RE: Low-Dose Aspirin in High-Risk Individuals With Screen-Detected Subsolid Lung Nodules: A Randomized Phase II Trial.
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ABSTRACT:
SUBMITTER: Braillon A
PROVIDER: S-EPMC7853177 | biostudies-literature | 2021 Feb
REPOSITORIES: biostudies-literature
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RE: Low-Dose Aspirin in High-Risk Individuals With Screen-Detected Subsolid Lung Nodules: A Randomized Phase II Trial.
JNCI cancer spectrum 20210123 1
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Project description:Lung cancer screening by helical low-dose computed tomography detects nonsolid nodules that may be lung adenocarcinoma precursors. Aspirin's anti-inflammatory properties make it an attractive target for prevention of multiple cancers, including lung cancer. Therefore, we conducted a phase IIb trial (NCT02169271) to study the efficacy of low-dose aspirin to reduce the size of subsolid lung nodules (SSNs). A total of 98 current or former smokers (67.3% current) undergoing annual low-dose computed tomography screening with persistent SSNs were randomly assigned to receive aspirin 100 mg/day or placebo for 1 year. There was no difference in change in the sum of the longest diameters of target nodules in the placebo and aspirin arm after 12 months of treatment (-0.12 mm [SD = 1.55 mm] and +0.30 mm [SD= 2.54 mm], respectively; 2-sided P = .33 primary endpoint). There were no changes observed in subgroup analyses by individual characteristics or nodule type. One year of low-dose aspirin did not show any effect on lung SSNs. SSNs regression may not be the proper target for aspirin, and/or longer duration may be needed to see SSNs modifications.
| S-EPMC7771428 | biostudies-literature
Project description:PurposeTo evaluate whether, and to which extent, experienced radiologists are able to visually correctly differentiate transient from persistent subsolid nodules from a single CT examination alone and to determine CT morphological features to make this differentiation.Materials and methodsWe selected 86 transient and 135 persistent subsolid nodules from the National Lung Screening Trial (NLST) database. Four experienced radiologists visually assessed a predefined list of morphological features and gave a final judgment on a continuous scale (0-100). To assess observer performance, area under the receiver operating characteristic (ROC) curve was calculated. Statistical differences of morphological features between transient and persistent lesions were calculated using Chi-square. Inter-observer agreement of morphological features was evaluated by percentage agreement.ResultsForty-nine lesions were excluded by at least 2 observers, leaving 172 lesions for analysis. On average observers were able to differentiate transient from persistent subsolid nodules ≥ 10 mm with an area under the curve of 0.75 (95% CI 0.67-0.82). Nodule type, lesion margin, presence of a well-defined border, and pleural retraction showed significant differences between transient and persistent lesions in two observers. Average pair-wise percentage agreement for these features was 81%, 64%, 47% and 89% respectively. Agreement for other morphological features varied from 53% to 95%.ConclusionThe visual capacity of experienced radiologists to differentiate persistent and transient subsolid nodules is moderate in subsolid nodules larger than 10 mm. Performance of the visual assessment of CT morphology alone is not sufficient to generally abandon a short-term follow-up for subsolid nodules.
| S-EPMC5810988 | biostudies-literature
Project description:Screening CT identifies small peripheral lung nodules, some of which may be pre- or early invasive neoplasia. Secondary end point analysis of a previous chemoprevention trial in individuals with bronchial dysplasia showed reduction in size of peripheral nodules by inhaled budesonide. We performed a randomized, double-blind, placebo-controlled phase IIb trial of inhaled budesonide in current and former smokers with CT-detected lung nodules that were persistent for at least 1 year. A total of 202 individuals received inhaled budesonide, 800 μg twice daily or placebo for 1 year. The primary endpoint was the effect of treatment on target nodule size in a per person analysis after 1 year. The per person analysis showed no significant difference between the budesonide and placebo arms (response rate 2% and 1%, respectively). Although the per lesion analysis revealed a significant effect of budesonide on regression of existing target nodules (P = 0.02), the appearance of new lesions was similar in both groups and thus the significance was lost in the analysis of all lesions. The evaluation by nodule type revealed a nonsignificant trend toward regression of nonsolid and partially solid lesions after budesonide treatment. Budesonide was well tolerated, with no unexpected side effects identified. Treatment with inhaled budesonide for 1 year did not significantly affect peripheral lung nodule size. There was a trend toward regression of nonsolid and partially solid nodules after budesonide treatment. Because a subset of these nodules is more likely to represent precursors of adenocarcinoma, additional follow-up is needed.
| S-EPMC3017323 | biostudies-literature
Project description:The broad application of low-dose computed tomography (CT) screening has resulted in the detection of many small pulmonary nodules. In Asia, a large number of these detected nodules with a radiological ground glass pattern are reported as lung adenocarcinomas or premalignant lesions, especially among female non-smokers. In this review article, we discuss controversial issues and conditions involving these subsolid pulmonary nodules that we often face in Asia, including a lack or insufficiency of current guidelines; the roles of preoperative biopsy and imaging; the location of lesions; appropriate selection of localization techniques; the roles of dissection and sampling of frozen sections and lymph nodes; multifocal lesions; and the roles of non-surgical treatment modalities. For these complex issues, we have tried to present up-to-date evidence and our own opinions regarding the management of subsolid nodules. It is our hope that this article helps surgeons and physicians to manage the complex issues involving ground glass nodules (GGNs) in a balanced manner in their daily practice and provokes further discussion towards better guidelines and/or algorithms.
| S-EPMC8182721 | biostudies-literature
Project description:The purpose of this case-cohort study was to investigate whether the frequency and computed tomography (CT) features of pulmonary nodules posed a risk for the future development of lung cancer (LC) at a different location. Patients scanned between 2004 and 2012 at two Dutch academic hospitals were cross-linked with the Dutch Cancer Registry. All patients who were diagnosed with LC by 2014 and a random selection of LC-free patients were considered. LC patients who were determined to be LC-free at the time of the scan and all LC-free patients with an adequate scan were included. The nodule count and types (solid, part-solid, ground-glass, and perifissural) were recorded per scan. Age, sex, and other CT measures were included to control for confounding factors. The cohort included 163 LC patients and 1178 LC-free patients. Cox regression revealed that the number of ground-glass nodules and part-solid nodules present were positively correlated to future LC risk. The area under the receiver operating curve of parsimonious models with and without nodule type information were 0.827 and 0.802, respectively. The presence of subsolid nodules in a clinical setting may be a risk factor for future LC development in another pulmonary location in a dose-dependent manner. Replication of the results in screening cohorts is required for maximum utility of these findings.
| S-EPMC8200192 | biostudies-literature
Project description:BackgroundDue to widespread use of low-dose computed tomography (LDCT) screening, increasing number of patients are found to have subsolid nodules (SSNs). The management of SSNs is a clinical challenge and primarily depends on CT imaging. We seek to identify risk factors that may help clinicians determine an optimal course of management.MethodsWe retrospectively reviewed the characteristics of 83 SSN lesions, including 48 pure ground-glass nodules and 35 part-solid nodules, collected from 83 patients who underwent surgical resection.ResultsOf the 83 SSNs, 16 (19.28%) were benign and 67 (80.72%) were malignant, including 23 adenocarcinomas in situ (AIS), 16 minimally invasive adenocarcinomas (MIA), and 28 invasive adenocarcinomas (IA). Malignant lesions were found to have significantly larger diameters (P<0.05) with an optimal cut-off point of 9.24 mm. Significant indicators of malignancy include female sex (P<0.05), air bronchograms (P<0.001), spiculation (P<0.05), pleural tail sign (P<0.05), and lobulation (P<0.05). When compared with AIS/MIA combined, IA lesions were found to be larger (P<0.05) with an optimal cut-off of 12 mm, and have a higher percentage of part-solid nodules (P<0.001), pleural tail sign (P<0.001), air bronchograms (P<0.05), and lobulation (P<0.05). Further multivariate analysis found that lesion size and spiculation were independent factors for malignancy while part-solid nodules were associated with IA histology.ConclusionsEast Asian females are at risk of presenting with a malignant lesion even without history of heavy smoking or old age. Nodule features associated with malignancy include larger size, air bronchograms, lobulation, pleural tail sign, spiculation, and solid components. A combination of patient characteristic and LDCT features can be effectively used to guide management of patients with SSNs.
| S-EPMC7475597 | biostudies-literature
Project description:Lung cancer screening (LCS) is gaining some interest worldwide after positive results from International trials. Unlike other screening practices, LCS is performed by an extremely sensitive test, namely low-dose computed tomography (LDCT) that can detect the smallest nodules in lung parenchyma. Up-to-date detection approaches, such as computer aided detection systems, have been increasingly employed for lung nodule automatic identification and are largely used in most LCS programs as a complementary tool to visual reading. Solid nodules of any size are represented in the vast majority of subjects undergoing LDCT. However, less than 1% of solid nodules will be diagnosed lung cancer. This fact calls for specific characterization of nodules to avoid false positives, overinvestigation, and reduce the risks associated with nodule work up. Recent research has been exploring the potential of artificial intelligence, including deep learning techniques, to enhance the accuracy of both detection and characterisation of lung nodule. Computer aided detection and diagnosis algorithms based on artificial intelligence approaches have demonstrated the ability to accurately detect and characterize parenchymal nodules, reducing the number of false positives, and to outperform some of the currently used risk models for prediction of lung cancer risk, potentially reducing the proportion of surveillance CT scans. These forthcoming approaches will eventually integrate a new reasoning for development of future guidelines, which are expected to evolve into precision and personalized stratification of lung cancer risk stratification by continuous fashion, as opposed to the current format with a limited number of risk classes within fixed thresholds of nodule size. This review aims to detail the standard of reference for optimal management of solid nodules by low-dose computed and its projection into the fine selection of candidates for work up.
| S-EPMC8182712 | biostudies-literature
Project description: Not available
| S-EPMC10777245 | biostudies-literature
Project description:Conventionally, evaluation of a new drug, A, is done in three phases. Phase I is based on toxicity to determine a "maximum tolerable dose" (MTD) of A, phase II is conducted to decide whether A at the MTD is promising in terms of response probability, and if so a large randomized phase III trial is conducted to compare A to a control treatment, C, usually based on survival time or progression free survival time. It is widely recognized that this paradigm has many flaws. A recent approach combines the first two phases by conducting a phase I-II trial, which chooses an optimal dose based on both efficacy and toxicity, and evaluation of A at the selected optimal phase I-II dose then is done in a phase III trial. This paper proposes a new design paradigm, motivated by the possibility that the optimal phase I-II dose may not maximize mean survival time with A. We propose a hybridized design, which we call phase I-II/III, that combines phase I-II and phase III by allowing the chosen optimal phase I-II dose of A to be re-optimized based on survival time data from phase I-II patients and the first portion of phase III. The phase I-II/III design uses adaptive randomization in phase I-II, and relies on a mixture model for the survival time distribution as a function of efficacy, toxicity, and dose. A simulation study is presented to evaluate the phase I-II/III design and compare it to the usual approach that does not re-optimize the dose of A in phase III.
| S-EPMC6486466 | biostudies-literature
Project description:ObjectivesTo validate the performances of two prediction models (Brock and Lee models) for the differentiation of minimally invasive adenocarcinoma (MIA) and invasive pulmonary adenocarcinoma (IPA) from preinvasive lesions among subsolid nodules (SSNs).DesignA retrospective cohort study.SettingA tertiary university hospital in South Korea.Participants410 patients with 410 incidentally detected SSNs who underwent surgical resection for the pulmonary adenocarcinoma spectrum between 2011 and 2015.Primary and secondary outcome measuresUsing clinical and radiological variables, the predicted probability of MIA/IPA was calculated from pre-existing logistic models (Brock and Lee models). Areas under the receiver operating characteristic curve (AUCs) were calculated and compared between models. Performance metrics including sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) were also obtained.ResultsFor pure ground-glass nodules (n=101), the AUC of the Brock model in differentiating MIA/IPA (59/101) from preinvasive lesions (42/101) was 0.671. Sensitivity, specificity, accuracy, PPV and NPV based on the optimal cut-off value were 64.4%, 64.3%, 64.4%, 71.7% and 56.3%, respectively. Sensitivity, specificity, accuracy, PPV and NPV according to the Lee criteria were 76.3%, 42.9%, 62.4%, 65.2% and 56.3%, respectively. AUC was not obtained for the Lee model as a single cut-off of nodule size (≥10 mm) was suggested by this model for the assessment of pure ground-glass nodules. For part-solid nodules (n=309; 26 preinvasive lesions and 283 MIA/IPAs), the AUC was 0.746 for the Brock model and 0.771 for the Lee model (p=0.574). Sensitivity, specificity, accuracy, PPV and NPV were 82.3%, 53.8%, 79.9%, 95.1% and 21.9%, respectively, for the Brock model and 77.0%, 69.2%, 76.4%, 96.5% and 21.7%, respectively, for the Lee model.ConclusionsThe performance of prediction models for the incidentally detected SSNs in differentiating MIA/IPA from preinvasive lesions might be suboptimal. Thus, an alternative risk calculation model is required for the incidentally detected SSNs.
| S-EPMC5988095 | biostudies-literature