Abstract Objective Soft-tissue sarcoma is a heterogeneous disease that frequently includes the development of pulmonary metastases. The purpose of this study is to determine factors associated with ...improved survival among patients with soft-tissue sarcoma to help guide selection for pulmonary metastasectomy. Methods We reviewed a prospectively maintained database and identified 803 patients who underwent pulmonary metastasectomy for metastatic soft-tissue sarcoma between September 1991 and June 2014; of these, 539 patients undergoing 760 therapeutic-intent pulmonary metastasectomies were included. Clinicopathologic variables and characteristics of treatment were examined. The outcomes of interest were overall survival and disease-free survival. Survival was estimated with the Kaplan-Meier method and compared between variables with the log-rank test. Factors associated with hazard of death and recurrence were identified via the use of univariable and multivariable Cox proportional hazards models. Results Median overall survival was 33.2 months (95% confidence interval, 29.9-37.1), and median disease-free survival was 6.8 months (95% confidence interval, 6.0-8.0). In multivariable analyses, leiomyosarcoma histologic subtype ( P = .007), primary tumor size ≤10 cm ( P = .006), increasing time from primary tumor resection to development of metastases ( P < .001), solitary lung metastasis ( P = .001), and minimally invasive resection ( P = .023) were associated with lower hazard of death. Disease-free interval ≥1 year ( P = .002), and 1 pulmonary metastasis ( P < .001) were associated with lower hazard of disease recurrence. Conclusions In a large single-institution study, primary tumor histologic subtype and size, numbers of pulmonary metastases, disease-free interval, and selection for minimally invasive resection are associated with increased survival in patients undergoing pulmonary metastasectomy for soft-tissue sarcoma.
Background Operative mortality rates are of great interest to surgeons, patients, policy makers, and payers as a metric for quality assessment. Thirty-day mortality and discharge mortality have been ...presumed to capture procedure-related deaths. However, many patients die after the 30-day mark or are transferred to other facilities or to home and die there, leading to the underreporting of surgically related deaths. We hypothesized that a longer period of observation would address these concerns and provide a more accurate measure of operative mortality. Methods We retrospectively reviewed institutional databases of patients undergoing resection for lung cancer, esophageal cancer, and mesothelioma. Mortality rates at 30 and 90 days were calculated with 95% confidence intervals (CIs). Results From 1999 to 2012, 7,646 surgical resections were performed: 6,119 for lung cancer, 1,258 for esophageal cancer, and 269 for mesothelioma. Among the different cancers and across operations, the additional mortality from day 31 to 90 (1.4%; 95% CI, 1.2% to 1.8%; n = 111) was similar to that by day 30 (1.2%; 95% CI, 1.0% to 1.5%; n = 95), resulting in overall 90-day mortality (2.7%; 95% CI, 2.3% to 3.1%; n = 206) that was more than double the 30-day mortality. Conclusions Among patients who have undergone operations for thoracic malignancies, mortality attributable to the operation occurs beyond the first 30 postsurgical days as well as after hospital discharge. Because cancer operations constitute a large portion of general thoracic surgery, we recommend national databases consider the inclusion of 90-day mortality in their data collection.
Background Smokers have a higher risk of developing non-small cell lung cancer (NSCLC) than never-smokers, but the relative risk of developing second primary lung cancer (SPLC) is unclear. ...Determining the risk of SPLC in smokers versus never-smokers after treatment of an initial cancer may help guide recommendations for long-term surveillance. Methods Patients who underwent resection for stage I adenocarcinoma were identified from a prospectively maintained institutional database. Patients with other histologies, synchronous lesions, or who received neoadjuvant or adjuvant therapy were excluded. The SPLCs were identified based on Martini criteria. Results From 1995 to 2012, a total of 2,151 patients underwent resection for stage I adenocarcinoma (308 never-smokers 14% and 1,843 ever-smokers 86%). SPLC developed in 30 never-smokers (9.9%) and 145 ever-smokers (7.8%). The SPLC was detected by surveillance computed tomography scan in the majority of patients (161; 92%). In total, 87% of never-smokers and 83% of ever-smokers had stage I SPLC. There was no significant difference in the cumulative incidence of SPLC between never-smokers and ever-smokers ( p = 0.18) in a competing-risks analysis. The cumulative incidence at 10 years was 20.3% for never-smokers and 18.2% for ever-smokers. Conclusions Although smokers have a greater risk of NSCLC, the risk of a second primary cancer developing after resection of stage I lung cancer is comparable between smokers and never-smokers. The majority of these second primary cancers are detectable at a curable stage. Ongoing postoperative surveillance should be recommended for all patients regardless of smoking status.
Objectives The objectives of this collaborative study were to characterize patients with thymic carcinoma, their treatment patterns, and association with overall survival (OS) and recurrence-free ...survival (RFS). Methods Clinical, pathologic, treatment, and follow-up information were analyzed. OS and RFS were the primary outcome measures. Results In 1042 cases of thymic carcinoma, 42 (5%) patients had pathologic Masaoka stage I, 138 (17%) had stage II, 370 (45%) had stage III, and 274 (33%) had stage IV disease. Overall, 166 patients (22%) underwent induction chemotherapy and 48 (6%) had preoperative radiation therapy. An R0 resection was performed in 447 cases (61%), R1 in 102 cases (14%), and R2 in 184 cases (25%). Squamous cell carcinoma was the predominant histologic subtype (n = 560; 79%). Adjuvant chemotherapy was administered to 237 (31%) patients, and 449 (60%) received adjuvant radiation therapy. The median OS was 6.6 years (95% confidence interval CI, 5.8-8.3) and the cumulative incidence of recurrence at 5 years was 35% (95% CI, 30%-40%). In univariate analysis, early Masaoka stage, R0 resection, chemotherapy, and radiation therapy were associated with OS. Early Masaoka stage and R0 resection were also associated with RFS. On multivariable analysis, R0 resection and radiation therapy were associated with prolonged OS. Radiation therapy and male gender were associated with prolonged RFS. Conclusions R0 resection and radiation therapy are associated with improved OS, whereas radiation therapy and male gender are associated with longer RFS.
Food allergy is an important public health problem because it affects children and adults, can be severe and even life-threatening, and may be increasing in prevalence. Beginning in 2008, the ...National Institute of Allergy and Infectious Diseases, working with other organizations and advocacy groups, led the development of the first clinical guidelines for the diagnosis and management of food allergy. A recent landmark clinical trial and other emerging data suggest that peanut allergy can be prevented through introduction of peanut-containing foods beginning in infancy.
Prompted by these findings, along with 25 professional organizations, federal agencies, and patient advocacy groups, the National Institute of Allergy and Infectious Diseases facilitated development of addendum guidelines to specifically address the prevention of peanut allergy.
The addendum provides 3 separate guidelines for infants at various risk levels for the development of peanut allergy and is intended for use by a wide variety of health care providers. Topics addressed include the definition of risk categories, appropriate use of testing (specific IgE measurement, skin prick tests, and oral food challenges), and the timing and approaches for introduction of peanut-containing foods in the health care provider's office or at home. The addendum guidelines provide the background, rationale, and strength of evidence for each recommendation.
Guidelines have been developed for early introduction of peanut-containing foods into the diets of infants at various risk levels for peanut allergy.
Summary Background Compared with traditional photon radiotherapy, proton radiotherapy irradiates less normal tissue and might improve health outcomes associated with photon radiotherapy by reducing ...toxic effects to normal tissue. We did a trial to assess late complications, acute side-effects, and survival associated with proton radiotherapy in children with medulloblastoma. Methods In this non-randomised, open-label, single-centre, phase 2 trial, we enrolled patients aged 3–21 years who had medulloblastoma. Patients had craniospinal irradiation of 18–36 Gy radiobiological equivalents (GyRBE) delivered at 1·8 GyRBE per fraction followed by a boost dose. The primary outcome was cumulative incidence of ototoxicity at 3 years, graded with the Pediatric Oncology Group ototoxicity scale (0–4), in the intention-to-treat population. Secondary outcomes were neuroendocrine toxic effects and neurocognitive toxic effects, assessed by intention-to-treat. This study is registered at ClinicalTrials.gov , number NCT00105560. Findings We enrolled 59 patients from May 20, 2003, to Dec 10, 2009: 39 with standard-risk disease, six with intermediate-risk disease, and 14 with high-risk disease. 59 patients received chemotherapy. Median follow-up of survivors was 7·0 years (IQR 5·2–8·6). All patients received the intended doses of proton radiotherapy. The median craniospinal irradiation dose was 23·4 GyRBE (IQR 23·4–27·0) and median boost dose was 54·0 GyRBE (IQR 54·0–54·0). Four (9%) of 45 evaluable patients had grade 3–4 ototoxicity according to Pediatric Oncology Group ototoxicity scale in both ears at follow-up, and three (7%) of 45 patients developed grade 3–4 ototoxicity in one ear, although one later reverted to grade 2. The cumulative incidence of grade 3–4 hearing loss at 3 years was 12% (95% CI 4–25). At 5 years, it was 16% (95% CI 6–29). Pediatric Oncology Group hearing ototoxicity score at a follow-up of 5·0 years (IQR 2·9–6·4) was the same as at baseline or improved by 1 point in 34 (35%) of 98 ears, worsened by 1 point in 21 (21%), worsened by 2 points in 35 (36%), worsened by 3 points in six (6%), and worsened by 4 points in two (2%). Full Scale Intelligence Quotient decreased by 1·5 points (95% CI 0·9–2·1) per year after median follow-up up of 5·2 years (IQR 2·6–6·4), driven by decrements in processing speed and verbal comprehension index. Perceptual reasoning index and working memory did not change significantly. Cumulative incidence of any neuroendocrine deficit at 5 years was 55% (95% CI 41–67), with growth hormone deficit being most common. We recorded no cardiac, pulmonary, or gastrointestinal late toxic effects. 3-year progression-free survival was 83% (95% CI 71–90) for all patients. In post-hoc analyses, 5-year progression-free survival was 80% (95% CI 67–88) and 5-year overall survival was 83% (95% CI 70–90). Interpretation Proton radiotherapy resulted in acceptable toxicity and had similar survival outcomes to those noted with conventional radiotherapy, suggesting that the use of the treatment may be an alternative to photon-based treatments. Funding US National Cancer Institute and Massachusetts General Hospital.
Abstract Objective Evaluating giant paraesophageal hernia (GPEH) repair requires long-term follow-up. GPEH repair can have associated high recurrence rates, yet this incidence depends on how ...recurrence is defined. Our objective was to prospectively evaluate patients undergoing GPEH repair with 1-year follow-up. Methods Patients undergoing elective GPEH repair between 2011 and 2014 were enrolled prospectively. Postoperatively, patients were evaluated at 1 month and 1 year. Radiographic recurrence was evaluated by barium swallow and defined as a gastroesophageal junction located above the hiatus. Quality of life was evaluated pre- and postoperatively with the use of a validated questionnaire. Results One-hundred six patients were enrolled. The majority of GPEH repairs were performed laparoscopically (80.2%), and 7.5% were redo repairs. At 1-year follow-up, 63.4% of patients were symptom free, and radiographic recurrence was 32.7%. Recurrence rate was 18.8% with standard definition (>2 cm of stomach above the diaphragm). Quality of life scores at 1 year were significantly better after operative repair, even in patients with radiographic recurrence (7.0 vs 22.5 all patients, 13.0 vs 22.5 with recurrence; P < .001). Patients with small radiographic recurrences have similar satisfaction and symptom severity to patients with >2 cm recurrences. Conclusions GPEH repair can be performed with low operative mortality and morbidity. The rate of recurrence at 1 year depends on the definition used. Patient satisfaction and symptom severity are similar between patients with radiographic and greater than 2 cm hernia recurrences. Longer follow-up and critical assessment of our results are needed to understand the true impact of this procedure and better inform perioperative decision making.
Background 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). Methods 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). Results 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). Conclusions 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.
Objective Video-assisted thoracoscopic lobectomy remains controversial. We compared outcomes from participants in a randomized study comparing lymph node sampling versus dissection for early-stage ...lung cancer who underwent either video-assisted thoracoscopic or open lobectomy. Methods Data from 964 participants in the American College of Surgeons Oncology Group Z0030 trial were used to construct propensity scores for video-assisted thoracoscopic versus open lobectomy (based on age, gender, histology, performance status, tumor location, and T1 vs T2). Propensity scores were used to estimate the adjusted risks of short-term outcomes of surgery. Patients were classified into 5 equal-sized groups and compared using conditional logistic regression or repeated measures analysis of variance. Results A total of 752 patients (66 video-assisted and 686 open procedures) were analyzed on the basis of propensity score stratification. Median operative time was shorter for video-assisted thoracoscopic lobectomy (video-assisted thoracoscopy 117.5 minutes vs open 171.5 minutes; P < .001). Median total number of lymph nodes retrieved (dissection group only) was similar (video-assisted thoracoscopy 15 nodes vs open 19 nodes; P = .147), as were instances of R1/R2 resection (video-assisted thoracoscopy 0% vs open 2.3%; P = .368). Patients undergoing video-assisted thoracoscopic lobectomy had less atelectasis requiring bronchoscopy (0% vs 6.3%, P = .035), fewer chest tubes draining greater than 7 days (1.5% vs 10.8%; P = .029), and shorter median length of stay (5 days vs 7 days; P < .001). Operative mortality was similar (video-assisted thoracoscopy 0% vs open 1.6%, P = 1.0). Conclusion Patients undergoing video-assisted lobectomy had fewer respiratory complications and shorter length of stay. These data suggest video-assisted thoracoscopic lobectomy is safe in patients with resectable lung cancer. Longer follow-up is needed to determine the oncologic equivalency of video-assisted versus open lobectomy.
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