Recommendations for implementing stereotactic radiotherapy in peripheral stage IA non-small cell lung cancer: report from the Quality Assurance Working Party of the randomised phase III ROSEL study Relationship between pulmonary function and lung cancer surgical outcome Complete video-assisted thoracoscopic surgery lobectomy and its learning curve. A single center study introducing the technique in The Netherlands. Video-assisted wedge resection and local radiotherapy for peripheral lung cancer in high-risk patients: the Cancer and Leukemia Group B (CALGB) 9335, a phase II, multi-institutional cooperative group study. Traditional versus up-front [18F] fluorodeoxyglucose-positron emission tomography staging of non-small-cell lung cancer: a Dutch cooperative randomized study. Stereotactic body radiation therapy for inoperable early stage lung cancer. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. Survival of patients with true pathologic stage I non-small cell lung cancer. Effectiveness of positron emission tomography in the preoperative assessment of patients with suspected non-small-cell lung cancer: the PLUS multicentre randomised trial
Background A phase III multi-centre r and omised trial ( ROSEL ) has been initiated to establish the role of stereotactic radiotherapy in patients with operable stage IA lung cancer . Due to rapid changes in radiotherapy technology and evolving techniques for image-guided delivery , guidelines had to be developed in order to ensure uniformity in implementation of stereotactic radiotherapy in this multi-centre study . Methods / Design A Quality Assurance Working Party was formed by radiation oncologists and clinical physicists from both academic as well as non-academic hospitals that had already implemented stereotactic radiotherapy for lung cancer . A literature survey was conducted and consensus meetings were held in which both the knowledge from the literature and clinical experience were pooled . In addition , a planning study was performed in 26 stage I patients , of which 22 were stage 1A , in order to develop and evaluate the planning guidelines . Plans were optimised according to parameters adopted from RTOG trials using both an algorithm with a simple homogeneity correction ( Type A ) and a more advanced algorithm ( Type B ) . Dose conformity requirements were then formulated based on these results . Conclusion Based on current literature and expert experience , guidelines were formulated for this phase III study of stereotactic radiotherapy versus surgery .  These guidelines can serve to facilitate the design of future multi-centre clinical trials of stereotactic radiotherapy in other patient groups and aid a more uniform implementation of this technique outside clinical trials The British Thoracic Society and American College of Chest Physician guidelines outline criteria for investigating patients for lung cancer surgery . However , the guidelines are based on relatively old studies . Therefore , the relationship between pulmonary function test results and surgical outcome were studied prospect ively in a large cohort of lung cancer patients . From January 2001 to December 2003 , 110 patients underwent surgery for lung cancer . All underwent full lung function testing in order to predict post-operative lung function . The hospital mortality rate was 3 % and major complication rate 22 % . There was poor overall outcome in 13 % . Mean pre-operative lung function values were : forced expiratory volume in one second ( FEV1 ) 2.0 L ( 79.4 % of the predicted value ) , and carbon monoxide diffusing capacity of the lung ( DL , CO ) 73.6 % pred . The mean post-operative lung function values were : FEV1 1.4 L ( 55.6 % pred ) , and DL , CO 51.3 % pred . All lung function values were better predictors of poor surgical outcome when expressed as a percentage of the predicted value . Using a threshold of pre-operative FEV1 of 47 % pred result ed in the most useful positive and negative predictive probabilities , 0.90 and 0.67 , respectively . Lung function values expressed as a percentage of the predicted value are more useful predictors of post-operative outcome than absolute values . The threshold of predicted forced expiratory volume in one second for surgical intervention could be lower ( 45–50 % pred ) than is currently accepted without increased mortality Data regarding the benefits for the complete video-assisted thoracic surgery ( c-VATS ) lobectomy over the open lobectomy are numerous . This article describes the experience of introducing this technique in a training hospital , the first reported cohort in The Netherl and s. From March 2006 to November 2008 , all patients operated on for proven or suspected lung cancer were analyzed . Prospect i ve data from these patients were evaluated . A subgroup analysis for the c-VATS lobectomy is presented . A total of 184 operations were performed on 172 patients . In 122 ( 66.3 % ) of the operations the resection ended in a lobectomy of which 70 were done by complete thoracoscopic procedure . For the c-VATS lobectomy the mean operating time was 179 min , with a mean blood loss of 444 ml . The median hospital stay was four days . Complications were present in 10 % of c-VATS lobectomies . No mortality was seen in the c-VATS group . After thorough evaluation and training , c-VATS lobectomy is a safe procedure that can be performed in a relatively low volume hospital . It has exceptional short-term benefits . For training purpose s all operations must start thoracoscopically . All patients must be operated according the intention to treat method OBJECTIVES This study examined the feasibility of thoracoscopic wedge resection and radiotherapy for clinical T1 lesions in patients with compromised cardiopulmonary status . METHODS In this phase II , prospect i ve , multicenter , cooperative group trial , high-risk patients had one or more of the following risk factors : forced expiratory volume in 1 second less than 40 % , carbon monoxide diffusing capacity in lung less than 50 % , and maximum oxygen consumption less than 45 mm Hg . Patients underwent video-assisted wedge resection followed by local ( 56 Gy ) radiotherapy . The primary end point was the proportion of patients whose disease could be completely resected and who received radiotherapy without treatment complications . RESULTS Between September 1995 and September 1999 , a total of 65 patients were accrued , of which 58 were eligible ( 52 % male , median age 69 years ) . Pathologic staging result ed in upgrading to T2 or greater in 16 of 58 cases ( 28 % ) and in re assessment as benign in 10 of 58 cases ( 17 % ) . Conversion to thoracotomy was required in 10 cases ( 17 % ) , including 1 of 10 benign T1-size lesion ( 10 % ) , 4 of 35 non-small cell lung cancer T1 lesions ( 13 % ) , and 5 of 14 non-small cell lung cancer T2 lesions ( 31 % ) . Resection margins were positive in 5 patients : 6 % of T1 and 23 % of T2 . Surgery was aborted in 2 cases ( 3.5 % ) , and operative mortality was 4 % . Overall operative failure rates of video-assisted wedge resection were 20 % for benign T1-size lesions , 22 % for T1 non-small cell lung cancer , 21 % for all T1 lesions , 50 % for T2 non-small cell lung cancer , and 29 % for all lesions in this study ( clinical T1 ) . Prolonged air leaks occurred in 10 % , pneumonia in 6 % , and respiratory failure in 4 % . Thirty-one patients were eligible for radiotherapy ;  3 of them refused , and 1 died before treatment . Among the 28 patients who received radiotherapy  , severe dyspnea was noted in 3 patients ( 11 % ) and moderate pneumonitis in 4 ( 14 % ) . CONCLUSIONS Clinical staging in high-risk patients is often inaccurate ( 45 % difference from pathologic staging ) . Intention to treat clinical ly staged T1 disease by video-assisted wedge resection is associated with a high failure rate . Pathologically staged T1 lesions can be successfully resected in 75 % of cases ; however , narrow resection margins remain a concern PURPOSE We investigated whether application of positron emission tomography ( PET ) immediately after first presentation might simplify staging while maintaining accuracy , as compared with traditional strategy in routine clinical setting . METHODS At first presentation , patients with a provisional diagnosis of lung cancer without overt dissemination were r and omly assigned to traditional work-up ( TWU ) according to international guidelines or early PET followed by histologic/cytologic verification of lesions , or imaging and follow-up . Patients with [ 18F ] fluorodeoxyglucose ( 18FDG ) -avid , non central tumors without suspicion of mediastinal or distant metastases on PET proceeded directly to thoracotomy .  Follow-up in presumed benign lesions was at least 12 months . In patients treated with surgery or neoadjuvant therapy  , the quality of staging was measured by comparing the clinical stage to the final stage ( combination of peroperative staging and 6 months of follow-up ) . To investigate test substitution , we analyzed the number of (non)invasive tests to achieve clinical TNM staging , and its associated costs . RESULTS Between 1999 and 2001 , 465 patients ( 233 TWU , 232 PET ) were enrolled at 22 hospitals . The mean ( st and ard deviation ) number of procedures to finalize staging was equal in the TWU arm and the PET arm : 7.9 ( 2.0 ) v 7.9 ( 1.9 ) , P = .90 , respectively . Mediastinoscopies occurred significantly less often in the PET arm . Agreement between clinical and final stage was good in both arms ( kappa = .85 v .78 ; P = .07 ) . Costs did not differ significantly . CONCLUSION Up-front 18FDG-PET in patients with ( suspected ) lung cancer does not reduce the overall number of diagnostic test , but it maintains quality of TNM staging with the use of less invasive surgery CONTEXT Patients with early stage but medically inoperable lung cancer have a poor rate of primary tumor control ( 30%-40 % ) and a high rate of mortality ( 3-year survival , 20%-35 % ) with current management . OBJECTIVE To evaluate the toxicity and efficacy of stereotactic body radiation therapy in a high-risk population of patients with early stage but medically inoperable lung cancer . DESIGN , SETTING , AND PATIENTS Phase 2 North American multicenter study of patients aged 18 years or older with biopsy-proven peripheral T1-T2N0M0 non-small cell tumors ( measuring < 5 cm in diameter ) and medical conditions precluding surgical treatment . The prescription dose was 18 Gy per fraction x 3 fractions ( 54 Gy total ) with entire treatment lasting between 1(1/2 ) and 2 weeks . The study opened May 26 , 2004 , and closed October 13 , 2006 ; data were analyzed through August 31 , 2009 . MAIN OUTCOME MEASURES The primary end point was 2-year actuarial primary tumor control ; secondary end points were disease-free survival ( ie , primary tumor , involved lobe , regional , and disseminated recurrence ) , treatment-related toxicity , and overall survival . RESULTS A total of 59 patients accrued , of which 55 were evaluable ( 44 patients with T1 tumors and 11 patients with T2 tumors ) with a median follow-up of 34.4 months ( range , 4.8 - 49.9 months ) . Only 1 patient had a primary tumor failure ; the estimated 3-year primary tumor control rate was 97.6 % ( 95 % confidence interval [ CI ] , 84.3%-99.7 % ) . Three patients had recurrence within the involved lobe ; the 3-year primary tumor and involved lobe ( local ) control rate was 90.6 % ( 95 % CI , 76.0%-96.5 % ) . Two patients experienced regional failure ; the local-regional control rate was 87.2 % ( 95 % CI , 71.0%-94.7 % ) . Eleven patients experienced disseminated recurrence ; the 3-year rate of disseminated failure was 22.1 % ( 95 % CI , 12.3%-37.8 % ) . The rates for disease-free survival and overall survival at 3 years were 48.3 % ( 95 % CI , 34.4%-60.8 % ) and 55.8 % ( 95 % CI , 41.6%-67.9 % ) , respectively . The median overall survival was 48.1 months ( 95 % CI , 29.6 months to not reached ) . Protocol -specified treatment-related grade 3 adverse events were reported in 7 patients ( 12.7 % ; 95 % CI , 9.6%-15.8 % ) ; grade 4 adverse events were reported in 2 patients ( 3.6 % ; 95 % CI , 2.7%-4.5 % ) . No grade 5 adverse events were reported . CONCLUSION Patients with inoperable non-small cell lung cancer who received stereotactic body radiation therapy had a survival rate of 55.8 % at 3 years , high rates of local tumor control , and moderate treatment-related morbidity BACKGROUND Lung-volume-reduction surgery has been proposed as a palliative treatment for severe emphysema . Effects on mortality , the magnitude and durability of benefits , and criteria for the selection of patients have not been established . METHODS A total of 1218 patients with severe emphysema underwent pulmonary rehabilitation  and were r and omly assigned to undergo lung-volume-reduction surgery or to receive continued medical treatment . RESULTS Overall mortality was 0.11 death per person-year in both treatment groups ( risk ratio for death in the surgery group , 1.01 ; P=0.90 ) . After 24 months , exercise capacity had improved by more than 10 W in 15 percent of the patients in the surgery group , as compared with 3 percent of patients in the medical-therapy group ( P<0.001 ) . With the exclusion of a subgroup of 140 patients at high risk for death from surgery according to an interim analysis , overall mortality in the surgery group was 0.09 death per person-year , as compared with 0.10 death per person-year in the medical-therapy group ( risk ratio , 0.89 ; P=0.31 ) ; exercise capacity after 24 months had improved by more than 10 W in 16 percent of patients in the surgery group , as compared with 3 percent of patients in the medical-therapy group ( P<0.001 ) . Among patients with predominantly upper-lobe emphysema and low exercise capacity , mortality was lower in the surgery group than in the medical-therapy group ( risk ratio for death , 0.47 ; P=0.005 ) . Among patients with non-upper-lobe emphysema and high exercise capacity , mortality was higher in the surgery group than in the medical-therapy group ( risk ratio , 2.06 ; P=0.02 ) . CONCLUSIONS Overall , lung-volume-reduction surgery increases the chance of improved exercise capacity but does not confer a survival advantage over medical therapy . It does yield a survival advantage for patients with both predominantly upper-lobe emphysema and low base-line exercise capacity . Patients previously reported to be at high risk and those with non-upper-lobe emphysema and high base-line exercise capacity are poor c and i date s for lung-volume-reduction surgery , because of increased mortality and negligible functional gain BACKGROUND Many patients with resected , pathologic (p)stage I non-small cell lung cancer ( NSCLC ) are not adequately staged preoperatively or intraoperatively . Reported 5-year survival is about 65 % . Recently , nonsurgical techniques are being offered to these patients . METHODS A prospect i ve data base was retrospectively review ed . All patients had an integrated positron-emission tomography/computed tomography ( CT ) and CT scan , an R0 pulmonary resection with lung palpation , and complete thoracic lymphadenectomy .  RESULTS From August 2002 until July 2008 , 2171 patients presented with presumed , resectable NSCLC . Of these , 721 were clinical ly (c)staged I , and 1450 were (c)staged II , III , or IV . Of the 721 (c)stage I , 405 ( 56 % ) had (p)stage I disease ; 101 ( 14 % ) were clinical ly over-staged ( benign nodules ) . Of those with NSCLC , 32 % were clinical ly under-staged ( stage II or higher on path ) . The 5-year Kaplan-Meier survival rates were 80 % for (p)stage IA , 72 % for (p)stage IB ( p = 0.026 ) , and 87 % for the 721 with (c)stage I disease . The median-follow up was 3.8 years . CONCLUSIONS When patients with NCSLC are accurately staged preoperatively and undergo complete thoracic lymphadenectomy , the 5-year survival is 80 % for (p)stage IA tumors and 87 % for (c)stage I disease . About 32 % of patients are under-staged ( most commonly from nonimaged N2 disease ) despite the liberal application of all of the techniques that assess mediastinal lymph nodes preoperatively . Thus surgical intervention offers improved staging with resection of unsuspected nodal or parenchymal disease . If stereotactic radiation and radiofrequency ablation are considered for patients with clinical ly staged I NSCLC , these results should be considered BACKGROUND Up to 50 % of curative surgery for suspected non-small-cell lung cancer is unsuccessful . Accuracy of positron emission tomography ( PET ) with 18-fluorodeoxyglucose ( 18FDG ) is thought to be better than conventional staging for diagnosis of this malignancy . Up to now however , there has been no evidence that PET leads to improved management of patients in routine clinical practice . We did a r and omised controlled trial in patients with suspected non-small-cell lung cancer , who were scheduled for surgery after conventional workup , to test whether PET with 18FDG reduces number of futile thoracotomies . METHODS Before surgery ( mediastinoscopy or thoracotomy ) , 188 patients from nine hospitals were r and omly assigned to either conventional workup ( CWU ) or conventional workup and PET ( CWU+PET ) . Patients were followed up for 1 year . Thoracotomy was regarded as futile if the patient had benign disease , explorative thoracotomy , pathological stage IIIA-N2/IIIB , or postoperative relapse or death within 12 months of r and omisation . The primary outcome measure was futile thoracotomy . Analysis was by intention to treat . FINDINGS 96 patients were r and omly assigned CWU and 92 CWU+PET . Two patients in the CWU+PET group did not undergo PET . 18 patients in the CWU group and 32 in the CWU+PET group did not have thoracotomy . In the CWU group , 39 ( 41 % ) patients had a futile thoracotomy , compared with 19 ( 21 % ) in the CWU+PET group ( relative reduction 51 % , 95 % CI 32 - 80 % ; p=0.003 ) . INTERPRETATION Addition of PET to conventional workup prevented unnecessary surgery in one out of five patients with suspected non-small-cell lung cancer
OBJECTIVES Patients with severe chronic obstructive pulmonary disease ( COPD ) have a high risk of lung cancer and of postsurgical complications .
We studied outcomes after stereotactic body radiotherapy ( SBRT ) in patients with severe COPD , as defined by Global Initiative for Chronic Obstructive Lung Disease ( GOLD ) criteria , and performed a systematic review of the literature on outcomes after SBRT or surgery in these patients .