Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial.

BACKGROUND: No novel chemotherapeutic combinations have demonstrated superior efficacy to etoposide/cisplatin (EP), a standard treatment regimen for extensive-stage small cell lung carcinoma (ES-SCLC) over the past decade. We aimed to compare the efficacy and safety of belotecan/cisplatin (BP) and EP regimens in chemotherapy- and radiotherapy-naïve patients with previously untreated ES-SCLC. METHODS: We conducted a multi-center, randomized, open-label, parallel-group, phase III clinical study. A total of 157 patients were recruited at 14 centers with 147 patients meeting the inclusion/exclusion criteria and randomized to either BP (n = 71) or EP (n = 76) treatment arms. A non-inferior response rate (RR) in the BP arm, analyzed by intent-to-treat analysis according to Response Evaluation Criteria in Solid Tumors version 1.0 criteria, was used as the primary endpoint. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). RESULTS: In the BP arm, one patient had a complete response, 41 had a partial response (PR), and 17 had stable disease (SD). In the EP arm, 35 patients had PR and 28 had SD. The RR in the BP arm was non-inferior to the EP regimen in patients with ES-SCLC (BP: 59.2 %, EP: 46.1 %, difference: 13.1 %, 90 % two-sided confidence interval: -0.3-26.5, meeting the predefined non-inferiority criterion of -15.0 %). No significant differences in OS or PFS were observed between the treatment arms. Hematologic toxicities, including grade 3/4 anemia and thrombocytopenia, were significantly more prevalent in the BP arm than the EP arm. CONCLUSIONS: The RR to the BP regimen was non-inferior to the EP regimen in chemotherapy- and radiotherapy-naïve patients with previously untreated ES-SCLC. Hematologic toxicities were significantly more prevalent in the BP group, indicating that BP should be used with care, particularly in patients with a poor performance status. Further studies assessing PFS and OS are required to validate the superiority of the BP regimen. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00826644 . Date of Registration: January 21, 2009.

Moderate hemoptysis: recurrent hemoptysis and mortality according to bronchial artery embolization.

INTRODUCTION: The studies on hemoptysis have focused mainly on hemoptysis causes and massive or life-threatening hemoptysis. And there is a limited data that non-massive hemoptysis, especially moderate hemoptysis. OBJECTIVES: We analyzed the prognosis and severity of bleeding on flexible bronchoscopy (FB) between moderate and massive hemoptysis. METHODS: We reviewed total 852 subjects (59.9 ± 16.0 years) identified with hemoptysis. Reviewed database included severity of subjective hemoptysis, bleeding on FB, comorbid conditions, time from admission to bronchial artery embolization (BAE), recurrent hemoptysis and mortality. RESULTS: In subjective hemoptysis, recurrent hemoptysis occurred in mild 8.0%, moderate 40.7%, massive hemoptysis 33.8%, and mortality was 4.7%, 13.4% and 13.5%. Especially, no statistical difference was shown in recurrent hemoptysis [hazard ratio (HR) = 0.795; 95% confidence interval (CI) 0.562-1.125, P = 0.196] and mortality (HR = 1.054; 95% CI 0.596-1.864, P = 0.856) between moderate and massive hemoptysis. In moderate hemoptysis patients, oozing or active bleeding on FB took up 83.3%. In this review, recurrent hemoptysis was more in oozing bleeding than active bleeding (HR = 1.781; 95% CI 1.214-2.431, P = 0.002), but mortality was similar (HR = 1.611; 95% CI 0.930-2.790, P = 0.089). Recurrent hemoptysis significantly decreased in the group with BAE performed within 24 h (HR = 0.308; 95% CI 0.149-0.637, P = 0.001) in moderate hemoptysis. Also, recurrent hemoptysis and mortality were significantly increased in the patients with smoking (≥40 pack-years), oozing or active bleeding on FB, and hypertension. CONCLUSION: Moderate hemoptysis has shown similar prognosis of recurrent hemoptysis and mortality to massive hemoptysis. Therefore, the more aggressive FB and BAE should be considered in moderate hemoptysis.

Clinical and microbiological features of patients admitted to the intensive care unit with nursing and healthcare-associated pneumonia.

OBJECTIVE: To evaluate clinical and microbiological features in patients with nursing and healthcare-associated pneumonia (NHCAP), admitted to the intensive care unit (ICU). METHODS: Demographic, clinical and microbiological data were retrospectively reviewed from patients with NHCAP admitted to a respiratory ICU. Patients were categorized into one of four NHCAP groups: (A) residence in a long-term nursing-home setting or healthcare home; (B) hospital discharge in the preceding 90 days; (C) elderly or physically disabled patients who stay at home but require healthcare; (D) continuously receiving outpatient endovascular therapy including chronic dialysis, anticancer drugs, and immunosuppressants. Pneumonia severity index (PSI), CURB-65, duration of ICU stay and 30-day mortality were evaluated. RESULTS: Out of 428 patients reviewed (male, 67.1%; mean age, 71.2 ± 11.9 years), 30-day mortality was 25.5%, and duration of ICU stay was 13.8 ± 13.3 days. Mortality rate was not significantly different between the four NHCAP groups; duration of ICU stay was significantly longer in groups C and D. PSI score, serum HCO3(-) level, duration of ICU stay, extended spectrum ß-lactamase (ESBL)-producing Klebsiella pneumoniae and multidrug resistant (MDR) Acinetobacter baumannii were significantly associated with 30-day mortality. CONCLUSION: ESBL-producing K. pneumoniae, MDR A. baumannii and PSI score should be considered in ICU patients with NHCAP.

The effects of bronchoscope diameter on the diagnostic yield of transbronchial lung biopsy of peripheral pulmonary nodules.

BACKGROUND: Transbronchial lung biopsy (TBLB) is a valuable diagnostic tool for peripheral pulmonary lesions. The diagnostic yield of TBLB reportedly ranges from 41%-60%. Many studies demonstrated the various factors that influence the yield of TBLB, including size, location, and distance from the carina or pleura. However, no study has evaluated the effects of the bronchoscope diameter. We evaluated whether the bronchoscope diameter affected the diagnostic yield of TBLB. METHODS: We reviewed records from 178 patients who underwent TBLB using bronchoscopes of two different diameters (5.7 mm, thick outer diameter, Olympus BF-200; 4.9 mm, thin, BF-260). The fluoroscopic guidance rates, yield of TBLB and flexible bronchoscopy (FB) were compared between the two groups. Additionally, we compared the results of the procedures with respect to diagnosis, distance from the pleura, and size of the lesion. RESULTS: The results of fluoroscopic guidance, TBLB, and FB yield using thin diameter bronchoscope were significantly better than those obtained with a thick diameter bronchoscope (p=0.021, p=0.036, and p=0.010, respectively). Particularly, when the distance from the pleura was ≤ 10 mm, success rates for fluoroscopic guidance and FB with thin bronchoscope were higher (p=0.013 and p=0.033, respectively), as compared to with thick bronchoscope. CONCLUSION: A thinner diameter bronchoscope increased the yield of bronchoscopy, and bronchial washing in conjunction with TBLB was useful in the diagnosis of peripheral pulmonary nodules.

A case of levofloxacin-induced anaphylaxis with elevated serum tryptase levels.

Levofloxacin, a fluoroquinolone and L-isomer of the racemate ofloxacin, has been approved for the treatment of acute and chronic bacterial infections. Gastrointestinal complaints are the most frequently reported adverse drug reactions to fluoroquinolones. Other adverse events include headache, dizziness, increased liver enzyme levels, photosensitivity, tachycardia, QT prolongation, and eruptions. Anaphylaxis has been documented as a rare adverse drug reaction to levofloxacin; however, diagnostic tests are needed to evaluate whether these reactions are the result of levofloxacin treatment. While the results of skin tests are considered unreliable due to false-positive responses, the oral provocation test is currently considered to be the most reliable test. Tryptase, a neutral protease, is the dominant protein component of secretory granules in human mast cells, and an increased serum concentration of tryptase is a highly sensitive indicator of anaphylaxis. Herein, we report a case of levofloxacin-induced anaphylaxis in which the patient exhibited elevated serum tryptase levels and a positive oral levofloxacin challenge test result. As anaphylaxis is potentially life-threatening, the administration of fluoroquinolones to patients who have experienced a prior reaction to this type of agent should be avoided.

A Case of Occupational Rhinitis Induced by Maize Pollen Exposure in a Farmer: Detection of IgE-Binding Components.

Corn is a major staple food, along with rice and wheat, in many parts of the world. There are several reports of hypersensitivity to maize pollen. However, cases of occupational allergic rhinitis induced by inhalation of maize pollen are very rare. We herein report the case of a 67-year-old male with occupational rhinitis caused by occupational exposure to maize pollen in a cornfield. He showed positive responses to maize pollen, as well as grass pollens, in skin prick tests. A high level of serum immunoglobulin E (IgE) specific to maize pollen extracts was detected by an enzyme-linked immunosorbent assay (ELISA). Laboratory tests showed a high serum level of total IgE (724 kU/L) and a high level of IgE specific to maize pollen (8.32 kU/L) using the Immuno-CAP system. Occupational rhinitis was confirmed by a nasal provocation test with maize pollen extracts. IgE ELISA inhibition tests showed antibody cross-reactivity between maize pollen and grass pollen extracts. IgE immunoblotting using maize pollen extracts demonstrated a 27 kDa IgE-binding component. These findings suggest that maize pollen can induce IgE-mediated occupational rhinitis in exposed workers.

Risk factors related with mortality in patient with pulmonary tuberculosis.

BACKGROUND: The prevalence rate of pulmonary tuberculosis (PTB) is steadily decreasing in South Korea. However, PTB is a disease with relatively high mortality and morbidity rates throughout Korea. Although there are many studies and statistics about the risk factors of PTB mortality in many countries, there are only a limited number of domestic papers on this topic. The aim of this study is to determine predictive factors for mortality among in-hospital patients associated with PTB. METHODS: From December 2006 to January 2011, we reviewed medical records of 2,122 adult patients diagnosed with tuberculosis at a single tertiary hospital in a suburban area. In this study period, 960 patients were diagnosed with PTB by positive Acid fast bacilli smear and/or mycobacterial culture of the respiratory specimen. We compared the groups of patients deceased and patients discharged alive with PTB. The number of dead patients was 82 (47 males, 35 females). RESULTS: Mortality was significantly associated with increased values of white blood cells (WBC), blood urine nitrogen (BUN), creatinine, C-reactive protein (CRP), numbers of involved lung field, and length of hospitalization. Also, it was associated with the decreased values of hemoglobin, lymphocyte, sodium, albumin, and cholesterol. Furthermore, admission through the emergency department, initial intensive care unit admission, and drug resistant PTB affected mortality in PTB patients. Independent predictors associated with PTB mortality are BUN, initial intensive care unit care, and admission during treatment of tuberculosis. CONCLUSION: In our study, mortality of pulmonary tuberculosis was related with parameters associated with nutritional status, disease severity at the time of admission, and drug resistance.

The efficacy of immediate diet for reducing local adverse events of inhaled corticosteroid: a pilot study.

BACKGROUND: Local adverse events associated with inhaled corticosteroid use, including dysphonia, pharyngitis and oral candidiasis, can affect adherence for treatment. 'Mouth rinsing method' has been used for reducing local adverse events, but it cannot ensure complete prevention. The goal of this pilot study was to identify whether the 'immediate diet method' can reduce local adverse events in a limited number of patients. METHODS: The study was conducted in a total of 98 patients, who had been prescribed a medium-dose fluticasone propionate for the first time, from January to October in 2010. One training nurse had performed the education on how to use the inhaler, including the mouth rinsing method. And with follow-ups at one month intervals, any patient who experienced such adverse events were educated on the immediate diet method, having a meal within 5 minutes after using an inhaler and they were checked on any incurrence of adverse events with one month intervals for 2 months. RESULTS: The mean age of patients was 65.9 years old. The local adverse events had incurred from 18.4% of the study subjects. When performed the follow-up observation in 18 patients with local adverse events after education on the immediate diet method, 14 patients (77.8%) had shown symptomatic improvements. Three of 4 patients did not show any improvement, in spite of implementing the immediate diet method. The other 1 patient did not practice the immediate diet method properly. CONCLUSION: The immediate diet method may be useful in reducing the local adverse events, caused by the use of inhaled corticosteroid.

A case of autoimmune progesterone dermatitis misdiagnosed as allergic contact dermatitis.

Autoimmune progesterone dermatitis is a rare autoimmune response to endogenous progesterone that usually occurs in fertile females. Cutaneous or mucosal lesions develop cyclically during the luteal phase of the menstrual cycle when progesterone levels are elevated. Symptoms usually start 3-10 days before menstruation and resolve 1-2 days after menstruation ceases. We report the case of a 48-year-old woman with intermittent eczematous skin lesions of the legs, forearms, and buttocks. She was diagnosed with allergic contact dermatitis, and topical steroids were prescribed. Her skin eruptions waxed and waned for 6 years and were associated with her menstrual cycle. We performed an intradermal test using progesterone, which was positive, and prescribed gonadotropin-releasing hormone analogues monthly for 3 months. The patient's skin lesions improved, confirming the diagnosis. Autoimmune progesterone dermatitis should be included in the differential diagnosis of recurrent eczema that is refractory to treatment in women of child-bearing age.

[Two cases of human infection by Echinostoma cinetorchis]

Eggs of Echinostoma sp. were found from two patients who were hospitalized between Oct. and Dec. 1985. Single dose of 10 mg/kg of praziquantel was prescribed to each patient and after purgation with magnesium salt seven and two adult worms of Echinostoma cinetorchis in respect were recovered from patients. The first case was a 54-year-old male residing at Chungju city in Chungbuk province. He was hospitalized because of severe weight loss and frequent urination. The second case was a 71-year-old male residing at Chungsun-kun in Kangwon province, and hospitalized due to suspected lung cancer. The average size of the eggs found in the stools was 98 x 63 micrometer (the first case) and 100 x 67 micrometer (the second case) respectively, and total nine worms collected were identified as E. cinetorchis.