Results from the first in man german pilot study of the silver graft, a vascular graft impregnated with metallic silver.

The purpose of this study was to assess the safety of a novel vascular prosthesis in 50 patients who underwent inguinal and infrainguinal vascular reconstructions. The safety data were based on ultrasound Doppler data at 2 and 18 months to quantify the graft-tissue integration in this patient cohort. Between August 9, 2005, and January 25, 2006, 50 patients underwent inguinal or infrainguinal reconstructions with the Silver Graft (SG; B. Braun Melsungen AG, B. Braun Aesculap AG, Tuttlingen, Germany) in six vascular centers. All participating centers received the metallic silver-coated polyester graft (SG) with a diameter of 8 mm and a total length of 60 cm, which was length adjusted to fit the patient's anatomy and the planned vascular reconstruction. The mean patient age was 69.1 +/- 9.0 years, the male inclusion rate was 72.0%, and the Fontaine classifications were stage IV (16%), stage III (14%), stage IIb (66%), and stage IIa (4%), whereas aneurysm repairs amounted to 4%. In-hospital results revealed the presence of minimal perigraft fluid in 14.0% of all cases (7 of 50). At the 2-month follow-up, perigraft fluid was detected in one patient (1 of 50). At 18 months, a single case of minimal perigraft fluid was detected in an asymptomatic patient. Wound healing was accomplished at discharge in 96% of all patients, whereas at the 2-month follow-up, no signs of wound infection or irritation could be detected. The accumulated primary patency rates were 94% at 2 months and 88% at 18 months. The available clinical data on perigraft fluid as a marker for graft-tissue incorporation at 2 and 18 months, patency, and wound healing are comparable to those of other relevant clinical results with polyester grafts and support the safety of the metallic SG in the studied patient population with inguinal and infrainguinal reconstructions. However, it cannot be guaranteed that all graft infections can be avoided with the SGs.

Neoadjuvant capecitabine combined with standard radiotherapy in patients with locally advanced rectal cancer: mature results of a phase II trial.

PURPOSE: The objective of this expanded phase II trial was to confirm the safety results of the preceding phase I study and establish the efficacy of neoadjuvant radiochemotherapy with capecitabine in rectal cancer in a multicenter setting. PATIENTS AND METHODS: 96 patients (63% male, age 34-81 years) with advanced rectal cancer (cT3-4 or cN+) from seven university centers in Germany were recruited. All were to receive a total irradiation dose of 50.4-55.8 Gy with conventional fractions. Capecitabine was given at an oral dosage of 825 mg/m(2)bid on each day of the radiotherapy period with the first daily dose applied 2 h before irradiation, followed by surgery 6 weeks later. RESULTS: Most of the patients suffered from an advanced primary tumor (cT3: 57%, cT4: 40%) with lymph node involvement in 60%. After neoadjuvant treatment, with a mean of 99% of the scheduled radiation dose actually delivered, a clinical response rate of 68% (95% confidence interval: 57-78%) was observed. Out of 87 evaluable patients undergoing surgery, a sphincter-preserving procedure could be performed in 51% and R0 resection in 94%. A pathologically complete response was achieved in six patients (7%, 95% confidence interval: 3-14%). The comparison of initial diagnosis and pathologic findings showed a downstaging in 61%. Acute toxicity with > 5% incidence of NCI (National Cancer Institute) grade >/= 3 included lymphopenia (12%), leukopenia (6%), and diarrhea (7%). Mild to moderate hand-foot syndrome occurred in 12% only. After a median follow-up of 48 months, the 5-year overall survival and tumor control data were, with regard to patient selection, in the expected range with an overall survival of 65%, a relapse-free survival of 47%, and a local recurrence rate after 5 years of 17%. CONCLUSION: The data clearly confirm that capecitabine is an adequate substitute for 5-fluorouracil in preoperative chemoradiation of rectal cancer with a favorable safety profile.