Randomized phase II trial of three schedules of pemetrexed and gemcitabine as front-line therapy for advanced non-small-cell lung cancer.

PURPOSE: A randomized three-arm phase II study was undertaken to evaluate the optimum administration schedule of pemetrexed and gemcitabine in chemotherapy-na?ve patients with non-small-cell lung cancer. PATIENTS AND METHODS: Patients were randomly assigned to three schedules of pemetrexed 500 mg/m2 plus gemcitabine 1,250 mg/m2, separated by a 90-minute interval, on a 21-day cycle as follows: schedule A, pemetrexed followed by gemcitabine on day 1 and gemcitabine on day 8; schedule B, gemcitabine followed by pemetrexed on day 1 and gemcitabine on day 8; and schedule C, gemcitabine on day 1 and pemetrexed followed by gemcitabine on day 8. RESULTS: One hundred fifty-two eligible patients (schedule A, n = 59; schedule B, n = 31, and schedule C, n = 62) received a median of five (schedule A), two (schedule B), and four (schedule C) treatment cycles. Overall, 66% of patients experienced grade 3 or 4 neutropenia. Common grade 3 and 4 nonhematologic toxicities were dyspnea (11%), fatigue (16%), and transaminase elevation (9%). Schedule A seemed less toxic compared with schedule C (grade 3 or 4 events: 86% v 94%, respectively; P = .19; grade 4 events: 39% v 48%, respectively; P = .30). Schedule B was closed at interim analysis for inferior efficacy. Schedule A, with a confirmed response rate of 31% (95% CI, 20% to 45%), met the protocol-defined efficacy criteria, whereas schedule C, with a confirmed response rate of 16.1% (95% CI, 11% to 34%), did not. Median survival time and time to progression were 11.4 and 4.4 months, respectively, with no observable difference between the arms. CONCLUSION: Pemetrexed and gemcitabine administered as outlined for schedule A met the protocol-defined efficacy criteria, was less toxic compared with the other treatment schedules, and should be further evaluated.     

Tetraplegia in the immediate postoperative period of stapedectomy

Management of the cervical spine in orotracheal intubation for general anesthesia is an important aspect of daily practice in anesthesiology. Also important are the requirements, techniques and consequences of patient position during surgery. We report a case of tetraplegia during the early postoperative period after stapedectomy for otosclerosis. After surgery, the spontaneously breathing patient was transferred to the recovery room, where a clinical picture of anesthesia and paralysis of all four limbs was evident. We ordered an emergency magnetic resonance image of the cervical spine, which revealed a massive acutely herniated disk at C6-C7 with signs of ischemia or necrosis of the medulla at the same level. After eight months, the patient was still paraplegic and lacked sensation in the lower limbs. Sensation and motor function in the upper limbs was nearly normal. We review the etiopathogenetic mechanisms that might be responsible for this clinical profile.     

Epidemiology,aetiology and knowledge,attitudes, and practices relating to burn injuries in Palestine: A community‐level research

The aim of this study was to identify the epidemiology, aetiology as well as the knowledge, attitudes, and practices relating to burn injuries in Palestine. A mixed‐method approach was used. A survey was distributed to a total of 1500 households selected by randomised approach. The survey was standardised based on World Health Organisation''s guidelines for conducting community surveys on injury. Additionally, there were 12 focus group discussions and 10 key informant interviews to collect rich qualitative data. In the West Bank and Gaza, 1.5% of Palestinians had experienced serious burn injuries in the 12 months. The total sample of 1500 yields a margin of error (plus/minus) = 2.5% at a 95% level of confidence and a response distribution (P = 50%) with 3% non‐response rate. Of the 1500 households approached, 184 reported a total of 196 burn injuries, with 87.2% occurring inside the home: 69.4% were females and 39.3% were children. The main source of reported cause of burn was heat and flame (36%), electric current (31.6%), hot liquid (28.6%), and chemicals (2.7%). The most common first aid for burns was pouring water (74.7%). People in rural, refugee, and Bedouin settings had the highest incidence of burns. This study provides the burn prevalence rate, explanatory factors that contribute to the frequency of burns in Palestine. Making burn prevention a higher priority within the national policy is crucial.