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Long-term effects of inhaled budesonide on screening-detected lung nodules.

ABSTRACT: BACKGROUND:A previously carried out randomized phase IIb, placebo-controlled trial of 1 year of inhaled budesonide, which was nested in a lung cancer screening study, showed that non-solid and partially solid lung nodules detected by low-dose computed tomography (LDCT), and not immediately suspicious for lung cancer, tended to regress. Because some of these nodules may be slow-growing adenocarcinoma precursors, we evaluated long-term outcomes (after stopping the 1-year intervention) by annual LDCT. PATIENTS AND METHODS:We analyzed the evolution of target and non-target trial nodules detected by LDCT in the budesonide and placebo arms up to 5 years after randomization. The numbers and characteristics of lung cancers diagnosed during follow-up were also analyzed. RESULTS:The mean maximum diameter of non-solid nodules reduced significantly (from 5.03 mm at baseline to 2.61 mm after 5 years) in the budesonide arm; there was no significant size change in the placebo arm. The mean diameter of partially solid lesions also decreased significantly, but only by 0.69 mm. The size of solid nodules did not change. Neither the number of new lesions nor the number of lung cancers differed in the two arms. CONCLUSIONS:Inhaled budesonide given for 1 year significantly decreased the size of non-solid nodules detected by screening LDCT after 5 years. This is of potential importance since some of these nodules may progress slowly to adenocarcinoma. However, further studies are required to assess clinical implications. CLINICAL TRIAL NUMBER:NCT01540552.

SUBMITTER: Veronesi G

PROVIDER: S-EPMC4405280 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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Long-term effects of inhaled budesonide on screening-detected lung nodules.

Veronesi G G Lazzeroni M M Szabo E E Brown P H PH DeCensi A A Guerrieri-Gonzaga A A Bellomi M M Radice D D Grimaldi M C MC Spaggiari L L Bonanni B B

Annals of oncology : official journal of the European Society for Medical Oncology 20150211 5

<h4>Background</h4>A previously carried out randomized phase IIb, placebo-controlled trial of 1 year of inhaled budesonide, which was nested in a lung cancer screening study, showed that non-solid and partially solid lung nodules detected by low-dose computed tomography (LDCT), and not immediately suspicious for lung cancer, tended to regress. Because some of these nodules may be slow-growing adenocarcinoma precursors, we evaluated long-term outcomes (after stopping the 1-year intervention) by a ...[more]

PMID: 25672894

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Project description:RATIONALE:Lung computed tomography (CT) Screening Reporting and Data System (lung-RADS) has standardized follow-up and management decisions in lung cancer screening. To date, little is known how lung-RADS classification compares with radiological semantic features in risk prediction and diagnostic discrimination. OBJECTIVES:To compare the performance of radiological semantic features and lung-RADS in predicting nodule malignancy in lung cancer screening. METHODS:We used data and low-dose CT (LDCT) images from the National Lung Screening Trial (NLST). The training cohort contained 60 patients with screen-detected incident lung cancers who had a positive baseline screen (T0) that was not diagnosed and then was diagnosed at second follow-up (T2), and 139 nodule-positive controls who had 3 consecutive positive screens (T0 to T2) that were not diagnosed as lung cancer. The testing cohort included 40 patients with incident lung cancers that were diagnosed at first follow-up (T1) and 40 nodule-positive controls. Twenty-four semantic features were scored on a point scale from the LDCT images. Multivariable linear predictor model was built on the semantic features and the performances were compared with lung-RADS in 3 screening rounds. We also combined non-size-based semantic features with lung-RADS to improve malignancy detection. RESULTS:At T0, the average area under the receiver operating characteristic curve (AUROC) for border definition in risk prediction was 0.72. The average AUROC for contour at T1 in risk prediction and T2 in diagnostic discrimination was 0.82 and 0.88, respectively. By comparison, the average AUROC of lung-RADS at T0, T1 and T2 were 0.60, 0.76 and 0.87, respectively. The combined model of the semantic features and lung-RADS shows improvement with AUROCs of 0.74, 0.88 and 0.96 at T0, T1, and T2, respectively, achieved by adding border definition (at T0) or contour (at T1 and T2). CONCLUSION:We find semantic features defined by border definition and contour performed similar to lung-RADS at follow-up time point and outperformed lung-RADS at baseline. These semantics alongside of lung-RADS shows improved performance to detect malignancy.

Project description:BackgroundMajor issues in the implementation of screening for lung cancer by means of low-dose computed tomography (CT) are the definition of a positive result and the management of lung nodules detected on the scans. We conducted a population-based prospective study to determine factors predicting the probability that lung nodules detected on the first screening low-dose CT scans are malignant or will be found to be malignant on follow-up.MethodsWe analyzed data from two cohorts of participants undergoing low-dose CT screening. The development data set included participants in the Pan-Canadian Early Detection of Lung Cancer Study (PanCan). The validation data set included participants involved in chemoprevention trials at the British Columbia Cancer Agency (BCCA), sponsored by the U.S. National Cancer Institute. The final outcomes of all nodules of any size that were detected on baseline low-dose CT scans were tracked. Parsimonious and fuller multivariable logistic-regression models were prepared to estimate the probability of lung cancer.ResultsIn the PanCan data set, 1871 persons had 7008 nodules, of which 102 were malignant, and in the BCCA data set, 1090 persons had 5021 nodules, of which 42 were malignant. Among persons with nodules, the rates of cancer in the two data sets were 5.5% and 3.7%, respectively. Predictors of cancer in the model included older age, female sex, family history of lung cancer, emphysema, larger nodule size, location of the nodule in the upper lobe, part-solid nodule type, lower nodule count, and spiculation. Our final parsimonious and full models showed excellent discrimination and calibration, with areas under the receiver-operating-characteristic curve of more than 0.90, even for nodules that were 10 mm or smaller in the validation set.ConclusionsPredictive tools based on patient and nodule characteristics can be used to accurately estimate the probability that lung nodules detected on baseline screening low-dose CT scans are malignant. (Funded by the Terry Fox Research Institute and others; ClinicalTrials.gov number, NCT00751660.).

Project description:IntroductionPrevious studies of breast cancer have shown that patients whose tumors are detected by mammography screening have a more favorable survival. Little is known, however, about the long-term prognostic impact of screen detection. The purpose of the current study was to compare breast cancer-specific long-term survival of patients whose tumors were detected in mammography screening compared with those whose tumors were detected by other methods.MethodsBreast cancer patients diagnosed within five specified geographical areas in Finland in 1991 and 1992 were identified (N = 2,936). Detailed clinical, treatment and outcome data, as well as tissue samples, were collected. Women with in situ carcinoma, distant metastases at the time of primary diagnosis and women who were not treated surgically were excluded. The main analyses were performed after excluding patients with other malignancy or contralateral breast cancer, followed by sensitivity analyses with different exclusion criteria. Median follow-up time was 15.4 years. Univariate and multivariate analyses of breast cancer-specific survival were performed.ResultsOf patients included in the main analyses (n = 1,884), 22% (n = 408) of cancers were screen-detected and 78% (n = 1,476) were detected by other methods. Breast cancer-specific 15-year survival was 86% for patients with screen-detected cancer and 66% for patients diagnosed using other methods (P < 0.0001, HR = 2.91). Similar differences in survival were observed in women at screening age (50 to 69 years), as well as in clinically important subgroups, such as patients with small tumors (? 1 cm in diameter) and without nodal involvement (N0). Women with breast cancer diagnosed on the basis of screening mammography had a more favorable prognosis than those diagnosed outside screening programs, following adjustments according to patient age, tumor size, axillary lymph node status, histological grade and hormone receptor status. Significant differences in the risk of having future contralateral breast cancer according to method of detection were not observed.ConclusionsBreast cancer detected by mammography screening is an independent prognostic factor in breast cancer and is associated with a more favorable survival rate as well as in long-term follow-up.

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Long-term effects of inhaled budesonide on screening-detected lung nodules.

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Long-term effects of inhaled budesonide on screening-detected lung nodules.

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