Benignant and malignant epidemiology among surgical resections for suspicious solitary lung cancer without preoperative tissue diagnosis.

OBJECTIVES: The aim of this study was to describe the epidemiology of patients undergoing diagnostic and/or curative surgical pulmonary resections for lung opacities suspected of being localized primary lung cancers without preoperative tissue confirmation. METHODS: We performed a single-centre retrospective study of a prospectively implemented institutional database of all patients who underwent pulmonary resection between January 2010 and December 2020. Patients were selected when surgery complied with the Fleischner society guidelines. We performed a multivariable logistic regression to determine the preoperative variables associated with malignancy. RESULTS: Among 1392 patients, 213 (15.3%) had a final diagnosis of benignancy. We quantified futile parenchymal resections in 29 (2.1%) patients defined by an anatomical resection of >2 lung segments for benign lesions that did not modified the clinical management. Compared with patients with malignancies, patients with benignancies were younger (57.5 vs 63.9 years, P < 0.001), had lower preoperative risk profile (thoracoscore 0.4 vs 2.1, P < 0.001), had a higher proportion of wedge resection (50.7% vs 12.2%, P < 0.01) and experienced a lower burden of postoperative complication (Clavien-Dindo IV or V, 0.4% vs 5.6%, P < 0.001). Preoperative independent variables associated with malignancy were (adjusted odd ratio [95% confident interval]) age 1.02 [1.00; 1.04], smoking (year-pack) 1.005 (1.00; 1.01), history of cardiovascular disease 2.06 [1.30; 3.30], history of controlled cancer 2.74 [1.30; 6.88] and clinical N involvement 4.20 [1.11; 37.44]. CONCLUSIONS: Futile parenchymal lung resection for suspicious opacities without preoperative tissue diagnosis is rare (2.1%) while surgery for benign lesions represented 15.3% and has a satisfactory safety profile with very low postoperative morbi-mortality.

Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial - the MIRO trial.

BACKGROUND: Open transthoracic oesophagectomy is the standard treatment for infracarinal resectable oesophageal carcinomas, although it is associated with high mortality and morbidity rates of 2 to 10% and 30 to 50%, respectively, for both the abdominal and thoracic approaches. The worldwide popularity of laparoscopic techniques is based on promising results, including lower postoperative morbidity rates, which are related to the reduced postoperative trauma. We hypothesise that the laparoscopic abdominal approach (laparoscopic gastric mobilisation) in oesophageal cancer surgery will decrease the major postoperative complication rate due to the reduced surgical trauma. METHODS/DESIGN: The MIRO trial is an open, controlled, prospective, randomised multicentre phase III trial. Patients in study arm A will receive laparoscopic-assisted oesophagectomy, i.e., a transthoracic oesophagectomy with two-field lymphadenectomy and laparoscopic gastric mobilisation. Patients in study arm B will receive the same procedure, but with the conventional open abdominal approach. The primary objective of the study is to evaluate the major postoperative 30-day morbidity. Secondary objectives are to assess the overall 30-day morbidity, 30-day mortality, 30-day pulmonary morbidity, disease-free survival, overall survival as well as quality of life and to perform medico-economic analysis. A total of 200 patients will be enrolled, and two safety analyses will be performed using 25 and 50 patients included in arm A. DISCUSSION: Postoperative morbidity remains high after oesophageal cancer surgery, especially due to major pulmonary complications, which are responsible for 50% of the postoperative deaths. This study represents the first randomised controlled phase III trial to evaluate the benefits of the minimally invasive approach with respect to the postoperative course and oncological outcomes in oesophageal cancer surgery. TRIAL REGISTRATION: NCT00937456 (ClinicalTrials.gov).

Tracheal glomus tumor: a multidisciplinary approach to management.

A 66-year-old man presented with acute respiratory distress due to a tracheal tumor involving the posterior wall of the upper trachea, with nearly complete airway obstruction. Partial debulking of the tumor's endoluminal component, via rigid bronchoscopy and yttrium-aluminum-perovskite laser, allowed timely and effective airway restoration. The diagnosis was benign tracheal glomus tumor. Two weeks later, elective tracheal sleeve resection with end-to-end anastomosis allowed complete resection of the lesion. No tumor recurrence was found at 21-month follow-up. We describe the multidisciplinary management of this extremely rare tracheal tumor, and review its features.

[Surgical results of type III and IV hiatal hernia with left thoracotomy]. / Resultados del tratamiento quirúrgico de las hernias hiatales tipo III y IV por vía transtorácica izquierda.

OBJECTIVE: The goal of the study is to report the short- and long-term outcome of a left approach in the management of type III and IV hiatal hernia. METHODS: We have retrospectively reviewed all the records of patients treated for type III and IV hiatal hernia with a left transthoracic approach. All the patients were evaluated before and after the surgery on clinical presentation, symptoms and functional assessment. We have specifically focused the evaluation on surgical results, mortality, morbidity and long term functional assessment. RESULTS: Sixty-five patients were included in this study. Type III hiatal hernia (86%) were majority compared to type IV(14%). Surgical techniques included Nissen fundoplication (37%), Collis Nissen elongation gastroplasty (20%) and Belsey-Mark IV (15%). Morbidity was low and there was no hospital mortality. Mean follow-up was 42 months. Long-term reassessment demonstrated a significant improvement of symptoms. Erosive esophagitis persisted in one patient (P < 0.001). Pressure at the level of lower esophageal sphincter was normal in all patients. 24-hours pH-metry was normal in 92% of patients. Anti-acid medication was reduced significantly (P < 0.001). CONCLUSION: Obesity, short esophagus, massive hiatal hernia, associated oesophageal diseases or previous failed surgery constituted the indications of choice for transthoracic approach. This procedure gives satisfactory functional and anatomical long term results with healing of mucosal damage.

[Alveolar microlithiasis with severe interstitial fibrosis leading to lung transplantation]. / Microlithiase alvéolaire avec fibrose interstitielle sévère conduisant à la greffe.

Pulmonary alveolar microlithiasis is a rare disease, characterized by extensive phosphocalcic concretions within the alveolar spaces. Pulmonary alveolar microlithiasis is usually asymptomatic and is incidentally found because radiologic findings are characteristic. In about half of the cases, it is an autosomal recessive disorder due to mutations in the SLC34A2 gene. Pulmonary alveolar microlithiasis can easily be diagnosed by bronchioloalveolar lavage or transbronchial biopsy. The clinical course is usually stable during several years and lung transplantation is the only effective treatment when a respiratory failure occurs. A 49-year-old woman was referred with a restrictive respiratory failure due to a pulmonary alveolar microlithiasis incidentally discovered on a chest radiography when she was 11 and was confirmed by surgical lung biopsy. She was asymptomatic until she was 43 when she presented a progressive dyspnea leading to continuous oxygen administration 4 years later. Laboratory findings only showed a polyglobulia related to hypoxemia. Chest radiography and computed tomography chest scan revealed a bilateral symmetric micronodular pattern. She underwent a lung transplantation when she was 49. Pathological examination confirmed the diagnosis of diffuse pulmonary alveolar microlithiasis with interstitial fibrosis. The patient died 3 months after surgery in an infectious context.

Multifocal T4 non-small cell lung cancer: a subset with improved prognosis.

OBJECTIVE: T4-disease for non-small cell lung cancer (NSCLC) includes different conditions: mediastinal invasion, neoplastic pleural cytology, and multifocal disease in the same lobe; regarding the last category, no strict criteria allow to differentiate satellite nodules from synchronous multiple primary tumours. METHODS: Retrospective study of 56 patients who underwent a complete resection from 1985 to 2006 of a NSCLC graded pT4N0 due to multifocal disease. A small nodule (<1cm) closed to the primary tumour, in a same pulmonary segment with an identical histology was considered as a satellite nodule (pT4sn). Multiple tumours, sized more than 1cm, with an identical histology, located in the same lobe but in different segment were considered as synchronous cancers (pT4sc). RESULTS: There were 44 males and 12 females: 35 patients were graded T4sn and 21 patients T4sc. The median age was 62.5 years. The two groups were similar for sex, age, tobacco consumption, ASA score, NYHA, Charlson's index, spirometric parameters, cardiovascular comorbidity and history of previous extra-thoracic malignancies. All had a complete anatomic resection with mediastinal lymphadenectomy. Thirty-day mortality rate was 3.6%. Overall 5-year and 10-year survival rates were 48.2% and 29.9%, respectively. There was a non-significant trend for a worse survival in T4sn group patients when compared to that of T4sc group patients: 42.9% vs 52.3% at 5 years, and 25% vs 34.9% at 10 years (p=0.62). CONCLUSIONS: Multifocal T4 stage IIIB disease is a heterogeneous category where overall prognosis is far better than those of other T4 subgroups. Survival rates associated with pT4sn and pT4sc look roughly similar because of the small size of the subgroups usually submitted to comparison in most series. In the present experience, respective survival figures diverge, suggesting different biological behaviours.

Stent placement in the management of oesophageal leaks.

OBJECTIVE: To examine retrospectively the patients of our department who had a self-expandable totally covered metal stent placed for oesophageal leak. METHODS: Patients hospitalised in our department for oesophageal cancer and/or oesophageal perforation between 2004 and 2006. All medical records were retrospectively reviewed. Seventy-two patients underwent oesophageal resection for oesophageal cancer and 16 were managed for oesophageal perforations. RESULTS: Eight out of 72 patients submitted to resection for oesophageal cancer had postoperative leaks, while one patient developed tracheo-oesophageal fistula (TEF) due to prolonged mechanical ventilation. Six of them had stent placement in first intention, whereas two received the procedure after an unsuccessful repeat operation. The mean stent placement time was 18.4 days (SD=15.2 days), whereas the median was 14 days. The leak was managed efficiently by the stent in seven patients, whereas two patients needed repeat operations (one with TEF). The mean stent removal time was 56.8 days (SD=30.5 days) and the median was 40 days. None developed anastomotic stricture. On the other hand, three out of 16 patients with perforation had a stent, two of them for Boerhaave syndrome and one for iatrogenic rupture after bariatric surgery. One of them required the stent 17 days after surgical repair with excellent results, while the other two patients had the stent placed immediately, but still needed thoracotomy to control the leak. CONCLUSIONS: Stent placement can prove very useful in the management of post-oesophagectomy anastomotic leaks, but its contribution needs to be evaluated with caution in cases of oesophageal perforations or TEF. Larger series and prospective comparative clinical trials could eventually clarify the role of stents in clinical practice of surgical patients.

Airway colonisation and postoperative pulmonary complications after neoadjuvant therapy for oesophageal cancer.

OBJECTIVE: To evaluate the clinical relevance of preoperative airway colonisation in patients undergoing oesophagectomy for cancer after a neoadjuvant chemoradiotherapy. METHODS: From 1998 to 2005, 117 patients received neoadjuvant chemoradiotherapy for advanced stage oesophageal cancer. Among them, 45 non-randomised patients underwent a bronchoscopic bronchoalveolar lavage (BAL group) prior to surgery to assess airways colonisation. The remaining patients (n=72) constituted the control group. The two groups were similar with respect to various clinical or pathological characteristics. RESULTS: Thirteen of the 45 BAL patients (28%) had a preoperative bronchial colonisation by either potentially pathogenic micro-organisms (PPMs) (n=7, 16%) or non-potentially pathogenic micro-organisms (n=6, 13%). Cytomegalovirus (CMV) was cultured from BAL in four patients. Pre-emptive therapy was administrated in seven patients: four antiviral and three antibiotic prophylaxes. Postoperatively, 14 patients (19%) developed acute respiratory distress syndrome (ARDS) in the control group and three (7%) in the BAL group (p=0.064). The cause of ARDS was attributed to CMV pneumonia in six control group patients on the basis of the results of open lung biopsies (n=3) or BAL cultures (n=3) versus none of the BAL group patients (p=0.08). Timing for extubation was shorter in the BAL group (mean 13+/-3 h) as compared with the control group (mean 19.5+/-14 h; p=0.039). In-hospital mortality was not significantly lower in BAL group patients when compared to that of control group patients (8% vs 12.5%). CONCLUSIONS: Airway colonisation by PPMs after neoadjuvant therapy is suggested as a possible cause of postoperative ARDS after oesophagectomy. Pre-emptive treatment of bacterial and viral (CMV) colonisation seems an effective option to prevent postoperative pneumonia.

Indications and outcome of salvage surgery for oesophageal cancer.

OBJECTIVE: Some patients with localised oesophageal cancer are treated with definitive chemoradiotherapy (CRT) rather than surgery. A subset of these patients experiences local failure, relapse or treatment-related complication without distant metastases, with no other curative treatment option but salvage oesophagectomy. The aim of this study was to assess the benefit/risk ratio of surgery in such context. METHODS: Review of a single institution experience with 24 patients: 18 men and 6 women, with a mean age of 59 years (+/-9). Histology was squamous cell carcinoma in 18 cases and adenocarcinoma in 6. Initial stages were cIIA (n=5), cIIB (n=1) and cIII (n=18). CRT consisted of 2-6 sessions of the association 5-fluorouracil/cisplatin concomitantly with a 50-75 Gy radiation therapy. Salvage oesophagectomy was considered for the following reasons: relapse of the disease with conclusive (n=11) or inconclusive biopsies (n=7), intractable stenosis (n=3), and perforation or severe oesophagitis (n=3), at a mean delay of 74 days (14-240 days) following completion of CRT. RESULTS: All patients underwent a transthoracic en-bloc oesophagectomy with 2-field lymphadenectomy. Thirty-day and 90-day mortality rates were 21% and 25%, respectively. Anastomotic leakage (p=0.05), cardiac failure (p=0.05), length of stay (p=0.03) and the number of packed red blood cells (p=0.02) were more frequent in patients who received more than 55 Gy, leading to a doubled in-hospital mortality when compared to that of patients having received lower doses. A R0 resection was achieved in 21 patients (87.5%). A complete pathological response (ypT0N0) was observed in 3 patients (12.5%). Overall and disease-free 5-year survival rates were 35% and 21%, respectively. There was no long-term survivor following R1-R2 resections. Functional results were good in more than 80% of the long-term survivors. CONCLUSION: Salvage surgery is a highly invasive and morbid operation after a volume dose of radiation exceeding 55 Gy. The indication must be carefully considered, with care taken to avoid incomplete resections. Given that long-term survival with a fair quality of life can be achieved, such high-risk surgery should be considered in selected patients at an experienced centre.

Long-term results of redo gastro-esophageal reflux disease surgery.

OBJECTIVE: To review the long-term results of redo gastro-esophageal reflux disease (GERD) surgery with special emphasis on residual acid-suppressing medications, pH monitoring results, and quality of life. METHODS: Retrospective analysis of 52 patients (24 males) who underwent redo GERD surgery between 1986 and 2006 through a transthoracic (n=14), or a transabdominal (n=38) approach. Indications were recurrent GERD in 41 patients, and complication of the initial surgery in 11. Quality of life was evaluated by telephone enquiry using a validated French questionnaire (reflux quality score, RQS). RESULTS: Postoperative complications occurred in 18 patients (35%), resulting in one death (2%). Reoperation was required in seven patients. At 1 year, 26 patients (51%) had 24h pH monitoring, among whom 2 (8%) were proved to have recurrence of GERD. RQS values were calculated in 38 patients with a mean follow-up of 113 months. Fifty percent of this subgroup had a RQS value beyond 26/32, indicating an excellent quality of life. Among these 38 patients, 20 (53%) had acid-suppressing medications whatever their RQS values. Patients who underwent transthoracic GERD surgery had the highest RQS values (p=0.02), a lower rate of complications (p=0.06) and a lower rate of reoperation (p=0.04). CONCLUSION: Our experience confirms that selection of candidates for redo GERD surgery is a challenging issue. A transthoracic approach seems to produce better results and lower rates of complications.

Single-lung and double-lung transplantation: technique and tips.

The first successful single-lung and double-lung transplantations were performed in the eighties. Since then both surgical and anesthesiological management have improved. The aim of this paper is to describe the surgical technique of lung transplantation: from the anesthesiological preparation, to the explantation and implantation of the lung grafts, and the preparation of the donor lungs. We will also describe the main surgical complications after lung transplantation and their management. Each step of the surgical procedure will be illustrated with photos and videos.

Oropharyngeal and nasopharyngeal decontamination with chlorhexidine gluconate in lung cancer surgery: a randomized clinical trial.

PURPOSE: Respiratory complications are the leading causes of morbidity and mortality after lung cancer surgery. We hypothesized that oropharyngeal and nasopharyngeal decontamination with chlorhexidine gluconate (CHG) would be an effective method to reduce these complications as reported in cardiac surgery. METHODS: In this multicenter parallel-group randomized double-blind placebo-controlled trial, we enrolled consecutive adults scheduled for anatomical pulmonary resection for lung cancer. Perioperative decontamination consisted in oropharyngeal rinse solution (0.12% CHG) and nasopharyngeal soap (4% CHG) or a placebo. The primary outcome measure was the proportion of patients requiring postoperative invasive and/or noninvasive mechanical ventilation (MV). Secondary outcome measures included occurrence of respiratory and non-respiratory healthcare-associated infections (HAIs) and outcomes within 90 days. RESULTS: Between July 2012 and April 2015, 474 patients were randomized. Of them, 24 had their surgical procedure cancelled or withdrew consent. The remaining 450 patients were included in a modified intention-to-treat analysis: 226 were allocated to CHG and 224 to the placebo. Proportions of patients requiring postoperative MV were not significantly different [CHG 14.2%; placebo 15.2%; relative risks (RRs) 0.93; 95% confidence interval (CI) 0.59-1.45; P = 0.76]. Neither of the proportions of patients with respiratory HAIs were different (CHG 13.7%; placebo 12.9%; RRs 1.06; 95% CI 0.66-1.69; P = 0.81). The CHG group had significantly decreased incidence of bacteremia, surgical-site infection and overall Staphylococcus aureus infections. However, there were no significant between-group differences for hospital stay length, change in tracheal microbiota, postoperative antibiotic utilization and outcomes by day 90. CONCLUSIONS: CHG decontamination decreased neither MV requirements nor respiratory infections after lung cancer surgery. Additionally, CHG did not change tracheal microbiota or postoperative antibiotic utilization. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov, number NCT01613365.

Results and impact of routine assessment of comorbidity in elderly patients with non-small-cell lung cancer aged > 80 years.

BACKGROUND: Elderly patients now represent a bigger proportion of patients with non-small-cell lung cancer (NSCLC). However, data from clinical trials are limited for this age group, and the elderly are often excluded from optimal treatment for several reasons, including comorbidity. PATIENTS AND METHODS: We reviewed a 10-year experience on proven patients with NSCLC aged > 80 years; comorbidity was assessed using the Charlson Comorbidity index (CCI). The main objective was the impact of comorbidity on survival outcome. RESULTS: Of 109 managed patients aged > 80 years, 74 patients had a proven diagnosis of NSCLC. Performance status was < 2 in 58 patients and TNM classification of malignant tumors was I-II, IIIA-IIIB, and IV in 18, 27, and 29 patients, respectively. Comorbidity was present for 49 patients. Charlson Comorbidity Index ranged from 4 to 12 with 31 patients having a CCI >or= 6. Sixteen patients received supportive care only, whereas 23 patients were operated on, 12 received radiation therapy, and 23 had chemotherapy. Eight grade 3/4 toxicities were reported (3 patients discontinued treatment). Multivariate analysis demonstrated a significant increase in the risk of death for patients with a poor Eastern Cooperative Oncology Group performance status (hazard ratio, 2.64; 95% confidence interval, 1.3-5.36; P = 0.007) and an advanced TNM stage (hazard ratio, 3.31; 95% confidence interval, 1.99-5.5; P < 0.00001). Although statistic significance was not reached, a difference in overall survival was shown between patients with a CCI < 6 and CCI >or= 6 (12.2 months vs. 8.2 months; P = 0.08). CONCLUSION: These results support a role for the CCI as a routine means to assess comorbidity, because patients with fewer comorbidities tolerate and derive survival benefit of optimal NSCLC management. These findings must be confirmed in prospective studies.

Pulmonary function tests as a predictor of quantitative and qualitative outcomes after thoracic surgery for lung cancer.

BACKGROUND: Pulmonary function tests are used to select patients with non-small-cell lung cancer (NSCLC) suitable for thoracic surgery. We studied the impact of pulmonary function tests on both quantitative (morbidity, mortality, and overall survival [OS]) and qualitative (quality of life [QOL]) outcomes of patients undergoing thoracic surgery for NSCLC. PATIENTS AND METHODS: Patients with proven or highly probable NSCLC referred for thoracic surgery were eligible. The postoperative outcomes morbidity, 90-day mortality, OS, and QOL based on PGWBI and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 were studied according to the results of the preoperative pulmonary function tests (forced expiratory volume in 1 second [FEV(1)]; vital capacity, residual volume, total lung capacity, airways resistance, diffusing capacity corrected for alveolar volume). RESULTS: A total of 110 patients were studied, with 94 patients eligible for analysis. Postoperative mortality and morbidity affected 9.5% and 40% of patients, respectively. These patients presented with significantly lower preoperative values of vital capacity, total lung capacity, and diffusing capacity corrected for alveolar volume and higher preoperative values of airways resistance compared with patients with an uncomplicated postoperative course. Better survival was correlated with higher preoperative values of FEV(1), vital capacity, total lung capacity, and a lower pulmonary distension, especially when expressed as a percentage of predicted value. None of the postoperative QOL scores was influenced by preoperative pulmonary function tests results. CONCLUSION: Pulmonary function tests allow a relatively good prediction of postoperative quantitative outcomes such as postoperative morbidity and mortality as well as OS after thoracic surgery for NSCLC. However, pulmonary function tests remain poorly correlated to postoperative qualitative outcomes, making QOL a separate and essential assessment of the health status of patients with resected NSCLC.

Inhaled nitric oxide does not prevent pulmonary edema after lung transplantation measured by lung water content: a randomized clinical study.

STUDY OBJECTIVE: In order to assess the effects of inhaled nitric oxide (iNO) in preventing early-onset lung edema from occurring after lung transplantation, we measured extravascular lung water (EVLW) in a group of lung transplant recipients who were at high risk for developing ischemia-reperfusion-induced lung injury. DESIGN: Prospective, randomized study. SETTINGS: Surgical ICU in a teaching hospital. PATIENTS: Thirty double-lung transplant recipients. INTERVENTIONS: Patients were randomized to receive or not receive 20 ppm iNO at the time of reperfusion (ie, before any occurrence of lung edema). In the NO group, iNO was then administered for a 12-h period. A double-dilution technique was used for the serial assessment of EVLW, intrathoracic blood volume, and cardiac index. Standard hemodynamic and pulmonary parameters were also recorded during the first 3 postoperative days. MEASUREMENTS AND RESULTS: Patients who received iNO did not have a different lung water content compared to control subjects (p = 0.61 [by analysis of variance (ANOVA)]). Blood oxygenation (ie, Pao(2)/fraction of inspired oxygen [Fio(2)] ratio) did not differ between the two groups (p = 0.61 [by ANOVA]). In both groups, EVLW and Pao(2)/Fio(2) ratio dropped significantly over time, regardless of the use of iNO (p < 0.01 [by ANOVA]). CONCLUSIONS: In the population studied, prophylactic iNO that was administered at 20 ppm had no effect on pulmonary edema formation and resolution following lung transplantation.

Preoperative psychological global well being index (PGWBI) predicts postoperative quality of life for patients with non-small cell lung cancer managed with thoracic surgery.

OBJECTIVE: Non-small cell lung cancer (NSCLC) patients surgically treated often experienced a postoperative disability related to the surgery but did not benefit from a long-term survival advantage (postoperative death and relapse). Therefore, improvement of quality of life (QOL) for all NSCLC patients surgically treated is necessary and the assessment of factors influencing the short-term postoperative QOL is required. Therefore, a prospective study to assess the value of the psychological global well being index (PGWBI) to predict short-term postoperative QOL was conducted. PATIENTS AND METHODS: Prospective study in Academic Hospital's departments of thoracic oncology and surgery. Socio-demographic and clinical characteristics as well as PGWBI scores of 110 NSCLC patients referred for thoracic surgery were prospectively compared to postoperative QOL evaluated by the mean of the EORTC QLQ-C30 and LC13 questionnaires, completed before hospital discharge. RESULTS: Eighty-four patients completed the postoperative QOL questionnaires. In the univariate analysis, most of the PGWBI scores significantly correlated with the postoperative QOL. Also, patients living alone presented with a significantly higher risk of experiencing a poor postoperative QOL. In the multivariate analysis, patients showing a lower preoperative global health status as evaluated through the PGWBI experienced a statistically significant lower postoperative global QOL (hazard ratio (HR) = 1.39, 95% confidence interval (CI) 1.12-1.74, p = 0.003) as well as a reduced physical (HR = 1.32, 95% CI 1.09-1.60, p = 0.004) and emotional (HR = 1.21, 95% CI 1.06-1.39, p = 0.004) functions. CONCLUSIONS: A simple assessment of patients at higher risk of a poor short-term postoperative QOL could be easily performed preoperatively, taking into account certain socio-demographic factors and the results of the QOL assessment using the PGWBI.

A new bioabsorbable sleeve for lung staple-line reinforcement (FOREseal): report of a three-center phase II clinical trial.

OBJECTIVE: To investigate on the feasibility, safety, and effectiveness of a new bioabsorbable material for lung staple-line reinforcement. METHODS: This prospective open trial included 66 patients (mean age of 56+/-17 years) who underwent various types of lung resection using staplers with knitted calcium alginate sleeves for buttressing (FOREseal, Laboratoires Brothier, Nanterre, France) at three academic centers: 29 lobectomies, 22 emphysema surgeries, 15 wedge resections or lung biopsies. Intraoperative air leakage was assessed at a mean respiratory peak pressure of 30 cmH2O, and rated as grade 1, 2, or 3. Persistent air leakage in the postoperative course, as well as any relevant event, was assessed daily. The follow-up period was of 6 months. RESULTS: No technical problem linked to the device occurred. Hemostasis of the cutting edges was completed in all patients. Fifty-six percent of the patients had no intraoperative air leak and 27.3% had grade 1 leaks. Mean postoperative air leaks and thoracic drainage times were 1.9+/-2.3 days and 6+/-5.3 days, respectively. In-hospital mortality was nil. There was no empyema. Mean hospital stay was 9.1+/-6.6 days. At follow-up, one patient underwent lung transplantation, and pathology of the explanted specimen showed the absence of device-related foreign-body inflammation. One patient complained from metalloptysis, and another one, with a metastatic invasive aspergillosis, developed an infectious recurrence that required reoperation. CONCLUSIONS: FOREseal is an ergonomic, safe, and promising new material instead of nonabsorbable materials and xenomaterials for staple-line reinforcement. A randomized comparative study is now in progress.

The place of patient satisfaction in quality assessment of lung cancer thoracic surgery.

STUDY OBJECTIVES: To compare the quality of non-small cell lung cancer (NSCLC) surgical care with patient satisfaction. DESIGN: Prospective study. SETTING: Academic hospital departments of thoracic oncology and surgery. PATIENTS AND METHODS: Patients presenting with recently diagnosed NSCLC and eligible for front-line thoracic surgery were eligible. Patient satisfaction was assessed using the Questionnaire of Satisfaction of Hospitalized Patients. Quality of surgical care was evaluated using an original score built accordingly to British Thoracic Society guidelines. Univariate analysis used parametric (Pearson correlation, t test) and nonparametric tests (Mann-Whitney U test) according to test conditions. Probability of survival was estimated using the Kaplan-Meier method. RESULTS: Seventy patients (mean age, 63.7 years) were included. Lobectomy was performed in 62 cases, and pneumonectomy was performed in 8 cases. In all, 28 patients had a postoperative complication. One-year survival rates for patients with stage I-II and stage IIIA NSCLC were 84% and 58%, respectively. Mean patient satisfaction was 78 +/- 13/100 and 69 +/- 13/100 for global staff and structure index, respectively (+/- SD). Mean score for quality of surgical care was 88.7/100 (range, 51 to 100). The absence of postoperative complication was significantly related to a high level of satisfaction regarding the structure (r = 0.30, p < 0.05). Other features of patient satisfaction did not show a significant correlation with the quality of the preoperative selection process or the surgical procedure itself (r < 0.20). CONCLUSIONS: Considering the lack of significant correlation, the present study does not support a shortcut between quality of care and patient satisfaction. Nonetheless, patient satisfaction should be integrated into rather than substituted for the quality of health-care assessment, which also needs further development.

One hundred consecutive pneumonectomies after induction therapy for non-small cell lung cancer: an uncertain balance between risks and benefits.

OBJECTIVE: We sought to assess postoperative outcome after pneumonectomy after neoadjuvant therapy in patients with non-small cell lung cancer. METHODS: This retrospective study included 100 patients treated from January 1989 through December 2003 for a primary lung cancer in whom pneumonectomy had been performed after an induction treatment. Surgical intervention had not been considered initially for the following reasons: N2 disease (stage IIIA, n = 79), doubtful resectability (stage IIIB [T4, N0], n = 19), and M1 disease (stage IV [T2, N0, M1, solitary brain metastasis], n = 2). All patients received a 2-drug platinum-based regimen with a median of 2.5 cycles (range, 2-4 cycles), and 30 had associated radiotherapy (30-45 Gy). RESULTS: There were 55 right and 45 left resections. Overall 30-day and 90-day mortality rates were 12% and 21%, respectively. At multivariate analysis, one independent prognostic factor entered the model to predict 30-day mortality: postoperative cardiovascular event (relative risk, 45.7; 95% confidence interval, 3.7-226.7; P = .001). Four variables predicted 90-day mortality: age of more than 60 years (relative risk, 5.06; 95% confidence interval, 1.47-17.48; P = .01), male sex (relative risk, 8.25; 95% confidence interval, 1.01-67.34; P = .049), postoperative respiratory event (relative risk, 3.64; 95% confidence interval, 1.14-9.37; P = .007), and postoperative cardiovascular event (relative risk, 7.84; 95% confidence interval, 3.12-19.71; P < .001). Estimated overall survivals in 90-day survivors were 35% (range, 29%-41%) and 25% (range, 19.3%-30.7%) at 3 and 5 years, respectively. At multivariate analysis, one independent prognostic factor entered the model: pathologic stage III-IV residual disease (relative risk, 1.89; 95% confidence interval, 1.09-3.26; P = .022). CONCLUSIONS: Pneumonectomy after induction therapy is a high-risk procedure, the survival benefit of which appears uncertain.

Gefitinib (ZD1839, Iressa) in non-small-cell lung cancer: a review of clinical trials from a daily practice perspective.

Gefitinib (ZD1839) is the most widely studied targeting agent in the area of non-small-cell lung cancer (NSCLC). Gefitinib is an orally active epidermal growth factor receptor (EGFR) tyrosine kinase (TK) inhibitor. In order to assess the role of gefitinib in the management of NSCLC patients, we systematically reviewed published clinical trials from a daily practice perspective. A systematic research was made in the international medical literature. Gefitinib demonstrated a good tolerance and an encouraging efficacy in pretreated NSCLC patients in preclinical studies. These results were then confirmed in two phase II trials (IDEAL 1 and 2) involving more than 400 patients mostly pretreated with a platinum-containing regimen and docetaxel. All these results were reinforced by those of retrospective studies on patients enrolled in a compassionate use programme. Thus, two phase III trials in chemo-naive patients were initiated (INTACT 1 and 2). Unfortunately, the use of gefitinib with standard combination chemotherapy provided no survival benefit nor response rate or progression-free survival improvement over placebo. Furthermore, we also reviewed the results of studies interested in the characterization of predictive clinical or biological markers for response to gefitinib and discussed the results obtained with other EGFR inhibitors. The efficacy of gefitinib in the first-line setting of each stage of NSCLC has to be further studied through clinical trials. Furthermore, translational studies characterizing the molecular features involved in the response to anti-EGFR-targeted therapies are needed.