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nonsmall cell lung cancer ; lymphadenectomy ; bilateral mediastinal lymphadenectomy
Abstract:
The evaluation of bilateral mediastinal lymphadenectomy in patients treated because of nonsmall lung cancer. Backgroung: Lung cancer is the biggest epidemiological problem among patients treated for neoplastic diseases. The number of new cases is greater than those combined: breast cancer, colorectal cancer, prostate cancer and stomach cancer. One of the most important factors determining the choice of treatment method is the presence of metastases in the mediastinal lymph nodes. Invasive methods of diagnosis of mediastinal lymph nodes include extended cervical mediastinoscopy, VAMLA (Video-assisted mediastinoscopic lymphadenectomy) and TEMLA (Transcervical extended mediastinal lymphadenectomy) - cervical extended mediastinal lymphadenectomy. Methods: The location and time of the study Patients were treated at the Clinical Department of Thoracic Surgery of the Jagiellonian University Collegium Medicum (UJ-CM), Krakow Specialist Hospital. John Paul II, in Krakow in 2010-2015. The method and inclusion criteria 89 patients treated for primary lung cancer in clinical stage I-III assessed on the basis of the history and clinical examination, chest radiograph, thoracic and upper abdomen tomography (CT), abdominal ultrasound (USG), positron tomography (PET-CT), classical bronchoscopy and ultrasound bronchoscopy with transbronchial biopsy (EBUS-TBNA) and transesophageal ultrasou ; nd with biopsy (EUS-FNA) were included in the analysis. Patients were qualified for surgical treatment according to the following criteria: a. ASA grade: 1 or 2, b. b. FEV1> 1.3 l (lobectomy) or> 1.8 l (pneumonectomy) 9,10,11. Randomization A prospective randomized clinical trial in a 1: 1 ratio. Surgery The patients were qualified for surgical treatment in accordance with the standard criteria. Standard mediastinal lymphadenectomy (SND) was performed in the control group, and extended one in the study group (BML). The patients with tumor localization on the right side, the lymph nodes of the following groups were removed during thoracotomy: 2R, 4R, 7, 8, 9; then the mediastinal lymph nodes of the 2L and 4L groups were removed from the cervical approach. The patients with tumor localization on the left side, the lymph nodes of the following groups were removed during thoracotomy: 5, 6, 7, 8, 9; then mediastinal lymph nodes 2R, 4R, 2L, 4L were removed from the cervical approach. The following parameters were assessed during the operation: a. number of lymph nodes removed b. perioperative complications. In the postoperative period, the following parameters were assessed: a. drainage volume and duration of drainage, b. postoperative air leak, spirometric parameters, c. complications. The study was approved by the Bioethics Committee. Statistical analysis The STATI ; STICA 6.1 (Stat. Soft USA) was used for statistical analysis. Results 89 patients aged 43-75 years (mean 61.7) were included in the study. The group of patients undergoing SND included 40 patients aged 43-75 years (mean age 61.45) (11 women (56-70) mean age 61.5 and 29 men (43-75) mean age 61.4. The group of patients subjected to BML was 49 aged 51-75, mean age 61.0 (13 women 51-70 mean age 61.4 and 36 men (52 - 75) mean age 62.4. No statistical difference was found, p = 0.608. Histological distribution of lung cancer in the studied groups. Histology of the primary tumor in the control group: squamous cell carcinoma - 32 (65.3%), adenocarcinoma 9 (18.4%), giant cell carcinoma - 1 (2%), adeno-squamous cell carcinoma - 4 (8.2%), cancer of the sarcomatic type - 2 (4%), bronchoalveolar cancer - 1 (2%). Primary tumor histology in the study group: squamous cell carcinoma - 21 (52.5%), adenocarcinoma 16 (40.0%), adeno-squamous - 2 (5%), adenocarcinoma-giant cell carcinoma 1 (2.5%) . Clinical TNM stage. Clinical advancement (c Stage) in the SND group: IA - 10 (20.4%), IB - 18 (36.7%), IIA - 12 (25.5%), IIB - 6 (12.2%), IIIA - 3 (6.1%). Clinical advancement (c Stage) in the BML group: IA - 11 (27.5%), IB - 12 (30.0%), IIA 10 (25.0%), IIB - 4 (10.0%), 3 (7.5%). There was no statistical difference between the studied stages, p = 0.921. Pathological TNM stage. pStage in the SND ; group: IA - 8 (16.3%), IB - 7 (14.3%), IIA - 14 (28.6%), IIB - 11 (22.4%), IIIA - 9 (18 , 4%). pStage in the BML group: IA - 9 (22.5%), IB - 7 (17.5%), IIA - 12 (30.0%), IIB 5 (12.5%), IIIA - 7 (17, 5%). There was no statistical difference between the studied stages, p = 0.769. Surgery The following types of surgeries were performed in the SND group: upper bilobectomy - 1 (2.0%), lower bilobectomy - 3 (6.1%), right upper lobectomy - 13 (26.5%, one operation was performed using the video technique, in one bronchial sleeve resection was performed), middle lobectomy - 1 (2%), right lower lobectomy - 5 (10.2%), upper left lobectomy - 12 (24.4%, in 1 case pulmonary artery resection was performed, in one case bronchial sleeve resection was performed), left lower lobectomy - 5 (10.2%) , left pneumonectomy - 8 (16.3%), right pneumonectomy - 1 (2.0%). In the control group, the percentage of pneumonectomy was 18.36%. The following types of operations were performed in the BML group: Upper bilobectomy - 1 (2.5%), lower bilobectomy -3 (7.5%), right upper lobectomy 10 (25%, left upper lobectomy - 6 (15%), left lower lobectomy - 7 (17,%) ), left pneumonectomy - 6 (15%), right pneumonectomy 1 (2.5%). The percentage of pneumonectomy in the study group was 17.5%. The mean number of mediastinal lymph nodes removed during surgery in the SND group was 14.57 and ranged from 0-42, the median ; was 14.0 (10.0; 18.0). In the BML group, the mean number of mediastinal lymph nodes removed was 24.7, ranged in the following range 5-44, median 24.0 (10.0; 30.0). For the number of removed mediastinal lymph nodes, p value <0.0001. Pathological assessment In the SND group, 7 patients had metastases in the mediastinal lymph nodes, which is 17.5%. The N2 nodes in this group was found in 5 patients and it was one-level metastases, and in 2 patients it was diagnosed in 2 and 3 stations. In 4 patients these were skip metastases, which were not present in the lymph nodes of N1 groups. In two cases, when both N1 and N2 were present, it was multilevel disease. Two out of three patients with both N1 and N2 disease, the N2 stage was multilevel. In the BML group, metastases in the mediastinal lymph nodes were found in 7 (14.28%) patients. Multilevel N2 was found in 2 patients, these were two-level metastases, and single-level N2 in 5 patients. No statistical difference was found for mediastinal lymph node metastases p = 0.253. There was no statistical difference for N1 lymph node metastases p = 0.836. The mean operating time in the SND group was 220.71 minutes and ranged from 125 to 360 minutes, the median was 210.0 (180.0; 250). The mean time of surgery in the BML group was 318.87 minutes and ranged from 105-520 minutes, the median was 315.0 (268.8; 360). P-value <0.001 The mean i ; ntraoperative blood loss in the SND group was 485.67 ml (60-1500 ml), median 400.0 (250; 630), in the BML group 469.35 ml (180-1300 ml), median 395 (292, 5; 612.5). There was no statistical difference for blood loss between the two groups, p = 0.853 The mean duration of drainage in the control group was 5.38 days (1-16 days), median 5.0 (3.0; 7.0), in the study group it was 5.97 days (1-15 days), median 6, 0 (4.8; 7.0). There was no statistical difference between the two groups depending on the duration of the drainage, p = 0.173. There was no statistical difference between the two groups depending on the parameters of spirometry and diffusion p = 0.187 Postoperative complications Complications were more frequent in the SND 11 group (2.5%) than in the BML 12 group (24.5%), but the difference was not statistically significant, p = 0.19. Discussion Surgical treatment is an essential treatment for lung cancer. Standard operations includes excision of a lobe or lung with mediastinal lymph nodes on the operated side. Extended lymphadenectomy is rarely performed and is not a routine procedure. Among the methods of treatment, only a few offer extended mediastinal lymphadenectomy. These include cervical extended mediastinal lymphadenectomy (TEMLA), video assisted VAMLA mediastinal lymphadenectomy and bilateral mediastinal lymphadenectomy with cervical approach. VAMLA (Video-assi ; sted mediastinoscopic lymphadenectomy) was described by Witte in 2007. In this method the excision of lymph nodes is done from the cervical access using the video technique. The second method that allows to remove lymph nodes from the cervical approach is TEMLA (Transcervical extended mediadistinal limphadenectomy), introduced in 2005 by Zieliński et al. The method is hybrid and it is a combination of a classic technique with videomediastinoscopy, and in the second stage the pulmonary resection is performed. TEMLA allows for the removal of lymph nodes within groups 1, 2L, 4L, 2R, 4R, 5, 6, 7, and in some cases it is also possible to remove group 8 lymph nodes. The number of lymph nodes removed in the BML technique was statistically greater than in the clasic technique. The percentage of patients who underwent BML and positive N2 lymph nodes was 14.28% and in the presented analysis, no statistical difference was found between the studied groups. The percentage of patients with N2 nodes in the TEMLA technique was 18.11% (50 patients). When performing extended lymphadenectomy in the BML technique, the average numer of nodes removed was 24.7, in the VAMLA 20.7 and TEMLA technique 37.9. The difference between the BML and TEMLA techniques is due to the greater technical possibilities of using the mediastinoscope. The average operation time for the BML technique is 318.87 minutes. ; The mean time of the operation, during which the VATS lobectomy combined with VAMLA was performed, was 159.8 minutes. The mean duration of the VATS lobectomy and TEMLA operations was 258.1 minutes. Conclusions 1. Based on the presented analysis, it has been shown that bilateral mediastinal lymphadenectomy is safe without an increased risk of complications, after surgical treatment in the early perioperative period. 2. During the surgical treatment, statistically more lymph nodes are removed during bilateral mediastinal lymphadenectomy. When performing BML at the same time as thoracotomy, more lymph nodes are removed from the mediastinal area than by performing thoracotomy alone. 3. There was no statistical difference between the metastatic lymph nodes in the mediastinum between the two groups in the conducted analysis.