In this prospective phase III trial, afatinib combined with paclitaxel improved progression-free survival and objective response, compared with single-agent chemotherapy, in patients with NSCLC who were clinically enriched for ErbB dependency having failed platinum-based chemotherapy, gefitinib/erlotinib and afatinib monotherapy after initial benefit on each tyrosine kinase inhibitor.

BackgroundPF-06439535 is a bevacizumab biosimilar. We aimed to compare the efficacy and safety of PF-06439535 with that of reference bevacizumab (Avastin®) sourced from the EU (bevacizumab-EU), each with paclitaxel and carboplatin, in the first-line treatment of advanced non-squamous non-small-cell lung cancer (NSCLC).MethodsIn this double-blind, parallel-group study, we recruited patients from 159 centers in 27 countries. Participants were randomized 1:1 to receive PF-06439535 plus paclitaxel and carboplatin or bevacizumab-EU plus paclitaxel and carboplatin on day 1 of each 21-day cycle for 4–6 cycles, followed by blinded monotherapy with PF-06439535 or bevacizumab-EU until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study. Randomization was stratified by region, sex, and smoking history. The primary endpoint was objective response rate (ORR) in accordance with RECIST 1.1, based on responses achieved by week 19 and confirmed by week 25.ResultsBetween 21 May 2015 and 14 November 2016, 719 patients were randomized to the PF-06439535 group (n = 358) or the bevacizumab-EU group (n = 361). As of data cutoff for analysis of the primary endpoint (8 May 2017), 45.3% (95% confidence interval [CI] 40.01–50.57) of patients in the PF-06439535 group and 44.6% (95% CI 39.40–49.89) of patients in the bevacizumab-EU group achieved an objective response by week 19 that was confirmed by week 25. The unstratified ORR risk ratio was 1.015 (95% CI 0.863–1.193; 90% CI 0.886–1.163), and the unstratified ORR risk difference was 0.653% (95% CI − 6.608 to 7.908); all three CIs fell within pre-specified equivalence margins. Using final data after study completion (22 December 2017), no notable differences in progression-free survival or overall survival were observed between the groups. The most frequently reported grade 3 or higher treatment-emergent adverse events were hypertension, neutropenia, and anemia. There were no clinically meaningful differences in safety, pharmacokinetics, or immunogenicity across treatment groups.ConclusionAmong patients with advanced non-squamous NSCLC, PF-06439535 demonstrated similarity to bevacizumab-EU in terms of efficacy. Safety profiles for the two treatments were comparable.Trial RegistrationClinicalTrials.gov, NCT02364999.FundingPfizer.Electronic supplementary materialThe online version of this article (10.1007/s40259-019-00363-4) contains supplementary material, which is available to authorized users.

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PurposeTo analyze and quantify the prevalence of six comorbidities from lung cancer screening (LCS) on computed tomography (CT) scans of patients from developing countries.MethodsFor this retrospective study, low-dose CT scans (n=775) from patients who underwent LCS in a tertiary hospital between 2016 and 2020 were examined. Age and sex- matched control group was obtained for comparison (n=370). Using the software, coronary artery calcification (CAC), the skeletal muscle area (SMA), interstitial lung abnormalities (ILAs), emphysema, osteoporosis, and hepatic steatosis was accessed. Clinical characteristics of each participant were identified. t-test and chi-squared test were used to examine differences between these values. Interclass correlation coefficients (ICCs) and Interobserver agreement (assessed by calculating kappa coefficients) were calculated to assess the correlation of measures interpreted by two observers. p values<0.05 were considered significant.ResultsOne or more comorbidities were identified in 86.6% of the patients and in 40% of the controls. The most prevalent comorbidity was osteoporosis, present in 44.2% of patients and on 24.8% of the controls. New diagnoses of cardiovascular disease, emphysema, and osteoporosis were made in 25%, 7%, and 46% of cases, respectively. The kappa coefficient for CAC was 0.906 (p<0.001). ICCs for measures of liver, spleen, and bone density were 0.88, 0.93, and 0.96, respectively (p<0.001).ConclusionsCT data acquired during LCS led to the identification of previously undiagnosed comorbidities. The LCS is useful to facilitate comorbidity diagnosis in developing countries, providing opportunities for its prevention and treatment.

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