Randomized phase II study of daily versus alternate-day administrations of S-1 for the elderly patients with completely resected pathological stage IA (tumor diameter > 2 cm)-IIIA of non-small cell lung cancer: Setouchi Lung Cancer Group Study 1201.

BACKGROUND: It is shown that the postoperative adjuvant chemotherapy for non-small cell lung cancer (NSCLC) was associated with survival benefit in an elderly population. We aimed to analyze the feasibility and efficacy of alternate-day S-1, an oral fluoropyrimidine, for adjuvant chemotherapy in elderly patients with completely resected pathological stage IA (tumor diameter > 2 cm) to IIIA (UICC TNM Classification of Malignant Tumours, 7th edition) NSCLC. METHODS: Elderly patients were randomly assigned to receive adjuvant chemotherapy for one year consisting of either alternate-day oral administration of S-1 (80 mg/m2/day) for 4 days a week (Arm A) or a daily oral administration of S-1 (80 mg/m2/day) for 14 consecutive days followed by 7-day rest (Arm B). The primary endpoint was feasibility (treatment completion rate), which was defined as the proportion of patients who completed the allocated intervention for 6 months with a relative dose intensity (RDI) of 70% or more. RESULTS: We enrolled 101 patients in which 97 patients received S-1 treatment. The treatment completion rate at 6 months was 69.4% in Arm A and 64.6% in Arm B (p = 0.67). Treatment completion rate in Arm B tended to be lower compared to Arm A, as the treatment period becomes longer (at 9 and 12 months). RDI of S-1 at 12 months and completion of S-1 administration without dose reduction or postponement at 12 months was significantly better in Arm A than in Arm B (p = 0.026 and p < 0.001, respectively). Among adverse events, anorexia, skin symptoms and lacrimation of any grade were significantly more frequent in Arm B compared with Arm A (p = 0.0036, 0.023 and 0.031, respectively). The 5-year recurrence-free survival rates were 56.9% and 65.7% for Arm A and B, respectively (p = 0.22). The 5-year overall survival rates were 68.6% and 82.0% for Arm A and B, respectively (p = 0.11). CONCLUSION: Although several adverse effects were less frequent in Arm A, both alternate-day and daily oral administrations of S-1 were demonstrated to be feasible in elderly patients with completely resected NSCLC. TRIAL REGISTRATION: Unique ID issued by UMIN: UMIN000007819 (Date of registration: Apr 25, 2012) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009128. Trial ID issued by jRCT: jRCTs061180089 (Date of registration: Mar 22, 2019, for a shift toward a "specified clinical trial" based on Clinical Trials Act in Japan) https://jrct.niph.go.jp/en-latest-detail/jRCTs061180089.

Postoperative tegafur-uracil for stage I lung adenocarcinoma: first real-world data with an exploratory subgroup analysis.

PURPOSE: The effect of postoperative tegafur-uracil on overall survival (OS) after resection of stage I adenocarcinoma has been shown in clinical trials. The purpose of this study was to investigate whether findings from randomized trials of adjuvant tegafur-uracil are reproducible in a real-world setting. METHODS: A retrospective cohort study was performed using a multi-institutional database that included all patients who underwent complete resection of pathological stage I adenocarcinoma between 2014 and 2016. Survival outcomes for patients managed with and without tegafur-uracil were analyzed using the Kaplan-Meier method and a Cox proportional hazards model for the whole patient cohort and in a selected cohort based on eligibility criteria of a previous randomized trial. Propensity score matching was used to adjust for confounding effects. RESULTS: After propensity score matching, the hazard ratios for OS were 0.57 (95% confidence interval (CI) 0.29-1.14, P = 0.11) in the whole cohort and 0.69 (95% CI 0.32-1.50, P = 0.35) in the selected cohort. CONCLUSIONS: The effects of tegafur-uracil in this retrospective study appear to be consistent with those found in randomized clinical trials. These effects may be maximized in patients aged from 45 to 75 years.

Epidermal growth factor receptor tyrosine kinase inhibitors as first-line treatment for postoperative recurrent EGFR-mutated lung adenocarcinoma: a multi-institutional retrospective study.

OBJECTIVES: The aim of this study was to analyse the long-term survival outcomes and prognostic factors of patients receiving epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) as first-line treatment for postoperative recurrent EGFR-mutated lung adenocarcinoma. METHODS: Using a multi-institutional database, we performed a retrospective chart review to identify all patients who had undergone complete resection of stage I-III EGFR-mutated lung adenocarcinoma at 11 acute care hospitals between 2009 and 2016 and had received first-line EGFR-TKI treatment for postoperative recurrence. Adverse events, progression-free survival (PFS) and overall survival (OS) were investigated. Survival outcomes were assessed using Kaplan-Meier analysis. Cox proportional hazards models were used to calculate the hazard ratios (HRs) and 95% confidence intervals (CIs) for PFS and OS. RESULTS: The study sample comprised 154 patients with a median age of 69. The total numbers of events were 101 for PFS and 60 for OS. The median PFS and OS were 26.1 and 55.4 months, respectively. In the multivariable analysis, EGFR ex 21 L858R mutation (HR: 1.71, 95% CI: 1.15-2.55) and shorter disease-free intervals (HR: 0.98, 95% CI: 0.96-0.99) were significantly associated with shorter PFS. Age (HR: 1.03, 95% CI: 1.00-1.07), smoking history (HR: 2.31, 95% CI: 1.35-3.94) and pathological N2 disease at the initial surgery (HR: 2.30, 95% CI: 1.32-4.00) were significantly associated with shorter OS. CONCLUSIONS: First-line EGFR-TKI treatment was generally associated with favourable survival outcomes in patients with postoperative recurrent EGFR-mutated lung adenocarcinoma. EGFR ex 21 L858R mutation may be an important prognostic factor for shorter PFS.

Multicentre, prospective, observational study investigating the most appropriate surgical option that can prevent the recurrence of primary spontaneous pneumothorax after surgery: the PATCH study, protocol.

INTRODUCTION: Thoracoscopic surgery is performed for refractory or recurrent primary spontaneous pneumothorax (PSP). To reduce postoperative recurrence, additional treatment is occasionally adopted during surgery after bulla resection. However, the most effective method has not been fully elucidated. Furthermore, the preference for additional treatment varies among countries, and its efficacy in preventing recurrence must be evaluated based on settings tailored for the conditions of a specific country. The number of registries collecting detailed data about PSP surgery is limited. Therefore, to address this issue, a prospective multicentre observational study was performed. METHODS AND ANALYSIS: This multicentre, prospective, observational study will enrol 450 participants aged between 16 and 40 years who initially underwent PSP surgery. Data about demographic characteristics, disease and family history, surgical details, and CT scan findings will be collected. Follow-up must be conducted until 3 years after surgery or in the event of recurrence, whichever came first. Patients without recurrence will undergo annual follow-up until 3 years after surgery. The primary outcome is the rate of recurrence within 2 years after surgery. A multivariate analysis will be performed to compare the efficacy of different surgical options. Then, adverse outcomes correlated with various treatments and the feasibility of treatment methods will be compared. ETHICS AND DISSEMINATION: This study was approved by the local ethics committee of all participating centres. The findings will be available in 2025, and they can be used as a basis for clinical decision-making regarding appropriate options for the initial PSP surgery. TRIAL REGISTRATION NUMBER: NCT04758143.

A novel technique for Endobronchial Watanabe Spigot placement for bronchopleural fistula: a traction method.

Empyema with bronchopleural fistula is a challenging condition that often requires open-window thoracostomy. Bronchial occlusion with Endobronchial Watanabe Spigot is an effective and less invasive procedure to close the fistula; however, delivering a spigot into the target bronchus requires high technical skills. Herein, we report a case of bronchopleural fistula occluded with a spigot using a new 'traction method' in which the spigot is tied as an anchor to a guidewire and pulled into the target bronchus. Our method allows selective and steady placement of the spigot for patients who undergo open-window thoracostomy for the treatment of bronchopleural fistula.

Randomized phase II study of daily and alternate-day administration of S-1 for adjuvant chemotherapy in completely-resected stage I non-small cell lung cancer: results of the Setouchi Lung Cancer Group Study 1301.

BACKGROUND: The aim of this multicenter, randomized phase II study was to analyze the feasibility and safety of alternate-day S-1, an oral fluoropyrimidine, for adjuvant chemotherapy in patients with completely resected pathological stage I (tumor diameter > 2 cm) non-small cell lung cancer (NSCLC). METHODS: Patients were randomly assigned to receive adjuvant chemotherapy for 1 year comprising either alternate-day oral administration of S-1 (80 mg/m2/day) for 4 days a week (Group A) or a 2-week oral administration of S-1 (80 mg/m2/day) followed by 1 week of rest (Group B). The primary endpoint was feasibility, which was defined as the proportion of patients who completed the allocated intervention for 6 months with a relative dose intensity (RDI) of 70% or more. RESULTS: Ninety-three patients were enrolled of whom 90 patients received S-1 treatment. Median follow-up was 66.9 months. The treatment completion rate based on an RDI of 70% or more for 6 months was 84.4% (95%CI; 70.5-93.5%) in group A and 64.4% (95%CI; 48.8-78.1%) in group B. There were no grade 4 adverse events in either group. Moderate or severe adverse events (grade 2 or grade 3) were significantly more frequent in group B (67%) compared with group A (29%, P = 0.001). The 5-year relapse-free survival rate was 87.0 and 80.9% for group A and B, respectively (P = 0.451). The 5-year overall survival rate for all patients (n = 93) was 100 and 89.4% for group A and B, respectively (P = 0.136). CONCLUSION: Alternate-day oral administration of S-1 for 1 year as adjuvant chemotherapy was demonstrated to be feasible with low toxicity in completely resected stage I (tumor diameter > 2 cm) NSCLC. TRIAL REGISTRATION: Trial registration number: UMIN000011994 . Date of registration: 10/8/2013.

The treatment and survival of patients with postoperative recurrent thymic carcinoma and neuroendocrine carcinoma: a multicenter retrospective study.

PURPOSE: There are few data available on the outcomes of postoperative recurrent thymic carcinoma (TC) and thymic neuroendocrine carcinoma (TNEC). The aim of this study is to evaluate the treatment and survival in patients with recurrent TC and TNEC after undergoing surgical resection. METHODS: A retrospective chart review was performed using our multicenter database to identify patients with a postoperative recurrence of TC and TNEC from 1995 to 2018. The clinicopathological factors were reviewed and the survival outcomes were analyzed. RESULTS: Sixty patients were identified among 152 patients who underwent resection of TC and TNEC. The median follow-up period from the first recurrence was 14.8 months (range 0-144). The 5-year post-recurrence survival was 23% for the whole cohort. According to a univariable analysis, advanced stage [hazard ratio (HR) 2.81, 95% confidence interval (CI) 1.09-9.54], interval between primary surgery and recurrence (HR 0.97, 95% CI 0.95-0.99), any treatment for recurrence (HR: 0.27, 95% CI 0.13-0.58) and chemotherapy for recurrence (HR: 0.46, 95% CI 0.22-0.95) were significant factors related to post-recurrence survival. CONCLUSIONS: Chemotherapy rather than surgery appears to be the mainstay treatment for managing patients with postoperative recurrent TC and TNEC and it may also be considered in multidisciplinary management. Further studies with a larger sample size are required to confirm our findings.

Congenital partial pericardial defect confirmed based on spontaneous pneumothorax: A case report and literature review.

INTRODUCTION: Congenital pericardial defects are rare but can cause fatal complications. Most cases are asymptomatic and incidentally detected during a thoracic surgery or autopsy. We report a case of a partial pericardial defect confirmed based on spontaneous pneumothorax. PRESENTATION OF CASE: A 16-year-old boy with left spontaneous pneumothorax showed pneumopericardium on chest X-ray. Chest computed tomography revealed a partial pericardial defect. Video-assisted thoracoscopic surgery was performed, and a small pericardial defect was confirmed at the level of the upper pulmonary hilum. We did not reconstruct the defect because of the improbability of cardiac herniation. DISCUSSION: Pneumopericardium combined with pneumothorax suggests the existence of a pericardial foramen. Partial pericardial defects could cause cardiac herniation or strangulation, and pneumothorax may worsen the protruding of the heart. Video-assisted thoracic surgery is an effective method to prevent the recurrence of pneumothorax and determine whether reconstruction of the defect is required. CONCLUSION: Video-assisted thoracic surgery should be performed in the case of a pericardial defect combined with pneumothorax.

Solitary pulmonary capillary hemangioma presenting with a ground glass opacity: A case report & literature review.

INTRODUCTION: Solitary pulmonary capillary hemangioma (SPCH) is a rare benign lung tumor that clinically resembles early lung cancer and precancerous pulmonary lesions that present with similar imaging manifestations. PRESENTATION OF CASE: The patient was a 54-year-old Japanese man who was referred to Nagara Medical Center with a ground glass opacity (GGO) lesion within the right upper lung that was incidentally detected on computed tomography. After 8 months of follow-up, video-assisted thoracoscopic segmental resection of the right upper lobe was performed with diagnostic and therapeutic intent. Pathologic examination of the resected specimen demonstrated thickening of the alveolar septum caused by the proliferation of capillary vessels. This lesion was positive for CD31 and CD34 and negative for thyroid transcription factor-1 and cytokeratin on immunohistochemical staining. The tumor was diagnosed as SPCH pathologically. DISCUSSION: When radiological examination demonstrates a GGO in the lung, SPCH must be considered as one of the differential diagnoses. For a definitive diagnosis, pathological examination of a surgically resected specimen must be conducted. CONCLUSION: This study describes a case of SPCH and a review of the literature.

Solitary Pulmonary Hematoma Radiographically Indistinguishable from Mediastinal Tumor.

Solitary pulmonary hematoma is a rare consequence of blunt chest trauma. Moreover, there has been no reported case of solitary pulmonary hematoma radiographically diagnosed as a posterior mediastinal tumor. We present the case of a 63-year-old man who was referred for an oval-shaped opacity at the left paraspinal area on a chest X-ray. Chest computed tomography showed a well-circumscribed posterior mediastinal tumor on the left paraspinal lesion with extrapleural sign and callus formation on the left ribs posteriorly (7th to 11th ribs). The tumor was thoracoscopically confirmed to be a subpleural pulmonary tumor of the left lower lobe, and wedge resection was performed. Histological examination confirmed the diagnosis of pulmonary hematoma. On reviewing the callus formation of the ribs, which was suggestive of rib fractures, the pulmonary hematoma was determined to be traumatic in origin. The postoperative course was uneventful. We reviewed a rare case of pathologically proven traumatic solitary pulmonary hematoma. The rarity of this case is enhanced because the hematoma initially appeared to be a posterior mediastinal tumor.

Survival outcomes after minimally invasive thymectomy for early-stage thymic carcinoma.

Minimally invasive surgery (MIS) has occasionally been used for selected patients with thymoma, but there is little information on the MIS approach for thymic carcinoma. The aim of this study was to evaluate survival outcomes after MIS for early-stage (Masaoka stage I-II) thymic carcinoma and thymic neuroendocrine carcinoma. A retrospective chart review of the cases recorded in our multi-institutional database was performed to identify patients who underwent resection for thymic carcinoma between 1995 and 2017. MIS thymectomy was performed in 17 cases (VATS, n = 14; RATS, n = 3. male, 41%; median age, 72 years). The median follow-up period was 32.7 (range 7.4-106) months. The five-year overall survival and relapse-free survival rates were 84.4% and 77.8%, respectively. The present study demonstrated encouraging preliminary results regarding MIS for the treatment of early-stage thymic carcinoma and thymic neuroendocrine carcinoma. Further studies with a larger sample size are required to evaluate the indications for this surgery.

A case of pulmonary sclerosing pneumocytoma in the hilar lesion.

Pulmonary sclerosing pneumocytoma (PSP) arising from the hilar lesion is extremely rare. We report an asymptomatic 70-year-old female with a thoracic tumor of unknown origin. Contrast-enhanced chest tomography showed a poorly and heterogeneously enhanced 40-mm tumor compressing the left upper lobe, bronchus, and pulmonary arteries. Positron-emission tomography did not detect abnormal integration in the tumor. Surgical resection was planned to confirm diagnosis and avoid further compression on the structures. Intraoperative findings revealed a dark red-colored tumor, projecting from the left upper lobe in the hilar lesion. Left upper lobectomy was performed through video-assisted thoracoscopic surgery to achieve complete resection and avoid contact bleeding. Immunohistochemical examination revealed the presence of PSP.

Low incidence of and mortality from a second malignancy after resection of thymic carcinoma†.

OBJECTIVES: Previous studies have suggested that a second malignancy often develops after resection of thymoma; however, it remains unknown whether this is applicable to thymic carcinoma. METHODS: A retrospective chart review was performed based on our multi-institutional database of resected thymic epithelial tumours between 1991 and 2016. A second malignancy was defined as newly diagnosed after thymic tumour resection. The cumulative incidence of and related death from a second malignancy after thymic and neuroendocrine carcinoma resections were estimated using a competing risk model and were compared to those of patients undergoing a thymoma resection. RESULTS: Two hundred and thirty-eight patients were identified (thymic carcinoma 59; thymoma 179). A second malignancy developed in 1 patient (1.7%) with thymic carcinoma and in 17 patients (9.5%) with thymoma. Deaths from second malignancies were noted in 7 patients with thymoma. There was a tendency towards a lower cumulative incidence of and a lower cumulative death from a second malignancy after thymic carcinoma resection (P = 0.139 and P = 0.20, respectively) than after thymoma resection. The cumulative incidence of a second malignancy in patients with thymic carcinoma was 2.8% at 5 years and at 10 years (8.0% at 5 years and 11.8% at 10 years in patients with thymoma). CONCLUSIONS: After resection of thymic and thymic neuroendocrine carcinoma, the probability of developing a second malignancy, as well as mortality from a second malignancy, is very low. A prospective study with a larger sample size is required to validate our results.

[Usefulness of Nutritional Enforcement by Percutaneous Gastrostomy in Successful Omentoplasty for Empyema with Fistula].

Omentoplasty has been accepted as an effective surgical procedure for fistulated empyema. However, it is difficult for patients with poor nutritional status because their omental volume is often too poor to be applied for omentoplasty. Percutaneous endoscopic gastrostomy(PEG) is useful for long-term nutritional management. There is no report on safety and usefulness of PEG before omentoplasty. We report a case of omentoplasty that was successfully performed after nutritional enforcement by using percutaneous endoscopic gastrostomy in a patient of postoperative empyema with fistula.

The frequency and treatment of pneumothorax associated with pulmonary nontuberculous mycobacterial infection.

OBJECTIVES: Characteristics of pneumothorax associated with nontuberculous mycobacterium (NTM) infection are rarely reported, especially in terms of surgical treatments. Our objectives were to show the tendency and clinical courses of pneumothorax due to NTM and discuss the way of therapy in our hospital. METHODS: We retrospectively analyzed 557 patients with NTM infection over a period of 5 years at the Nagara Medical Center. RESULTS: A total of 12 out of the 557 patients (2.2%) suffered from pneumothorax caused by NTM infection without other pulmonary diseases. The diagnosis of all NTM cases was mycobacterium avium complex. Of these 12 patients, three required observation only (25%), five required drainage only (42%), and four required surgery after drainage (33%). The four surgically treated patients suffered from empyema as well as pneumothorax. They were in worse nutritional condition than non-surgically treated patients. For the patients requiring surgery, we selected reasonable surgical methods; we sutured the fistula of lung in all cases and covered it with muscle or omentum or polyglycolic acid sheets without a case in which endobronchial embolization was performed in advance before surgery. Finally, all pneumothorax healed. Thereafter, three of these four patients took unfavorable courses: progressing malnutrition, complications worsening or contralateral pneumothorax. CONCLUSION: We should select an appropriate treatment including surgery against NTM-associated pneumothorax without losing an opportunity because of its intractability and exhausting effect.

A case of surgery for congenital esophagobronchial fistula accompanied by a destroyed lung.

Congenital esophagobronchial fistula (EBF) is rarely seen in adults. We report a case of EBF detected in adulthood with a destroyed lung. A 67-year-old man experienced repeated pneumonia during his childhood. Since the age of 38, he had often suffered from bloody phlegm and always had a cough and sputum during oral intake. Before cardiac surgery for atrial fibrillation and valvular disease, computed tomography (CT) detected bronchiectasis, which could cause pulmonary bleeding during heart surgery, and the patient was introduced to our hospital for lung resection. A fistula between the esophagus and the right lower lung lobe was found using CT, esophagoscopy, and esophagography. Contrast CT and angiography revealed an abnormal artery branching from the inferior phrenic artery into the lobe. As indicated by intraoperative findings, the middle and lower lobes had strongly adhered to chest wall and diaphragm, but we located the fistula easily without adhesion to the surroundings, severed it using an automatic stapler, and resected the middle and lower lobes. The symptoms disappeared immediately, and the patient was uneventfully discharged.The diagnosis of congenital EBF was established with intraoperative findings and pathological exam. The existence of pulmonary sequestration was suggested because of the long-term absence of any symptoms during his adulthood, the tract of the EBF running into the lung, not directly into the bronchus, and a septum pathologically detected in the right lower lobe. A congenital EBF should be considered for differential diagnosis in cases of limited bronchiectasis in elderly people.

The importance of pleural integrity for effective and safe thoracic paravertebral block: a retrospective comparative study on postoperative pain control by paravertebral block.

OBJECTIVES: Recently, paravertebral block (PVB) has been reported to be an effective analgesic modality for post-thoracotomy pain, but there is no consensus on how thoracic PVB can be more effective. Our hypothesis that intact pleura has a significant impact on the analgesic effectiveness of thoracic PVB was evaluated. METHODS: Data of patients who underwent general thoracic surgery [thoracotomy or video-assisted thoracic surgery (VATS)] and paravertebral catheterization at Nagara Medical Center between April 2010 and March 2013 were collected. To compare the frequency of non-steroidal anti-inflammatory drugs taken as well as the usage of rescue pain medications between patients with pleural disruption and those without, data were analysed after matching on propensity scores. Covariates for match estimation were age, sex, body mass index, American Society of Anesthesiologists score, diagnosis, operative details and local anaesthesia infused. RESULTS: There were 278 patients who underwent general thoracic surgery and paravertebral catheterization. The propensity score-matching process created 78 matched patients with pleural disruption and those without. Based on the propensity score matching, a significant increase in the frequency of non-steroidal anti-inflammatory drugs taken on postoperative day 1 and in the usage of rescue drugs was observed in patients with pleural disruption. CONCLUSIONS: According to our analysis, creating a sub-pleural space without pleural disruption is essential for quality thoracic PVB.

Noninvasive assessment for acute allograft rejection in a rat lung transplantation model.

After lung transplantation, early detection of acute allograft rejection is important not only for timely and optimal treatment, but also for the prediction of chronic rejection which is a major cause of late death. Many biological and immunological approaches have been developed to detect acute rejection; however, it is not well known whether lung mechanics correlate with disease severity, especially with pathological rejection grade. In this study, we examined the relationship between lung mechanics and rejection grade development in a rat acute rejection model using the forced oscillation technique, which provides noninvasive assessment of lung function. To this end, we assessed lung resistance and elastance (RL and EL) from implanted left lung of these animals. The perivascular/interstitial component of rejection severity grade (A-grade) was also quantified from histological images using tissue fraction (TF; tissue + cell infiltration area/total area). We found that TF, RL, and EL increased according to A-grade. There was a strong positive correlation between EL at the lowest frequency (Elow; EL at 0.5 Hz) and TF (r(2) = 0.930). Furthermore, the absolute difference between maximum value of EL (Emax) and Elow (Ehet; Emax - Elow) showed the strong relationship with standard deviation of TF (r(2) = 0.709), and A-grade (Spearman's correlation coefficients; rs = 0.964, P < 0.0001). Our results suggest that the dynamic elastance as well as its frequency dependence have the ability to predict A-grade. These indexes should prove useful for noninvasive detection and monitoring the progression of disease in acute rejection.

Phase II study of adjuvant vinorelbine and cisplatin in Japanese patients with completely resected stage II and III non-small cell lung cancer.

PURPOSE: Adjuvant vinorelbine and cisplatin chemotherapy is recognized as a standard regimen for patients with completely resected stage II and III non-small cell lung cancer (NSCLC). However, efficacy of adjuvant chemotherapy in Japanese phase III trials with cisplatin-containing regimen has been controversial, and data are limited on the long-term outcome of adjuvant vinorelbine and cisplatin chemotherapy for NSCLC patients. METHODS: This was a single-arm phase II study in patients with completely resected pathological stage II or III NSCLC, who had not received prior chemotherapy or radiotherapy. Patients received 4 cycles of vinorelbine [25 mg/m(2) of body surface area (BSA)] and cisplatin (40 mg/m(2) of BSA) on days 1 and 8, every 4 weeks. Primary end point was the 3-year relapse-free survival; secondary end points were overall survival and safety. RESULTS: Between December 2006 and January 2011, 60 patients (40 men and 20 women, median age 64 years) were enrolled; all patients were evaluable for survival and safety. Three-year relapse-free survival rate was 55.0 % (95 % confidence interval 42.4-67.6 %). Three- and five-year overall survival rates were 83.3 and 77.8 %, respectively. There were no chemotherapy-related deaths, and adverse effects were acceptable. CONCLUSIONS: Adjuvant vinorelbine and cisplatin chemotherapy was safe and showed a valid relapse-free survival rate. This regimen could be used as a standard regimen and deserves to be a control arm of trials on adjuvant chemotherapy in the Japanese NSCLC patient population.

Paravertebral block for video-assisted thoracoscopic surgery: analgesic effectiveness and role in fast-track surgery.

BACKGROUND: Appropriate postoperative analgesia is crucial in fast-track surgery, which is a multimodal therapeutic strategy that aims toward enhanced postoperative recovery and shortened hospital stay. Paravertebral block (PVB) has been reported to be as effective as thoracic epidural blockade (TEB), but PVB is not often employed for video-assisted thoracoscopic surgery (VATS) for 2 reasons. First, TEB is still the gold standard for thoracic surgery, and second, thoracoscopic insertion of a PVB catheter is challenging. METHODS: In this retrospective observational study, 185 patients who underwent VATS and thoracoscopic paravertebral catheterization were analyzed. Postoperatively, the patients were continuously administered a local anesthetic (0.5% bupivacaine hydrochloride or 0.2% ropivacaine hydrochloride). Additionally, they were given an oral non-steroidal anti-inflammatory drug (NSAID) as needed. Intramuscular/intravenous pentazocine was administered as a rescue medication. The effect of pain control was measured in terms of the frequency of NSAID taken orally and the necessity for a rescue drug on postoperative days (POD) 0, 1, 2, and 3. RESULTS: The mean age of the 185 patients included in the study was 67 years (Confidence Interval: 66-69). The mean frequency of NSAID use was 0.67 (0-3), 1.59 (0-4), 1.43 (0-4), and 1.33 (0-4) on POD 0, 1, 2, and 3, respectively. 32 (17.3%) and 3 patients (1.6%) were administered a rescue medication on POD 0 and 1, respectively. The most common postoperative complication was nausea/vomiting, which occurred in 17 patients (9.1%). CONCLUSIONS: PVB may greatly contribute to enhanced recovery after thoracic surgery owing to effective analgesia and fewer side effects.