Perioperative Nivolumab in Resectable Lung Cancer.

BACKGROUND: Standard treatment with neoadjuvant nivolumab plus chemotherapy significantly improves outcomes in patients with resectable non-small-cell lung cancer (NSCLC). Perioperative treatment (i.e., neoadjuvant therapy followed by surgery and adjuvant therapy) with nivolumab may further improve clinical outcomes. METHODS: In this phase 3, randomized, double-blind trial, we assigned adults with resectable stage IIA to IIIB NSCLC to receive neoadjuvant nivolumab plus chemotherapy or neoadjuvant chemotherapy plus placebo every 3 weeks for 4 cycles, followed by surgery and adjuvant nivolumab or placebo every 4 weeks for 1 year. The primary outcome was event-free survival according to blinded independent review. Secondary outcomes were pathological complete response and major pathological response according to blinded independent review, overall survival, and safety. RESULTS: At this prespecified interim analysis (median follow-up, 25.4 months), the percentage of patients with 18-month event-free survival was 70.2% in the nivolumab group and 50.0% in the chemotherapy group (hazard ratio for disease progression or recurrence, abandoned surgery, or death, 0.58; 97.36% confidence interval [CI], 0.42 to 0.81; P<0.001). A pathological complete response occurred in 25.3% of the patients in the nivolumab group and in 4.7% of those in the chemotherapy group (odds ratio, 6.64; 95% CI, 3.40 to 12.97); a major pathological response occurred in 35.4% and 12.1%, respectively (odds ratio, 4.01; 95% CI, 2.48 to 6.49). Grade 3 or 4 treatment-related adverse events occurred in 32.5% of the patients in the nivolumab group and in 25.2% of those in the chemotherapy group. CONCLUSIONS: Perioperative treatment with nivolumab resulted in significantly longer event-free survival than chemotherapy in patients with resectable NSCLC. No new safety signals were observed. (Funded by Bristol Myers Squibb; CheckMate 77T ClinicalTrials.gov number, NCT04025879.).

Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer.

BACKGROUND: No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemoradiotherapy and surgery for esophageal or gastroesophageal junction cancer. METHODS: We conducted CheckMate 577, a global, randomized, double-blind, placebo-controlled phase 3 trial to evaluate a checkpoint inhibitor as adjuvant therapy in patients with esophageal or gastroesophageal junction cancer. Adults with resected (R0) stage II or III esophageal or gastroesophageal junction cancer who had received neoadjuvant chemoradiotherapy and had residual pathological disease were randomly assigned in a 2:1 ratio to receive nivolumab (at a dose of 240 mg every 2 weeks for 16 weeks, followed by nivolumab at a dose of 480 mg every 4 weeks) or matching placebo. The maximum duration of the trial intervention period was 1 year. The primary end point was disease-free survival. RESULTS: The median follow-up was 24.4 months. Among the 532 patients who received nivolumab, the median disease-free survival was 22.4 months (95% confidence interval [CI], 16.6 to 34.0), as compared with 11.0 months (95% CI, 8.3 to 14.3) among the 262 patients who received placebo (hazard ratio for disease recurrence or death, 0.69; 96.4% CI, 0.56 to 0.86; P<0.001). Disease-free survival favored nivolumab across multiple prespecified subgroups. Grade 3 or 4 adverse events that were considered by the investigators to be related to the active drug or placebo occurred in 71 of 532 patients (13%) in the nivolumab group and 15 of 260 patients (6%) in the placebo group. The trial regimen was discontinued because of adverse events related to the active drug or placebo in 9% of the patients in the nivolumab group and 3% of those in the placebo group. CONCLUSIONS: Among patients with resected esophageal or gastroesophageal junction cancer who had received neoadjuvant chemoradiotherapy, disease-free survival was significantly longer among those who received nivolumab adjuvant therapy than among those who received placebo. (Funded by Bristol Myers Squibb and Ono Pharmaceutical; CheckMate 577 ClinicalTrials.gov number, NCT02743494.).

Stenting in Palliation of Unresectable Esophageal Cancer.

BACKGROUND: The aim of this study was to analyze the safety and effectiveness of stenting using partially covered self-expandable stents in palliation of dysphagia in patients with unresectable esophageal cancer. METHODS: Retrospective analysis of hospital records of all patients who underwent esophageal stenting in the period 2008-2015 was performed. The study included patients with unresectable esophageal and esophagogastric cancer. RESULTS: There were 442 patients included. Mean age was 56 years (range 28-89), and 379 were males. In 40 (9.0%) patients, stenting was performed in the cervical, in 150 (39.3%)-in the middle thoracic, in 141 (31.9%)-in lower thoracic esophagus and in 111 (25.1%)-in the esophagogastric junction. Stenting resulted in significant alleviation of dysphagia grade (3.0 vs. 1.0, p = 0.00001). During the follow-up, 55 (12.4%) patients experienced recurrent dysphagia due to tumor or granulation tissue overgrowth, and in 18 (4.1%) patients, migration of the stent occurred, for which an independent risk factor was adjuvant chemo- and/or radiation therapy (p = 0.001). Minor complications included chest pain (54.5%), delayed complete stent expansion (12.0%), feeling of a foreign body (25.3%), hiccup (1.6%), gastroesophageal reflux (45.6%) and post-discharge pneumonia (2.5%). A feeling of a foreign body in the esophagus was significantly more common after stenting of the cervical esophagus (p = 0.0001), and hiccup was more common after stenting of the esophagogastric junction (p = 0.02). Major complications included bleeding (1.3%), respiratory insufficiency (0.7%), esophageal perforation (0.9%) and irregular heartburn (2.3%). Overall procedure-related mortality was 0.4%. The median survival time was 117.8 days (range 2-732). CONCLUSIONS: Stenting is an effective procedure in relieving dysphagia in patients with unresectable malignant esophageal stenosis and is associated with low rate of postoperative and long-term complications.

Surgical Treatment Results of Burn-Related Oesophageal Strictures.

BACKGROUND: Post-burn oesophageal stricture is a late complication, which may require surgical intervention. The aim of the study was to compare gastric and colonic conduits and to evaluate the safety, efficacy and complications of these techniques. METHODS: Retrospective analysis of all patients treated for burn-related oesophageal strictures between 1989 and 2013. Oesophagectomy was performed via laparotomy and right thoracotomy, and/or cervical incision. RESULTS: Forty-six patients, including 29 men, aged 17-67 years (mean: 41 years), had burn-related oesophageal strictures. The post-operative follow-up period ranged between 3 months and 30 years. Colonic transposition was used in 23 patients. In 21 patients, the oesophageal substitute was introduced through the posterior mediastinum, and in two patients the retrosternal route was used. Gastric conduit in was used in 21 patients and jejunal interposition in one patient. One patient underwent segmental oesophageal resection with end-to-end anastomosis. One patient had necrosis of the colonic conduit with anastomotic leakage, two patients had oesophago-colonic anastomosis leakage, five developed anastomotic stenosis, and two had respiratory insufficiency. Among patients with a gastric conduit, anastomotic leakage occurred in four, cervical anastomotic stenosis occurred in two, and respiratory insufficiency occurred in three, and one patient had impaired gastric emptying that required surgical re-intervention. Operative mortality was three patients (6.5%). CONCLUSIONS: The use of colonic and gastric conduit is an effective and safe method for restoring the continuity of the gastrointestinal tract, with an acceptable rate of post-operative complications. Patients who undergo oesophageal resection for post-burn stricture require post-operative systematic endoscopic control.

Residua of thymus in the mediastinum - clinical aspects - cadaveric study.

The main goal of this study was to investigate possible residua of thymic tissue in 100 adult cadavers with no thoracic pathology known before, by dissection of standard locations of thymic tissue in perithyroid, periaortic, peritracheal and retrotracheal spaces, as well as areas located next to the course of phrenic, vagus and left recurrent laryngeal nerves. Thus obtained tissue samples were studied by two pathologists independently. The remnants of the thymic tissue were found in 61 out of 100 specimens studied. It means that residua of ectopic thymic tissue is common, which may have a huge impact on the results of treatment of many diseases i.e. myasthenia gravis in course of thymoma.

Expression of ß-catenin and its correlation with metastatic progression of esophagogastric junction adenocarcinoma.

The evaluation of ß-catenin expression in adenocarcinoma of the esophagogastric junction and its influence on cancer progression. Sixty-one patients who were diagnosed with adenocarcinoma of the esophagogastric junction were examined. We evaluated ß-catenin distribution in the cell membrane and the cell nucleus in adenocarcinoma of the esophagogastric junction type 1 and type 3. Our findings showed lack of a statistically significant difference in evaluation of adenocarcinoma type 1 and type 3 aggressiveness. However, we found a statistically significant association with the T and N stage, although we did not find an effect of them on patient survival. Patients with cellular membrane and cell nucleus staining comprise a group of patients with higher risk of malignancy progression in adenocarcinoma of the esophagogastric junction types 1 and 3.

The influence of lung volume reduction with intrabronchial valves on the quality of life of patients with heterogeneous emphysema - a prospective study.

INTRODUCTION: A heterogeneous emphysema is one of the most severe forms of chronic obstructive pulmonary disease (COPD). In some cases, besides the standard pharmacotherapy, a new treatment option of emphysema can be used - bronchoscopic lung volume reduction (BLVR) with the use of intrabronchial valves. OBJECTIVES: To examine the health-related quality of life (HRQoL) of patients with severe emphysema after intrabronchial valve (IBV) implantation for the treatment of one lung. MATERIAL AND METHODS: From 2011 to 2013 a single centre prospective observational study was performed. The study assessed the effect of the therapeutic BLVR intervention, measured by St. George Respiratory Questionnaire (SGRQ). A statistical analysis by use of Wilcoxon test for dependent variables was performed. RESULTS: Twenty patients were enrolled to the study (mean age 63 ± 10 years), all ex-smokers with tobacco exposure 38 ± 11.3 packyears. After 3 months of IBV treatment the average SGRQ score improved significantly in total (-12.8; p < 0.001) and in domains and the differences were for: "symptoms" (-8.5; p < 0.001), "activity" (-13.9; p < 0.001) and "influence on life"(-13.5; p < 0.002). CONCLUSIONS: The presented study revealed a significant improvement of the quality in the life measured by SGRQ after IBV treatment for heterogeneous emphysema. For the first time our study showed the significant improvement of all three domains of SGRQ after IBV treatment.

Prevalence and quantity of lymph nodes at mediastinal stations in patients with lung cancer: lessons from 181 bilateral mediastinal lymphadenectomies.

BACKGROUND: This study evaluated the prevalence and quantity of lymph nodes at particular stations of the mediastinum in patients with lung cancer. These data are important to radiologists, pathologists, and thoracic surgeons because they can serve as a benchmark when assessing the completeness of lymph node dissection. However, relevant data in the literature are scarce. METHODS: Data regarding the number of lymph nodes derived from two randomised trials of bilateral mediastinal lymph node dissection, the BML-1 and BML-2 study, were included in this analysis. Detectable nodes at particular stations of the mediastinum and the number of nodes at these stations were analysed. RESULTS: The mean number of removed nodes was 28.67 (range, 4-88). Detectable lymph nodes were present at stations 2R, 4R, and 7 in 93%, 98%, and 99% of patients, respectively. Nodes were rarely present at stations 9 L (33%), and 3 (35%). The largest number of nodes was observed at stations 7 and 4R (mean, 5 nodes). CONCLUSION: The number of mediastinal lymph nodes in patients with lung cancer may be greater than that in healthy individuals. Lymph nodes were observed at stations 2R, 4R, and 7 in more than 90% of patients with lung cancer. The largest number of nodes was observed at stations 4R and 7. Detectable nodes were rarely observed at stations 3 and 9 L. TRIAL REGISTRATION: ISRCTN 86,637,908.

Various clinical scenarios of primary melanoma of the esophagus: A retrospective 20-year analysis from two university thoracic surgery centers.

BACKGROUND: Primary melanoma of the esophagus (PME) represents a rare type of gastrointestinal malignancy with an exceptionally poor diagnosis. So far, only few descriptions of PME which satisfactorily summarize their clinical characteristics and prognosis have been published. OBJECTIVES: The aim of our study was to summarize our experience with PME patients. MATERIAL AND METHODS: In a group of 1387 patients who underwent esophagectomy due to neoplastic process in the years 2000-2020 in 2 high-volume university thoracic surgery centers, we identified those with confirmed PME diagnosis. Subsequently, their clinical characteristics, imaging and histopathological results were compared. The data regarding the long-term survival were obtained from the Polish National Death Registry. RESULTS: The PME was identified in 4 (0.29%) patients. Three of them (75%) were males. The mean age on admission was 64.3 ±17.5 years. The main symptom in all patients was dysphagia. In 1 patient with the most advanced PME, the clinically relevant weight loss was noted. In 3 patients, Ivor Lewis esophagectomy was performed, and 1 patient underwent McKeown resection. Histopathologic examination revealed a metastasis of lymph nodes only in 1 patient. The average maximum size of tumor was 6.9 ±4.7 cm and all tumors were located in distal part of the esophagus. Two out of those 4 patients are still alive and the longest survival time is 17 years. One patient died due to postoperative massive gastrointestinal bleeding complicated with cardiac arrest and the other one due to progression of PME systemic dissemination 6 months after surgical treatment. CONCLUSION: The PME is an extremely rare diagnosis. A long-term survival can be achieved with the complete resection. Clinical scenarios of surgically treated PME patients may significantly differ.

Exogenous lipoid pneumonia (oil granulomas of the lung).

The authors observed three cases of exogenous lipid pneumonia clinically suspected of lung carcinoma. Histological examination of material after thoracotomy gave the possibility of correct diagnosis. The lesions in lungs were characteristic granulomas around lipid material and with surrounding advanced fibrosis.

Characterization of Partially Covered Self-Expandable Metallic Stents for Esophageal Cancer Treatment: In Vivo Degradation.

Partially covered self-expandable metallic esophageal stent (SEMS) placement is the most frequently applied palliative treatment in esophageal cancer. Structural characterization of explanted 16 nitinol-polyurethane SEMS (the group of 6 females, 10 males, age 40-80) was performed after their removal due to dysfunction. The adverse bulk changes in the polymer structure were identified using differential scanning calorimetry (DSC), differential mechanical thermal analysis (DMTA), and attenuated total reflectance infrared spectroscopy (ATR-IR) and discussed in terms of melting point shift (9 °C), glass-transition shift (4 °C), differences in viscoelastic behavior, and systematic decrease of peaks intensities corresponding to C-H, C═O, and C-N polyurethane structural bonds. The scanning electron and confocal microscopic observations revealed all major types of surface degradation, i.e., surface cracks, peeling off of the polymer material, and surface etching. The changes in the hydrophobic polyurethane surfaces were also revealed by a significant decrease in wettability (74°) and the corresponding increase of the surface free energy (31 mJ/m2). To understand the in vivo degradation, the in vitro tests in simulated salivary and gastric fluids were performed, which mimic the environments of proximal and distal ends, respectively. It was concluded that the differences in the degradation of the proximal and distal ends of prostheses strongly depend on the physiological environment, in particular stomach content. Finally, the necessity of the in vivo tests for SEMS degradation is pointed out.

Influence of bilateral mediastinal lymph node dissection on survival in non-small cell lung cancer patients - Randomized study.

OBJECTIVES: This study aimed to analyze the effect of bilateral mediastinal lymphadenectomy (BML) on survival of non-small cell lung cancer (NSCLC) patients. The hypothesis was: BML offers survival benefit as compared with SLND. METHODS: A randomized clinical trial including stage I-IIIA NSCLC patients was performed. All patients underwent anatomical lung resection. BML was performed during the same operation via additional cervical incision (BML group). In the control group, standard lymphadenectomy (systematic lymph node dissection, SLND) was performed. RESULTS: In total, 102 patients were randomized. No significant difference was found in the type of lung resection, blood loss, chest tube output, air leak, pain, and complications (p = 0.188-0.959). In the BML group, the operative time was longer (318 vs 223 min, p < 0.001) with higher number of removed N2 nodes (24 vs 14, p < 0.001). The 5-year survival rate was 72 % in the BML group vs 53 % in the SLND group (OR 2.33, 95 % CI 0.95-5.69, p = 0.062). Separate comparisons for different lobar locations of the tumor have shown no significant difference in survival for the right lung tumors and left upper lobe tumors. For the left lower lobe tumors, survival time was longer in the BML group (p = 0.021), and the 5-year survival rate was 90.9 % vs 37.5 %, (OR 16.66, 95 % CI 1.36-204.04, p = 0.0277). CONCLUSIONS: In patients with NSCLC located in the left lower lobe, bilateral lymph node dissection may be associated with better survival. The invasiveness of BML is comparable to that of SLND.

Early chemotherapy de-escalation strategy in patients with advanced-stage Hodgkin lymphoma with negative positron emission tomography scan after 2 escalated BEACOPP cycles.

INTRODUCTION Escalated BEACOPP (escBEACOPP: bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) significantly improves overall response rates (ORRs) and prolongs progression­free survival (PFS) in patients with advanced­stage Hodgkin lymphoma (HL). However, 6 to 8 cycles of escBEACOPP are associated with increased acute toxicity and late complications. OBJECTIVES We aimed to determine the role of early positron emission tomography-computed tomography (PET­CT) response assessment in a de­escalation strategy. PATIENTS AND METHODS We retrospectively analyzed 188 consecutive patients with advanced­stage HL treated at diagnosis. Patients received 2 cycles of escBEACOPP followed by an early PET­CT response assessment performed after 2 cycles of chemotherapy (PET2). Patients with an active disease continued therapy with escBEACOPP, while those with negative PET2 were de­escalated to ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine). Radiotherapy was allowed in patients with stage IIBX. RESULTS PET2 allowed for de­escalation of therapy in 141 patients (75%). Their ORR was 92.2%, with a complete remission (CR) rate of 91.5%; 10­year PFS and overall survival (OS) were 87.2% and 95%, respectively. In the whole cohort, ORR was 87.8% (CR, 85.6%), while the 10­year PFS and OS were 79.3% and 89.4%, respectively. Hematological and thromboembolic complications were significantly more frequent in patients treated with 6 escBEACOPP cycles, including febrile neutropenia (25 patients, [53.2%] vs 7 [5%]), serious anemia (35 [74.5%] vs 11 [7.8%]), or thrombocytopenia (16 [34%] vs 7 [5%]) (P <0.001 for all comparisons with de­escalation strategy) as well as pulmonary embolism (3 [6.4%] vs 0) (P = 0.02). CONCLUSIONS The early de­escalation strategy allows for effective treatment of advanced HL, with a comparable efficacy to that of 6 to 8 cycles of escBEACOPP, but with significantly reduced toxicity.

[Ultrasound guided transbronchial needle aspiration as a diagnostic tool for lung cancer and sarcoidosis]. / Przezoskrzelowa biopsja wezlów chlonnych sródpiersia i wnek pluca pod kontrola ultrasonografii wewnatrzoskrzelowej w czasie rzeczywistym w diagnostyce raka pluca i sarkoidozy.

INTRODUCTION: The aim of the study was to assess the diagnostic yield of ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in mediastinal or hilar adenopathy in: 1) staging of non-small cell lung cancer (NSCLC) (97); 2) other malignant neoplasms including: small cell lung cancer (SCLC), metastatic neoplasms and Hodgkin's disease (16); 3) NSCLC recurrence (7); 4) sarcoidosis and other non-malignant diseases (29). MATERIAL AND METHODS: Real time EBUS-TBNA was performed under local anaesthesia and sedation in 149 consecutive patients - 237 biopsies in groups of lymph nodes: subcarinal (7) - 107, all paratracheal (2R, 2L, 4R, 4L) - 86, hilar (10R, 10L) - 41 and interlobar (11R, 11L) - 3. A mean axis of punctured node was 15 mm (range: 7-42 mm). All negative results were verified by transcervical extended bilateral mediastinal lymphadenectomy (TEMLA), mediastinoscopy or thoracotomy. RESULTS: Lymph node biopsy was technically successful in 92% and was diagnostic in 55% of lung cancer patients and in 85.7% of sarcoidosis patients. In NSCLC staging sensitivity of EBUS-TBNA was 88.7%, specificity 100%, accuracy 92.8% and NPV 83.3% (89.7%, 100%, 94.9% and 90.9% per biopsy), and in the whole group it was 91.5%, 98.7%, 94.6% and 87.3% respectively. In 7.2% of NSCLC staging patients with false negative results of EBUS-TBNA (mainly subcarinal) there was observed partial involvement of metastatic lymph nodes, mean 34.3% (range 10-50%), confirmed by TEMLA. CONCLUSION: The diagnostic value of EBUS-TBNA is very high in lung cancer, NSCLC staging and sarcoidosis.

Safety and efficacy of airway stenting in patients with malignant oesophago-airway fistula.

BACKGROUND: Close anatomical relationships between the oesophagus and the bronchial tree can lead to the formation of oesophageal fistula particularly in patients with advanced lung or oesophageal carcinoma. Stenting is a most often used treatment in such patients, but data regarding the relative value of unilateral (US) vs. double stenting (DS) are scarce. METHODS: Retrospective analysis of hospital records of patients with oesophageal fistula who underwent stenting between 2008 and 2016. In those in whom airway stenosis was >30%, double stenting (oesophagus and bronchial tree) was performed, whereas in those with lesser airway stenosis unilateral stenting (i.e., oesophagus only) was performed. In all patients, the degree of dysphagia, the degree of dyspnoea and the quality of life were assessed before and after the stenting. RESULTS: There were 46 patients, analysed, including 26 who underwent DS and 20 patients who underwent US. Both, DS and US resulted in significant improvement of dysphagia (2.72 vs. 1.2, P=0.0001 and 2.65 vs. 1.0, P=0.0001), dyspnoea (2.89 vs. 0.34, P=0.0001 and 1.71 vs. 0.09, P=0.0001) and performance score (53.2 vs. 66.3, P=0.0001 and 54.3 vs. 62.38, P=0.0001). Neither fistula type, nor stenting method, weight loss and gain, and BMI, had an effect on survival (P=0.34). Disease progression and recurrence of fistula requiring re-intervention occurred in 9 patients (19.5%). CONCLUSIONS: Double and unilateral stenting is an effective measure to alleviate dysphagia and dyspnoea in patients treated with malignant oesophageal fistula. In those with airway stenosis of ≤30%, stenting of the oesophagus only, instead of DS, is a safe method of treatment.

Safety and efficacy of oesophageal stenting with simultaneous percutaneous endoscopic gastrostomy as a supplementary feeding route in unresectable proximal oesophageal cancer.

INTRODUCTION: Proximally located oesophageal cancer poses an especially difficult problem in terms of restoration of patency and the stenting procedure. Supplementary percutaneous endoscopic gastrostomy (PEG) may be useful in these patients. AIM: To assess the safety of the stenting procedure in the proximal oesophagus in patients with unresectable upper oesophageal cancer, performed simultaneously with PEG insertion. MATERIAL AND METHODS: Patients with obstructing upper oesophageal tumours were scheduled for an oesophageal stenting procedure and simultaneous PEG insertion. Degree of dysphagia, body weight loss, daily energy requirement, body mass index and performance status before and after the stenting procedure as well as complications were assessed. RESULTS: Forty-five patients aged 19-88 years were included in the study. Six of them had a fistula to the trachea and underwent stenting of the oesophagus or both the oesophagus and the airway. The technical success rate was 100%. Following the procedure all patients were able to swallow fluids and semi-liquids, and PEG was used as the primary feeding route. Body mass index increased from 20.4 to 21.1 (p = 0.0001), body weight gain improved from -10.1 to +2.0 kg and metabolic requirements improved (p = 0.0001). Also, the Karnofsky score improved significantly (56.7 vs. 65.1, p = 0.0001). Mean survival time was 133 days (range: 36-378). CONCLUSIONS: Stenting of the proximal oesophagus with simultaneous PEG is a safe procedure, allowing the patients to resume oral intake of liquids whilst improving nutritional status and general performance, with an acceptable rate of complications.

Preoperative thrombocytosis in surgically treated patients with non-small cell lung cancer.

Introduction Lung cancer is the most common cause of cancer­related death. Accurate and easy­to­use prognostic factors are necessary. Increased platelet count might be a potential prognostic factor. Objectives We aimed to investigate the relationship between thrombocytosis and stage of lung cancer and to assess the frequency and clinical importance of thrombocytosis in this patient group. Patients and methods We retrospectively analyzed hospital records of consecutive patients with non-small cell lung cancer (NSCLC) who underwent curative­intent pulmonary resections. Results Of 323 patients, 285 patients with NSCLC were selected (mean [SD] age, 66.55 [8.52] years; men, 63.86%). Squamous cell carcinoma was diagnosed in 130 patients (45.61%); adenocarcinoma, in 128 (44.91%); large cell carcinoma, in 16 (5.61%); and adenosquamous carcinoma, in 11 (3.86%). The prevalence of preoperative thrombocytosis in the whole sample was 10.18% (n = 29). Anemia was more common in patients with thrombocytosis compared with those without thrombocytosis (65.52% vs 30.08%; P <0.001). Thrombocytosis was found in 22.41% of patients with stage III+IV cancer and in 3.82% of those with stage I (P <0.001). Moreover, in patients with no metastases (N0, M0 according to the 7th edition of the TNM classification), thrombocytosis was more frequent in the group with stage II than in that with stage I cancer (3.85% vs 20.00%; P = 0.002). Thrombocytosis was also more frequent in patients with N2 than with N1 disease (9.76% vs 23.81%; P = 0.09). Conclusions Thrombocytosis is often observed in patients with NSCLC and is significantly associated with the higher stage of disease.

The right upper lobe pulmonary resection performed through the transcervical approach.

OBJECTIVE: Preliminary report: presentation of the new technique of transcervical right upper lobectomy with transcervical extended mediastinal lymphadenectomy (TEMLA) for NSCLC. METHODS: Two patients underwent the operation that was performed through the collar incision, with elevation of the sternal manubrium with the mechanical sternal retractor. TEMLA and bilateral mediastinal lymph node excision (stations 1, 2R, 4R, 2L, 4L, 3A, 3P, 7 and 8) and bilateral supraclavicular lymph node excision were performed (frozen section analysis: all nodes negative). The mediastinal pleura was opened and the following structures were dissected in the open fashion with standard surgical instruments and divided with the use of endostaplers: the azygos vein, the upper trunk of the right pulmonary artery, the branch of the superior pulmonary vein to the upper lobe, the upper lobe bronchus, the segment 2 artery, the posterior part of the oblique fissure and the horizontal fissure. The operation was performed with the use of one videothoracoscopic (VTS) port for insertion of 5mm, 30 degree VTS camera for intraoperative control and for single thoracic drain for the postoperative period. RESULTS: The operative times were 250 and 270 min, respectively; intraoperative blood loss was 110 and 100ml, respectively. There were no intraoperative complications. The postoperative course was remarkably smooth. The final pathologic report: large cell carcinoma pT2N0M0 and squamous cell carcinoma pT2N0M0, no metastatic changes of 51 and 41 mediastinal and intrapulmonary (stations 10, 11 and 12) and supraclavicular nodes, respectively. CONCLUSIONS: This preliminary report indicates possible advantages of the transcervical right upper lobe pulmonary resection including: (1) extremely radical, minimal invasive procedure with no need for utility thoracotomy; (2) dissection performed with standard surgical instruments in the open fashion.

Effect of bilateral mediastinal lymphadenectomy on short-term pulmonary function.

OBJECTIVE: To assess if the bilateral mediastinal lymphadenectomy results in lymphatic congestion in the lungs producing clinically significant impairment of respiratory function. METHODS: In the prospective, randomized, double-blind clinical study, non-small cell lung carcinoma patients underwent preoperatively mediastinoscopy or the transcervical extended mediastinal lymphadenectomy (TEMLA). In both groups, the blood gas analysis and spirometry were measured preoperatively and on the 1st, 3rd, and 5th postoperative day, and the carbon monoxide diffusing capacity of the lung (DLCO) and lung compliance were measured preoperatively and on the 3-5 postoperative day. Any respiratory complications were also recorded. RESULTS: Forty-one patients were randomized: 21 to the TEMLA group and 20 to the mediastinoscopy group. There was no significant difference of the baseline and the 1st, 3rd, and 5th day measurements of vital capacity and forced expiratory volume (FEV1) (p>0.98), pH, pO(2), pCO(2), standard bicarbonates and base excess (p>0.31), nor significant difference of baseline and 3-5 day measurements for DLCO (p=0.91) and lung compliance (p=0.38). The incidence of respiratory insufficiency was not significantly different (p=0.51). CONCLUSIONS: (1) Complete excision of mediastinal lymph nodes stations 1, 2R, 2L, 3A, 4R, 4L, 5, 6, 7, and 8 (TEMLA) is not associated with greater incidence of respiratory insufficiency comparing with standard mediastinoscopy. (2) The TEMLA procedure does not produce greater alterations in spirometry, blood gas analysis, DLCO and lung compliance comparing with standard mediastinoscopy.

The transcervical extended mediastinal lymphadenectomy versus cervical mediastinoscopy in non-small cell lung cancer staging.

OBJECTIVE: To compare the diagnostic yield of the transcervical extended mediastinal lymphadenectomy (TEMLA) and the cervical mediastinoscopy (CM) in detecting metastatic mediastinal lymph nodes in NSCLC patients. METHODS: Prospective, randomized, single-blind clinical study. RESULTS: There were 41 NSCLC patients enrolled in the study; 21 were randomized to the TEMLA group and 20 to the cervical mediastinoscopy group. The TEMLA revealed mediastinal metastases in 7 patients, and mediastinoscopy in 3. In the TEMLA group one patient out of the 14 with negative nodes was finally found unfit for surgery, and in the remaining 13 lung resections with mediastinal dissection were performed. In the mediastinoscopy group one patient out of the 17 with negative nodes was finally found unfit for surgery and another one refused surgery, so in 15 of them lung resections with mediastinal dissection were performed. In no patient in the TEMLA group did the pathological examination of the operative specimen reveal metastatic lymph nodes, whereas in the mediastinoscopy group metastatic nodes were found in 5 patients. The number of false negative results was significantly greater in the mediastinoscopy group (5 vs 0, p=0.019), and the difference was the reason for terminating the randomization before reaching the initially planned number of 100 patients. The sensitivity of mediastinoscopy was 37.5% and its negative predictive value was 66.7%, compared to 100% and 100% in the TEMLA group. The comparison of the time of the operation, blood loss, complications, postoperative pain and the use of analgetics has shown significant differences between groups only regarding the operative time and the pain intensity, being greater in the TEMLA group. CONCLUSIONS: 1. The sensitivity and the NPV of the TEMLA in detecting mediastinal metastases in NSCLC are significantly greater than those of cervical mediastinoscopy. 2. The invasiveness of TEMLA and mediastinoscopy does not significantly differ, except for the postoperative pain.