Efficacy of herbal medicine TJ-14 for acute radiation-induced enteritis: a multi-institutional prospective Phase II trial.

The purpose of this multi-institutional Phase II trial study was to prospectively investigate the efficacy of the herbal medicine TJ-14 for acute radiation-induced enteritis (ARE). TJ-14 was administered orally as a first-line treatment for ARE. The primary end point was efficacy at 1 week. The secondary end points were: (i) the efficacy of TJ-14 at 2 and 3 weeks after its administration, (ii) the quality of life score (FACT-G) at 1, 2 and 3 weeks after its administration, and (iii) adverse events. If the efficacy of TJ-14 was observed in eight patients or fewer, its efficacy was rejected. Results: Forty patients receiving pelvic radiotherapy were enrolled. Of these, 22 developed ARE and received TJ-14. Among these, 19 had cervical cancer and 9 received chemoradiotherapy. TJ-14 efficacy was shown in 19 out of the 22 patients (86%). Stool frequency per day at 1 week significantly decreased (mean ± SD: 4.9 ± 2.1 vs 3.7 ± 1.9, P = 0.02). This effect continued at 2 (2.2 ± 1.4, P = 0.004) and 3 weeks (2.1 ± 0.9, P = 0.05). Thirteen out of the 22 patients (59%) continued TJ-14 until the end of radiotherapy. FACT-G score deterioration was not observed after the administration of TJ-14. Grade 1 hypokalemia was observed in 4 patients, and Grade 1 constipation in 3. We concluded that TJ-14 is sufficiently promising to be examined in a Phase III trial. A randomized controlled trial is currently being planned.

11C-methionine positron emission tomography for target delineation of recurrent glioblastoma in re-irradiation planning.

AIM: To define the optimal margin on MRI scans in the re-radiation planning of recurrent glioblastoma using methionine positron emission tomography (MET-PET). BACKGROUND: It would be very useful if the optimal margin on MRI to cover the uptake area on MET-PET is known. MATERIALS AND METHODS: CT, MRI, and MET-PET were performed separately over the course of 2 weeks. Among the MRI scans, we used the contrast-enhanced T1-weighted images (Gd-MRI) and T2-weighted images (T2-MRI). The Gd-MRI-based clinical target volume (CTV) (CTV-Gd) and the T2-MRI-based CTV (CTV-T2) were defined as the contrast-enhanced area on Gd-MRI and the high intensity area on T2-MRI, respectively. We defined CTV x mm (x = 5, 10, 15, 20) as x mm outside the CTV. MET-PET-based CTV (CTV-MPET) was defined as the area of accumulation of MET-PET. We calculated the sensitivity and specificity of CTV-Gd and CTV-T2 following comparison with CTV-MPET, which served as the gold standard in this study. RESULTS: The sensitivity of CTV-T2 5 mm (98%) was significantly higher than CTV-T2 (87%), and there was no significant difference in the sensitivity between CTV-T2 5 mm and CTV T2 10, 15, or 20 mm. The sensitivity of CTV-Gd 20 mm (97%) was lower than that of CTV-T2 5 mm (98%). CONCLUSIONS: A margin of at least 5 mm around the high intensity area on T2-MRI is necessary in the target volume delineation of recurrent glioblastoma for the coverage of MET-PET findings in re-radiation therapy planning.

Treatment outcomes and late toxicities of intensity-modulated radiation therapy for 1091 Japanese patients with localized prostate cancer.

AIM: This study aimed to evaluate the treatment result of intensity-modulated radiation therapy (IMRT) in a large number of Japanese patients with prostate cancer. BACKGROUND: A total of 1091 patients with localized prostate cancer were recruited between March 2006 and July 2014. The patients were stratified into low- (n = 205 [18.8%]), intermediate- (n = 450 [41.2%]), high- (n = 345 [31.6%]), and very high-risk (n = 91 [8.3%]) groups according to the National Comprehensive Cancer Network classification. All patients were irradiated via IMRT at a dose of 74-78 Gy with or without androgen-deprivation therapy. The mean follow-up period was 50 months (range, 2-120 months). RESULTS: The biochemical failure-free rate (BFFR), the clinical failure-free rate, and the overall survival rate at the 5-year follow-up for all patients was 91.3%, 96.2%, and 99.1%, respectively. In univariate analysis, the prostate-specific antigen (PSA) levels (≤20 vs. >20 ng/ml) were significantly correlated with BFFR. A trend toward higher BFFR was noted in patients with a Gleason score (GS) of ≤7 than in patients with GS ≥8. In multivariate analysis, only PSA (≤20 vs. >20 ng/ml) was significantly correlated with BFFR. The cumulative incidence rate of gastrointestinal and genitourinary toxicity (≥grade 2) at the 5-year follow-up was 11.4% and 4.3%, respectively. CONCLUSIONS: The findings of this study indicate that IMRT is well tolerated and is associated with both good long-term tumor control and excellent outcomes in patients with localized prostate cancer.

High Tangent Radiation Therapy With Field-in-Field Technique for Breast Cancer.

PURPOSE: We evaluated whether the field-in-field (FIF) technique improves the homogeneity of the target in high tangent radiation therapy (HTRT). MATERIALS AND METHODS: This study included 30 patients. In total, 3 HTRT plans were created: 1 with conventional opposed fields (Conv-p), 1 with the FIF technique (FIF-p), and 1 with FIF technique using lung-blocked subfields (FIF-LB-p). RESULTS: The maximum dose of the breast and planning target volume (PTV) was significantly lower for FIF-p and FIF-LB-p than Conv-p. Homogeneity index of PTV was also significantly lower for FIF-p and FIF-LB-p than Conv-p. Homogeneity index of the breast or PTV was significantly better for FIF-p than FIF-LB-p. The volumes of the breast or the PTV receiving 95% and 90% of the prescribed dose were also significantly better for FIF-p, indicating the advantages of FIF-p. CONCLUSIONS: The FIF technique was useful in HTRT and improved homogeneity in the target.

Does intensity-modulated radiation therapy (IMRT) alter prostate size? Magnetic resonance imaging evaluation of patients undergoing IMRT alone.

AIM: To assess the changes in prostate size in patients with prostate cancer undergoing intensity-modulated radiation therapy (IMRT). BACKGROUND: The effect of size change produced by IMRT is not well known. MATERIALS AND METHODS: We enrolled 72 patients who received IMRT alone without androgen-deprivation therapy and underwent magnetic resonance imaging (MRI) examination before and after IMRT. The diameter of the entire prostate in the anterior-posterior (P-AP) and left-right (P-LR) directions was measured. The transitional zone diameter in the anterior-posterior (T-AP) and left-right (T-LR) directions was also measured. RESULTS: The average relative P-AP values at 3, 6, 12, 24, and 36 months after IMRT compared to the pre-IMRT value were 0.94, 0.90, 0.89, 0.89, and 0.90, respectively; the average relative P-LR values were 0.93, 0.92, 0.91, 0.91, and 0.90, respectively. The average P-AP and P-LR decreased by approximately 10% during the 12 months post-IMRT, and remained unchanged thereafter. The average relative T-AP values at 3, 6, 12, 24, and 36 months after IMRT compared to the pre-IMRT value were 0.93, 0.88, 0.91, 0.87, and 0.89, respectively; the average relative T-LR values were 0.96, 0.90, 0.91, 0.87, and 0.88, respectively. The average T-AP and T-LR also decreased by approximately 10% during the 12 months post-IMRT, and remained unchanged thereafter. At 12 months after IMRT, the average relative T-AP was significantly lower in patients with recurrence than in those without recurrence. CONCLUSIONS: The average prostate diameter decreased by approximately 10% during the 12 months after IMRT; thereafter remained unchanged.

Radiotherapy for locally recurrent rectal cancer treated with surgery alone as the initial treatment.

PURPOSE: Although the technical developments of radiotherapy have been remarkable, there are currently few reports on the treatment results of radiotherapy for local recurrence of rectal cancer treated with surgery alone as initial treatment in this three-dimensional conformal radiotherapy era. Thus, we retrospectively evaluated the treatment results of radiotherapy for local recurrence of rectal cancer treated with surgery alone as the initial treatment. MATERIALS AND METHODS: Thirty-two patients who underwent radiotherapy were enrolled in this study. The dose per fraction was 2.0-3.5 Gy. Because the treatment schedule was variable, the biological effective dose (BED) was calculated. RESULTS: Local control (LC) and overall survival (OS) rates from the completion of radiotherapy were calculated. The 1-, 2-, 3-, 4-, and 5-year LC rates were 51.5%, 24.5%, 19.6%, 19.6%, and 13.1%, respectively. LC rates were significantly higher for the high BED group (≥75 Gy10) than for the lower BED group (<75 Gy10). All patients who reported pain achieved pain relief. The duration of pain relief was significantly higher for the high BED group than for the lower BED group. The 1-, 2-, 3-, 4-, and 5-year OS rates were 82.6%, 56.5%, 45.2%, 38.7%, and 23.2%, respectively. There was a trend toward higher OS rates in with higher BED group compared to lower BED group. CONCLUSION: For patients with unresectable locally recurrent rectal cancer treated with surgery alone, radiotherapy is effective treatment. The prescribed BED should be more than 75 Gy10, if the dose to the organ at risk is within acceptable levels.