Tocilizumab in COVID-19 interstitial pneumonia.

BACKGROUND: Published reports on tocilizumab in COVID-19 pneumonitis show conflicting results due to weak designs or heterogeneity in critical methodological issues. METHODS: This open-label trial, structured according to Simon's optimal design, aims to identify factors predicting which patients could benefit from anti-IL6 strategies and to enhance the design of unequivocal and reliable future randomized trials. A total of 46 patients with COVID-19 pneumonia needing of oxygen therapy to maintain SO2 > 93% and with recent worsening of lung function received a single infusion of tocilizumab. Clinical and biological markers were measured to test their predictive values. Primary end point was early and sustained clinical response. RESULTS: Twenty-one patients fulfilled pre-defined response criteria. Lower levels of IL-6 at 24 h after tocilizumab infusion (P = 0.049) and higher baseline values of PaO2/FiO2 (P = 0.008) predicted a favourable response. CONCLUSIONS: Objective clinical response rate overcame the pre-defined threshold of 30%. Efficacy of tocilizumab to improve respiratory function in patients selected according to our inclusion criteria warrants investigations in randomized trials.

Perioperative anemia and blood transfusions as prognostic factors in patients undergoing resection for non-small cell lung cancers.

We hypothesised that anemia could represent an important prognostic factor and perioperative blood transfusions do not reduce the risk of relapse. In order to explore this topic, we assessed the correlation of preoperative anemia and blood transfusions with survival in patients with resected non-small cell lung cancer (NSCLC). Patients who underwent radical surgery for NSCLC at the Department of Thoracic Surgery of Università Politecnica delle Marche from January 1996 through December 2001, were included in our study. Four hundred and thirty-nine patients were eligible for our analysis. Survival appeared worse in patients with haemoglobin (Hb) < or =10 g/dl versus Hb >10 g/dl (p=0.012). Stratifying patients in three groups on their Hb level (group 1: Hb < or =10 g/dl; group 2: Hb=10-12 g/dl; group 3: Hb > or =12 g/dl), we observed a worse prognosis in patients with lower Hb levels, too (p=0.0325) and also in the transfused population (p=0.046). At multivariate analysis, only the age of patients, pathological stage and Hb levels resulted indicators of prognosis. Our results suggested that anemia could represent an important prognostic factor in resected NSCLC and correction of anemia in the perioperative setting does not reduce the risk of relapse.

Integration of TBNA and TCNA in the diagnosis of peripheral lung nodules. Influence on staging.

Although transbronchial and percutaneous approaches to peripheral pulmonary lesions (PPL) are widely diffused, effective and safe diagnostic techniques, no standardised strategy yet exists that defines the specific role of each in this clinical setting. With the aim of defining the role of each approach and of verifying if the two techniques are alternative or may be integrated in a logical diagnostic sequence based on the advantages and the limits of each biopsy method, the authors analysed their experience with the integrated use of transbronchial and percutaneous approach to PPL performed on 1,680 consecutive patients affected by PPL. The procedure used was as follows: 1) bronchoscopy with exploration of the bronchial tree and transbronchial needle aspiration (TBNA) of hilar/mediastinal lympho nodes for staging N factor followed by TBNA and transbronchial pulmonary biopsy (TBPB) of the PPL under fluoroscopic guidance and immediate cytological assessment (ICA); 2) if TBNA was diagnostic, the procedure was stopped; if not, a second pass with the needle was performed and then the bronchoscope removed; 3) if the second TBNA was not diagnostic, percutaneous approach (PCNA) with ICA was performed up to a maximum of three needle passes. Diagnostic sensitivity for malignant lesions was: 50.0% for TBPB, 70.1% for TBNA, 76.0% for TBPB and TBNA together, 92.8% for PCNA, and 95.0% overall. The percentage of benign nodules correctly defined was 43.0% for TBPB, 16.7% for TBNA, 47.8% for PCNA. Examination of the upper airways and bronchial tree was positive for lesions endoscopically visible in 11.4% of cases. TBNA of hilar/mediastinal lympho nodes was positive for metastatic involvement in 43.9%. The authors' experience demonstrates that transbronchial and percutaneous approaches must be considered complementary and that their integrated use not only increases diagnostic yield but also permits important information to be obtained for the staging of lung cancer. The creation of teams able to utilise both approaches with the cytopathologist present for ICA should be encouraged in order to optimise the diagnostic management of PPL.

A phase II study of mitomycin C, vindesine and cisplatin combined with alpha interferon in advanced non-small cell lung cancer.

AIMS AND BACKGROUND: MVP chemotherapy (mitomycin C, vindesine or vinblastine, cisplatin) is one of the most commonly used regimens for advanced non-small cell lung cancer (NSLCLC). Experimental data suggest a synergistic cytotoxic activity of alpha-interferon (alpha-IFN) when combined with cisplatin, mitomycin C and vinca alkaloids. In an effort to improve MVP chemotherapy activity, we have combined this regimen with alpha-IFN. PATIENTS AND METHODS: Thirty-five patients with advanced NSCLC (19 stage IV) were treated with the MVP regimen (mitomycin C, 8 mg/m2; vindesine, 3 mg/m2, cisplatin, 75 mg/m2, all on day 1) plus alpha-2a-IFN, 3x10(6) U from day 1 to 7. The cycles were repeated every 28 days. RESULTS: There were no complete responses and 18 partial responses, for an overall response rate of 51%. Median time to treatment failure was 6 months (range, 1-18), and the median survival was 9.5 months (range, 1-32). WHO grade 3 toxicity was recorded in up to 8% of patients, flu-like syndrome was a common complaint; one toxic death occurred. CONCLUSIONS: The combination yielded a level of response comparable to that of other cisplatin-based regimens. Larger randomized trials are needed to assess the role of alpha-IFN combined with chemotherapy in advanced NSCLC.

Integration of transbronchial and percutaneous approach in the diagnosis of peripheral pulmonary nodules or masses. Experience with 1,027 consecutive cases.

A study to evaluate the usefulness of the integration of the transbronchial and percutaneous approaches in the diagnosis of peripheral pulmonary nodules or masses (PPN/M) was conducted. The authors used both procedures, performed by a single diagnostic team, a pulmonologist, radiologist, and cytopathologist, who were all simultaneously present in the radiologic suite during the maneuvers. From January 1985 to June 1993, under fluoroscopic guidance, the authors performed 557 transbronchial pulmonary biopsies (TBPB), 483 transbronchial needle aspirations (TBNA), and 652 percutaneous needle aspirations (PCNA) on 1,027 consecutive patients referred because of a PPN/M (mean diameter, 3.5 cm; range, 0.8 to 8 cm). The procedure used was as follows: (1) bronchoscopy with exploration of the upper airways and bronchial tree, followed by TBNA and immediate cytologic assessment (ICA); (2) at least three TBPB; (3) if TBNA was diagnostic, the procedure was stopped; if not, a second pass with the needle was performed and then the bronchoscope was removed; (4) if the second TBNA was not diagnostic, PCNA with ICA was performed up to a maximum of three needle passes. Diagnostic sensitivity for malignant lesions was as follows: 53.9% for TBPB, 69.3% for TBNA, 75.4% for TBPB and TBNA together, 93.2% for PCNA, and 95.2% overall. The percentage of benign nodules correctly defined was 41.4% for TBPB, 17.4% for TBNA, 45.8% for PCNA, and 59.5% overall. Examination of the upper airways and bronchial tree was positive for lesions endoscopically visible in 12.6% of cases. The authors' experience shows that transbronchial and percutaneous approaches must be considered complementary and that their integrated use not only increases diagnostic yield but also permits important information to be obtained for disease staging. The creation of teams able to use both approaches with the cytopathologist present for ICA should be encouraged to optimize the diagnostic management of PPN/M with a reduction in diagnostic and hospitalization time and consequent cost saving.

New indices of arterial oxygen status: an experience on 168 subjects.

We investigated the repeatability and the clinical usefulness of assessing several parameters related to oxygen status in arterial blood. pH, PaCO2, PaO2, oxygen saturation, total hemoglobin concentration, and fractions of carboxy- and methemoglobin were measured in arterial blood. Applying a new algorithm, other parameters were calculated from the above mentioned, among which total oxygen concentration, half saturation tension, 2,3-DPG concentration, uncompensated mixed venous oxygen tension, and cardiac oxygen compensation factor. In 12 subjects we performed three simultaneous determinations of these indices with a good repeatability of the measures. Then, we examined the same parameters in 92 subjects with normal PaO2, 52 patients with respiratory failure (38 normocapnic and 14 hypercapnic), 9 of which were monitored to follow the behaviour of the measures with time according to variations of the clinical status, and in 12 subjects before and after exercise. We found that important alterations in oxygen transport and delivery may be present even when oxygen tension in arterial blood is normal. Furthermore, oxygen status of arterial blood in respiratory failure may be affected by several factors, whose knowledge is essential for a proper treatment. Our data suggest that such an approach to the evaluation of oxygen status offers interesting clinical perspectives.