Final results of a safety and efficacy trial of preoperative sequential chemoradiation therapy for the nonsurgical treatment of early breast cancer: Japan Clinical Oncology Group Study JCOG0306.

OBJECTIVE: To explore the possibility of nonsurgical treatment of primary breast cancers by a sequential treatment of chemotherapy and radiotherapy. METHODS: We conducted a safety and efficacy trial of chemotherapy and radiation therapy sequentially as primary therapy in patients with stage I-IIIA breast cancer. All patients underwent mastectomy or lumpectomy 12-16 weeks after the completion of radiation therapy to maximize the effect of radiation therapy. The primary endpoint was the pathological complete response (pCR) rate. RESULTS: Between June 2004 and April 2005, one hundred eight patients were enrolled. Thirty six percent of the entire population achieved a pCR, which could not reject the null hypothesis. The pCR rate was 57% in patients with hormone receptor (HR)-negative/HER-2-positive tumors and 52% in patients with triple-negative tumors. While 7% of the HR-negative/HER2-positive patients recurred, a higher incidence of recurrence (24%) was observed in triple-negative tumors in a follow-up of 4.5 years. The rate of breast-conserving surgery was 88.9% (96/108). CONCLUSION: The pCR rate was not high enough, even though preoperative sequential chemoradiation therapy did not increase the risk of operative complications and could achieve a high rate of breast-conserving surgery.

A multicenter investigation of late adverse events in Japanese women treated with breast-conserving surgery plus conventional fractionated whole-breast radiation therapy.

OBJECTIVE: To investigate late adverse events in Japanese women treated with breast-conserving surgery plus conventional fractionated radiation therapy in 24 hospitals. METHODS: This is a prospective investigation into patients who have been followed for 3 years or more after the completion of radiation therapy. The women visited hospitals for routine medical follow-up between 1 March and 31 May 2008. All patients underwent interviews and visual/palpating examinations. Their clinical chart, past chest X-rays and laboratory findings were reviewed. Evaluation criteria for late adverse events and breast cosmetic outcome were based on the Common Terminology Criteria for Adverse Events v.3 and the European Organization for Research and Treatment of Cancer Global Cosmetic Rating System. RESULTS: Seven hundred and three women, including 448 treated with whole-breast irradiation and 255 treated with whole-breast and boost irradiation, were examined by radiation oncologists in 24 hospitals. The frequent adverse events were breast pain (Grade 1, 115; Grade 2, 2), breast fibrosis (Grade 1, 72; Grade 2, 8), chest wall pain (Grade 1, 67; Grade 2, 3), telangiectasia (Grade 1, 29; Grade 2, 5) and pneumonitis (Grade 1, 20; Grade 2, 6; Grade 3, 3). Adverse events of Grade 2 or 3 were found in 27 patients (3.8%); 3 presented with radiation pneumonitis of Grade 3. The percentage of patients with an excellent or good cosmetic outcome was 69.1%. CONCLUSIONS: In the first multicenter investigation for Japanese women after breast-conserving therapy, the evaluation of late adverse events and breast cosmetic outcome was similar to several other reports from clinical trials in North America and Europe.

Patterns of radiotherapy practice for patients with cervical cancer in Japan, 2003-2005: changing trends in the pattern of care process.

PURPOSE: The patterns of care study (PCS) of radiotherapy for cervical cancer in Japan over the last 10 years was reviewed. METHODS AND MATERIALS: The Japanese PCS working group analyzed data from 1,200 patients (1995-1997, 591 patients; 1999-2001, 324 patients; 2003-2005, 285 patients) with cervical cancer treated with definitive radiotherapy in Japan. RESULTS: Patients in the 2001-2003 survey were significantly younger than those in the 1999-2001 study (p < 0.0001). Histology, performance status, and International Federation of Gynecology and Obstetrics stage were not significantly different among the three survey periods. Use of combinations of chemotherapy has increased significantly during those periods (1995-1997, 24%; 1999-2001, 33%; 2003-2005, 54%; p < 0.0001). The ratio of patients receiving concurrent chemotherapy has also dramatically increased (1995-1997, 20%; 1999-2001, 54%; 2003-2005, 83%; p < 0.0001). As for external beam radiotherapy (EBRT), the application rate of four-field portals has greatly increased over the three survey periods (1995-1997, 2%; 1999-2001, 7%; 2003-2005, 21%; p < 0.0001). In addition, the use of an appropriate beam energy for EBRT has shown an increase (1995-1997, 67%; 1999-2001, 74%; 2003-2005, 81%; p = 0.064). As for intracavitary brachytherapy (ICBT), an iridium source has become increasingly popular (1995-1997, 27%; 1999-2001, 42%; 2003-2005, 84%; p < 0.0001). Among the three surveys, the ratio of patients receiving ICBT (1995-1997, 77%; 1999-2001, 82%; 2003-2005, 78%) has not changed. Although follow-up was inadequate in each survey, no significant survival differences were observed (p = 0.36), and rates of late Grade 3 or higher toxicity were significantly different (p = 0.016). CONCLUSIONS: The Japanese PCS has monitored consistent improvements over the past 10 years in the application of chemotherapy, timing of chemotherapy, and EBRT methods. However, there is still room for improvement, especially in the clinical practice of ICBT.

National medical care system may impede fostering of true specialization of radiation oncologists: study based on structure survey in Japan.

PURPOSE: To evaluate the actual work environment of radiation oncologists (ROs) in Japan in terms of working pattern, patient load, and quality of cancer care based on the relative time spent on patient care. METHODS AND MATERIALS: In 2008, the Japanese Society of Therapeutic Radiology and Oncology produced a questionnaire for a national structure survey of radiation oncology in 2007. Data for full-time ROs were crosschecked with data for part-time ROs by using their identification data. Data of 954 ROs were analyzed. The relative practice index for patients was calculated as the relative value of care time per patient on the basis of Japanese Blue Book guidelines (200 patients per RO). RESULTS: The working patterns of RO varied widely among facility categories. ROs working mainly at university hospitals treated 189.2 patients per year on average, with those working in university hospitals and their affiliated facilities treating 249.1 and those working in university hospitals only treating 144.0 patients per year on average. The corresponding data were 256.6 for cancer centers and 176.6 for other facilities. Geographically, the mean annual number of patients per RO per quarter was significantly associated with population size, varying from 143.1 to 203.4 (p < 0.0001). There were also significant differences in the average practice index for patients by ROs working mainly in university hospitals between those in main and affiliated facilities (1.07 vs 0.71: p < 0.0001). CONCLUSIONS: ROs working in university hospitals and their affiliated facilities treated more patients than the other ROs. In terms of patient care time only, the quality of cancer care in affiliated facilities might be worse than that in university hospitals. Under the current national medical system, working patterns of ROs of academic facilities in Japan appear to be problematic for fostering true specialization of radiation oncologists.

Changing trend in the patterns of pretreatment diagnostic assessment for patients with cervical cancer in Japan.

OBJECTIVE: Cancer staging systems should be responsive to the development of diagnostic tools. The International Federation of Gynecology and Obstetrics (FIGO) cervical cancer guidelines were modified in 2009 regarding the pretreatment assessment. We report the recent Japanese patterns of pretreatment workup for cervical cancer. METHODS: The Japanese Patterns of Care Study (PCS) working group analyzed the pretreatment diagnostic assessment data of 609 patients with cervical cancer treated with definitive radiotherapy in the two survey periods (1999-2001, 324; 2003-2005, 285) in Japan. Sixty-one of 640 institutions were selected for this survey using a stratified two-staged cluster sampling method. RESULTS: The use of optional examinations in the latest FIGO guidelines such as intravenous urography, cystoscopy, and proctoscopy was gradually decreasing. Surgical staging was rarely performed in either survey period. Computed tomography (CT) and magnetic resonance imaging (MRI) were widely used, and MRI has become increasingly prevalent even between the two survey periods. Primary lesion size and pelvic lymph node status was evaluated by CT/MRI for most patients in both surveys. CONCLUSIONS: The use of CT/MRI that is encouraged in the latest FIGO staging guidelines already replaced intravenous urography, cystoscopy, and proctoscopy in Japan. Japanese patients received the potential benefit of CT/MRI because prognostic factors such as primary lesion size and pelvic lymph node status were evaluated by these modalities. The use of cystoscopy and proctoscopy should be continuously monitored in the future PCS survey because only CT/MRI could lead to the stage migration for patients on suspicion of bladder/rectum involvement on CT/MRI.

Identifying gaps in the locoregional management of early breast cancer: highlights from the Kyoto Consensus Conference.

A consensus conference was held to investigate issues related to the local management of early breast cancer. Here, we highlight the major topics discussed at the conference and propose ideas for future studies. Regarding axillary management, we examined three major issues. First, we discussed whether the use of axillary reverse mapping could clarify the lymphatic system of breast and whether the ipsilateral arm might help avoid lymphedema. Second, the use of an indocyanine green fluorescent navigation system was discussed for intraoperative lymphatic mapping. These new issues should be examined further in practice. Finally, some agreement was reached on the importance of "four-node diagnosis" to aid in the diagnostic accuracy of sentinel nodes. Regarding breast treatment, there was general agreement that the clinical value of surgical margins in predicting local failure was dependent on the tumor's intrinsic biology and subtypes. For patients treated with preoperative chemotherapy, less extensive excision may be feasible in those who respond to systemic therapy in an acceptable manner. Most trials of preoperative chemotherapy lack outcome data on local recurrence. Therefore, there is a need for such data for overview analysis. We also agreed that radiation after mastectomy may be beneficial in node-positive cases where more than four nodes are involved. Throughout the discussions for both invasive and noninvasive disease, the investigation of nomograms was justified for major issues in the decision-making process, such as the presence or absence of microinvasion and the involvement of nonsentinel nodes in sentinel node-positive patients.

Japanese structure survey of radiation oncology in 2007 with special reference to designated cancer care hospitals.

BACKGROUND AND PURPOSE: The structure of radiation oncology in designated cancer care hospitals in Japan was investigated in terms of equipment, personnel, patient load, and geographic distribution. The effect of changes in the health care policy in Japan on radiotherapy structure was also examined. MATERIAL AND METHODS: The Japanese Society of Therapeutic Radiology and Oncology surveyed the national structure of radiation oncology in 2007. The structures of 349 designated cancer care hospitals and 372 other radiotherapy facilities were compared. RESULTS: Respective findings for equipment and personnel at designated cancer care hospitals and other facilities included the following: linear accelerators/facility: 1.3 and 1.0; annual patients/linear accelerator: 296.5 and 175.0; and annual patient load/full-time equivalent radiation oncologist was 237.0 and 273.3, respectively. Geographically, the number of designated cancer care hospitals was associated with population size. CONCLUSION: The structure of radiation oncology in Japan in terms of equipment, especially for designated cancer care hospitals, was as mature as that in European countries and the United States, even though the medical costs in relation to GDP in Japan are lower. There is still a shortage of manpower. The survey data proved to be important to fully understand the radiation oncology medical care system in Japan.

Phase II study of radiation therapy combined with weekly low-dose gemcitabine for locally advanced, unresectable pancreatic cancer.

BACKGROUND: Through a phase I study with a fixed radiation dose of 54 Gy and escalating doses of weekly gemcitabine, we established a recommended dose of gemcitabine at 250 mg/m in combination with radiation therapy for patients with unresectable pancreatic cancer. OBJECTIVE: The purpose of this phase-II study was to evaluate the safety and efficacy of the regimen which was established in the phase I study. METHODS: In all patients with unresectable stage III and limited stage IV pancreatic cancer with no distant metastasis except for para-aortic lymph node involvement at a level as low as the left renal vein, a total dose of 54 Gy was delivered in 30 fractions of 1.8 Gy/d. Gemcitabine was given weekly at a dose of 250 mg/m. RESULTS: Between December 2002 and March 2006, 22 patients were enrolled in this study and one withdrew after enrollment. Twenty of 21 patients (95%) completed the protocol therapy. Radiologic partial response was observed in 6 and stable disease was noted in 15. Normalization of the tumor marker (CA19-9) occurred in 61% of patients. The 1-year survival rate was 74% and the median survival time was 16.6 months. The major toxicity was leucopenia; grade 3 in 14 (67%), anorexia grade 3 in 2 (9.5%), and grade 3 gastric ulcer in 2 (10%) in National Cancer Institute's Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0). Neither grade 4 nor 5 was recognized. CONCLUSION: Treatment with gemcitabine combined with radiation therapy according to the present schedule is well tolerated and can provide prolonged survival in patients with localized, unresectable pancreatic cancer.

Preparation of magnetic iron oxide nanoparticles for hyperthermia of cancer in a FeCl2-NaNO3-NaOH aqueous system.

Magnetic iron oxide nanoparticles (MIONPs) were synthesized in a FeCl2-NaNO3-NaOH aqueous system under various initial Fe(2+)/NO⁻3 molar ratios (α) and Fe(2+)/OH- molar ratios (ß) in order to clarify the effects of the initial molar ratio of reactants on the reaction mechanism. The Fe(2+)/NO⁻3 /OH(-) molar ratio of 3 : 1 : 5 led to the formation of magnetic nanoparticles mainly composed of magnetite (Fe3O4) and maghemite (γ-Fe2O3). The 36 nm sized γ-Fe2O3 and 413 nm sized Fe3O4 were obtained by changing the order in which NaNO3 was added to a NaOH solution. The in vitro heat generations of the resulting MIONPs in an agar phantom were measured under an alternating magnetic field (100 kHz, 23.9 kA/m). The temperature rise (ΔT) of the agar phantom for the 36 nm sized γ-Fe2O3 was 55°C in the first 140 s, with a concentration of 58 mg Fe/mL. Our results showed that it is possible to prepare MIONPs with high heating efficiencies under optimal conditions using the present method.

Radical external beam radiotherapy for clinically localized prostate cancer in Japan: changing trends in the patterns of care process survey.

PURPOSE: To delineate changing trends in radical external beam radiotherapy (EBRT) for prostate cancer in Japan. METHODS AND MATERIALS: Data from 841 patients with clinically localized prostate cancer treated with EBRT in the Japanese Patterns of Care Study (PCS) from 1996 to 2005 were analyzed. RESULTS: Significant increases in the proportions of patients with stage T1 to T2 disease and decrease in prostate-specific antigen values were observed. Also, there were significant increases in the percentages of patients treated with radiotherapy by their own choice. Median radiation doses were 65.0 Gy and 68.4 Gy from 1996 to 1998 and from 1999 to 2001, respectively, increasing to 70 Gy from 2003 to 2005. Moreover, conformal therapy was more frequently used from 2003 to 2005 (84.9%) than from 1996 to 1998 (49.1%) and from 1999 to 2001 (50.2%). On the other hand, the percentage of patients receiving hormone therapy from 2003 to 2005 (81.1%) was almost the same as that from 1996 to 1998 (86.3%) and from 1999 to 2001 (89.7%). Compared with the PCS in the United States, patient characteristics and patterns of treatments from 2003 to 2005 have become more similar to those in the United States than those from 1996 to 1998 and those from 1999 to 2001. CONCLUSIONS: This study indicates a trend toward increasing numbers of patients with early-stage disease and increasing proportions of patients treated with higher radiation doses with advanced equipment among Japanese prostate cancer patients treated with EBRT during 1996 to 2005 survey periods. Patterns of care for prostate cancer in Japan are becoming more similar to those in the United States.

Magnetic SiO2 gel microspheres for arterial embolization hyperthermia.

We have prepared magnetic SiO(2) microspheres with a diameter of 20-30 µm as thermoseeds for hyperthermia of cancer. These were prepared by directly introducing preformed magnetic iron oxide nanoparticles (IONPs) into microspheres of a SiO(2) gel matrix derived from the hydrolysis of tetramethoxysilane (TMOS) in a water-in-oil (W/O) emulsion. Dimethylformamide (DMF) was used as a stabilizer, methanol (CH(3)OH) as a dispersant and ammonia (NH(4)OH) as the catalyst for the formation of the spherical particles in the aqueous phase of the W/O emulsion. The magnetic IONPs were synthesized hydrochemically in an aqueous system composed of ferrous chloride, sodium nitrate and sodium hydroxide. Mono-dispersed magnetic SiO(2) gel microspheres with a diameter of approximately 20 µm were successfully obtained by adding a determined amount of solution with a molar ratio of TMOS/DMF/CH(3)OH/H(2)O/NH(4)OH = 1:1.4:9:20:0.03 to kerosene with a surfactant (sorbitan monooleate/sorbitan monostearate = 3:1 by weight ratio) that was 30 wt% of the total amount of the oil phase. These were estimated to contain up to 60 wt% of IONPs that consisted mainly of Fe(3)O(4) and showed a higher specific absorption rate (SAR = 27.9-43.8 W g(-1)) than that of the starting IONPs (SAR = 25.3 W g(-1)) under an alternating current magnetic field of 300 Oe and 100 kHz.

Long-term outcomes of three-dimensional conformal radiation therapy combined with neoadjuvant hormonal therapy in Japanese patients with locally advanced prostate cancer.

BACKGROUND: The outcomes of three-dimensional conformal radiation therapy (3D-CRT) combined with neoadjuvant hormonal therapy (NAHT) in Japanese patients with locally advanced prostate cancer who initiated salvage hormonal therapy (SHT) at a relatively early phase were evaluated. METHODS: Between April 1998 and April 2003, 70 Japanese patients with T3N0M0 prostate cancer who received radical 3D-CRT treatment were evaluated. The median age, initial prostate-specific antigen (PSA) level, and duration of NAHT were 73 years old, 26.3 ng/ml, and 4 months, respectively. Seventy grays were given in 35 fractions that were confined to the prostate and seminal vesicles. Adjuvant hormonal therapy was not administered after 3D-CRT in any of the cases. RESULTS: The median follow-up period was 64.9 months. The median PSA value at the time of initiation of SHT was 5.0 ng/ml (range 0.1-21.6 ng/ml). Overall, disease-specific, PSA failure-free (based on the Phoenix definition) and SHT-free survival rates at 5 years were 90.3% (95% CI 86.5-94.0), 96.5% (94.0-98.9), 60.5% (48.2-72.7), and 63.5% (57.2-69.8), respectively. Therefore, two-thirds of the patients were still hormone-free at 5 years. CONCLUSIONS: PSA control rates in our series of Japanese patients with stage T3N0M0 prostate cancer treated with the standard dose of 3D-CRT combined with NAHT seemed higher than expected. This approach involving 3D-CRT combined with NAHT with the initiation of SHT at PSA values of around 5 ng/ml may be one option for Japanese patients with locally advanced prostate cancer, although further prospective study is required to confirm the validity.

Japanese structure survey of radiation oncology in 2007 based on institutional stratification of patterns of care study.

PURPOSE: To evaluate the ongoing structure of radiation oncology in Japan in terms of equipment, personnel, patient load, and geographic distribution to identify and improve any deficiencies. METHODS AND MATERIALS: A questionnaire-based national structure survey was conducted from March to December 2008 by the Japanese Society of Therapeutic Radiology and Oncology (JASTRO). These data were analyzed in terms of the institutional stratification of the Patterns of Care Study. RESULTS: The total numbers of new cancer patients and total cancer patients (new and repeat) treated with radiation in 2007 were estimated at 181,000 and 218,000, respectively. There were 807 linear accelerator, 15 telecobalt, 46 Gamma Knife, 45 (60)Co remote-controlled after-loading, and 123 (192)Ir remote-controlled after-loading systems in actual use. The linear accelerator systems used dual-energy function in 539 units (66.8%), three-dimensional conformal radiation therapy in 555 (68.8%), and intensity-modulated radiation therapy in 235 (29.1%). There were 477 JASTRO-certified radiation oncologists, 826.3 full-time equivalent (FTE) radiation oncologists, 68.4 FTE medical physicists, and 1,634 FTE radiation therapists. The number of interstitial radiotherapy (RT) administrations for prostate, stereotactic body radiotherapy, and intensity-modulated radiation therapy increased significantly. Patterns of Care Study stratification can clearly identify the maturity of structures based on their academic nature and caseload. Geographically, the more JASTRO-certified physicians there were in a given area, the more RT tended to be used for cancer patients. CONCLUSIONS: The Japanese structure has clearly improved during the past 17 years in terms of equipment and its use, although a shortage of personnel and variations in maturity disclosed by Patterns of Care Study stratification were still problematic in 2007.

Postoperative radiotherapy for localized prostate cancer: clinical significance of nadir prostate-specific antigen value within 12 months.

AIM: To analyze retrospectively the results of postoperative radiotherapy for localized prostate cancer and to investigate the clinical significance of nadir prostate-specific antigen (PSA) value within 12 months (nPSA12) as an early estimate of clinical outcome after radiotherapy. PATIENTS AND METHODS: Seventy-six patients with localized prostate cancer treated with postoperative radiotherapy were retrospectively reviewed. Total radiation doses ranged from 50 to 70 Gy (median: 60 Gy), and the median follow-up period for all 76 patients was 47.9 months (range, 12.4-101.3 months). RESULTS: The 5-year actuarial overall survival, progression-free survival, biochemical relapse-free survival (BRFS) and local control rates in all 76 patients after radiotherapy were 86.1%, 77.8%, 80.0% and 92.2%, respectively. Distant metastases and/or regional lymph node metastases developed in 11 patients (14%) after radiotherapy, while local progression was observed in only 5 patients (7%). Of all 76 patients, the median nPSA12 in patients with biochemical failure and that in patients without biochemical failure were 1.16 ng/ml and 0.05 ng/ml, respectively. The 5-year BRFS rates in patients with low nPSA12 (<0.5 ng/ml) and those with high nPSA12 (> or =0.5 ng/ml) were 92.7% and 42.2%, respectively (p<0.0001). In univariate analysis, nPSA12, pre-radiotherapy PSA, Karnofsky performance status and the use of chemotherapy had a significant impact on BRFS, and in multivariate analysis, nPSA12 alone was an independent prognostic factor for BRFS. CONCLUSION: Postoperative radiotherapy results in an excellent local control rate for localized prostate cancer and nPSA12 is predictive of biochemical failure after postoperative radiotherapy.

Patterns of radiation treatment planning for localized prostate cancer in Japan: 2003-05 patterns of care study report.

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.

Radiation therapy for esophageal cancer in Japan: results of the Patterns of Care Study 1999-2001.

PURPOSE: To describe patient characteristics and the process of radiotherapy (RT) for patients with esophageal cancer treated between 1999 and 2001 in Japan. METHODS AND MATERIALS: The Japanese Patterns of Care Study (PCS) Working Group conducted a third nationwide survey of 76 institutions. Detailed information was accumulated on 621 patients with thoracic esophageal cancer who received RT. RESULTS: The median age of patients was 68 years. Eighty-eight percent were male, and 12% were female. Ninety-nine percent had squamous cell carcinoma histology. Fifty-five percent had the main lesion in the middle thoracic esophagus. Fourteen percent had clinical Stage 0-I disease, 32% had Stage IIA-IIB, 43% had Stage III, and 10% had Stage IV disease. Chemotherapy was given to 63% of patients; 39% received definitive chemoradiotherapy (CRT) without surgery and 24% pre- or postoperative CRT. Sixty-two percent of the patients aged > or =75 years were treated with RT only. Median total dose of external RT was 60 Gy for definitive CRT patients, 60 Gy for RT alone, and 40 Gy for preoperative CRT. CONCLUSIONS: This PCS describes general aspects of RT for esophageal cancer in Japan. Squamous cell carcinoma accounted for the majority of patients. The standard total external RT dose for esophageal cancer was higher in Japan than in the United States. Chemoradiotherapy had become common for esophageal cancer treatment, but patients aged > or =75 years were more likely to be treated by RT only.

Radiotherapy for patients with localized hormone-refractory prostate cancer: results of the Patterns of Care Study in Japan.

OBJECTIVE: To evaluate the clinical results of radiotherapy (RT) for patients with regionally localized hormone-refractory prostate carcinoma (HRPC). PATIENTS AND METHODS: As part of a Patterns of Care Study in Japan, a nationwide survey was conducted of RT for patients with prostate adenocarcinoma. We reviewed the detailed information of 140 patients with regionally localized HRPC who received RT between 1996 and 1998, and between 1999 and 2001, in 117 randomly selected institutes in Japan. The median (range) age of the patients was 74 (51-94) years, and their tumours were defined as well (14), moderately (51) or poorly (54) differentiated, or of unknown differentiation (21). The median (range) interval between hormonal therapy (HT) and RT was 32.5 (1.1-168.4) months. Ninety-five patients had T3-4 tumours and 28 had regional lymph node metastases before treatment. The median (range) prostate-specific antigen levels before the initial HT and before RT were 35.0 (1.5-276) and 10.0 (0.06-760.3) ng/mL, respectively. External beam RT was administered, with a median total dose of 66 Gy; 70 patients (50%) received pelvic irradiation. RESULTS: At a median follow-up of 20.7 months, the 5-year overall and clinical progression-free survival rates (95% confidence interval) were 48.1 (36-60)% and 36.7 (26-47)%, respectively. Although there were distant metastases in 46 patients, only six had local progression. There was late morbidity of grade > or =3 in six patients. CONCLUSION: To the best of our knowledge, this study comprises the largest series of regionally localized HRPC treated with RT reported to date. RT might have a limited role for HRPC, because in most patients RT failed, with distant metastasis.

Impact of radiation therapy on breast-conserving therapy for breast cancer in Japanese women: a retrospective analyses of multi-institutional experience. Kansai Breast Cancer Radiation Therapy Study Group.

Whole breast radiation therapy (RT) after breast-conserving surgery is sometimes omitted in Japan; however, its impact on the outcome has not been properly evaluated. A multi-institutional retrospective study was conducted to clarify the impact of RT on local control after breast-conserving therapy (BCT). Data were collected from 3576 patients from 37 participating hospitals, of whom 1763 were eligible for analyses. Five hundred and five patients had ipsilateral breast tumor recurrence (IBTR) and 1258 patients did not. Details of IBTR were available for 245 of 505 patients who had IBTR, the location of IBTR was within or adjacent to the original tumor bed in 168 patients (68.6%). IBTR was salvaged with partial mastectomy in 119 patients (48.6%). Second recurrence in the ipsilateral breast was observed in 27 patients (11.0%). Univariate analyses demonstrated that administration of RT, the resection margin status, hormone responsiveness, T stage, N stage and stage were significantly related to IBTR. Multivariate analysis demonstrated that administration of RT, T stage and N stage were significantly correlated to IBTR. Among them, administration of RT had the largest impact on RT and it decreased the risk of IBTR by 77.3%. Omission of RT had the most significant impact on IBTR. RT should be given as a standard component of BCT.

External beam radiotherapy for clinically localized hormone-refractory prostate cancer: clinical significance of Nadir prostate-specific antigen value within 12 months.

PURPOSE: To analyze retrospectively the results of external beam radiotherapy for clinically localized hormone-refractory prostate cancer and investigate the clinical significance of nadir prostate-specific antigen (PSA) value within 12 months (nPSA12) as an early estimate of clinical outcomes after radiotherapy. METHODS AND MATERIALS: Eighty-four patients with localized hormone-refractory prostate cancer treated with external beam radiotherapy were retrospectively reviewed. The total radiation doses ranged from 30 to 76 Gy (median, 66 Gy), and the median follow-up period for all 84 patients was 26.9 months (range, 2.7-77.3 months). RESULTS: The 3-year actuarial overall survival, progression-free survival (PFS), and local control rates in all 84 patients after radiotherapy were 67%, 61%, and 93%, respectively. Although distant metastases and/or regional lymph node metastases developed in 34 patients (40%) after radiotherapy, local progression was observed in only 5 patients (6%). Of all 84 patients, the median nPSA12 in patients with clinical failure and in patients without clinical failure was 3.1 ng/mL and 0.5 ng/mL, respectively. When dividing patients according to low (<0.5 ng/mL) and high (>or=0.5 ng/mL) nPSA12 levels, the 3-year PFS rate in patients with low nPSA12 and in those with high nPSA12 was 96% and 44%, respectively (p < 0.0001). In univariate analysis, nPSA12 and pretreatment PSA value had a significant impact on PFS, and in multivariate analysis nPSA12 alone was an independent prognostic factor for PFS after radiotherapy. CONCLUSIONS: External beam radiotherapy had an excellent local control rate for clinically localized hormone-refractory prostate cancer, and nPSA12 was predictive of clinical outcomes after radiotherapy.

A randomized phase II study of cisplatin/5-FU concurrent chemoradiotherapy for esophageal cancer: Short-term infusion versus protracted infusion chemotherapy (KROSG0101/JROSG021).

PURPOSE: A randomized phase II study was conducted to compare the toxicity and efficacy of combining short-term chemotherapy (CT) or protracted CT with radiotherapy (RT) for esophageal cancer. MATERIALS AND METHODS: Eligible patients were <75 years and with performance status (PS) of 0-2, and had stages II-IVA esophageal cancer. Two cycles of cisplatin 70 mg/m(2) for 1 day and 5FU 700 mg/m(2) for 5 days (arm A) or cisplatin 7 mg/m(2) for 10 days and 5FU 250 mg/m(2) for 14 days (arm B) were given with RT of 60Gy/30 fractions/7 weeks (1-week split). RESULTS: Of 91 patients enrolled, 46 were randomized to arm A and 45 to arm B. Two cycles of CT were given concurrently with RT for 89% in arm A and for 71% in arm B with significant difference (P=.031). The 2- and 5-year overall survival rates for arm A were 46% and 35%, while those for arm B were 44% and 24%, respectively, without significant difference. The 2- and 5-year progression-free survival rates for arm A were 30% and 30%, while those for arm B were 29% and 12%, respectively. CONCLUSIONS: Protracted infusion CT with RT provides no advantage over standard short-term infusion CT with RT for esophageal cancer.