Search

Objective: To evaluate the safety and efficacy of hypofractionated whole breast irradiation for Asian women after breast-conserving surgery. This is an updated report with 5-year follow-up., Methods and Materials: Asian women who had invasive breast cancer with clinical tumor size ≤3 cm, pN0-1c and negative inked margins were enrolled. Hypofractionated whole breast irradiation of 42.56 Gy/16 fractions was delivered, and boost irradiation of 10.64 Gy/4 fractions was added when the surgical margin was ≤5 mm. The primary endpoint was the proportion of grade ≥ 2 late adverse reactions within 3 years. Secondary endpoints included early adverse events, overall survival, disease-free survival, ipsilateral breast relapse-free survival, late adverse reactions and cosmetic outcome. Toxicities were evaluated using CTCAE ver3.0. Cosmetic outcomes were assessed using a 4-point scale and CTCAE ver3.0 for hyper/hypopigmentation, breast nipple/areolar deformity and breast volume/deformity., Results: Between February 2010 and August 2012, 312 patients were enrolled, and 306 received hypofractionated whole breast irradiation. Median follow-up was 70.5 (range 7.6-88.9) months. The proportion of grade ≥ 2 late adverse reactions within 3 years was 4.3% (90% confidence interval 2.5-6.7%). Grade 2 early adverse events occurred in 38 (12.4%); none had grade 3/4. Five-year overall survival, disease-free survival and ipsilateral breast relapse-free survival were 98.7, 95.4 and 98.0%, respectively. Of the 304 evaluable patients, 29 (9.5%; 95% confidence interval 6.5-13.4%) had grade 2/3 late adverse reactions; none had grade 4/5. At 5 years, 70/289 (24.2%) showed any worsening of breast cosmetic changes., Conclusions: Hypofractionated whole breast irradiation is considered a standard treatment for Asian women with margin-negative invasive breast cancer after breast-conserving surgery., (© The Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permission@oup.com.)

Background: Shorter duration of infusion of monoclonal antibody treatments may reduce treatment burden and improve healthcare resource utilization., Methods: This phase II study recruited Japanese patients with previously untreated CD20+ B-cell non-Hodgkin lymphoma. Patients received intravenous obinutuzumab 1000 mg by regular infusion on Days 1, 8 and 15 of Cycle 1, followed by 90-min shorter duration of infusion in up to seven subsequent cycles, provided they received ≥3 regular infusions without any grade ≥3 infusion-related reactions and had a lymphocyte count <5.0 × 109 cells/l. Standard cyclophosphamide, doxorubicin, vincristine and prednisolone chemotherapy was given in Cycles 1-6. The primary endpoints were as follows: incidence of grade ≥3 infusion-related reactions in Cycle 2 in patients who started shorter duration of infusion in Cycle 2, serum obinutuzumab concentrations and pharmacokinetic parameters and the time course of cytokine release. Adverse events and serious adverse events were monitored., Results: Of 35 patients treated, 28 completed eight cycles; 31 started shorter duration of infusion in Cycle 2 and two patients in subsequent cycles. Two patients discontinued before starting shorter duration of infusion. No grade ≥3 infusion-related reactions occurred in Cycle 2. Twenty-one infusion-related reactions (all grades 1-2) were reported in 17/35 (49%) patients overall, mostly in Cycle 1 (18/21 infusion-related reactions [86%]). Grade ≥3 AEs occurring in ≥10% of patients included neutropenia/neutrophil count decreased (66%) and leukopenia/white blood cell count decreased (23%). Steady-state pharmacokinetics of obinutuzumab were attained in Cycle 2 and were not affected by shorter duration of infusion. No relevant cytokine elevations were reported with shorter duration of infusion., Conclusions: Regular infusion and shorter duration of infusion of obinutuzumab have comparable tolerability and pharmacokinetics in Japanese patients.

Objective: To estimate selective neck irradiation omitting surgical Sublevel IIb., Methods: Bilateral necks of 47 patients (94 necks) were subjected to definitive radiotherapy for supraglottic cancer. Sixty-nine and 25 necks were clinically node negative (cN-) and clinically node positive (cN+), respectively. We subdivided Sublevel IIb by the international consensus guideline for radiotherapy into Sublevel IIb/a, directly posterior to the internal jugular vein, and Sublevel IIb/b, which was behind Sublevel IIb/a and coincided with surgical Sublevel IIb. Bilateral (Sub)levels IIa, III, IV and IIb/a were routinely irradiated, whereas Sublevel IIb/b was omitted from the elective clinical target volume in 73/94 treated necks (78%)., Results: Two patients presented with ipsilateral Sublevel IIb/a metastases. No Sublevel IIb/b metastasis was observed. Five patients experienced cervical lymph node recurrence; Sublevel IIb/a recurrence developed in two patients, whereas no Sublevel IIb/b recurrence occurred even in the cN- necks of cN+ patients or cN0 patients. The 5-year regional control rates were 91.5% for Sublevel IIb/b-omitted patients and 77.8% for Sublevel IIb/b treated patients., Conclusions: Selective neck irradiation omitting Sublevel IIb/b did not compromise regional control and could be indicated for cN- neck of supraglottic cancer., (© The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Objective: A second lung cancer is occasionally observed in patients who underwent surgical resection of the index lung cancer. The purpose of this study is to evaluate stereotactic body radiation therapy for second lung cancer., Methods: Fifty-one medically inoperable patients who underwent stereotactic body radiation therapy for second lung cancer were the subjects: 31 cases of multiple primary lung cancer and 20 of pulmonary metastasis from the index cancer. Clinical stage was T1a in 27 patients, T1b in 13 patients and T2a in 11 patients, and 70% of subjects had impaired respiratory function. Histology of second lung cancer was adenocarcinoma in 16 patients, squamous cell carcinoma in 9 patients and not assessed in 25 patients. The interval between index cancer operation and stereotactic body radiation therapy was 31 months (range: 4-171). The total stereotactic body radiation therapy doses were 48 Gy in 4 fractions or 60 Gy in 10 fractions., Results: With the median follow-up of 36 months, 3-year overall survival rates were 62% with the median survival time of 46 months. Cause-specific survival was 73% at 3 years. Overall survival for multiple primary lung cancer and pulmonary metastasis was quite similar: 62 and 61% at 3 years, respectively. Three-year overall survival was 77% for T1a and 43% for T1b or T2a. Grade 2 pulmonary toxicities occurred in five patients and one patient died of Grade 5 pneumonitis., Conclusions: Even though the subjects were medically inoperable, the survival outcomes of stereotactic body radiation therapy were favorable. Furthermore, having acceptable toxicity, stereotactic body radiation therapy is feasible and could be an option for multiple primary lung cancer and pulmonary metastasis after surgical resection for the index cancer., (© The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Objective: The purpose of this study was to clarify operational situations, treatment planning and processes, quality assurance and quality control with relevance to stereotactic radiotherapy, intensity-modulated radiotherapy and image-guided radiotherapy in Japan., Methods: We adopted 109 items as the quality indicators of high-precision radiotherapy to prepare a questionnaire. In April 2012, we started to publicly open the questionnaire on the website, requesting every institution with radiotherapy machines for response. The response ratio was 62.1% (490 out of 789 institutions responded)., Results: Two or more radiotherapy technologists per linear accelerator managed linear accelerator operation in ∼90% of the responded institutions while medical physicists/radiotherapy quality managers were engaged in the operation in only 64.9% of the institutions. Radiotherapy certified nurses also worked in only 18.4% of the institutions. The ratios of the institutions equipped for stereotactic radiotherapy of lung tumor, intensity-modulated radiotherapy and image-guided radiotherapy were 43.3, 32.6 and 46.8%, respectively. In intensity-modulated radiotherapy planning, radiation oncologists were usually responsible for delineation while medical physicists/radiotherapy quality managers or radiotherapy technologists set up beam in 33.3% of the institutions. The median time required for quality assurance of intensity-modulated radiotherapy at any site of brain, head and neck and prostate was 4 h. Intensity-modulated radiotherapy quality assurance activity had to be started after clinical hours in >60% of the institutions., Conclusions: This study clarified one major issue in the current high-precision radiotherapy in Japan. A manpower shortage should be corrected for high-precision radiotherapy, especially in the area relevant to quality assurance/quality control., (© The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Objective: To assess compliance with the radiotherapy protocol of a multi-institutional prospective study (JAROG0401/JROSG04-2), which investigated the efficacy and toxicity of definitive radiotherapy using high-dose-rate intracavitary brachytherapy (HDR-ICBT) for early-stage uterine cervical cancer patients., Methods: Individual case reviews (ICRs) were performed on all 60 study participants. Radiotherapy data were submitted to the quality assurance (QA) committee, which performed ICRs on 16 QA items according to previously selected criteria. The items focused on quality of external beam radiotherapy (EBRT), HDR-ICBT and both. Each item was determined to be either acceptable or a deviation. The QA committee performed ICR three times as planned, two during the patient accrual and the final one just after the final patient accrued. The QA results of the first and second reviews were reported back to the investigators after each ICR., Results: In 40 cases (67%), all 16 QA items were classified as acceptable. One deviation was found in 16 cases, two deviations were identified in 3 cases and three deviations were noted in 1 case. The most frequently observed deviation was missing the rules for determining point A (10 cases). The items described by quantitative values, such as prescribed doses, certain time intervals and overall treatment time, were well followed. The proportion of deviations gradually decreased during the ICR process., Conclusions: The present ICR demonstrated the favorable radiotherapy compliance with the JAROG0401/JROSG04-2 protocol. The QA process using ICRs can potentially be used to improve the quality of radiotherapy, including HDR-ICBT in the multi-institutional prospective studies for cervical cancer.

Objective: The purpose of this study is to identify the treatment planning process for Japanese patients with localized prostate cancer., Methods: The Patterns of Care Study conducted a random survey of 61 institutions nationwide. Detailed information was collected on prostate cancer patients without distant metastases who were irradiated during the periods 2003-05. Radiation treatment planning and delivery were evaluated in 397 patients who were treated radically with external photon beam radiotherapy., Results: Computed tomography data were used for planning in approximately 90% of the patients. Contrast was rarely used for treatment planning. Simulations and treatments were performed in the supine position in almost all patients. Immobilization devices were used in only 15% of the patients. Verification of the treatment fields using portal films or electric portal imaging devices was performed in most of the patients. However, regular or multiple verifications in addition to initial treatment and/or portal volume changes were performed in only 30% of the patients. Typical beam arrangements for treatment of the prostate consisted of a four-field box. Three-dimensional conformal techniques were applied less frequently in non-academic hospitals than in academic ones. Modernized multileaf collimators with leaf widths < or =10 mm were used in about two-thirds of the patients. Although the total doses given to the prostate were affected by the leaf widths, there were no significant differences between leaf widths of 5 and 10 mm., Conclusions: The results of the survey identified certain patterns in the current treatment planning and delivery processes for localized prostate cancer in Japan.

Background: The third Japanese Patterns of Care Study (JPCS) was conducted for esophageal cancer patients receiving radiotherapy (RT). The aim of this study is to analyse the data of the non-surgery group., Methods: Of the 621 patients receiving RT from 1999 to 2001, 385 non-surgical patients were analysed., Results: Median age was 71 years and 85% were male. Karnofsky performance status (KPS) was > or =80 in 71% and better in T1 cases than in T2-4 cases. Ninety-nine per cent had squamous cell carcinoma and 56% had the main lesion in the middle thoracic esophagus. Twenty-one per cent had T1 disease, 12% T2, 38% T3 and 29% T4. Endoscopic ultrasound was used in 29% and mainly in T1 cases. Endoscopic mucosal resection was performed in 40% of mucosal cancer. Utilization of chemotherapy had remarkably increased compared with the 1995-1997 JPCS (61% versus 35%), however was significantly less in T1 cases than in T2-4 cases. The most frequently used agents for concurrent use were 5-fluorouracil and cisplatin. The median total dose of external beam RT (ERT) was 60 Gy and did not differ between T1 and T2-4 cases and also in comparison with the 1995-1997 JPCS. Brachytherapy was used in 10% and mainly in T1 cases., Conclusions: Utilization of chemotherapy had remarkably increased. However the common treatment for T1 cases was RT alone. The standard dose of ERT was 60 Gy in spite of the increase in chemotherapy administration. Moreover, this survey showed significant differences in many parameters of treatment process between T1 and T2-4 cases.

Objective: To evaluate the changing trends of standards and practices for postoperative radiotherapy (RT) for patients with prostate cancer in Japan., Methods: The Japanese Patterns of Care Study (PCS) conducted a national survey in 84 institutions from 1996 to 1998 (PCS96-98) and 76 institutions from 1999 to 2001 (PCS99-01). Detailed information relevant to RT was collected on a total of 169 patients (64 from 1996 to 1998 and 105 from 1999 to 2001) with prostate cancer who had undergone radical prostatectomy., Results: The fraction of clinical T3-4 tumours before prostatectomy decreased from 63% in the period 1996-98 to 26% in the period 1999-2001 (P = 0.0004). The pre-RT prostate-specific antigen level was significantly lower in 1999-2001 than in 1996-98 (P = 0.0002). We did not find a significant difference in the percentage of patients who received pelvic irradiation in the time periods between PCS96-98 and PCS99-01 (P = 0.18). Although the median radiation doses of 60 Gy were not changed between the surveys, various doses (from 20 to 74.6 Gy) were delivered to the prostatic bed. In the 1999-2001 survey, 73 of 105 patients received a median dose of 56 Gy in an adjuvant setting, while the other 32 received a median dose of 60 Gy in a salvage setting (P = 0.0015)., Conclusion: These data suggest that consensus has not been reached on the practice and management of postoperative RT for patients with prostate cancer in Japan.

Background: Three prospective randomized clinical trials (RCT) in the 1990s demonstrated the survival benefit of postmastectomy radiotherapy (PMRT) for patients with locally advanced breast cancer. The present study was performed to evaluate whether the Patterns of Care Study (PCS) fulfills a role in monitoring the patterns of changes in clinical practices in Japan., Methods: The first survey (JPCS-1) involved 79 Japanese facilities by two-stage cluster sampling of facilities and patients, and was carried out during 1998-2000. JPCS-1 included 1124 patients with breast cancer who were treated between 1995 and 1997. The second survey (JPCS-2) was carried out during 2001-2003, involving 827 patients who were treated between 1999 and 2001 in 76 facilities., Results: Patients with adverse risk factors, including pathologically axillary positive nodes (> or =4) and/or advanced primary disease (pT3-4) accounted for 57% of the patients who received PMRT in JPCS-1 and 72% of those in JPCS-2 (P = 0.039). The multiple radiotherapy target volume including the chest wall and regional lymph nodes was applied in 18% of the patients in JPCS-1 and 44% of those in JPCS-2 (P < 0.001). However, the dose distribution was calculated in only 42% of the patients in both surveys (P = 0.467)., Conclusions: The eligibility and the target volume for PMRT were influenced by the outcome of RCT, but the quality of radiotherapy did not improve sufficiently. The PCS survey is useful to monitor the changes in patterns of clinical practice and can clarify some problems with radiotherapy techniques.

Background: The Patterns of Care Study evaluated standards of practice for patients with clinically localized prostate cancer treated with radiotherapy in Japan. This study examined the influence of institutional stratification on care for patients receiving radical external beam radiotherapy., Methods: A national survey of 66 institutions was conducted using two-stage cluster sampling, and detailed information was accumulated on 283 patients who received radiotherapy between 1999 and 2001., Results: In A (academic) and B (non-academic) institutions, more than 80% of patients had intermediate or unfavorable risk disease. Although there were no significant differences in disease characteristics between A and B institutions, institutional stratification significantly affected radiotherapy practice patterns, such as the use of a CT-based treatment planning (A1: 91.5%, B: 77.1%; P = 0.0007) and the use of conformal therapy (A: 56.4%, B: 24.1%; P < 0.0001). CT-based treatment planning and conformal therapy significantly influenced total radiation dose (P < 0.0001 for each). Hormonal therapy was commonly used in both A and B institutions (A: 89.0%, B: 90.7%). Many patients with a favorable prognosis (A: 62.5%, B: 91.7%) received hormonal therapy, and most patients with unfavorable risk disease (A: 93.6%, B: 91.6%) also received hormonal therapy., Conclusion: During the period 1999-2001, the majority of prostate cancer patients treated in Japan with radical external beam radiotherapy had advanced diseases. Institutional stratification significantly affected radiotherapy practice patterns, with the notable exception that radiotherapy was commonly combined with hormonal therapy regardless of the institutional stratification and individual risk.

Background: The Patterns of Care Study (PCS), started in the 1970's, is a well-known study used for clinical quality assurance (QA) in radiation oncology in the United States. PCS has been introduced in Japan since 1996., Methods: Three national PCS surveys have been performed by means of external audit to evaluate patterns of care for the patients with carcinoma of any of esophagus and cervix treated with radiation between 1992 and 1994, for those with carcinoma of any of esophagus, cervix, breast, lung and prostate between 1995 and 1997, and for those with any of the five disease sites between 1999 and 2001. In the first PCS, feasibility of the study was confirmed. In the second PCS, two-stage cluster sampling of institutions and patients was performed and national averages for the survey items were calculated as QA measures. In the third PCS, additional imaging data were collected. The Japan/USA PCS workshops were held at San Francisco in 2001 and at Tokyo in 2003., Results: Significant variations in process and structure were observed according to institutional stratification. In academic institutions, external beam energy > or =6 MV for deep-seated tumors of esophagus, lung, prostate and cervix, and brachytherapy for those of cervix and esophagus were used more frequently. There was an average of less than one full-time equivalent radiation oncologist in most non-academic institutions. These variations influenced the outcomes. There were also significant differences between USA and Japan in various aspects, e.g. a difference in radiation dose of 20% for uterine cervix cancer patients. It is higher in the USA. The number of new cancer patients requiring radiation is increasing steeply (120,000 in 2000 and 170,000 in 2005). Based on PCS data, structural guidelines were published and distributed throughout Japan., Conclusion: PCS is useful for establishing the clinical QA for radiation oncology as well as other specialties through detailed monitoring and evaluation of their structures, processes and outcomes.

Objective: The aim of this study is to establish Japanese national practice patterns for uterine cervical cancer patients who received radiotherapy without surgery., Methods: The Japanese Patterns of Care Study (JPCS) conducted a national survey of 73 institutions using two-stage cluster sampling, and collected specific information on 591 patients with uterine cervical cancer treated by radiotherapy without planned surgery between 1995 and 1997., Results: The median age of the patients was 70 years. Karnofsky performance status (KPS) was >/=90 for 37%. Most patients (95%) had histology of squamous cell carcinoma. Ten percent were stage I, 29% stage II, 48% stage III and 13% stage IVA. Photon beams of 10-14 MV were the most used for external beam radiotherapy (EBRT). The beam energy utilized varied significantly by institution strata. Midline block was used in approximately 70% of institutions. Intracavitary brachytherapy (ICBT) was performed in 77%. Institution strata correlated significantly with the ICBT application. The majority of patients (89%) were treated with high-dose-rate (HDR) ICBT. The median single point A dose of HDR-ICBT was 600 cGy. The median summated point A dose from EBRT and HDR-ICBT was 5800 cGy (range: 1196-8600). The median overall treatment time including ICBT was 49 days. Twenty-four percent of the patients received chemotherapy. Concurrent chemoradiation was performed in 5%., Conclusions: The JPCS established the Japanese national practice patterns of care for uterine cervical cancer patients treated with radiotherapy without planned surgery between 1995 and 1997. This survey demonstrated that the institutional strata significantly affected several practice patterns.

Objective: To report the preliminary results of a study to delineate the changing trends in radical external beam radiotherapy usage for prostate cancer between the 1996-1998 and 1999-2001 survey periods in Japan., Methods: The 1996-1998 Patterns of Care Study (PCS) and the 1999-2001 PCS in Japan reviewed the detailed information on 694 patients with prostate cancer treated with radiotherapy. Of them, 298 patients with clinically localized prostate cancer treated with radical external beam radiotherapy in A1 and B1 institutions were selected for analysis (1996-1998 PCS, 117 patients; 1999-2001 PCS, 181 patients)., Results: High-risk prostate cancer (defined as T3-T4 tumors, a pretreatment prostate-specific antigen level >20 ng/ml, and/or poorly differentiated adenocarcinoma) was diagnosed in 82.1% of the patients in the 1996-1998 PCS and in significantly less (70.2%) of those in the 1999-2001 PCS (P = 0.021). Moreover, significantly earlier T stages (T1-T2: 49.7%) and more well-differentiated tumors (24.7%) were found between 1999 and 2001 than between 1996 and 1998 (T1-T2: 31.9%, well-differentiated tumors: 13.9%). Although only 6.1% of patients were treated with radiotherapy by patient's choice in 1996-1998, a larger proportion (32.2%) chose this treatment in 1999-2001. The median radiation dose was 65.0 Gy (range, 24-74 Gy) in 1996-1998 and increased to 69 Gy (range, 14-80 Gy) in 1999-2001. The percentage of radiation doses <60 Gy was 20.5% in 1996-1998 but only 2.2% in 1999-2001. Moreover, the incidence of treatment with total doses of > or =70 Gy was higher in 1999-2001 (43.9%) than in 1996-1998 (19.7%). These increased radiation doses were predominantly observed in B1 institutions. Although the usage of > or =10 MV was significantly increased in 1999-2001 (82.0%) compared with that in 1996-1998 (65.8%), conformal therapy administered to 52.1% of patients in 1996-1998 was almost the same (55.8%) in 1999-2001. The median number of full-time equivalent (FTE) radiation oncologists (2.4 in A1 institutions and only 0.6 in B1 institutions) in 1996-1998 increased slightly in 1999-2001 (2.7 in A1 institutions, 0.7 in B1 institutions), but remained low in B1 institutions., Conclusions: In Japan, there is a trend to fewer high-risk prostate cancer patients being treated with radical external beam radiotherapy. An increasing percentage of patients chose radiotherapy and also increased radiation doses, which might reflect the growing acceptance of radical external beam radiotherapy as a treatment of choice for prostate cancer in Japan. Therefore, to optimize delivery of radiotherapy, more advanced equipment and more FTE radiation oncologists are warranted.

Objective: To determine the average national practice of postoperative radiotherapy for uterine cervical cancer in Japan., Methods: The Japanese Patterns of Care Study (PCS) reviewed the process of care employed for 455 uterine cervical cancer patients who were treated with surgery followed by postoperative radiotherapy (RT) during 1995-1997. Cases with missing data were excluded from calculations of percentage and significance for each of the surveyed items., Results: According to FIGO stages, 198 patients (45%) were in stage I, 52 patients (12%) were in stage IIA, 146 patients (33%) were in stage IIB and 46 patients (10%) were in stage III/IVA. The most common surgical procedure among the patients was radical hysterectomy (73%). Three hundred and seventy patients (82%) were treated with external beam RT (ERT) alone, and 74 patients (17%) were treated with a combination of ERT and intracavitary RT (ICRT). A midline block was used for the pelvic field in 63 patients (14%). Only seven patients (2%) were treated with extended field ERT. Pelvic ERT was most often performed using AP-PA opposed fields for 431 patients (97%). A majority of the patients (312 patients, 70%) were treated with a total dose of 45.0-50.4 Gy for ERT. Chemotherapy (CT) was administered to 178 patients (40%), neoadjuvant preoperative CT was administered to 80 patients (22%) and concurrent CT with postoperative RT was administered to 29 patients (8%)., Conclusion: This PCS established the national practice average of postoperative RT for uterine cervical cancer. Follow-up studies need to be conducted to determine whether the observed differences in treatment processes affect outcomes.

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: This is the first study to examine the characteristics and changes of the patterns of radiotherapy for prostate cancer in Japan., Methods: The Japanese Patterns of Care Study (PCS) conducted a random survey of 84 institutions nationwide. Detailed information was collected on prostate cancer patients without distant metastases, who received radiotherapy during 1996-1998 and 1999-2001., Results: The patients were divided into three groups: The Fresh Group (n = 338) was treated with radical radiotherapy with photon beams; the Surgery Group (n = 115) was treated after prostatectomy; and the Hormone-Refractory Group (n = 117) was treated after progression from hormonal therapy. In the Fresh Group, there was a decline in the fraction of patients with T3-4 tumors, from 65.2% in 1996-1998 to 43.9% in 1999-2001. In 1999-2001, a higher median dose of 69 Gy was irradiated as compared to 65 Gy in 1996-1998. In particular, the fraction of the patients treated with doses >or=70 Gy increased from 16.4% to 46.3%. In the Surgery Group, the percentage of clinical T3-4 tumors before prostatectomy decreased from 71.4% in 1996-1998 to 16.2% in 1999-2001. The median radiation dose of 60 Gy did not change, but the 1999-2001 results showed a decrease in the use of doses <60 Gy. In the Hormone-Refractory Group, the median dose increased from 60 Gy in 1996-1998 to 67 Gy in 1999-2001., Conclusion: These data suggest that radiation doses for prostate cancer in Japan have increased dramatically within a short period of time.

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.

Background: Two prospective studies reported in 1997 demonstrated that postoperative radiotherapy after mastectomy was not only associated with a higher loco-regional control rate but also with a higher overall survival rate. The purpose of this study is to clarify the processes of care for patients undergoing mastectomy and postoperative radiotherapy in Japan., Methods: A national survey carried out in 1998-2000, involving 79 Japanese institutions by two-stage cluster sampling of institutions and patients, disclosed that 1124 patients with breast cancer had been treated between 1995 and 1997. Mastectomy followed by radiotherapy was performed on 258 patients., Results: The compliance rates for pre-treatment evaluation, including history, physical examination and mammography, averaged approximately 50% (24-81%). The chest wall was irradiated in only 19% of the patients and regional node irradiation was carried out for 70-86%. Radiation treatment planning with the aid of computed tomography was done in only 29% of patients (university hospitals or cancer centers, 39%; other hospitals, 17%; P = 0.001). Hormonal therapy was administered to 56% of the patients who showed no endocrine responsiveness. Non-intensive chemotherapy, which did not include the use of anthracycline or taxol, was used in 55% of the patients who received chemotherapy., Conclusions: There is room for improvement regarding some aspects of radiotherapy and adjuvant systemic therapies. Especially in the field of radiotherapy, significant differences were found among the treatment techniques employed in various institutions.

Background: The patterns of radical radiation therapy for prostate cancer are unclear in Japan. A Patterns of Care Study was performed throughout Japan to examine the patterns of radiation therapy for prostate cancer., Methods: From 1999 to 2000, extramural audits were performed on 50 randomly selected institutions (approximately 7% of all institutions in Japan). Detailed information was collected on a total of 311 prostate cancer patients without evidence of distant metastases, who were treated by radiation therapy between 1996 and 1998. Of these 311 patients, 162 treated radically using photon beams were analyzed in this study., Results: Eighty percent of the patients had high-risk diseases defined as T3 or T4 tumors, a pretreatment prostate-specific antigen level >20 ng/ml or poorly differentiated adenocarcinoma. Androgen ablation was performed in 85.8% of patients and the median duration of hormonal therapy before and after radiation therapy was 5.3 and 21.4 months, respectively. The median total dose of radiation therapy to the prostate was 65.0 Gy (range: 20-74 Gy). The 3-year overall and biochemical relapse-free survival rates were 86.7 and 86.1%, respectively. Late toxicity was mild, with only nine patients (5.6%) exhibiting grade 2 late morbidity., Conclusions: The majority of the patients who received radical radiation therapy in Japan have high-risk disease. Androgen ablation plus radiation therapy was commonly used to treat these patients and resulted in high rates of initial control with a low risk of complications.

Background: Recently, as the number of elderly people in Japan is growing, so is the number of new cancer cases. The number of patients treated with radiotherapy is therefore also on the increase, so that it is important to estimate the future demand for radiotherapy and to make preparations for it., Methods: All the surveys were conducted for 106 facilities selected randomly out of 556 radiotherapy facilities in Japan. To obtain trends in the number of new cancer patients treated with radiotherapy in Japan, we conducted a survey with a self-administered mail questionnaire designed to obtain the number of new patients treated with radiotherapy for each year of the past decade (1990-99). The future number of new patients treated with radiotherapy was estimated from the data thus obtained. To investigate structural problems of Japanese radiotherapy, surveys about the number of treatment machines and full-time equivalent (FTE) radiation oncologists were conducted according to data from the Japanese Society for Therapeutic Radiology and Oncology (JASTRO) structure survey and the Patterns of Care Study (PCS). We also compared the structure of Japanese radiotherapy with that in the USA., Results: The number of patients treated with radiotherapy has increased for every institutional stratum, with an overall increase of 1.4-fold over the past 10 years in Japan. It is estimated that the number of cancer patients treated with radiotherapy will reach 190 000 in 2015. In Japanese non-academic institutions, less than one FTE radiation oncologist has been managing many of these patients. In both equipment and manpower, academic institutions exceed nonacademic institutions., Conclusion: The future demand for Japanese radiotherapy will grow substantially, so that it is of vital importance to prepare for it. Specifically, the number of FTE radiation oncologists must be increased.