Neoadjuvant Radiotherapy with Capecitabine Plus Bevacizumab for Locally Advanced Lower Rectal Cancer: Results of a Single-institute Phase II Study.

BACKGROUND/AIM: A single-arm phase II clinical trial was conducted to evaluate the safety and efficacy of adding bevacizumab to standard capecitabine-based neoadjuvant chemoradiotherapy (CRT) for the treatment of locally advanced rectal cancer (LARC). PATIENTS AND METHODS: Twenty-five patients were enrolled. Patients received capecitabine-based CRT for 5 weeks and 3 days. Bevacizumab was administered every 2 weeks during CRT. Within 6-10 weeks after completion of CRT, surgery was performed. RESULTS: With regard to CRT-related acute toxicities, most of the adverse events were limited to grade 1. A pathological complete response was obtained in four (16%) patients. In total, six patients (24%) developed postoperative complications. Six out of five (83%) patients healed without the need for surgical intervention. CONCLUSION: Although acute toxicity during CRT with bevacizumab was minimal and postoperative complications do not seem to increase, the addition of bevacizumab apparently offers no clinically-significant benefit for patients with LARC.

Results of surgery plus postoperative radiotherapy for patients with malignant parotid tumor.

PURPOSE: The latest version of the World Health Organization (WHO) histologic classification of salivary gland malignancies was published in 2005. To contribute to data accumulation on the basis of this latest version, a retrospective study was performed. MATERIALS AND METHODS: Participants comprised 27 patients who underwent postoperative radiotherapy between 2000 and 2013. Two, eight, and 17 patients were allocated to low, intermediate, and high-grade groups, respectively, in accordance with the latest WHO classification. The radiation field included the tumor bed and ipsilateral regional lymph nodes for 25 patients. The radiation dose was 46-60 Gy (median 56 Gy). RESULTS: Median duration of follow-up was 41 months. Five-year locoregional control was 89 %. Two patients experienced local recurrence and 7 patients developed distant metastases. No patients in the low or intermediate-grade groups developed distant metastases. Overall 3 and 5-year survival for all patients were 81 and 75 %, respectively. Five-year overall survival for patients in the low and intermediate-grade groups was 100 %, compared with 59 % for patients in the high-grade group (p = 0.03). CONCLUSION: Favorable locoregional control was achieved for patients with malignant parotid tumors who underwent surgery plus postoperative radiotherapy. Patients with high-grade tumors frequently experienced distant metastases and prognosis was poor.

Neoadjuvant capecitabine, bevacizumab and radiotherapy for locally advanced rectal cancer: results of a single-institute Phase I study.

The aim of this Phase I clinical trial was to assess the feasibility and safety of capecitabine-based preoperative chemoradiotherapy (CRT) combined with bevacizumab and to determine the optimal capecitabine dose for Japanese patients with locally advanced rectal cancer. Patients with cT3/T4 rectal cancer were eligible. Bevacizumab was administered at 5 mg/kg intravenously on Days 1, 15 and 29. Capecitabine was administered on weekdays concurrently with pelvic radiotherapy at a daily dose of 1.8 Gy, totally to 50.4 Gy. Capecitabine was initiated at 825 mg/m(2) twice daily at Dose Level 1, with a planned escalation to 900 mg/m(2) twice daily at Dose Level 2. Within 6.1-10.3 (median, 9.4) weeks after the completion of the CRT, surgery was performed. Three patients were enrolled at each dose level. Regarding the CRT-related acute toxicities, all of the adverse events were limited to Grade 1. There was no Grade 2 or greater toxicity. No patient needed attenuation or interruption of bevacizumab, capecitabine or radiation. All of the patients received the scheduled dose of CRT. All of the patients underwent R0 resection. Two (33.3%) of the six patients had a pathological complete response, and five (83.3%) patients experienced downstaging. In total, three patients (50%) developed postoperative complications. One patient developed an intrapelvic abscess and healed with incisional drainage. The other two patients healed following conservative treatment. This regimen was safely performed as preoperative CRT for Japanese patients with locally advanced rectal cancer. The recommended capecitabine dose is 900 mg/m(2) twice daily.

A dose-volume intercomparison of volumetric-modulated arc therapy, 3D static conformal, and rotational conformal techniques for portal vein tumor thrombus in hepatocellular carcinoma.

We created volumetric-modulated arc therapy (VMAT) plans for portal vein tumor thrombus (PVTT) in hepatocellular carcinoma, and compared the results with those from three-dimensional conformal radiotherapy (3D-CRT) and rotational conformal radiotherapy (R-CRT) plans. CT scan data from 10 consecutive patients with PVTT treated with 3D-CRT between January 2008 and January 2010 were utilized in the analysis. We analyzed the dosimetric properties of the plans for the 10 patients using the three different techniques with three different isocenter doses of 50, 56 and 60 Gy in 2-Gy fractions. The D95, Dmean, homogeneity index and conformity index were compared for the planning target volume (PTV). The Dmean, V20 and V30 were also compared for normal livers. The monitor units (MUs) and the treatment time were also evaluated. The normal liver V30 for VMAT was significantly less than that for 3D-CRT for the prescribed doses of 56 and 60 Gy (P < 0.05). It was also found that the normal liver V30 resulting from 3D-CRT was prohibitively increased when the prescribed dose was increased in two steps. For PTV D95, we found no significant differences between the three techniques for the 50- and 56-Gy prescriptions, or between VMAT and the other techniques for the 60-Gy prescription. The differences in the MUs and treatment times were not statistically significant between VMAT and 3D-CRT. We have demonstrated that VMAT may be a more advantageous technique for dose escalation reaching 60 Gy in the treatment of PVTT due to the reduced normal liver V30.

Delivery parameter variations and early clinical outcomes of volumetric modulated arc therapy for 31 prostate cancer patients: an intercomparison of three treatment planning systems.

We created volumetric modulated arc therapy (VMAT) plans for 31 prostate cancer patients using one of three treatment planning systems (TPSs)--ERGO++, Monaco, or Pinnacle--and then treated those patients. A dose of 74 Gy was prescribed to the planning target volume (PTV). The rectum, bladder, and femur were chosen as organs at risk (OARs) with specified dose-volume constraints. Dose volume histograms (DVHs), the mean dose rate, the beam-on time, and early treatment outcomes were evaluated and compared. The DVHs calculated for the three TPSs were comparable. The mean dose rates and beam-on times for Ergo++, Monaco, and SmartArc were, respectively, 174.3 ± 17.7, 149.7 ± 8.4, and 185.8 ± 15.6 MU/min and 132.7 ± 8.4, 217.6 ± 13.1, and 127.5 ± 27.1 sec. During a follow-up period of 486.2 ± 289.9 days, local recurrence was not observed, but distant metastasis was observed in a single patient. Adverse events of grade 3 to grade 4 were not observed. The mean dose rate for Monaco was significantly lower than that for ERGO++ and SmartArc (P < 0.0001), and the beam-on time for Monaco was significantly longer than that for ERGO++ and SmartArc (P < 0.0001). Each TPS was successfully used for prostate VMAT planning without significant differences in early clinical outcomes despite significant TPS-specific delivery parameter variations.