years. Regarding radiotherapy, conformal radiotherapy was less frequently administered to patients in Japan than patients in Germany or the United States, and the total radiation dose was higher in Germany and the United States than in Japan. Concerning changes in trends in the patterns of radiotherapy, the percentage of patients treated with higher dose levels in the United States has rapidly increased, whereas the percentage of patients receiving these dose levels in Japan has remained extremely low. On the other hand, hormonal therapy has been used more frequently in Japan than in Germany or the United States. These findings indicate that patient characteristics and patterns of care for prostate cancer in Japan are considerably different from those in Germany or the United States.

Unlabelled: The current study focused on the differences in the patterns of care between Japan and the United States for clinically localized prostate cancer patients treated with radical external beam radiotherapy., Materials and Methods: Results from the 1999-2001 Japanese Patterns of Care Study (PCS) survey were compared with those of the 1999 PCS in the United States. In addition, the changing trends in the patterns of care between Japan and the United States were also analyzed., Results: Patients in Japan were found to have more advanced primary disease than patients in the United States: with higher PSA levels, advanced T stages and a Gleason combined score of 8-10. These patient characteristics in both countries have not changed from previous PCS studies. The prescribed dose of radiotherapy to the primary tumor was significantly higher in the United States and there was a rapid increase in patients treated with higher prescription dose levels (> or = 72 Gy) in the United States, while only a small number of patients received these dose levels in Japan. Hormonal therapy was used more frequently in Japan than in the United States, and the percentage of patients receiving hormonal therapy has remained high for several years in Japan. Furthermore, most of the patients in the favorable risk group in Japan were treated with hormonal therapy, contrary to those in the United States., Conclusion: Japanese prostate cancer patients treated with radical external beam radiotherapy were found to have more advanced disease than those in the United States and these trends have continued for the last few years. Patterns of care for prostate cancer in Japan are considerably different from those in the United States, especially in terms of the radiation dose and the use of hormonal therapy. Moreover, the changing trends in the patterns of care are also different between the two countries.

Background: A Patterns of Care Study (PCS) has been conducted to evaluate the standards of practice for prostate cancer patients treated with radiotherapy in Japan. This study examines the influence of institutional stratification on the process of care for patients receiving radical external beam radiotherapy for prostate cancer in the 1999-2001 PCS in Japan. These PCS results were compared with those of the 1999 PCS in the USA., Methods: A national survey of 36 institutions was conducted using two-stage cluster sampling and detailed information was accumulated on 305 clinically localized prostate cancer patients who received radiotherapy between 1999 and 2001. Of these, 181 patients treated with radical external beam radiotherapy were selected and the preliminary results were analyzed. Institutions were classified as A1 (academic institutions treating >or=430 patients a year) or B1 (non-academic institutions treating >or=130 patients a year)., Results: In both A1 and B1 institutions, more than 80% of the patients had intermediate or unfavorable risk diseases. There were no significant differences in the patients' disease characteristics between A1 and B1 institutions, while the institutional stratification significantly affected the patterns of radiotherapy; such as the beam energy (>or=10 MV, A1 89.9%, B1 72.2%; P = 0.0022), the use of a CT simulator (A1 91.0%, B1 80.0%; P = 0.0340) and the administration of conformal therapy (A1 85.0%, B1 20.5%; P < 0.0001). The median number of full-time equivalent (FTE) radiation oncologists was 2.7 in A1 institutions and only 0.7 in B1 institutions. Median radiation doses of 66.00 Gy (A1 institutions) and 69.00 Gy (B1 institutions) were delivered and hormonal therapy was commonly used before, during and after radiotherapy, with a mean duration of 1.3 years (88.0% in A1 institutions; 90.0% in B1 institutions). In comparing the results of PCS in Japan (1999-2001) with those in the USA (1999), patients in Japan were found to have more advanced primary diseases with higher PSA levels than those in the USA. The median prescribed dose to the primary tumor was not significantly different between the two countries (69.00 Gy in Japan and 70.45 Gy in the USA). Conversely, almost half of the patients in the USA were treated with higher prescription dose levels (>or=72 Gy), whereas only 9.4% of the Japanese patients received these dose levels. Hormonal therapy was used more frequently in Japan (88.1% of the patients) than in the USA (50% of the patients). Most of the Japanese patients with a favorable prognosis (72.0%) were treated with hormonal therapy, compared with 30% in the USA. On the other hand, most of the patients in the unfavorable risk group were treated with radiotherapy in conjunction with hormonal therapy both in Japan (91.1%) and the USA (81%)., Conclusions: During the period 1999-2001, the majority of the prostate cancer patients treated in Japan with radical external beam radiotherapy had advanced diseases and institutional stratification significantly affected the patterns of radiotherapy. In both academic and non-academic institutions, radiotherapy in conjunction with long-term hormonal therapy was commonly used. In comparison with the 1999 PCS in the USA, Japanese patients had more advanced diseases, but the higher prescribed doses (>or=72 Gy) were less common in Japan. Administration rates of hormonal therapy for favorable risk patients were different between Japan and the USA. On the other hand, for unfavorable risk patients, radiotherapy in conjunction with hormonal therapy appeared to be an accepted approach both in Japan and in the USA.

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.

Purpose: To evaluate the quality of radiotherapy (RT) in Japan, we have been carrying out a national survey through patterns-of-care studies (PCSs) since 1996. We present the preliminary results of surgery combined with RT with or without chemotherapy for thoracic esophageal cancer., Methods and Materials: A Japanese PCS data format for esophageal cancer was established based on one used in the United States and including information used in the surgical registration system in Japan, so that the results in both countries could be compared. An independent panel of radiation oncologists surveyed randomly selected institutions and patients between September 1998 and March 2001. There were 767 esophageal cancer patients, of whom 220 had undergone preoperative or postoperative RT., Results: The median age of the 220 patients was 62.3 years (range 31-89); of them, 88.1% were men. Pathologically, 218 patients (99.5%) had squamous cell carcinoma, predominantly located in the middle and lower thoracic esophagus, 41.7% of the patients had Stage III disease; they accounted for 52.6% of patients in nonacademic institutions and for 37.7% of those in academic institutions (p = 0.016). Sixty-nine patients received preoperative RT; of them, 60.9% received chemotherapy; 145 patients received postoperative RT with or without chemotherapy. The spinal cord of 23 (11.7%) of 196 patients was irradiated with >/=50 Gy. In academic institutions, extended radical "three-field" lymphatic dissection was performed for 72 (48.7%) of 148 patients; however, this sophisticated surgical procedure was done in only 13 (25.5%) of 51 patients in nonacademic settings (p = 0.004). In all large academic institutions (those treating >/=300 patients annually), >/=6 MV of photon energy was used; 30.5% of nonacademic institutes had linear accelerators of <6 MV photon (p = 0.001). No deviations occurred in the radiation dose (median 46 Gy), fractionations, or fields between the two types of institutions. Univariate analyses showed that the statistically significant prognostic factors affecting overall survival were stage (p = 0.001), extended radical "three-field" lymphatic dissection (p = 0.001), no residual tumor (p = 0.001), supraclavicular RT (p = 0.001), mediastinal RT (p = 0.025), Karnofsky performance status (p = 0.006) photon energy (p = 0.011), and stratification of the institutions (p = 0.001). Multivariate analysis showed that the type of institution (p = 0.045, risk ratio = 0.604), stage (p 0.029, risk ratio = 0.572), no residual tumor (p = 0.006, risk ratio = 0.487), photon energy (p = 0.043, risk ratio = 0.579), and use of chemotherapy (p = 0.012, risk ratio = 1.907) significantly affected overall survival., Conclusion: This PCS showed that in Japan important issues are present regarding RT for esophageal cancer that should be solved immediately, namely, treatment strategy, photon energy, and dose applied to the spinal cord. The PCS provided important information on how much improvement in structure and process would be required nationwide for RT of esophageal cancer.

Purpose: A Patterns of Care Study (PCS) national survey was conducted to show the national averages for processes of radiation therapy care for prostate cancer patients in 1989. In the current study we report an analysis of pretreatment prostate-specific antigen (PSA) by stage, grade, and ethnic origin., Methods and Materials: Process data were collected from 672 patients treated in 1989 at 71 separate institutions. Four hundred and twenty-seven (64%) of these patients had a pretreatment PSA value recorded. Three hundred and forty-three of the 427 patients were treated with external beam irradiation alone and were selected for the current analysis. The 1992 AJCC staging system was used., Results: There was a significant increase in pretreatment PSA with increasing stage. The median values of PSA were 8.3 ngm/ml in the T1 group (n = 65), 11.2 ngm/ml in the T2 group (n = 178), and 20.9 ngm/ml in the T3 group (n = 90) (p < 0.001). Ten patients were not staged. There was a significant increase in pretreatment PSA with decreasing differentiation. The median pretreatment PSA was 9.7 ngm/ml in well-differentiated tumors (n = 109), 13.0 ngm/ml in moderately differentiated tumors (n = 163), and 22.0 ngm/ml in poorly differentiated tumors. (n = 61) (p < 0.001). Ten patients had no differentiation recorded. African Americans (24) showed a significant increase in pretreatment PSA compared to Caucasians (304). The respective medians were 23.2 ng/ml and 11.9 ng/ml (p = 0.04). They also show more poorly differentiated tumors (33% vs. 17%) and more T3 tumors (46% vs. 25%). Other minorities, although small in number (n = 9) were similar to African Americans., Conclusion: Pretreatment PSA levels were established for patients treated with external beam irradiation in 1989 in the United States. They increase with stage and decreasing differentiation. African Americans and other minorities show a doubling of median values compared to Caucasians' pretreatment PSA with an increase in stage and grade. The adverse prognosis observed for African Americans is predicted by their pretreatment PSA. The cause of this PSA elevation is not known and may be related to lack of access to care or to a more aggressive biology for prostate cancer in African Americans.