Acute adverse events of ultra-hypofractionated whole-breast irradiation after breast-conserving surgery for early breast cancer in Japan: an interim analysis of the multi-institutional phase II UPBEAT study.

BACKGROUND: The applicability of ultra-hypofractionated (ultra-HF) whole-breast irradiation (WBI) remains unknown in Japanese women. This study aimed to evaluate the safety and efficacy of this approach among Japanese women and report the results of an interim analysis performed to assess acute adverse events (AEs) and determine whether it was safe to continue this study. METHODS: We enrolled Japanese women with invasive breast cancer or ductal carcinoma in situ who had undergone breast-conserving surgery, were aged ≥ 40 years, had pathological stages of Tis-T3 N0-N1, and had negative surgical margins. Ultra-HF-WBI was delivered at 26 Gy in five fractions over one week. When the number of enrolled patients reached 28, patient registration was paused for three months. The endpoint of the interim analysis was the proportion of acute AEs of grade ≥ 2 (Common Terminology Criteria for Adverse Events v5.0) within three months. RESULTS: Of the 28 patients enrolled from seven institutes, 26 received ultra-HF-WBI, and 2 were excluded due to postoperative infections. No AEs of grade ≥ 3 occurred. One patient (4%) experienced grade 2 radiation dermatitis, and 18 (69%) had grade 1 radiation dermatitis. The other acute grade 1 AEs experienced were skin hyperpigmentation (n = 10, 38%); breast pain (n = 4, 15%); superficial soft tissue fibrosis (n = 3, 12%); and fatigue (n = 1, 4%). No other acute AEs of grade ≥ 2 were detected. CONCLUSIONS: Acute AEs following ultra-HF-WBI were within acceptable limits among Japanese women, indicating that the continuation of the study was appropriate.

Long-term outcomes of an esophagus-preserving chemoradiotherapy strategy for patients with endoscopically unresectable stage I thoracic esophageal squamous cell carcinoma.

BACKGROUND AND PURPOSE: To assess the long-term outcomes of a multimodal approach for maximum esophagus preservation in operable patients with endoscopically unresectable stage I thoracic esophageal squamous cell carcinoma (ESCC). MATERIALS AND METHODS: The medical records of patients with stage I thoracic ESCC treated with our protocol between 1992 and 2005 were retrospectively reviewed. Our protocol consisted of neoadjuvant concurrent chemoradiotherapy, followed by either additional definitive chemoradiotherapy for good responders (CRT group) or surgery for moderate or poor responders (CRT-S group) after an interim appraisal. RESULTS: A total of 51 patients were analysed. The median age of the patients was 67 years. The median follow-up period was 124.8 months. After the interim assessment, 49 and 2 cases were assigned to the CRT and CRT-S groups, respectively. In the intent-to-treat analyses, overall survival (OS), disease-free survival (DFS), cumulative incidence for death from esophageal cancer, and that for loss of esophageal function were 78.9%, 53.5%, 10.5%, and 20.4% at 5 years, and 55.2%, 27.8%, 18.2%, and 22.9% at 10 years, respectively. Grade 3 late toxicities occurred with the following incidences: esophageal stenosis in 1 case, esophageal ulcer in 1 case, and pericardial effusion in 2 cases. No grade 4 or higher toxicities were observed. CONCLUSION: Long-term survival and esophagus preservation outcomes were favorable, with acceptable toxicities. Our results suggest that CCRT is an alternative treatment for majority of operable patients with endoscopically unresectable stage I thoracic ESCC in combination with salvage therapy.

Application and limitation of radiomics approach to prognostic prediction for lung stereotactic body radiotherapy using breath-hold CT images with random survival forest: A multi-institutional study.

PURPOSE: To predict local recurrence (LR) and distant metastasis (DM) in early stage non-small cell lung cancer (NSCLC) patients after stereotactic body radiotherapy (SBRT) in multiple institutions using breath-hold computed tomography (CT)-based radiomic features with random survival forest. METHODS: A total of 573 primary early stage NSCLC patients who underwent SBRT between January 2006 and March 2016 and met the eligibility criteria were included in this study. Patients were divided into two datasets: training (464 patients in 10 institutions) and test (109 patients in one institution) datasets. A total of 944 radiomic features were extracted from manually segmented gross tumor volumes (GTVs). Feature selection was performed by analyzing inter-segmentation reproducibility, GTV correlation, and inter-feature redundancy. Nine clinical factors, including histology and GTV size, were also used. Three prognostic models (clinical, radiomic, and combined) for LR and DM were constructed using random survival forest (RSF) to deal with total death as a competing risk in the training dataset. Robust models with optimal hyper-parameters were determined using fivefold cross-validation. The patients were dichotomized into two groups based on the median value of the patient-specific risk scores (high- and low-risk score groups). Gray's test was used to evaluate the statistical significance between the two risk score groups. The prognostic power was evaluated by the concordance index with the 95% confidence intervals (CI) via bootstrapping (2000 iterations). RESULTS: The concordance indices at 3 yr of clinical, radiomic, and combined models for LR were 0.57 [CI: 0.39-0.75], 0.55 [CI: 0.38-0.73], and 0.61 [CI: 0.43-0.78], respectively, whereas those for DM were 0.59 [CI: 0.54-0.79], 0.67 [CI: 0.54-0.79], and 0.68 [CI: 0.55-0.81], respectively, in the test dataset. The combined DM model significantly discriminated its cumulative incidence between high- and low-risk score groups (P < 0.05). The variable importance of RSF in the combined model for DM indicated that two radiomic features were more important than other clinical factors. The feature maps generated on the basis of the most important radiomic feature had visual difference between high- and low-risk score groups. CONCLUSIONS: The radiomics approach with RSF for competing risks using breath-hold CT-based radiomic features might predict DM in early stage NSCLC patients who underwent SBRT although that may not have potential to predict LR.

Risk factors for severe gastrointestinal toxicity in patients receiving palliative radiotherapy for metastatic bone tumors: association with the use of molecular-targeted agents.

This study aimed to investigate whether the use of molecular-targeted agents could affect gastrointestinal (GI) toxicity in palliative radiotherapy (RT) for metastatic bone tumors in the abdominopelvic region. We collected data of patients who received palliative RT for bone metastases in the abdominopelvic region between 2013 and 2014 from six institutions. Data of 395 patients were collected and184 patients received molecularly targeted therapy, of whom 80 received vascular endothelial growth factor (VEGF)-targeted agents. For 556 lesions, 410 sessions of irradiation were undergone. GI toxicity of ≥G3 was observed in 3.8% of patients. The incidence rates of ≥G3 GI toxicity in patients without targeted agents use, in those using VEGF-targeted agents and in those using non-VEGF-targeted agents were 3.8, 7.5 and 1.0%, respectively. Regarding risk factors of the occurrence of ≥G3 GI toxicity, univariate analysis in all patients showed that a history of abdominopelvic surgery was a significant risk factor (P = 0.01), and the use of VEGF-targeted agents showed a trend of high incidence (P = 0.06). In patients using VEGF-targeted agents, both univariate and multivariate analysis showed that combined anticoagulant use (P = 0.03 and 0.01) and agent use between 1 week before and after RT (P = 0.046 and 0.03) were significant risk factors. In conclusion, the history of abdominopelvic surgery was associated with ≥G3 GI toxicity and the use of VEGF-targeted agents showed a trend for high incidence. When using VEGF-targeted agents, caution should be exercised in the combined use of anticoagulants and in the agent use between 1 week before and after RT.

The Use of External-beam Radiotherapy for Muscle-invasive Bladder Cancer in Elderly or Medically-fragile Patients.

AIM: To evaluate the clinical results of external-beam radiotherapy (EBRT) for muscle-invasive bladder cancer (MIBC) in elderly or medically-fragile patients. PATIENTS AND METHODS: Twenty-five consecutive patients with MIBC (cT2-4N0-1M0) receiving EBRT were retrospectively analyzed. Their median age was 82 years. Radiotherapy median dose was 60 Gy administered in 30 fractions. RESULTS: Median follow-up period was 14.7 months. Median overall survival (OS) and progression-free survival (PFS) were 14.7 months and 7.8 months, respectively. The OS, cause-specific survival (CSS), and PFS rates at 1-year were 56.0%, 68.5%, and 40.0%, respectively. The local progression-free rates (LPFR) at 6 months and 1 year were 89.3% and 59.5%, respectively. Performance status 3 was a significantly unfavorable factor for OS, CSS, and progression-free survival; clinical N stage was a significantly unfavorable factor for progression-free survival; and lower irradiation dose (≤50.4 Gy) was a significantly unfavorable factor for LPFR. CONCLUSION: EBRT for elderly or medically-fragile patients is feasible, and achieves acceptable local progression-free status.

Clinical outcomes of radiotherapy for esophageal cancer between 2004 and 2008: the second survey of the Japanese Radiation Oncology Study Group (JROSG).

BACKGROUND: This second questionnaire-based survey was performed to determine the clinical results of definitive esophageal cancer treatment with radiotherapy (RT) or chemoradiotherapy (CRT) between 2004 and 2008. MATERIALS/METHODS: Clinical results of definitive RT for patients were collected from major Japanese institutions. Patients were classified into three groups: (A) stage I, (B) resectable stages II-III, (C) unresectable stages III-IVA. For group A, all patients treated with RT alone or CRT were included. For groups B and C, only those treated with CRT were included. RESULTS: In total, 990 patients (group A 259, group B 333, group C 398 patients) were included from 11 institutions. In group A, 199 patients (78 %) were treated with CRT, and 60 patients (23 %) received RT alone. In groups B and C, 420 patients (57 %) were treated with full-dose cisplatin/5-FU, and 181 patients (25 %) with low-dose protracted-infusion cisplatin/5-FU. The median and range of the 5-year overall survival rate were 73 % (40-94 %) for group A, 40 % (0-57 %) for group B, and 18 % (6-26 %) for group C, respectively. The 5-year overall survival rates were consistently good for five high-volume centers where more than 20 patients/year with esophageal cancer were treated definitively as compared with the remaining six medium-volume centers (5-15 patients/year). The median and range of the incidence of grade ≥3 late toxicities were 10 % and 6-22 %, respectively. CONCLUSIONS: A wide disparity in 5-year overall survival rates among the institutions was still apparent in the second survey for groups A and B.

Comparison of the outcomes of stereotactic body radiotherapy and surgery in elderly patients with cT1-2N0M0 non-small cell lung cancer.

BACKGROUND: This study aimed to compare the outcomes of stereotactic body radiotherapy (SBRT) and surgery in elderly patients with cT1-2N0M0 non-small cell lung cancer (NSCLC). METHODS: Elderly patients (≥75 years) with cT1-2 (≤5 cm) N0M0 NSCLC who were treated with SBRT (n=35) or surgery (n=183) between January 2001 and December 2011 were analyzed. RESULTS: The following radiation doses were administered: 48 Gy/4-6 fractions in 12 patients; 50 Gy/4-5 fractions in 20; and 60 Gy/8 fractions in 3. The following surgical methods were performed: pneumonectomy in 2 patients, lobectomy in 154, segmentectomy in 23, and wedge resection in 4. Patients in the SBRT group had a higher mean age, a worse performance status, and a lower percentage of forced expiratory volume in 1.0 s than those in the surgery group. The overall 5-year survival rates were 43.8% and 67.6% for the SBRT and surgery groups, respectively (p=0.057, log-rank test). Regarding tumor diameter, patients in the surgery group survived significantly longer than did those in the SBRT group (>20-mm tumors, p=0.027; >30-mm tumors p=0.043), whereas survival did not differ significantly between the groups for ≤20-mm tumors (p=0.982). Multivariate analysis confirmed the improved survival in the surgery group compared to the SBRT group for all tumors (p=0.034) and for >20-mm tumors (p=0.016). CONCLUSIONS: Post-therapeutic survival among elderly patients might be better with surgery than with SBRT in NSCLC patients with tumors >20 mm.

Efficacy of intraoperative radiotherapy targeted to the abdominal lymph node area in patients with esophageal carcinoma.

We investigated whether intraoperative radiotherapy (IORT) during curative surgery for esophageal carcinoma is useful or not. The cases of 117 patients diagnosed with thoracoabdominal esophageal carcinoma who underwent curative surgery between 1986 and 2007 were reviewed: 72 patients received IORT (IORT group) and 45 did not (non-IORT group). Upper abdominal lymphadenectomy was performed in 115 patients (98.5%). Seventy patients (59.8%) received chemotherapy and 80 patients (68.4%) received external radiotherapy. IORT encompassed the upper abdominal lymph node area. A single-fraction dose of 20-30 Gy was delivered using high-energy electrons. Median follow-up duration for patients was 7.4 years. The 5-year overall survival rate did not significantly differ between the IORT and non-IORT groups. However, the 5-year abdominal control rate was significantly higher in the IORT group (89.2%) than in the non-IORT group (72.9%; P = 0.022). We next focused on a patient subgroup with a primary lesion in the lower thoracic or abdominal esophagus or measuring >6 cm in length since this subgroup is probably at high risk of upper abdominal lymph node metastasis. Of the 117 patients, 75 belonged to this subgroup, and among them 45 received IORT. Both univariate and multivariate analysis revealed the survival rate was significantly higher in patients who received IORT than in those who did not (P = 0.033 univariate; 0.026 multivariate). There were no obvious perioperative complications solely attributed to IORT. IORT for esophageal carcinoma will likely be effective for patients with a primary lesion in the lower thoracic or abdominal esophagus, or with a long lesion.

Long-term follow-up of a randomized Phase II study of cisplatin/5-FU concurrent chemoradiotherapy for esophageal cancer (KROSG0101/JROSG021).

OBJECTIVE: Long-term survival and late toxicities of a randomized Phase II study of chemoradiotherapy for esophageal cancer were analyzed. METHODS: Eligible patients were <75 years old and performance status 0-2, and had Stages II-IVA esophageal cancer. For arm A (short-term infusion), cisplatin 70 mg/m(2) Days 1 and 29 and 5-fluorouracil 700 mg/m(2) Days 1-5 and 29-33 were given concurrently with radiotherapy of 60 Gy/30 fr/7 weeks (1 week split). For arm B (protracted infusion), cisplatin 7 mg/m(2) Days 1-5, 8-12, 29-33 and 36-40, and 5-fluorouracil 250 mg/m(2) Days 1-14 and 29-42 were given with the same radiotherapy. Two cycles of consolidation cisplatin/5-fluorouracil chemotherapy were given to both arms. RESULTS: Between 2001 and 2006, 91 patients were enrolled; 46 were randomized to arm A, and 45 to arm B. The 2- and 5-year overall survival rates for arm A were 46 and 35% (95% confidence interval: 22-48%), while those for arm B were 44 and 22% (11-35%), respectively. Excluding four patients with early death, seven (17%) patients in arm A and eight (18%) in arm B showed late toxicities of Grade 3 or more. Most of the toxicities were cardiac or pleural toxicities. Patients with severe late toxicities often had coexistent hypothyroidism. There were three patients with a secondary malignancy possibly related to treatment. CONCLUSIONS: Low-dose protracted infusion chemotherapy with radiotherapy is not superior to full-dose short-term infusion chemotherapy with radiotherapy for esophageal cancer. Late toxicities, including cardiac and pleural toxicities, hypothyroidism and secondary malignancy, should be carefully monitored.

Clinical practice and outcome of radiotherapy for esophageal cancer between 1999 and 2003: the Japanese Radiation Oncology Study Group (JROSG) Survey.

BACKGROUND: To determine the clinical results of radiotherapy (RT) for esophageal cancer in Japan. MATERIALS AND METHODS: A questionnaire-based survey was conducted for esophageal cancer treated by definitive RT between 1999 and 2003. Clinical results of definitive RT for patients were collected from 9 major institutions. Only patients with good performance status (PS 0-2) who received a total dose of 50 Gy or more were included. Patients were classified into three groups: (A) stage I, (B) resectable stages II-III, (C) unresectable stages III-IVA. For group A, all patients treated by RT alone or chemo-radiotherapy (CRT) were included. For groups B and C, only those treated by CRT were included. RESULTS: In total, 167 patients were included in group A, 239 in group B, and 244 in group C. Approximately half of the patients in group A were treated by CRT. The median total RT dose ranged from 60 to 66 Gy. The median and range of the 5-year overall survival rates were 56% (48-83%) for group A, 29% (12-52%) for group B, and 19% (0-31%) for group C, respectively. A wide disparity in overall survival rates was noted among the institutions. A significant correlation between the number of patients treated per year and the 5-year overall survival rate was noted for groups B and C (both p < 0.05). CONCLUSION: Although the overall survival rates for stage I esophageal cancer were excellent, a significant disparity in survival rates was noted among the institutions for stage II-IVA tumors treated by CRT.

Impact of double-balloon rectal catheter use in external-beam radiotherapy for prostate cancer.

BACKGROUNDS: Prostate motion and rectal sparing are important treatment strategy issues in external-beam radiotherapy for localized prostate cancer. To address these issues, we prospectively investigated the feasibility of using a double-balloon rectal catheter. METHODS: The rectal catheter has inner and outer balloons that wedge the anus between them. Computed tomography (CT) examinations with and without the catheter were conducted in seven patients with localized prostate cancer treated by external-beam radiotherapy. The rectal wall sparing effect was evaluated using virtual three-dimensional conformal radiotherapy plans in each arm. To evaluate interfractional prostate motion, each patient underwent a series of four CT examinations consisting of a planning CT followed by three additional series of CT with and without a catheter during the course of radiotherapy. RESULTS: Virtual plans demonstrated the reduction of the dose to the rectum by expanding the posterior wall to lie outside the high- to intermediate-dose area when a catheter was applied. Interfractional prostate motion in the anteroposterior direction was effectively reduced by catheter usage; the mean ± standard deviation (SD) of the displacement was 1.3 ± 0.9 mm with a catheter as compared to 2.8 ± 1.8 mm without a catheter (P = 0.014), and the maximum displacement was successfully suppressed to 3 mm with a catheter compared to 6 mm without a catheter. Systematic and random components were also reduced with the catheter. CONCLUSION: These results suggest the feasibility and clinical applicability of the double-balloon rectal catheter.

Intraoperative radiotherapy for resected pancreatic cancer: a multi-institutional retrospective analysis of 210 patients.

PURPOSE: To retrospectively analyze the results of intraoperative radiotherapy (IORT) with or without external beam radiotherapy (EBRT) for resected pancreatic cancer. METHODS AND MATERIALS: The records of 210 patients treated with gross complete resection (R0: 147 patients; R1: 63 patients) and IORT with or without EBRT were reviewed. One hundred forty-seven patients (70.0%) were treated without EBRT and 114 patients (54.3%) were treated in conjunction with chemotherapy. The median doses of IORT and EBRT were 25 Gy (range, 20-30 Gy) and 45 Gy (range, 20-60Gy), respectively. The median follow-up of the surviving 62 patients was 26.3 months (range, 2.7-90.5 months). RESULTS: At the time of this analysis, 150 of 210 patients (71.4%) had disease recurrences. Local failure was observed in 31 patients (14.8%), and the 2-year local control rate in all patients was 83.7%. The median survival time and the 2-year actuarial overall survival (OS) in all 210 patients were 19.1 months and 42.1%, respectively. Patients treated with IORT and chemotherapy had a significantly more favorable OS than those treated with IORT alone (p = 0.0011). On univariate analysis, chemotherapy use, degree of resection, carbohydrate antigen 19-9, and pathological N stage had a significant impact on OS and on multivariate analysis; these four factors were significant prognostic factors. Late gastrointestinal morbidity of NCI-CTC Grade 4 was observed in 7 patients (3.3%). CONCLUSION: IORT yields an excellent local control rate for resected pancreatic cancer with few frequencies of severe late toxicity, and IORT combined with chemotherapy confers a survival benefit compared with that of IORT alone.

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.

Patterns of care study of breast-conserving therapy in Japan: comparison of the treatment process between 1995 1997 and 1999 2001 surveys.

BACKGROUND: The Japan Patterns of Care Study (JPCS) conducted two national surveys to identify changes associated with the treatment process of care for patients undergoing breast-conserving therapy (BCT). Between the two national surveys, the Japanese Breast Cancer Society published its treatment guideline for BCT. METHOD: The first survey collected data on 865 patients treated between 1995 and 1997 (JPCS-1), and the second on 746 patients treated between1999 and 2001 (JPCS-2) by extramural audits. RESULTS: There was a shift to an older age distribution in JPCS-2 compared with JPCS-1. In JPCS-2, the average patient age was 53.9 compared with 51.5 in JPCS-1 (P < 0.001). There was a reduction in the extent of breast surgery and the proportion of the patients who received quadrantectomy was 57.0% in JPCS-1 and 30.3% in JPCS-2 (P < 0.001). In JPCS-2, a cast or shell for immobilization was used at a significantly higher rate of 52.9% compared with 32.6% for JPCS-1 (P < 0.001). The rate of boost irradiation was increased in JPCS-2, especially for patients with a positive surgical margin; it was significantly increased to 83.5% in JPCS-2 compared with 53.9% in JPCS-1 (P < 0.001). CONCLUSIONS: The second survey revealed a rapid change in the trend of the treatment of BCT in Japan and represented high compliance of the treatment guideline for BCT published by the Japanese Breast Cancer Society (JBCS) in 1999.

Results of radiation therapy combined with neoadjuvant hormonal therapy for stage III prostate cancer: comparison of two different definitions of PSA failure.

BACKGROUND: We herein report the clinical outcome of radical radiation therapy combined with neoadjuvant hormonal therapy (NHT) for stage III (International Union Against Cancer [UICC] 1997: UICC 97) prostate cancer. Prostate-specific antigen (PSA) failure-free survival was assessed according to two different definitions, and the appropriateness of each definition is discussed. METHODS: Between October 1997 and December 2000, 27 patients with stage III prostate cancer were enrolled in this study. The median pretreatment PSA level was 29 ng/ml (range, 7.4-430 ng/ml). The Gleason score (GS) was 7 or more in 22 patients (81%). All patients received 3 months of NHT with a luteinizing hormone-releasing hormone (LH-RH) analogue, in combination with an antiandrogen (flutamide), given during the first 2 weeks, followed by 70-Gy external-beam radiation therapy (EBRT) in 35 fractions. The initial 46 Gy was given with a four-field technique, while the remainder was given with a dynamic conformal technique. No adjuvant hormonal therapy (AHT) was given. RESULTS: The median follow-up time was 63 months. PSA levels decreased to the normal range (<4 ng/ml) after irradiation in all but one patient. The 5-year PSA failure-free survival was 34.8% according to the American Society for Therapeutic Radiology and Oncology (ASTRO) definition and it was 43.0% according to the "nadir plus 2" definition. Discordance of the results between the two definitions was seen in two patients. The 5-year overall and cause-specific survivals were 83.0% and 93.3%, respectively. No severe acute or late adverse effects were observed. CONCLUSION: Seventy Gy of EBRT following 3 months of NHT produced therapeutic results comparable to those reported in other studies which used long-term AHT. The value of long-term AHT for Japanese men should be tested in a clinical trial.

The patterns of care study for breast-conserving therapy in Japan: analysis of process survey from 1995 to 1997.

PURPOSE: To present the results of a process survey on breast-conserving therapy (BCT) in Japan from 1995 to 1997. METHODS AND MATERIALS: From September 1998 to December 1999, data on the treatment process of 865 randomly selected BCT patients were collected by extramural audits. RESULTS: For primary surgery, wide excision or tumorectomy was performed in 372 patients (43.0%), and quadrantectomy or segmental mastectomy was performed in 493 patients (57%). The extent of axillary dissection was equal or beyond Level II in 590 patients (68.2%). Systemic chemotherapy was administered to 103 of 160 node-positive patients (64.4%) and 180 of 569 node-negative patients (31.6%). Tamoxifen was administered to 234 of 323 hormone receptor-positive patients (72.5%) and 68 of 130 hormone receptor-negative patients (52.3%). Photon energy of 10 MV was administered for whole breast irradiation in 38 patients (4.4%) without bolus. CONCLUSIONS: The extent of surgical resection for BCT was large in Japan. Pathologic assessment and the technique of radiation therapy were apparently suboptimal in some cases. Information on prognostic/predictive factors was not fully utilized to individualize systemic adjuvant therapy. Establishment and widespread use of guidelines for BCT for in Japan are desirable. Repeated surveys will demonstrate how such guidelines affect clinical practices.

Treatment planning of stereotactic radiotherapy for solitary lung tumor.

PURPOSE: To analyze the stereotactic radiotherapy (SRT) plans in terms of internal target volume (ITV) and organs at risk (OARs). METHODS AND MATERIALS: Treatment planning and dose distributions were analyzed using dose-volume histograms (DVHs) of ITV and OARs in 37 patients, who were treated for a solitary lung tumor with SRT. The stereotactic body frame (SBF) was used for immobilization and accurate setup. Prescription dose was 48 Gy in four fractions at the isocenter. RESULTS: Use of SBF limits the extent of the noncoplanar beam directions to prevent a collision with the Linac gantry. DVH analyses showed that the homogeneity index, defined as the ratio of maximum and minimum dose to ITV, ranged from 1.03 to 1.25 (mean, 1.12). The volume irradiated with 20 Gy or more (V(20)) of the lung ranged from 0.3 to 11.6% (mean, 4.4%) of the whole lung volume. The maximum dose to the other OARs ranged from 0 to 11.8 Gy (mean, 0.5-2.7) per fraction. No clinically significant complications were encountered. CONCLUSIONS: Despite the limitation of the beam arrangement, a homogeneous target dose distribution, while avoiding high doses to normal tissues, was obtained.

Evaluation of lung injury after three-dimensional conformal stereotactic radiation therapy for solitary lung tumors: CT appearance.

PURPOSE: To evaluate the computed tomographic (CT) appearance of tumors and lung injury in patients who have undergone stereotactic radiation therapy (SRT) for solitary lung tumors. MATERIALS AND METHODS: Twenty-seven patients with primary lung cancer and four with metastatic lung cancer who underwent SRT for solitary lung tumors were enrolled for evaluation. SRT was delivered by using a three-dimensional conformal technique with a stereotactic body frame. A total dose of 48 Gy was administered in four fractions during a period of 2 weeks. After SRT, follow-up CT images were obtained every 2-3 months. Radiation-induced pulmonary injuries were classified into four patterns on CT images. The minimal lung dose to areas demonstrating pulmonary injury at CT was evaluated, and the correlation between the dose and the percentage volume of the whole lung irradiated by more than 20 Gy in total (V20) was assessed by using Spearman rank correlation. RESULTS: Tumor shrinkage continued for 2-15 months after SRT. Asymptomatic changes in the irradiated lung were noted at CT in all patients within 2-6 months (median, 4 months) after SRT. As the pattern at pulmonary CT changed, patchy consolidation was more predominantly seen as an acute change than were slight homogeneous increase in opacity, discrete consolidation, or solid consolidation; solid consolidation was the more predominantly seen late change. The minimal lung dose to the area demonstrating pulmonary injury in each patient ranged between 16 and 36 Gy (median, 24 Gy). The dose was significantly (P <.001) inversely correlated with the V20 in each patient. CONCLUSION: The reaction to SRT of the lungs seems similar to the reaction to conventional radiation therapy.

18F-FDG and 11C-methionine PET for evaluation of treatment response of lung cancer after stereotactic radiotherapy.

This study was performed to investigate the feasibility of FDG- and L-[methyl-11C]methionine (Met)-PET for the follow up of lung cancer after stereotactic radiotherapy (SRT). Nine patients (pt) with solitary lung cancer underwent SRT. Met- and FDG-PET studies were performed one week before SRT and from one week to 8 months after SRT. Responses to SRT were complete in 2 pt and partial in 7 pt. Met- and FDG-PET scan showed high tracer uptake in all tumors before SRT. After SRT, standardized uptake values (SUV) of FDG and Met changed concordantly. Both decreased with time in 5 pt but did not decrease steadily in 4 pt, where 2 pt showed an increase at 1 to 2 weeks after SRT and 2 pt showed an increase at more than 3 months after SRT. The former appears to reflect the acute reaction to SRT and the latter radiation-induced pneumonitis. Although the addition of Met-PET did not provide additional information over FDG-PET, FDG- and Met-PET could be used to evaluate the treatment effect of SRT.

Clinical evaluation of dynamic arc conformal radiotherapy for paraaortic lymph node metastasis.

PURPOSE: This study was performed to evaluate the efficacy and safety of dynamic arc conformal radiotherapy, a simple intensity modulated radiation therapy (IMRT), for the treatment of paraaortic lymph node metastases. MATERIALS AND METHODS: Twenty-nine patients with paraaortic lymph node metastases were enrolled in this study. The total planned dose was 55-60 Gy. A computed tomography (CT) simulator was used in the treatment planning. RESULTS: The total radiation dose delivered was 50-63.4 Gy (median 60 Gy). Sixteen of 29 patients showed local tumor shrinkage on CT, and the 2 year in-field recurrence free survival rate was 58%. Acute Grade 1 and Grade 2 gastrointestinal disorders occurred in 31% and 17%, respectively, and acute Grade 2 liver dysfunction occurred in 7%. As a late complication, Grade 1 and Grade 2 liver dysfunction occurred in six patients (21%) and five patients (17%), respectively. There was no renal dysfunction or myelopathy detected. CONCLUSION: Dynamic arc conformal radiotherapy, a simple IMRT, is a safe and effective treatment method for paraaortic lymph node metastasis.