A randomised, controlled, non-inferiority trial comparing the performance of a soft silicone-coated wound contact layer (Mepitel One) with a lipidocolloid wound contact layer (UrgoTul) in the treatment of acute wounds.

Wound contact layer (WCL) dressings are intended to protect tissue during the healing process. A randomised controlled trial was undertaken to compare 2 such dressings. Outpatients with acute wounds were randomly allocated to treatment with either a soft silicone-coated WCL (intervention group, n = 59) or a lipidocolloid-impregnated WCL (control group, n = 62). At the first dressing removal (day 3), 89.8% of patients in the intervention group experienced non-painful dressing removal (defined as a pain rating <30 mm on a 100 mm visual analogue scale), compared with 73.6% of patients in the control group (P = .017) (per protocol population). At day 21, wounds were considered as healed in 66.1% of patients in the intervention group compared with 43.5% in the control group (P = .012) (intention-to-treat population). Both dressings were well tolerated and rated highly in terms of in-use characteristics, although the soft silicone-coated WCL was rated significantly higher than the lipidocolloid-impregnated WCL in terms of its ability to remain in place (P= .016). The results indicate that the soft silicone-coated WCL is suitable for the management of acute wounds as it can minimise dressing-associated pain and support healing.

High efficacy with five days schedule of oral fludarabine phosphate and cyclophosphamide in patients with previously untreated chronic lymphocytic leukaemia.

A multicentre single-arm study testing the efficacy and toxicity of the oral combination of fludarabine and cyclophosphamide (FC) over 5 d in 75 patients with untreated B cell-chronic lymphocytic leukaemia. Oral FC demonstrated high efficacy with overall (OR) and complete response (CR) rates of 80% and 53%, respectively. Out of the 30 CR patients studied for Minimal Residual Disease (MRD) using 4-colour flow-cytometry and the 22 using Clonospecific polymerase chain reaction, 22 (66%) and 16 (68%), respectively, were MRD negative. Median survival and median treatment-free interval had not been reached at 7 years of follow-up. Median progression-free survival (PFS) was 5 years. Toxicity was acceptable, with 52% and 16% of National Cancer Institute grade 3/4 neutropenia and infections, respectively. Gastrointestinal toxicity was mild. Oral FC demonstrated a high efficacy and an acceptable safety profile and may be considered as the standard first line treatment in chronic lymphocytic leukaemia.

Fludarabine phosphate-CVP in patients over 60 years of age with advanced, low-grade and follicular lymphoma: a dose-finding study.

The aim of this study was to establish a safe and effective regimen of fludarabine phosphate, cyclophosphamide, vincristine and prednisone (F-CVP) as first-line treatment for elderly patients with advanced, low-grade non-Hodgkin's lymphoma. Twenty-three patients >60 years were assigned successively to eight treatment cycles (Dose level 1: low F, low CV [n=4]; 2A: high F, low CV [n=8]; 2B: low F, high CV [n=4]; 3: high F, high CV [n=7]). High and low levels were: F, 25 and 20mg/m(2), respectively (Days 1-5); C, 750 and 500 mg/m(2), respectively (Day 1); and V, 1.4 and 1mg/m(2), respectively (Day 1). Patients received P at 40 mg/m(2) on Days 1-5. Response was assessed after Cycles 2, 4, 6 and 8. At level 3, dose-limiting toxicity (opportunistic infections and neutropenia) became evident, particularly after Cycle 6. Further patients were recruited at Dose level 2A. All regimens proved effective, with an OR rate of 78% (65% CR), and 3-year survival of 65% (+/-10%). Among 18 responders, 51% were still in response at 3 and 5 years. The study shows that this combination therapy is highly effective. The addition of F to CVP at Dose level 2A was feasible and increased the CR rate, with good tolerability in elderly patients.