Becerra C.R.,Texas Oncology Sammons Cancer Center at Baylor |
Salazar R.,Hospital Duran i Reynals |
Garcia-Carbonero R.,University of Seville |
Thomas A.L.,University of Leicester |
And 8 more authors.
Cancer Chemotherapy and Pharmacology | Year: 2014
Purpose: Figitumumab (CP-751,871) is a human IgG2 monoclonal antibody that binds and down-regulates insulin-like growth factor receptor-1 (IGF-1R) and inhibits activation of this receptor by IGF-1 and IGF-2. This nonrandomized, open-label, single-arm, phase II trial evaluated the antitumor activity and safety of figitumumab in patients with metastatic colorectal cancer that was refractory to ≥ 2 systemic therapies. Methods: Cohorts A and B received intravenous figitumumab 20 and 30 mg/kg in 3-week cycles, respectively. Both received loading doses (20 or 30 mg/kg) on days 1 and 2 of cycle 1. The primary endpoint was 6-month survival (null hypothesis for each cohort, H0: p6 mo surv = 0.45). Secondary endpoints included progression-free survival (PFS), overall survival (OS), objective response, safety, and pharmacokinetics. Results: A total of 168 patients (Cohort A, n = 85; Cohort B, n = 83) received figitumumab. Estimated 6-month survival was 49.4 % (95 % CI 38.8-60.0) in Cohort A and 44.1 % (95 % CI 33.4-54.9) in Cohort B. Median OS was 5.8 and 5.6 months, respectively; median PFS was 1.4 months in both cohorts. No objective partial or complete responses occurred. The respective rates of treatment discontinuation due to treatment-related adverse events (AEs) were 5 and 7 %. The most common grade 3/4 nonhematologic AEs in both cohorts were hyperglycemia and asthenia. No grade 4 hematologic laboratory abnormalities occurred. Most deaths were reported as due to progressive disease; none were due to figitumumab. Conclusion: Six-month survival data do not support further study of figitumumab 20 or 30 mg/kg in this patient population. © 2014 Springer-Verlag Berlin Heidelberg.
PubMed | Elche General University Hospital and University Miguel Hernández
Type: | Journal: Chest | Year: 2016
Some studies suggest that lung ultrasound could be useful for diagnosing pneumonia; moreover, it has a more favorable safety profile and lower cost than chest X-ray (CXR) and computed tomography (CT). The aim of this study is to assess the accuracy of bedside lung ultrasound for diagnosing pneumonia in adults through a systematic review and meta-analysis.We searched MEDLINE, Scopus, The Cochrane Library, Web of Science, DARE, HTA Database, Google Scholar, LILACS, ClinicalTrials.gov, TESEO and OpenGrey. In addition, we reviewed the bibliographies of relevant studies. Two researchers independently selected studies that met the inclusion criteria. Quality of the studies was assessed in accordance with the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. The summary receiver operating characteristics (SROC) curve and a pooled estimation of the diagnostic odds ratio (DOR) was estimated using using a bivariate random-effects analysis. The sources of heterogeneity were explored using predefined subgroup analyses and bivariate meta-regression.Sixteen studies (2359 participants) were included. There was significant heterogeneity of both sensitivity and specificity according to Q test, without clear evidence of threshold effect. The area under the SROC curve was 0.93, with a DOR at the optimal cutpoint of 50 (95% confidence interval (CI): 21, 120). A tendency towards a higher area under the SROC curve in high quality studies was detected, however these differences were not significant after applying the bivariate meta-regression.Lung ultrasound can help to accurately diagnose pneumonia, and it may be promising as an adjuvant resource to traditional approaches.