Efficacy and Safety of Necitumumab Continuation Therapy in the Phase III SQUIRE Study of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer.

INTRODUCTION: In a retrospective analysis of the SQUamous NSCLC treatment with the Inhibitor of EGF REceptor (SQUIRE) study, we investigated the efficacy and safety of single-agent necitumumab continuation therapy in patients with stage IV squamous non-small-cell lung cancer and in a subpopulation of patients with epidermal growth factor receptor (EGFR)-expressing tumors. PATIENTS AND METHODS: Patients were randomized 1:1 for ≤ 6 cycles of gemcitabine and cisplatin either with or without necitumumab. Patients who received necitumumab continued receiving single-agent necitumumab until progressive disease (necitumumab continuation). Tissue collection was mandatory in SQUIRE. EGFR protein expression was assessed using immunohistochemistry in a central lab. In this subgroup analysis we compared patients treated with necitumumab monotherapy after completion of ≥ 4 cycles of chemotherapy with those in the chemotherapy arm who were progression-free and did not discontinue because of adverse events (AEs) after completion of ≥ 4 cycles of chemotherapy (gemcitabine-cisplatin nonprogressors). The same analysis was done for the subgroup of EGFR-expressing patients (EGFR > 0). RESULTS: Baseline characteristics and chemotherapy exposure were well balanced between the necitumumab continuation (n = 261) and gemcitabine-cisplatin nonprogressor (n = 215) arms and in the EGFR-expressing population. Median overall survival (OS) from randomization in the necitumumab with gemcitabine-cisplatin versus gemcitabine-cisplatin nonprogressor arm was 15.9 versus 15.0 months (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.69-1.05) and median progression-free survival (PFS) from randomization was 7.4 versus 6.9 months (HR, 0.86; 95% CI, 0.70-1.06). OS and PFS benefits were similar when assessed from the postinduction period and in EGFR-expressing patients. No new safety findings emerged. CONCLUSION: There was a consistent treatment effect in favor of necitumumab continuation versus that in gemcitabine-cisplatin nonprogressors, with no unexpected increases in AEs in intention-to-treat as well as EGFR-expressing populations.

[Occult bronchial foreign bodies - analysis of own material]. / Ciala obce przewlekle zalegajace w oskrzelach, analiza przypadków w materiale wlasnym

INTRODUCTION: The aspiration of a foreign body is usually combined with acute clinical symptoms requiring immediate medical intervention. Nevertheless, in approximately one third of patients the symptoms of aspiration are less prominent; such a clinical condition is called occult bronchial foreign body (OBFB). The aim of our study was to assess the frequency of OBFB in the pulmonary unit of a district hospital and to evaluate the diagnostic difficulties and treatment modalities in such patients. MATERIAL AND METHODS: The examined group consisted of patients hospitalized in the Department of Lung Diseases in Radom District Hospital. A retrospective analysis of medical records was preformed. RESULTS: In the period 1978-2008 - 12 patients (10 males, 2 females) were hospitalized due to OBFB. The foreign bodies occluded the bronchi over 2 months (3 to 7) in 4 patients. The moment of aspiration was not remembered by 8 patients. Cases of OBFB were rare. In the presented material the frequency was 4 per 10,000 hospitalizations and 8 per 10,000 bronchoscopies. In our region of 600,000 population the index of hospitalization due to OBFB in adults (〉 14 years of age) was 0.07 per 100,000 inhabitants/year. Foreign bodies mainly included bone fragments (5 cases), vegetal remnants - clove of garlic, ear of corn (3 patients), and other food remnants (2 patients). Occasionally other aspirates were found, such as a wooden peg or a piece of plastic. The aspiration took place mostly during meals. The patients developed one or more of the following symptoms: purulent pneumonia (3 cases), pleural empyema (1 case), atelectasis (5 cases), and recurrent bronchitis and pneumonia (2 cases). The foreign body (fragments of plants) was mimicking a bronchial tumour in 4 patients. Fibre optic or rigid bronchoscopy was applied successfully in 11 patients. Only one patient needed surgical intervention. CONCLUSION: OBFB is a rare condition, but has to be taken into consideration as a cause of chest radiological pathology and in patients with chronic and/or recurrent inflammatory disease of the respiratory system.

[Interstitial lung diseases among patients hospitalized in the Department of Respiratory Medicine in Radom District Hospital during the years 2000-2009]. / Analiza grupy chorych na sródmiazszowe choroby pluc hospitalizowanych w latach 2000­2009 na oddziale plucnym wojewódzkiego szpitala w Radomiu.

INTRODUCTION: There is little epidemiological data on interstitial lung diseases (ILDs) in Poland. The aim of the present study was to estimate the frequency of ILDs and frequency of the respiratory failure and the hospital mortality due to ILDs during the period 2000-2009 in Radom District Hospital. METHODS: Cases were identified through database of 20481 patients hospitalized in the Department of Respiratory Medicine in Radom District Hospital. The study encompassed the period from January 1, 2000 to December 31, 2009. According to national census data the total population of Radom region (former Radom Voivodeship) is about 630,000 adult (〉 14 years) inhabitants. The population is mixed urban/rural and remained stable during the period 2000-2009. Diagnosis of ILD was based on: clinical data, laboratory examination, high resolution lung CT scan (HRCT), lung function tests and in some patients - the results of open or transbronchial lung biopsies. ILDs were recorded in the hospital database according to ICD-10 criteria. RESULTS: Between 2000 and 2009 a total of 554 patients were diagnosed with ILDs, in the course of 708 hospitalizations. The mean number of hospitalizations per patient was 1.3 (range 1-11). Admissions due to ILDs encompassed 3.5% of the total hospital admissions. A 20% increase in the annual rate of hospitalizations due to ILDs (from 10.7/100,000 between 2000- -2004 to 12.8/100,000 between 2005-2009) was recorded. Most frequent ILD diagnosis was interstitial pneumonia and fibrosis (J84) - 55.7% (including idiopathic pulmonary fibrosis [IPF] - J84.1-27.5%) and sarcoidosis (D86) - 25%. During the study period the increase in hospitalizations was observed in patients with sarcoidosis (+55%) and in the group of interstitial pneumonia and fibrosis (+39%), but the decrease (-38%) in the group of pneumoconiosis (J60-J68). Sex ratio (M/F) was 1.5/1 for all ILDs; ranging from 1.2/1 for D86 and J84 to 4.7/1 for radiotherapy and drug induced ILDs (J70) and 7.1/1 for J60-J68. Respiratory failure was found in over 50% of patients with IPF and pneumoconiosis but only occasionally in the course of sarcoidosis (7%). 6.3% of all ILDs patients died within 10 years, the mortality was the highest in interstitial pneumonia and fibrosis (4.3% of all ILDs patients died due to J84) and the lowest in sarcoidosis (only 1 patient - 0.18% died due to D86). Crude incidence rates were estimated to be 8.8/100,000 adults (〉 14 years) for all ILDs; 5/100,000 for J84 (2.5/100 000 for J84.1, 0.3/100,000 for COP - cryptogenic organizing pneumonia and rare ILD's); 2.3/100,000 for D86, 1/100,000 for J60- -J68, 0.2/100,000 for J70 and 0.3/100,000 for collagen tissue disease associated ILDs (J99). Ten years prevalence rates per 100,000 adults were: 87.7 for all ILDs; 50 for J84 (25.5 for J84.1; 3 for COP and rare ILDs); 23.1 for D86; 9.8 for J60-J68; 2.1 for J70 and 2.7 for J99. CONCLUSIONS: The incidence rates of ILDs found in our study are lower than that reported in recent European studies. Our study was based on data of single hospital center for respiratory medicine and probably underestimate the real incidence rates of ILDs. On the other hand, 10 years prevalence estimates are concordant with available epidemiological data. Comparisons of the relative frequencies are probably accurate and idiopathic pulmonary fibrosis and sarcoidosis appear to be the most frequent ILDs.

[Long-term domiciliary oxygen therapy (LTOT) in Poland in the years 1986-2005]. / Domowe leczenie tlenem (DLT) w Polsce w latach 1986-2005.

INTRODUCTION: Long-term domiciliary oxygen therapy (LTOT) is part to of pulmonary care system. Uniform qualification criteria and methods of follow-up for patients undergoing LTOT have been adopted. There are 63 LTOT centres located in Poland run by specialists in pulmonology. On the occasion of 20 years of LTOT in Poland, an analysis of its development, number of patients treated, diagnoses, survival and equipment was performed. MATERIAL AND METHODS: Data were taken from structurized LTOT centres reports. RESULTS AND CONCLUSIONS: A history of LTOT may be divided into 3 periods, steady grow in the years 1986-1991, stagnation between 1992-2000 and rapid grow in the last 3 years. On 01.01.2006 there was 2601 patients receiving LTOT therapy. The most common diagnosis was COPD (85%) followed by kyphoscolisis (5%), TB sequels (4.6%), IPF (3.6%) and other rare diseases. Treatment is reimbursed by the National Health System. Oxygen is administered via an oxygen concentrator. Due to insufficient resources from the NHS the needs for LTOT treatment are not fulfilled. There are 8.4 patients treated with LTOT per 100 000 people, with large regional differences ranging from 3.7 to 14.9/100 000. The most frequent cause of death in patients receiving LTOT treatment was exacerbation of respiratory failure (71.3%), followed by sudden death (5.1%), myocardial infarction or pulmonary embolism (4.4%), lung cancer (4%) and other or not known causes (15.2%). Survival in patients receiving LTOT treatment from the years 1986-1995 was rather short: 54.6% survived less than 3 years, 3-4 years survived 13.3%, 4-5 years 11.3% and more than 5 years survived 19.7% of treated patients.

A pooled analysis of FEV1 decline in COPD patients randomized to inhaled corticosteroids or placebo.

BACKGROUND: There is controversy about whether therapy with inhaled corticosteroids (ICSs) modifies the natural history of COPD, characterized by an accelerated decline in FEV(1). METHODS: The Inhaled Steroids Effect Evaluation in COPD (ISEEC) study is a pooled study of patient-level data from seven long-term randomized controlled trials of ICS vs placebo lasting >/= 12 months in patients with moderate-to-severe COPD. We have previously reported a survival benefit for ICS therapy in COPD patients using ISEEC data. We aimed to determine whether the regular use of ICSs vs placebo improves FEV(1) decline in COPD patients, and whether this relationship is modified by gender and smoking. RESULTS: There were 3,911 randomized participants (29.2% female) in this analysis. In the first 6 months after randomization, ICS use was associated with a significant mean (+/- SE) relative increase in FEV(1) of 2.42 +/- 0.19% compared with placebo (p < 0.01), which is quantifiable in absolute terms as 42 mL in men and 29 mL in women over 6 months. From 6 to 36 months, there was no significant difference between placebo and ICS therapy in terms of FEV(1) decline (-0.01 +/- 0.09%; p = 0.86). The initial treatment effect was dependent on smoking status and gender. Smokers who continued to smoke had a smaller increase in FEV(1) during the first 6 months than did ex-smokers. Female ex-smokers had a larger increase in FEV(1) with ICS therapy than did male ex-smokers. CONCLUSIONS: We conclude that in COPD in the first 6 months of treatment, ICS therapy is more effective in ex-smokers than in current smokers with COPD in improving lung function, and women may have a bigger response to ICSs than men. However, it seems that after 6 months, ICS therapy does not modify the decline in FEV(1) among those who completed these randomized clinical trials.