Prospective, Observational Study of Aflibercept Use in Combination with FOLFIRI in Patients with Metastatic Colorectal Cancer: A Real-World Effectiveness Study.

BACKGROUND: This was an observational study prospectively evaluating the effectiveness and safety of aflibercept/FOLFIRI administered in second-line mCRC per the reimbursement criteria in Poland. METHODS: Consecutive mCRC patients who progressed with first-line oxaliplatin-based chemotherapy received aflibercept (4 mg/kg IV) followed by FOLFIRI every 2 weeks until progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS); overall survival (OS) and safety were the secondary endpoints. RESULTS: A total of 93 patients were treated at 17 Polish sites. A median of 10 cycles was administered. Over a median treatment duration of 5.3 months, median PFS and median OS were 8.4 months [95% CI, 6.9-9.9] and 27.0 months [95% CI, 23.9-30.1], respectively. There was no significant impact of primary tumor location, metastatic site, or KRAS status on PFS and OS. Main grade ≥ 3 adverse events were neutropenia (16%), hypertension (8%), diarrhea (4%), and stomatitis (4%). CONCLUSIONS: The benefits/risks of Aflibercept plus FOLFIRI administered per the Polish reimbursement criteria in second-line treatment of mCRC after failure of a prior oxaliplatin-based regimen is confirmed.

Effect of different drying conditions for the viability of Candida albicans present on carriers.

BACKGROUND: Problems in substantial under recovery of Pseudomonas aeruginosa and Candida albicans from carriers have been demonstrated for laboratories performing phase 2, step 2 efficacy tests on disinfectants relative to levels required by the EN 13697 standard. It was thus necessary to determine recoveries of these microorganisms following procedural losses incurred during drying and to optimise drying conditions such that recoveries then complied with the standard. OBJECTIVES: The aim of the study was to establish optimal drying conditions for the recovery of Candida albicans ATCC 10231 from carriers. MATERIALS AND METHODS: The evaluation was performed according to the EN 13697:2001 standard procedure. A test suspension of Candida albicans and interfering substance were inoculated onto the surface of carriers (2 cm diameter stainless steel discs) and then dried under different conditions consisting of: a 37 degrees C incubation with and without an incubator fan as well as at 23 degrees C (room temperature) in a laminar air flow cabinet. Carriers were dried until the surfaces appeared visibly dry and the number of surviving organisms then recovered from the surface were quantified. The following were calculated for colony forming units (cfu); N (log10 cfu in a 0.05 ml test suspension), NC (the control log10 cfu in neutralizing medium), Nts (cfu numbers remaining on the surface) and the N-NC difference which should not exceed 2 log10 when microorganism recoveries are adequate and without any toxicity effects of the neutralising medium. Experiments was conducted using validating procedure (NC) which is performed with distilled water. RESULTS: Drying at 37 degrees C adversely affected the survival of Candida albicans and prevented the levels of microbial recovery from carriers to reach those specified by the EN 13697 standard. However, drying at around room temperatures of 23 degrees C reduced Candida albicans mortality and increased recoveries from the carrier to levels compliant with the standard, where the N-NC differences were not greater than 2 log10. CONCLUSIONS: The viability of Candida albicans ATCC 10231 is sufficiently improved when carriers are dried at 23 degrees C, even if the drying time exceeds 60 minutes. The density of the initial test suspension (N) should also be increased.

Recommendations for thermal disinfection based on the A0 concept according to EN ISO 15883.

The use of aseptic instruments for the care of patients is an essential element in the prevention of nosocomial infections. Significant risks have been associated with inadequate or improper cleaning and disinfection of reusable medical devices. Thermal disinfection with moist heat, based on the A0 concept (EN ISO 15883-1), is the most common method for disinfection of medical devices in the hospital setting. A0 is a physical parameter denoting the inactivation of microorganisms. The concept of A0 is intended to allow equivalent disinfection efficiencies to a reference time/temperature to occur at other disinfection temperatures. This paper focuses on parametric control of thermal disinfection--A0 values as recommended in the standard and their interpretation. The experimental fundamentals regarding of an A0 concept are rare. Data on thermal disinfection are partly contradictory. The washer disinfectors use thermal disinfection programs set in accordance with the parameters: time and temperature, which is proven suitable biocidal activity, not based on the A0 value. Many authorities in the field of disinfection recommends to use higher values of A0 than those specified in the standard EN ISO 15883.