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      Development and Validation of a Risk Score for Predicting Death after Pneumonectomy

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          Abstract

          Pneumonectomy is associated with significant postoperative mortality. This study was undertaken to develop and validate a risk model of mortality following pneumonectomy. We reviewed our prospective database and identified 774 pneumonectomies from a total of 7792 consecutive anatomical lung resections in the years 2003 to 2010 (rate of pneumonectomy: 9.9%). Based on data from 542 pneumonectomies between 2003 and 2007 (i.e., the "discovery set"), a penalized multivariable logistic regression analysis was performed to identify preoperative risk factors. A risk model was developed and validated in an independent data set of 232 pneumonectomies that were performed between 2008 and 2010 (i.e., the "validation set"). Of the 542 patients in the discovery set (DS), 35 patients (6.5%) died after pneumonectomy during the same admission. We developed a risk prediction model for in-hospital mortality following pneumonectomy; that model included age, current alcohol use, coronary artery disease, preoperative leukocyte count and palliative indication as possible risk factors. The risk model was subsequently successfully validated in an independent data set (n = 232) in which 18 patients (7.8%) died following pneumonectomy. For the validation set, the sensitivity of the model was 53.3% (DS: 54.3%), the specificity was 88.0% (DS: 87.4%), the positive predictive value was 26.7% (DS: 22.9%) and the negative predictive value was 95.8% (DS: 96.5%). The Brier score was 0.062 (DS: 0.054). The prediction model is statistically valid and clinically relevant.

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          Radiotherapy plus chemotherapy with or without surgical resection for stage III non-small-cell lung cancer: a phase III randomised controlled trial.

          Results from phase II studies in patients with stage IIIA non-small-cell lung cancer with ipsilateral mediastinal nodal metastases (N2) have shown the feasibility of resection after concurrent chemotherapy and radiotherapy with promising rates of survival. We therefore did this phase III trial to compare concurrent chemotherapy and radiotherapy followed by resection with standard concurrent chemotherapy and definitive radiotherapy without resection. Patients with stage T1-3pN2M0 non-small-cell lung cancer were randomly assigned in a 1:1 ratio to concurrent induction chemotherapy (two cycles of cisplatin [50 mg/m(2) on days 1, 8, 29, and 36] and etoposide [50 mg/m(2) on days 1-5 and 29-33]) plus radiotherapy (45 Gy) in multiple academic and community hospitals. If no progression, patients in group 1 underwent resection and those in group 2 continued radiotherapy uninterrupted up to 61 Gy. Two additional cycles of cisplatin and etoposide were given in both groups. The primary endpoint was overall survival (OS). Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00002550. 202 patients (median age 59 years, range 31-77) were assigned to group 1 and 194 (61 years, 32-78) to group 2. Median OS was 23.6 months (IQR 9.0-not reached) in group 1 versus 22.2 months (9.4-52.7) in group 2 (hazard ratio [HR] 0.87 [0.70-1.10]; p=0.24). Number of patients alive at 5 years was 37 (point estimate 27%) in group 1 and 24 (point estimate 20%) in group 2 (odds ratio 0.63 [0.36-1.10]; p=0.10). With N0 status at thoracotomy, the median OS was 34.4 months (IQR 15.7-not reached; 19 [point estimate 41%] patients alive at 5 years). Progression-free survival (PFS) was better in group 1 than in group 2, median 12.8 months (5.3-42.2) vs 10.5 months (4.8-20.6), HR 0.77 [0.62-0.96]; p=0.017); the number of patients without disease progression at 5 years was 32 (point estimate 22%) versus 13 (point estimate 11%), respectively. Neutropenia and oesophagitis were the main grade 3 or 4 toxicities associated with chemotherapy plus radiotherapy in group 1 (77 [38%] and 20 [10%], respectively) and group 2 (80 [41%] and 44 [23%], respectively). In group 1, 16 (8%) deaths were treatment related versus four (2%) in group 2. In an exploratory analysis, OS was improved for patients who underwent lobectomy, but not pneumonectomy, versus chemotherapy plus radiotherapy. Chemotherapy plus radiotherapy with or without resection (preferably lobectomy) are options for patients with stage IIIA(N2) non-small-cell lung cancer. National Cancer Institute, Canadian Cancer Society, and National Cancer Institute of Canada.
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            STS database risk models: predictors of mortality and major morbidity for lung cancer resection.

            The aim of this study is to create models for perioperative risk of lung cancer resection using the STS GTDB (Society of Thoracic Surgeons General Thoracic Database). The STS GTDB was queried for all patients treated with resection for primary lung cancer between January 1, 2002 and June 30, 2008. Three separate multivariable risk models were constructed (mortality, major morbidity, and composite mortality or major morbidity). There were 18,800 lung cancer resections performed at 111 participating centers. Perioperative mortality was 413 of 18,800 (2.2%). Composite major morbidity or mortality occurred in 1,612 patients (8.6%). Predictors of mortality include the following: pneumonectomy (p < 0.001), bilobectomy (p < 0.001), American Society of Anesthesiology rating (p < 0.018), Zubrod performance status (p < 0.001), renal dysfunction (p = 0.001), induction chemoradiation therapy (p = 0.01), steroids (p = 0.002), age (p < 0.001), urgent procedures (p = 0.015), male gender (p = 0.013), forced expiratory volume in one second (p < 0.001), and body mass index (p = 0.015). Thoracic surgeons participating in the STS GTDB perform lung cancer resections with a low mortality and morbidity. The risk-adjustment models created have excellent performance characteristics and identify important predictors of mortality and major morbidity for lung cancer resections. These models may be used to inform clinical decisions and to compare risk-adjusted outcomes for quality improvement purposes. 2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
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              Pneumonectomy for malignant disease: factors affecting early morbidity and mortality.

              The purpose of this report is to analyze factors affecting morbidity and mortality after pneumonectomy for malignant disease. We retrospectively reviewed the cases of all patients who underwent pneumonectomy for malignancy at the Mayo Clinic. Between January 1, 1985, and September 30, 1998, 639 patients (469 men and 170 women) were identified. Median age was 64 years (range 20 to 86 years). Indication for pneumonectomy was primary lung cancer in 607 (95.0%) patients and metastatic disease in 32 (5.0%). Factors affecting morbidity and mortality were analyzed by univariate and multivariate analysis. Cardiopulmonary complications occurred in 245 patients (38.3%; 95% confidence interval 34.6%-42.2%). Factors adversely affecting morbidity with univariate analysis included age (P <.0001), male sex (P =.04), associated respiratory (P =.02) or cardiovascular disease (P <.0001), cigarette smoking (P =.02), decreased vital capacity (P =.01), forced expiratory volume in 1 second (P <.0001), forced vital capacity (P =.002), diffusion capacity of the lung to carbon monoxide (P =.005), oxygen saturation (P <.05), arterial PO (2) (P =.007), preoperative radiation (P =.02), bronchial stump reinforcement (P =.007), crystalloid infusion (P =.01), and blood transfusion (P =.02). Factors adversely affecting morbidity with multivariate analysis included age (P =.0001), associated cardiovascular disease (P =.001), and bronchial stump reinforcement (P =.0005). There were 45 deaths (7.0%; 95% confidence intervals 5.2%-9.3%). Factors adversely affecting mortality with univariate analysis included associated cardiovascular (P <.0001) or hematologic disease (P <.005), lower preoperative serum hemoglobin level (P =.004), preoperative chemotherapy (P =.01), decreased diffusion capacity of lung to carbon monoxide (P =.002), right pneumonectomy (P =.0006), extended resection (P =.04), bronchial stump reinforcement (P =.007), and crystalloid infusion (P =.01). Factors affecting mortality with multivariate analysis included hematologic disease (P =.01), lower preoperative serum hemoglobin (P =.003), and completion pneumonectomy (P =.01). Multiple factors adversely affected morbidity and mortality after pneumonectomy for malignant disease. Appropriate selection and meticulous perioperative care are paramount to minimize risks in those patients who require pneumonectomy.
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                Author and article information

                Contributors
                Role: Academic Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                9 April 2015
                2015
                : 10
                : 4
                : e0121295
                Affiliations
                [1 ]Department of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany
                [2 ]Division of Biostatistics, German Cancer Research Center, Heidelberg, Baden-Württemberg, Germany
                [3 ]Department of Thoracic Surgery, St. Vincentius Kliniken Karlsruhe, Karlsruhe, Baden-Württemberg, Germany
                Harvard Medical School, UNITED STATES
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Conceived and designed the experiments: SS AB MR HD HH TS. Analyzed the data: SS AB JW MR JO TM KS HD HH TS. Contributed reagents/materials/analysis tools: SS AB JW MR JO TM KS HD HH TS. Wrote the paper: SS AB JW MR JO TM KS HD HH TS.

                Article
                PONE-D-14-48534
                10.1371/journal.pone.0121295
                4391778
                25856315
                b98b625f-423c-4867-9c32-d256894cacbc
                Copyright @ 2015

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

                History
                : 3 November 2014
                : 29 January 2015
                Page count
                Figures: 0, Tables: 5, Pages: 12
                Funding
                The authors received no specific funding for this work.
                Categories
                Research Article
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                All relevant data are within the paper.

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