[Effect of AM3 on health-related quality of life in patients with chronic obstructive pulmonary disease belonging to risk groups]. / Efecto de AM3 en la calidad de vida de pacientes con enfermedad pulmonar obstructiva crónica en subgrupos de riesgo.

BACKGROUND AND OBJECTIVE: AM3 is an immunomodulator that significantly improves the quality of life of patients with chronic obstructive pulmonary disease (COPD). This study examined the effect of AM3 on the quality of life of patients in different risk groups and identified the factors associated with change in this variable. PATIENTS AND METHOD: This was a randomized, double-blind, placebo-controlled trial involving parallel groups of patients. The duration of the trial was 6 months. The study involved 253 patients with a mean (standard deviation) age of 67.7 (8.1) years and a mean forced expiratory volume in one second (FEV1) of 49.7% (10.2%). RESULTS: Only 121 patients (47.8%) suffered at least one exacerbation during the 6 months period. At the end of the study period, the improvement in St. George's Respiratory Questionnaire (SGRQ) score in those patients who suffered an exacerbation but who received AM3 was significantly greater than that experienced by similar placebo-treated patients (-8.10 compared to -2.5 units; p=0.034). Patients treated with inhaled corticoids also improved more with AM3 than with placebo (-9.17 compared to -4.44; p=0.035). In the 108 patients with an FEV1 of <50%, the improvements were not significantly different (-9.57 vs. -6.57; p=0.23). The factors influencing the change in SGRQ score were baseline SGRQ (p<0.001), exacerbations (p<0.008), an FEV1 of <50% (p<0.032) and treatment with AM3 (p<0.004). CONCLUSIONS: Among the patients who experienced exacerbations, treatment with AM3 helped prevent the deterioration of their quality of life. Along with AM3 treatment, the factors that independently influenced the change in SGRQ score were suffering from an exacerbation and poorer pulmonary function.

Low-dose CT: a useful and accessible tool for the early diagnosis of lung cancer in selected populations.

OBJECTIVE: An evaluation is made of the effectiveness of low-dose computed tomography (LDCT) in diagnosing early stage lung cancer in the Autonomous Community of Madrid (Spain). METHODS: The study comprised subjects over 50 years of age who were active smokers (or who had stopped smoking up to 6 months previously) who smoked more than 30 cigarettes daily for at least 15 years, or 20 cigarettes daily for 20 years, or more than 10packs/year and in contact with asbestos at work. The study group was evaluated using LDCT. For all participants in whom LDCT showed no pathological findings, or in those cases classified as benign, a new LDCT scan was performed 2 years after the first. In case of doubt regarding the benign nature of the findings, an assessment algorithm was applied. RESULTS: Among the initial 482 candidates in the study group, 466 LDCT scans were performed at baseline, revealing 9 extrapulmonary lesions and 114 pulmonary lesions in 98 subjects. The latter raised diagnostic doubts in 32 cases; of these, 15 were confirmed as benign by high resolution computed tomography (HRCT). In the remaining 17 cases, stage IAp adenocarcinoma was diagnosed at baseline (0.2%). With LDCT after 2 years, an additional four adenocarcinomas were diagnosed-all in stage IAp (0.98%). The complete study, including prevalence cut-off and incidence calculation after 2 years, resulted in the diagnosis of five cancers (1.1%) and two false positive cases (28%). CONCLUSIONS: The use of low-dose computed tomography in risk groups is valid for the early diagnosis of bronchogenic cancer. Nevertheless, significant problems remain, particularly those associated with false positive interpretations. The results of randomized studies on lung cancer mortality such as the US NLST trial and the Dutch-Belgian NELSON trial have to be awaited before any conclusion regarding the effectiveness of LDCT screening can be drawn.

Treatment with the immunomodulator AM3 improves the health-related quality of life of patients with COPD.

BACKGROUND: COPD has a severe impact on patient quality of life. AM3 is an orally effective immunomodulator that can normalize the defective antimicrobial functions of the immune system effector cells of COPD patients. OBJECTIVES: We analyzed the effect of AM3 on exacerbation frequency and health-related quality of life (HRQL) of COPD patients with moderate disease. DESIGN: A randomized, double-blind, placebo-controlled trial. SETTING: Outpatient departments of 21 hospitals. METHODS: A total of 253 COPD patients with a mean age of 67.7 years (SD, 8.1 years) and mean FEV(1) percentage of predicted of 49.6% (SD, 10.2%) were evaluated. Patients received (orally) either 3 g/d AM3 or a matched placebo for 180 consecutive days. Patient quality of life was measured using the St. George's Respiratory Questionnaire (SGRQ). RESULTS: There were no differences in the exacerbation frequency of the two groups (0.82 episodes per patient in the AM3 arm vs 0.84 in the placebo arm), and 55.3% of patients were exacerbation free in the AM3 arm compared to 48.8% in the placebo arm (p = 0.11). At the end of treatment, quality of life was significantly better in the AM3 arm than in the placebo arm (SGRQ total score, 32.9; SD, 16.4, compared to 37.5; SD, 17.5 [p < 0.05]: activity score, 47.5; SD, 22.4, compared to 54.6; SD, 20.5 [p < 0.05]). The improvements in total SGRQ scores were 8.9 U (SD, 13.4 U) in the AM3 arm and 5.6 U (SD, 15.9 U) in the placebo arm (p = 0.076). Improvements on the symptoms subscale were 15.9 U (SD, 20.7 U) for the AM3 arm and 10.2 U (SD, 21.3 U) for the placebo arm (p < 0.05). Both AM3 and the placebo were clinically, biochemically, and hematologically well tolerated. CONCLUSIONS: AM3 is a safe, easily tolerated, effective treatment that improves the quality of life of COPD patients as measured by SGRQ scores. This effect was observed with no significant reduction in the frequency of exacerbations.

Prognostic significance of tumor infiltrating natural killer cells subset CD57 in patients with squamous cell lung cancer.

Natural killer (NK) cells have been implied in the resistance against certain tumors and virally-infected cells. The prognostic significance of tumor infiltrating NK cells in primary squamous cell lung carcinoma (SqCLC) has not been fully studied. Fifty patients with primary SqCLC were evaluated for the presence of tumor infiltrating natural killer cells subset CD57 (TINK) after surgery. None of them received adjuvant therapy. Immunohistochemical studies of surgery pieces were performed by using the monoclonal antibody CD57. The number of TINK cells was counted by using a MICRON image analyzer. The total area studied for each tumor was of 1 cm(2). In this area, 50 intratumoral fields of 0.173 mm(2) were selected. The reference value used was the median (five TINK cells/field) of all tumors analyzed. After a minimum follow-up of 2 years the Kaplan-Meier method was used to obtain survival curves. Multivariate analysis were performed by using the Cox regression model. The survival was significantly better in patients with more than five TINK cells/field (Logrank P=0.0317). According to TNM classification, in those patients screened as stage IB (37 patients) the differences in survival were significantly higher (Logrank P=0.0016). In the multivariate analysis including TNM (surgical-pathologic stage), age, and endoscopy localization, the risk of death in patients with less than five TINK cells/field was 2.50 fold higher (CI 95%; range 1.07-5.85) than in those patients with more than five TINK cells/field. These results show that TINK cells appear to be a prognostic factor in the survival of patients with SqCLC. The possible antitumoral role of these cells in SqCLC is discussed.