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1.
EClinicalMedicine ; 74: 102707, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-39105193

RESUMO

Background: The long-term survival and perioperative outcomes of robotic-assisted lobectomy (RAL) and video-assisted lobectomy (VAL) in resectable non-small-cell lung cancer (NSCLC) were found to be comparable in retrospective studies, but they have not been investigated in a randomized trial setting. We conducted the RVlob trial to investigate if RAL was non-inferior to VAL in patients with resectable NSCLC. Methods: In this single-center, open-label, and parallel-arm randomized controlled trial conducted in Ruijin Hospital (Shanghai, China) between May 2017 and May 2020, we randomly assigned patients with resectable NSCLC in a 1:1 ratio to receive either RAL or VAL. One of the primary endpoints was 3-year overall survival. Secondary endpoints included 3-year disease-free survival. The Kaplan-Meier approach was used to calculate overall survival and disease-free survival at 3 years. This study was registered with ClinicalTrials.gov, NCT03134534. Findings: A total of 320 patients were randomized to receive RAL (n = 157) or VAL (n = 163). The baseline characteristics of patients were well balanced between the two groups. After a median follow-up of 58.0 months, the 3-year overall survival was 94.6% (95% confidence interval [CI], 91.0-98.3) in the RAL group and 91.5% (95% CI, 87.2-96.0) in the VAL group (hazard ratio [HR] for death, 0.65; 95% CI, 0.33-1.28; P = 0.21); noninferiority of RAL was confirmed according to the predefined margin of -5% (absolute difference, 2.96%; a one-sided 90% CI, -1.39% to ∞; P = 0.0029 for noninferiority). The 3-year disease-free survival was 88.7% (95% CI, 83.6-94.1) in the RAL group and 85.4% (95% CI, 80.0-91.2) in the VAL group (HR for disease recurrence or death, 0.87; 95% CI, 0.50-1.52; P = 0.62). Interpretation: This study is the first randomized trial to show that RAL resulted in non-inferior overall survival compared with VAL in patients with resectable NSCLC. Based on our results, RAL is an equally oncologically effective treatment and can be considered as an alternative to VAL for resectable NSCLC. Funding: National Natural Science Foundation of China (82072557), National Key Research and Development Program of China (2021YFC2500900), Shanghai Municipal Education Commission-Gaofeng Clinical Medicine Grant (20172005, the 2nd round of disbursement), program of Shanghai Academic Research Leader from Science and Technology Commission of Shanghai Municipality (20XD1402300), Novel Interdisciplinary Research Project from Shanghai Municipal Health Commission (2022JC023), and Interdisciplinary Program of Shanghai Jiao Tong University (YG2023ZD04).

2.
Transl Cancer Res ; 13(6): 3075-3089, 2024 Jun 30.
Artigo em Inglês | MEDLINE | ID: mdl-38988931

RESUMO

Background: While the widespread use of endoscopic submucosal dissection (ESD) has significantly reduced the incidence of early esophageal cancer (ESCA), the limited ability of ESD to strip deep infiltrating esophageal lesions results in a considerable risk of intraoperative perforation. Circulating-free DNA (cfDNA) is widely used in modern tumor screening due to its non-invasive detection capabilities. A methylation analysis offers vital insights into the condition and advancement of malignancies due to its unique positioning, such as a marker of cancer. This study investigated the potential of combining a non-invasive liquid biopsy technique, along with a methylation analysis, to assess the surgical perforation risk of ESCA patients. Methods: In this study, we conducted an analysis of gene expression differences between stage I esophageal squamous carcinoma samples and healthy tissue samples using data from The Cancer Genome Atlas (TCGA) database. We also identified the genes associated with progression-free survival (PFS) in esophageal squamous carcinoma. Integrating the framework of the methylation analysis, we explored the methylated sites of these distinct genes. To refine this process, we used the Shiny Methylation Analysis Resource Tool (SMART) to conduct a comprehensive analysis of these sites. We then confirmed the stability of the methylation sites in different lesion conditions using methylation-specific quantitative polymerase chain reaction (MS-qPCR) with paraffin tissue samples collected after ESD. Results: We analyzed RNA-sequencing data from 42 early stage ESCA patients and 17 controls, identifying 1,263 up-regulated and 460 down-regulated genes. Functional analyses revealed involvement in key pathways such as cell cycle regulation and immune responses. Furthermore, we identified 38 differentially expressed genes associated with PFS. Using SMART analysis, we found 217 hyper-methylated regions in 38 genes, suggesting potential early markers for ESCA. Validation experiments confirmed the reliability of 29 hyper-methylated regions in FFPE tissue samples and 6 regions in cfDNA. A LunaCAM model showed high accuracy [area under the curve (AUC) =0.89] in discriminating early ESCA. Integrated assessment of six highly methylated regions significantly improved predictive performance, with 90.56% sensitivity, highlighting the importance of combinatorial biomarker evaluation for early cancer detection. Conclusions: This study established a novel approach that integrates non-invasive testing with a methylation analysis to assess the surgical risk of early ESCA patients. The significance of changes in methylation sites in relation to lesion status should not be underestimated, as they have the potential to offer vital insights for proactive risk assessments before surgery.

3.
Ann Surg Oncol ; 31(4): 2443-2450, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-37962741

RESUMO

BACKGROUND: Chemotherapy and chemoradiation have become essential adjuncts to improve the survival of patients with resectable esophageal squamous cell carcinoma (ESCC) in the perioperative period. Although preoperative treatment plus surgery is commonly used, controversy remains regarding the optimal treatment strategy for patients with locally advanced ESCC. METHODS: A retrospective review of clinical stage II and III ESCC patients who underwent esophagectomy at Henan Cancer Hospital between October 2014 and October 2017 was performed. The patients were divided into a neoadjuvant chemotherapy (NAC) group and an adjuvant chemotherapy (AC) group. Propensity score matching (PSM) was used to exclude confounders. Survival was estimated using Kaplan‒Meier analysis and compared by the log-rank test. The Cox proportional hazards regression model was used for both the univariate and multivariate analyses. RESULTS: A total of 684 patients were enrolled, including 365 (53.4%) patients in the NAC group. After PSM, 294 pairs of patients were left. NAC prolonged the OS (not reached versus 57.3 months, P = 0.002) and DFS (57.2 vs. 36.4 months, P = 0.010) and decreased the total rate of recurrence (50.1% vs. 59.2%, P = 0.025) and local recurrence (27.9% vs. 36.7%, P = 0.022) compared with AC. The multivariable analyses showed that NAC plus surgery modality was an independent predictor for improved OS (HR: 0.582, 95% CI: 0.467-0.786, P = 0.001). CONCLUSION: NAC plus surgery prolonged OS and DFS, and significantly decreased the total rate of recurrence compared with surgery plus AC in patients with clinical stage II and III ESCC.


Assuntos
Neoplasias Esofágicas , Carcinoma de Células Escamosas do Esôfago , Humanos , Carcinoma de Células Escamosas do Esôfago/patologia , Neoplasias Esofágicas/tratamento farmacológico , Neoplasias Esofágicas/cirurgia , Terapia Neoadjuvante , Quimioterapia Adjuvante , Quimiorradioterapia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Esofagectomia , Estudos Retrospectivos , Estadiamento de Neoplasias
5.
Transl Lung Cancer Res ; 12(8): 1728-1737, 2023 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-37691871

RESUMO

Background: With the increasing number of small pulmonary nodules detected, effective localization of pulmonary nodules has become an issue. The goal of this study is to determine the safety and feasibility of a newly developed augmented reality navigation technology for intraoperative localization of small pulmonary nodules. Methods: We conducted a prospective single-center feasibility study of a novel augmented reality navigation system and lung localization (LungBrella) marker on ten patients between July and October 2020. For augmented reality navigation-guided localization, a preoperative chest computed tomography scan was performed to generate 3-dimensional (3D) virtual images and individualized localization plan, which were uploaded into Hololens (a head-mounted augmented reality device). Under the guidance of established procedure plan displayed by HoloLens, localization marker was placed in operating room. Segmentectomy or wedge resection was subsequently performed. The primary endpoint was the localization procedure success rate, and the secondary endpoints were localization time, operation time, and complications. Results: Localization was successful in seven of the ten procedures. Due to different reasons, failures were noted in three cases, after which immediate adjustments were made. In the successful cases, the LungBrella marker was positioned at a median of 5.8 mm (range, 0-10 mm) from the edge of the nodule. Median localization time was 9.4 min (range, 5-19 min), and median operation time was 172.9 min (range, 105-200 min). There were no complications during the entire process. Conclusions: This exploratory study suggests that augmented reality navigation-guided pulmonary nodule localization is a safe and feasible technique (ClinicalTrials.gov identifier, NCT04211051).

6.
Hepatobiliary Surg Nutr ; 12(4): 534-544, 2023 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-37601001

RESUMO

Background: Existing reporting guidelines pay insufficient attention to the detail and comprehensiveness reporting of surgical technique. The Surgical techniqUe rePorting chEcklist and standaRds (SUPER) aims to address this gap by defining reporting standards for surgical technique. The SUPER guideline intends to apply to articles that encompass surgical technique in any study design, surgical discipline, and stage of surgical innovation. Methods: Following the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network approach, 16 surgeons, journal editors, and methodologists reviewed existing reporting guidelines relating to surgical technique, reviewed papers from 15 top journals, and brainstormed to draft initial items for the SUPER. The initial items were revised through a three-round Delphi survey from 21 multidisciplinary Delphi panel experts from 13 countries and regions. The final SUPER items were formed after an online consensus meeting to resolve disagreements and a three-round wording refinement by all 16 SUPER working group members and five SUPER consultants. Results: The SUPER reporting guideline includes 22 items that are considered essential for good and informative surgical technique reporting. The items are divided into six sections: background, rationale, and objectives (items 1 to 5); preoperative preparations and requirements (items 6 to 9); surgical technique details (items 10 to 15); postoperative considerations and tasks (items 16 to 19); summary and prospect (items 20 and 21); and other information (item 22). Conclusions: The SUPER reporting guideline has the potential to guide detailed, comprehensive, and transparent surgical technique reporting for surgeons. It may also assist journal editors, peer reviewers, systematic reviewers, and guideline developers in the evaluation of surgical technique papers and help practitioners to better understand and reproduce surgical technique. Trial Registration: https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-other-study-designs/#SUPER.

7.
Gland Surg ; 12(6): 749-766, 2023 Jun 30.
Artigo em Inglês | MEDLINE | ID: mdl-37441012

RESUMO

Background: Surgical technique plays an essential role in achieving good health outcomes. However, the quality of surgical technique reporting remains heterogeneous. Reporting checklists could help authors to describe the surgical technique more transparently and effectively, as well as to assist reviewers and editors evaluate it more informatively, and promote readers to better understand the technique. We previously developed SUPER (surgical technique reporting checklist and standards) to assist authors in reporting their research that contains surgical technique more transparently. However, further explanation and elaboration of each item are needed for better understanding and reporting practice. Methods: We searched surgical literature in PubMed, Google Scholar and journal websites published up to January 2023 to find multidiscipline examples in various article types for each SUPER item. Results: We explain the 22 items of the SUPER and provide rationales item by item alongside. We provide 69 examples from 53 literature that present optimal reporting of the 22 items. Article types of examples include pure surgical technique, and case reports, observational studies and clinical trials that contain surgical technique. Examples are multidisciplinary, including general surgery, orthopaedical surgery, cardiac surgery, thoracic surgery, gastrointestinal surgery, neurological surgery, oncogenic surgery, and emergency surgery etc. Conclusions: Along with SUPER article, this explanation and elaboration file can promote deeper understanding on the SUPER items. We hope that the article could further guide surgeons and researchers in reporting, and assist editors and peer reviewers in reviewing manuscripts related to surgical technique.

8.
Ann Thorac Surg ; 116(3): 571-578, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37003580

RESUMO

BACKGROUND: The current gold standard for treatment of locally advanced esophageal adenocarcinoma is neoadjuvant chemotherapy or chemoradiotherapy followed by surgery. The shift toward neoadjuvant chemoradiotherapy (nCRT) was driven by the Chemoradiotherapy for Oesophageal Cancer Followed by Surgery Study (CROSS) trial. This study reassessed, in daily practice, the presumed advantage of nCRT followed by surgery on long-term survival compared with primary surgery, in a group of all adenocarcinomas treated through a transthoracic approach with extensive 2-field lymphadenectomy. METHODS: This retrospective cohort study with propensity score-matched analysis included all surgically treated patients between 2000 and 2018 with locally advanced adenocarcinoma (cT1/2 N+ or cT3/4 N0/+). For appropriate comparison, exclusion criteria of the CROSS trial were applied. Patients were matched on age, Charlson comorbidity score, clinical tumor length, and lymph node status. The primary end point was 5-year overall survival. RESULTS: There were 473 eligible patients who underwent primary surgery (225 patients) or nCRT + surgery (248 patients). After propensity score-matched analysis, 149 matched cases were defined in each group for analysis. There was no significant difference after 5 years between the matched groups in median overall survival (32.5 and 35.0 months, P = .41) and median disease-free survival (14.3 and 13.5 months, P = .16). nCRT was associated with significantly more postoperative complications (mean Comprehensive Complication Index score: 21.0 vs 30.5, P < .0001) and longer mean stay in the hospital (14.0 vs 18.2 days, P = .05) and intensive care unit (11.7 vs 37.7 days, P = .05). CONCLUSIONS: Our propensity score-matched results indicate that primary surgery, performed through transthoracic approach with extensive 2-field lymphadenectomy, can offer a comparable overall and disease-free survival after 5 years, with potentially fewer postoperative complications and shorter hospital and intensive care unit stay compared with nCRT followed by surgery.


Assuntos
Adenocarcinoma , Neoplasias Esofágicas , Humanos , Terapia Neoadjuvante/efeitos adversos , Estudos Retrospectivos , Estadiamento de Neoplasias , Quimiorradioterapia/efeitos adversos , Adenocarcinoma/terapia , Complicações Pós-Operatórias/etiologia , Esofagectomia/métodos
9.
Eur J Surg Oncol ; 49(9): 106916, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37120317

RESUMO

BACKGROUND: Brain metastases after esophagectomy are rare. Moreover, a diagnostic uncertainty remains as pathology is rarely obtained and radiological features can show similarities to primary brain tumors. Our aim was to demonstrate the diagnostic uncertainty and identify risk factors associated with brain tumors (BT) after esophagectomy with curative intent. METHODS: All patients who underwent an esophagectomy with curative intent from 2000 to 2019 were reviewed. Diagnostics and characteristics of BT were analyzed. Multivariable logistic and cox regression were performed to determine factors associated with development of BT and survival, respectively. RESULTS: In total, 2131 patients underwent esophagectomy with curative intent, of which 72 patients (3.4%) developed BT. Pathological diagnosis was obtained in 26 patients (1.2%), of which 2 patients were diagnosed with glioblastoma. On multivariate analysis, radiotherapy (OR, 7.71; 95%CI: 2.66-22.34, p < 0.001) was associated with an increased risk of BT and early-stage tumors (OR, 0.29; 95%CI: 0.10-0.90, p = 0.004) with a decreased risk of BT. Median overall survival was 7.4 months (95%CI: 4.80-9.96). BT treated with curative intent (surgery or stereotactic radiation) had a significantly better median overall survival (16 months; 95%CI: 11.3-20.7) compared to those without (3.7 months; 95%CI: 0.9-6.6, p < 0.001) CONCLUSIONS: Advanced stage tumors and radiotherapy seem related to the development of brain tumors after esophagectomy with curative intent. However, an important diagnostic uncertainty remains in these patients as pathological diagnosis is only obtained in a minority of cases. Tissue confirmation can be useful to inform a patient-tailored multimodality treatment strategy in select patient.


Assuntos
Neoplasias Encefálicas , Neoplasias Esofágicas , Humanos , Esofagectomia , Neoplasias Esofágicas/patologia , Terapia Combinada , Neoplasias Encefálicas/cirurgia , Estudos Retrospectivos , Taxa de Sobrevida
11.
J Surg Oncol ; 127(2): 221-227, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36630089

RESUMO

Since the first successful esophagectomy for cancer in 1913 spectacular advancements have been made in diagnosis, staging, and therapy. Refinement of imaging, surgery, perioperative management together with multidisciplinary collaboration are the cornerstones. Today therapy with curative option is offered to more patients than ever. Further innovations in imaging, molecular biology, genetics, artificial intelligence, machine learning, robotics, nanotechnology will have an increasing impact. The end result being a unique therapeutic plan shaped on each patient's individual profile.


Assuntos
Neoplasias Esofágicas , Humanos , Inteligência Artificial , Neoplasias Esofágicas/patologia , Neoplasias Esofágicas/terapia , Esofagectomia/métodos , Estadiamento de Neoplasias , Narração
12.
Chest ; 163(6): 1576-1588, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36621757

RESUMO

BACKGROUND: Robot-assisted lobectomy (RAL) is increasingly used as an alternative to video-assisted lobectomy (VAL) for resectable non-small cell lung cancer (NSCLC). However, there is little evidence of any difference in postoperative health-related quality of life (HRQoL) between these two approaches. RESEARCH QUESTION: Is RAL superior to VAL in improving quality of life in patients with resectable NSCLC? STUDY DESIGN AND METHODS: We performed a single-center, open-label randomized clinical trial from May 2017 to May 2020 with 320 enrolled patients undergoing RAL or VAL for resectable NSCLC (RVlob trial; NCT03134534). Postoperative pain was evaluated by visual analog score or numeric rating score on postoperative day 1 and at weeks 4, 24, and 48. The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30), EORTC Quality of Life Questionnaire in Lung Cancer (QLQ-LC13), and the European Quality of Life 5 Dimensions (EQ-5D) questionnaire were also administered at weeks 4, 24, and 48 after surgery. RESULTS: One hundred and fifty-seven patients underwent RAL and 163 underwent VAL. The mean pain score of patients after RAL was significantly lower at week 4 (2.097 ± 0.111 vs 2.431 ± 0.108; P = .032). QLQ-C30 and QLQ-LC13 summary scores (P > .05) were similar for both RAL and VAL during the first 48 weeks of follow-up. HRQoL scores assessed with the EQ-5D questionnaire were also comparable between the two groups (P > .05) during the whole study period. INTERPRETATION: Both RAL and VAL showed satisfactory and comparable HRQoL and postoperative pain up to 48 weeks after surgery, despite some minor statistical differences at week 4. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT03134534; URL: www. CLINICALTRIALS: gov.


Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Procedimentos Cirúrgicos Robóticos , Humanos , Carcinoma Pulmonar de Células não Pequenas/cirurgia , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Neoplasias Pulmonares/cirurgia , Neoplasias Pulmonares/tratamento farmacológico , Qualidade de Vida , Dor Pós-Operatória/epidemiologia
13.
Dis Esophagus ; 36(5)2023 Apr 29.
Artigo em Inglês | MEDLINE | ID: mdl-36385581

RESUMO

This study aimed to investigate the survival impact of the number of lymph nodes dissection (LND) in patients receiving neoadjuvant chemotherapy (NCT) for esophageal squamous cell carcinoma (ESCC). We retrospectively analyzed the clinical pathological data and survival of 407 ESCC patients who underwent esophagectomy after NCT between January 2015 and December 2016. The relationship between the number of LNDs and 5-year overall survival (OS) or disease-free survival (DFS) was plotted by using restricted cubic spline analysis. A Cox proportional hazards regression model was used to identify prognostic factors of OS and DFS. We observed an obvious non-linear relationship between LND and the hazard ratios (HRs) for OS (P = 0.0015) and DFS (P < 0.001) of all the patients. In the multivariate analysis of OS and DFS, the number of LNDs (greater than 28 and less than 46) had a significant protective effect on survival (OS: HR: 0.61, 95% CI: 0.42-0.88, P = 0.007; DFS: HR: 0.50, 95% CI: 0.36-0.70, P < 0.001). For patients with nodal metastases, it was also an independent prognostic factor for OS (HR, 0.56, 95% CI, 0.35-0.90, P = 0.017) and DFS (HR, 0.42, 95% CI, 0.28-0.65, P < 0.001). Some degree of lymphadenectomy after NCT was beneficial in improving 5-year OS and DFS for ESCC patients with nodal metastases. For patients with nodal negativity, more extended lymphadenectomy did not improve patient survival.


Assuntos
Carcinoma de Células Escamosas , Neoplasias Esofágicas , Carcinoma de Células Escamosas do Esôfago , Humanos , Carcinoma de Células Escamosas do Esôfago/cirurgia , Carcinoma de Células Escamosas do Esôfago/patologia , Neoplasias Esofágicas/tratamento farmacológico , Neoplasias Esofágicas/cirurgia , Terapia Neoadjuvante , Carcinoma de Células Escamosas/tratamento farmacológico , Carcinoma de Células Escamosas/cirurgia , Estudos Retrospectivos , Prognóstico , Estadiamento de Neoplasias , Excisão de Linfonodo , Linfonodos/cirurgia , Linfonodos/patologia , Esofagectomia
14.
Chin Med J (Engl) ; 135(18): 2143-2156, 2022 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-36525602

RESUMO

ABSTRACT: Esophageal cancer (EC) has a high incidence and poor prognosis. The two major histological types, squamous cell carcinoma and adenocarcinoma, differ in their epidemiology and treatment options. Patients with locally advanced EC benefit from multimodal therapy concepts including neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy, and perioperative chemotherapy. Currently, immunotherapy for the solid tumor is a hot spot. Treatment with adjuvant immune checkpoint inhibitors (ICIs) is the first immunotherapy for resectable EC listed in the latest National Comprehensive Cancer Network Guidelines for the Esophageal and Esophagogastric Junction Cancers. Recent clinical trials have established ICIs for three treatment models of resectable EC. Their short-term results demonstrated ideal efficacy and tolerable toxicity, though some concerns remain. This review summarizes the novel data on the ICIs for resectable EC and lists the registered related clinical trials. Hopefully, this review can provide a reference for ongoing research on the treatment options for resectable EC.


Assuntos
Adenocarcinoma , Neoplasias Esofágicas , Humanos , Neoplasias Esofágicas/tratamento farmacológico , Neoplasias Esofágicas/patologia , Junção Esofagogástrica/patologia , Terapia Neoadjuvante/métodos , Adenocarcinoma/tratamento farmacológico , Imunoterapia
15.
Ann Surg ; 275(4): e659-e663, 2022 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-35129533

RESUMO

Transhiatal esophagectomy facilitates esophageal resection without the need for thoracotomy. However, this procedure carries the risks of blind and blunt dissection within the mediastinum. More recently, video-assisted or mediastinoscopic transhiatal esophagectomy was introduced to mobilize the esophagus under direct visualization. Even though, the procedure is technically demanding and animal studies have shown that the CO2 pneumomediastinum may be associated with hemodynamic instability. By further developing already established techniques, we pioneered the transhiatal esophageal mobilization by using hybrid gastroscope (Fig. 1). Laparo-gastroscopic esophagectomy, which integrates gastroscope and laparoscope for esophageal mobilization, was successfully implemented on an esophageal cancer patient with a history of lung cancer surgery. The operative duration was 240 minutes with an estimated blood loss of 110 mL. The patient experienced an uneventful recovery and was discharged on postoperative day 9. Further studies will be required to confirm the surgical and oncological efficacy of this innovation.


Assuntos
Neoplasias Esofágicas , Esofagectomia , Animais , Dissecação , Neoplasias Esofágicas/cirurgia , Esofagectomia/métodos , Gastroscópios , Humanos , Mediastino/cirurgia
16.
Int J Cancer ; 151(1): 128-137, 2022 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-35188268

RESUMO

Optimal treatment for resectable esophageal squamous cell carcinoma (ESCC) is controversial, especially in the context of potential benefit of combining PD-1 blockade with neoadjuvant therapy. This phase 2 study aimed to assess neoadjuvant camrelizumab plus chemotherapy in this population. Patients (clinical stage II-IVA) received two cycles of neoadjuvant chemoimmunotherapy (NIC) with camrelizumab (200 mg on day 1) plus nab-paclitaxel (260 mg/m2 in total on day 1 and day 8) and cisplatin (75 mg/m2 in total on days 1-3) of each 21-day cycle. Surgery was performed approximately 6 weeks after completion of NIC. Primary endpoint was complete pathologic response (CPR) rate in primary tumor. Secondary endpoints were objective response rate (ORR) per RECIST v1.1, 2-year progression-free survival (PFS) rate after surgery, PFS, overall survival (OS) and safety during NIC and perioperative period. Between 17 January 2020 and 8 December 2020, 56 patients were enrolled, and 51 received esophagectomy. Data cutoff date was 25 August 2021. The CPR rate was 35.3% (95% CI, 21.7%-48.9%). NIC had an ORR of 66.7% (95% CI, 40.0%-70.4%) and treatment-related adverse events (TRAEs) of low severity (grade 1-2, 75.0%; grade 3, 10.7%; grade 4-5, no). No perioperative mortality occurred. Three (5.9%) patients had tumor recurrence and one (2.0%) patient died. The 2-year PFS rate, median PFS and median OS had not been reached yet. Camrelizumab plus neoadjuvant chemotherapy in resectable ESCC demonstrates promising efficacy with acceptable toxicity, providing a feasible and effective option. Study is ongoing for long-term survival analyses.


Assuntos
Neoplasias Esofágicas , Carcinoma de Células Escamosas do Esôfago , Anticorpos Monoclonais Humanizados , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Cisplatino/uso terapêutico , Neoplasias Esofágicas/patologia , Carcinoma de Células Escamosas do Esôfago/tratamento farmacológico , Carcinoma de Células Escamosas do Esôfago/patologia , Humanos , Terapia Neoadjuvante/efeitos adversos , Recidiva Local de Neoplasia/tratamento farmacológico , Recidiva Local de Neoplasia/etiologia
18.
Ann Surg ; 275(2): 295-302, 2022 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-33938492

RESUMO

OBJECTIVE: To determine whether RAL affects perioperative outcomes and long-term efficacy in NSCLC patients, compared with traditional VAL. SUMMARY OF BACKGROUND DATA: RAL is a promising treatment for NSCLC. However, its efficacy has not been fully evaluated. METHODS: A single-center, open-labeled prospective randomized clinical trial was launched in May 2017 to compare the efficacy of RAL and VAL. By May 2020, 320 patients were enrolled. The perioperative results of RAL and VAL were compared. RESULTS: The 320 enrolled patients were randomly assigned to the RAL group (n = 157) and the VAL group (n = 163). Perioperative outcomes were comparable between the 2 groups, including the length of hospital stay (P = 0.76) and the rate of postoperative complications (P = 0.45). No perioperative mortality occurred in either group. The total amount of chest tube drainage {830 mL [interquartile range (IQR), 550-1130 mL] vs 685 mL [IQR, 367.5-1160 mL], P = 0.007} and hospitalization costs [$12821 (IQR, $12145-$13924) vs $8009 (IQR, $7014-$9003), P < 0.001] were significantly higher in the RAL group. RAL group had a significantly higher number of LNs harvested [11 (IQR, 8-15) vs 10 (IQR, 8-13), P = 0.02], higher number of N1 LNs [6 (IQR, 4-8) vs 5 (IQR, 3-7), P = 0.005], and more LN stations examined [6 (IQR, 5-7) vs 5 (IQR, 4-6), P < 0.001]. CONCLUSIONS: Both RAL and VAL are safe and feasible for the treatment of NSCLC. RAL achieved similar perioperative outcomes, together with higher LN yield. Further follow-up investigations are required to evaluate the long-term efficacy of RAL. (ClinicalTrials.gov identifier: NCT03134534).


Assuntos
Carcinoma Pulmonar de Células não Pequenas/cirurgia , Neoplasias Pulmonares/cirurgia , Pneumonectomia/métodos , Procedimentos Cirúrgicos Robóticos , Cirurgia Torácica Vídeoassistida , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento
19.
Gland Surg ; 10(8): 2591-2599, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34527570

RESUMO

BACKGROUND: Standardized and transparent reporting of surgical technique is the cornerstone of effective dissemination, implementation and improvement. However, current reporting of surgical techniques is inadequate. The existing guidelines potentially applied to guide surgical technique reporting are with a minimal highlight of the surgical technique, lack requirements explaining what extent and dimensions need to be described in detail, or are unlikely to extrapolate to a wide range of surgical techniques. This study aims to formulate a rigorous protocol to develop a surgical technique reporting checklist and standards (SUPER) that defines what a clear, comprehensive and detailed surgical technique report should be contained. METHODS: This protocol is designed following the classic guidance for developing reporting guidelines recommended by the EQUATOR network. RESULTS: The development team will consist of surgeons (~80%), methodologists, and journal editors. The draft checklist sources will include a scoping review of existing reporting guidelines related to surgical technique, surgical technique articles from 15 top journals published in the last year, and brainstorming by the multidisciplinary development team. The final SUPER checklist will be formed after three rounds of Delphi surveys, one round of face-to-face meeting, and a month-long pilot test. The SUPER checklist will be published as open-access and be used in combination with existing reporting guidelines related to surgical techniques (e.g., IDEAL). This protocol will steer the SUPER checklist's development, allowing us to further elaborate surgical technique reporting for all surgical specialties, and enabling a more favorable experience for surgeons, nurses, medical students, residents, editors, and reviewers. TRIAL REGISTRATION: This trial is registered at the EQUATOR network on December 18th, 2020. Available at: https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-other-study-designs/.

20.
Acta Chir Belg ; 121(6): 449-454, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34474643

RESUMO

The technique for bronchial stump suturing following lung resection which is currently applied in the Department of Thoracic Surgery at the University Hospitals Leuven, Belgium owes its name to the Dutch surgeon Dr. Klinkenbergh (1891-1985). A true pioneer of cardiothoracic surgery in Europe, Dr. Klinkenbergh dedicated himself to the surgical treatment of pulmonary tuberculosis. His work was praised by his peers for his precision and the reasoning behind every gesture. The Klinkenbergh technique consists in performing two running sutures which cross each other 'in the same manner as the laces of a shoe' to close the bronchus, limiting the occurrence of broncho-pleural fistulas. In our experience with more than 100 patients in the last 5 years (2016-2020) who underwent open pneumonectomy for benign or malignant disease, less than 2% developed post-operative broncho-pleural fistulas.


Assuntos
Fístula Brônquica , Neoplasias Pulmonares , Brônquios/cirurgia , Fístula Brônquica/cirurgia , Epônimos , Humanos , Neoplasias Pulmonares/cirurgia , Pneumonectomia , Complicações Pós-Operatórias , Suturas
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