One hundred ninety-three frozen food samples collected in Korea various public bazaars from October 2006 to September 2007. Staphylococci were detected in 21.8% of frozen food samples. Staphylococcus aureus was isolated from 17 (8.8%) samples. Other staphylococci isolates were identified as S. warneri (7.8%), S. epidermidis (2.1%), S. xylosus (1.6%), S. eguorum (1%), and S. vitulinus (0.5%). Additionally, the antimicrobial susceptibility of 42 staphylococcal isolates to ten different antimicrobial agents was determined. The staphylococcal isolates demonstrated antimicrobial resistance to mupirocin (31%) oxacillin (14.3%), gentamicin (9.5%), teicoplanin (7.1%) and ciprofloxacin (7.1%). Most of the staphylococcal isolates showed high-level resistance to mupirocin (MIC(90), >128 microg/mL). Fortunately, most of the isolates were susceptible to vancomycin. The total bacteria and Escherichia coli count were tested to investigate the microbiological quality of frozen foods. From 193 frozen food samples, 43 (22.3%), 34 (17.6%) and 19 (9.8%) samples were shown to be of unacceptable quality due to total bacteria, coliform and E. coli counts, respectively.

Objectives The authors propose a new checklist model adapted for safety miniscalpel acupuncture procedure of cervical and lumbar spine. Methods On the basis of available literature and expert opinion, a prototype checklist was developed. The checklist was adapted on the basis of observation of daily practice. Results The checklist has three parts: 1. prevention and management of healthcare associated infections, 2. verification list before and after miniscalpel acupuncture treatment, 3. adverse event monitoring after procedure. We presented a summary checklist based on the above contents. Conclusions We propose the first patient safety checklist for minicalpel acupuncture treatment of cervical and lumbar spine. The checklist will be complemented using further research methodologies. (J Korean Med Rehabil 2018;28(1):61-72)

Background In this open‐label, international phase 2 study, the authors assessed the efficacy and safety of olmutinib in patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) who had a confirmed T790M mutation and disease progression on previous epidermal growth factor receptor‐tyrosine kinase inhibitor therapy. Methods Patients aged ≥20 years received once‐daily oral olmutinib 800 mg continuously in 21‐day cycles. The primary endpoint was the objective response rate (patients who had a confirmed best overall response of a complete or partial response), assessed by central review. Secondary endpoints included the disease control rate, the duration of objective response, progression‐free survival, and overall survival. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03). Results Overall, 162 patients (median age, 63 years; women, >60%) were enrolled from 68 sites in 9 countries. At the time of database cutoff, 23.5% of enrolled patients remained on treatment. The median treatment duration was 6.5 months (range, 0.03‐21.68 months). Overall, 46.3% of patients (95% CI, 38.4%‐54.3%) had a confirmed objective response (all partial responses). The best overall response (the objective response rate regardless of confirmation) was 51.9% (84 patients; 95% CI, 43.9%‐59.8%). The confirmed disease control rate for all patients was 86.4% (95% CI, 80.2%‐91.3%). The median duration of objective response was 12.7 months (95% CI, 8.3‐15.4 months). Estimated median progression‐free survival was 9.4 months (95% CI, 6.9‐12.3 months), and estimated median overall survival was 19.7 months (95% CI, 15.1 months to not reached). All patients experienced treatment‐emergent adverse events, and 71.6% of patients had grade ≥3 treatment‐emergent adverse events. Conclusions Olmutinib has meaningful clinical activity and a manageable safety profile in patients with T790M‐positive non–small cell lung cancer who received previous epidermal growth factor receptor‐tyrosine kinase inhibitor therapy.

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3007 Background: Belvarafenib, a potent, selective RAF dimer (type II) inhibitor, exhibits clinical activity in BRAFV600E- and NRAS-mutant (NRASm) melanoma patients. The combination of belvarafenib and cobimetinib more potently and durably suppressed MAPK pathway output and tumor growth than currently approved BRAF/MEK inhibitors in RAS- or RAF-mutant tumor xenograft models. This interim results of phase 1b trial evaluated the safety, tolerability, pharmacokinetics, and anti-tumor activity of belvarafenib in combination with cobimetinib in dose-escalation and NRASm melanoma patients among the 9 indication-specific expansion cohorts. Methods: Patients with locally advanced or metastatic solid tumors harboring RAS or RAF mutation were enrolled in the dose-escalation stage, and the recommended doses were explored in the indication-specific expansion stage. Patients in the dose-escalation stage were given belvarafenib (100–300mg BID) in combination with cobimetinib (20–40mg QD) and the dose of subsequent cohorts was decided by a traditional 3+3 design and safety profile. Primary objectives were to evaluate the safety and tolerability, to estimate the maximum tolerable dose, and to identify the RP2D of the combination. Results: A total of 32 patients enrolled were evaluated for safety analysis; 19 were enrolled in 4 cohorts in the dose-escalation stage and 13 NRASm melanoma patients were enrolled in the indication-specific expansion stage (cut-off date: 2020-7-24). There were 3 DLTs (G3 colitis, G3 diarrhoea, G3 nausea) in 2 patients at the starting dose of belvarafenib 200mg BID continuously and cobimetinib 40mg QD 21/7 schedule. Belvarafenib dose was escalated to 300mg BID with cobimetinib 20mg QD, which did not result in DLTs. The most common treatment-emergent adverse events that occurred in ≥30% of 32 patients were dermatitis acneiform, diarrhoea, constipation, and increase in blood creatine phosphokinase. Two combination doses were explored in the indication-specific expansion stage. Out of the 9 indication-specific expansion cohorts, NRASm melanoma patients exhibited promising efficacy signal; 5 patients reached partial responses (PRs) out of 13, giving a response rate of 38.5%. Among them, 11 had been previously treated with checkpoint inhibitors (CPIs), including 5 (45.5%) who achieved PR. The median PFS was 7.3 months and 5 patients remained on the treatment at the cut-off date. Conclusions: Belvarafenib in combination with cobimetinib showed acceptable tolerability and encouraging efficacy in NRASm melanoma, and in those with prior CPI treatment. Further research is ongoing in other cohorts (Clinicaltrial.gov, NCT03284502) and in NRASm melanoma (reference GO42273 by clinicaltrials.gov ID number). *S.J.S and J.L contributed equally to this work. Clinical trial information: NCT03284502.