BACKGROUND: This study focused on the association between preoperative serum carcinoembryonic antigen (CEA) and cytokeratin 19 fragment (Cyfra 21-1) levels and pathologic parameters in patients with resected non-small-cell lung cancer (NSCLC). MATERIALS AND METHODS: The records of 527 patients who underwent pulmonary resection of NSCLC were reviewed. The association between preoperative serum CEA and Cyfra 21-1 levels and variables that had p-values of less than 0.05 in a t-test or one-way analyses of variance was analyzed by multiple linear regression. RESULTS: The mean serum CEA and Cyfra 21-1 levels prior to surgery were 6.8+/-23.1 mg/dL (range, 0.01 to 390.8 mg/dL) and 5.4+/-12.3 mg/dL (range, 0.65 to 140.2 mg/dL). The serum CEA levels were associated with tumor (T) and lymph node (N) stage and histology. The serum Cyfra 21-1 levels were associated with T stage, tumor size, and histology. Multiple linear regression indicated that serum CEA levels were associated with T (T3/4 vs. T1: beta=8.463, p=0.010) and N stage (N2/3 vs. N0: beta=9.208, p<0.001) and histology (adenocarcinoma vs. squamous cell: beta=6.838, p=0.001), and serum Cyfra 21-1 levels were associated with tumor size (beta=2.579, p<0.001) and histology (squamous cell vs. adenocarcinoma: beta=4.420, p=0.020). CONCLUSION: Serum CEA level was correlated with T and N stage, and Cyfra 21-1 with tumor size. CEA and Cyfra 21-1 showed histologic correlation. CEA is mainly elevated in adenocarcinoma and Cyfra 21-1 in squamous cell carcinoma. These results might be helpful for predicting pathologic status in preoperative NSCLC.
Adenocarcinoma ; Antigens, Neoplasm ; Carcinoembryonic Antigen ; Carcinoma, Non-Small-Cell Lung ; Carcinoma, Squamous Cell ; Humans ; Keratin-19 ; Keratins ; Linear Models ; Lung Neoplasms ; Lymph Nodes

BACKGROUND: This study focused on the association between preoperative serum carcinoembryonic antigen (CEA) and cytokeratin 19 fragment (Cyfra 21-1) levels and pathologic parameters in patients with resected non-small-cell lung cancer (NSCLC). MATERIALS AND METHODS: The records of 527 patients who underwent pulmonary resection of NSCLC were reviewed. The association between preoperative serum CEA and Cyfra 21-1 levels and variables that had p-values of less than 0.05 in a t-test or one-way analyses of variance was analyzed by multiple linear regression. RESULTS: The mean serum CEA and Cyfra 21-1 levels prior to surgery were 6.8+/-23.1 mg/dL (range, 0.01 to 390.8 mg/dL) and 5.4+/-12.3 mg/dL (range, 0.65 to 140.2 mg/dL). The serum CEA levels were associated with tumor (T) and lymph node (N) stage and histology. The serum Cyfra 21-1 levels were associated with T stage, tumor size, and histology. Multiple linear regression indicated that serum CEA levels were associated with T (T3/4 vs. T1: beta=8.463, p=0.010) and N stage (N2/3 vs. N0: beta=9.208, p<0.001) and histology (adenocarcinoma vs. squamous cell: beta=6.838, p=0.001), and serum Cyfra 21-1 levels were associated with tumor size (beta=2.579, p<0.001) and histology (squamous cell vs. adenocarcinoma: beta=4.420, p=0.020). CONCLUSION: Serum CEA level was correlated with T and N stage, and Cyfra 21-1 with tumor size. CEA and Cyfra 21-1 showed histologic correlation. CEA is mainly elevated in adenocarcinoma and Cyfra 21-1 in squamous cell carcinoma. These results might be helpful for predicting pathologic status in preoperative NSCLC.
Adenocarcinoma ; Antigens, Neoplasm ; Carcinoembryonic Antigen ; Carcinoma, Non-Small-Cell Lung ; Carcinoma, Squamous Cell ; Humans ; Keratin-19 ; Keratins ; Linear Models ; Lung Neoplasms ; Lymph Nodes

BACKGROUND: The aim of this study was to establish whether pulmonary lobectomy using video-assisted thoracic surgery (VATS) can be safely performed by trainees with limited experience with open lobectomy. METHODS: Data were retrospectively collected from 251 patients who underwent VATS lobectomy at a single institution between October 2007 and April 2011. The surgical outcomes of the procedures that were performed by three trainee surgeons were compared to the outcomes of procedures performed by a surgeon who had performed more than 150 VATS lobectomies. The cumulative failure graph of each trainee was used for quality assessment and learning curve analysis. RESULTS: The surgery time, estimated blood loss, final pathologic stage, thoracotomy conversion rate, chest tube duration, duration of hospital stay, complication rate, and mortality rate were comparable between the expert surgeon and each trainee. Cumulative failure graphs showed that the performance of each trainee was acceptable and that all trainees reached proficiency in performing VATS lobectomy after 40 cases. CONCLUSION: This study shows that trainees with limited experience with open lobectomy can safely learn to perform VATS lobectomy for the treatment of lung cancer under expert supervision without compromising outcomes.
Chest Tubes ; Education ; Humans ; Learning Curve ; Length of Stay ; Lung Neoplasms ; Mortality ; Organization and Administration ; Retrospective Studies ; Thoracic Surgery, Video-Assisted* ; Thoracotomy

Due to the global public health crisis caused by the coronavirus disease 2019 (COVID-19) pandemic, the importance of vaccine development has increased. In particular, a rapid supply of vaccines and prompt deployment of vaccination programs are essential to prevent and overcome the spread of COVID-19. As a part of the vaccine regulations, national lot release is regulated by the responsible authorities, and this process involves the assessment of the lot before a vaccine is marketed. A lot can be released for use when both summary protocol (SP) review and quality control testing are complete. Accelerated lot release is required to distribute COVID-19 vaccines in a timely manner. In order to expedite the process by simultaneously undertaking the verification of quality assessment and application for approval, it is necessary to prepare the test methods before marketing authorization. With the prolonged pandemic and controversies regarding the effectiveness of the COVID-19 vaccine against new variants, public interest for the development of a new vaccine are increasing. Domestic developers have raised the need to establish standard guidance on the requirements for developing COVID-19 vaccine. This paper presents considerations for quality control in the manufacturing process, test items, and SP content of viral vector vaccines.