Dataset Information

Mortality for Robotic- vs Video-Assisted Lobectomy-Treated Stage I Non-Small Cell Lung Cancer Patients.

ABSTRACT: Background:To address the US Food and Drug Administration's recent safety concern on robotic surgery procedures, we compared short- and long-term mortality for stage I non-small cell lung cancer (NSCLC) patients treated by robotic-assisted thoracoscopic surgical lobectomy (RATS-L) vs video-assisted thoracoscopic surgical lobectomy (VATS-L). Methods:From the National Cancer Database, we identified 18?908 stage I NSCLC patients who underwent RATS-L or VATS-L as the primary operation from 2010 to 2014. Cox proportional hazards models were used to estimate hazard ratios (HRs) for short- and long-term mortality using unmatched and propensity score-matched analyses. All statistical tests were 2-sided. Results:Patients treated by RATS-L had higher 90-day mortality than those with VATS-L (6.6% vs 3.8%, P = .03) if conversion to open thoracotomy occurred. After excluding first-year observation, multiple regression analyses showed RATS-L was associated with increased long-term mortality, compared with VATS-L, in cases with tumor size 20?mm or less: hazard ratio (HR) = 1.33 (95% confidence interval [CI] = 1.15 to 1.55), HR = 1.36 (95% CI = 1.17 to 1.58), and HR = 1.33 (95% CI = 1.11 to 1.61) for unmatched, N:1 matched, and 1:1 matched analyses, respectively, in the intention-to-treat analysis. Among patients without conversion to an open thoracotomy, the respective hazard ratios were 1.19 (95% CI = 1.10 to 1.29), 1.19 (95% CI = 1.10 to 1.29), and 1.17 (95% CI = 1.06 to 1.29). Similar associations were observed when follow-up time started 18 or 24 months postsurgery. No statistically significant mortality difference was found for patients with tumor size of greater than 20?mm. These associations were not related to case volume of VATS-L or RATS-L performed at treatment institutes. Conclusions:Patients with small (?20?mm) stage I NSCLC treated with RATS-L had statistically significantly higher long-term mortality risk than VATS-L after 1 year postsurgery.

SUBMITTER: Cui Y

PROVIDER: S-EPMC7660043 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Mortality for Robotic- vs Video-Assisted Lobectomy-Treated Stage I Non-Small Cell Lung Cancer Patients.

Cui Yong Y Grogan Eric L EL Deppen Stephen A SA Wang Fei F Massion Pierre P PP Bailey Christina E CE Zheng Wei W Cai Hui H Shu Xiao-Ou XO

JNCI cancer spectrum 20200415 5

<h4>Background</h4>To address the US Food and Drug Administration's recent safety concern on robotic surgery procedures, we compared short- and long-term mortality for stage I non-small cell lung cancer (NSCLC) patients treated by robotic-assisted thoracoscopic surgical lobectomy (RATS-L) vs video-assisted thoracoscopic surgical lobectomy (VATS-L).<h4>Methods</h4>From the National Cancer Database, we identified 18 908 stage I NSCLC patients who underwent RATS-L or VATS-L as the primary operation ...[more]

PMID: 33215060

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Project description:BackgroundThe 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.MethodsIn 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.FindingsA 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).InterpretationThis 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.FundingNational 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).

Project description:BackgroundRetrospective data demonstrates that robotic-assisted thoracoscopic surgery provides many benefits, such as decreased postoperative pain, lower mortality, shorter length of stay, shorter chest tube duration, and reductions in the incidence of common postoperative pulmonary complications, when compared to video-assisted thoracoscopic surgery. Despite the potential benefits of robotic surgery, there are two major barriers against its widespread adoption in thoracic surgery: lack of high-quality prospective data, and the perceived higher cost of it. Therefore, in the face of these barriers, a prospective randomized controlled trial comparing robotic- to video-assisted thoracoscopic surgery is needed. The RAVAL trial is a two-phase, international, multi-centered, blinded, parallel, randomized controlled trial that is comparing robotic- to video-assisted lobectomy for early-stage non-small cell lung cancer that has been enrolling patients since 2016.MethodsThe RAVAL trial will be conducted in two phases: Phase A will enroll 186 early-stage non-small cell lung cancer patients who are candidates for minimally invasive pulmonary lobectomy; while Phase B will continue to recruit until 592 patients are enrolled. After consent, participants will be randomized in a 1:1 ratio to either robotic- or video-assisted lobectomy, and blinded to the type of surgery they are allocated to. Health-related quality of life questionnaires will be administered at baseline, postoperative day 1, weeks 3, 7, 12, months 6, 12, 18, 24, and years 3, 4, 5. The primary objective of the RAVAL trial is to determine the difference in patient-reported health-related quality of life outcomes between the robotic- and video-assisted lobectomy groups at 12 weeks. Secondary objectives include determining the differences in cost-effectiveness, and in the 5-year survival data between the two arms. The results of the primary objective will be reported once Phase A has completed accrual and the 12-month follow-ups are completed. The results of the secondary objectives will be reported once Phase B has completed accrual and the 5-year follow-ups are completed.DiscussionIf successfully completed, the RAVAL Trial will have studied patient-reported outcomes, cost-effectiveness, and survival of robotic- versus video-assisted lobectomy in a prospective, randomized, blinded fashion in an international setting.Trial registrationClinicalTrials.gov, NCT02617186. Registered 22-September-2015. https://clinicaltrials.gov/ct2/show/NCT02617186.

Project description:RATIONALE:Video-assisted thoracoscopic surgery (VATS) and open lobectomy are both standard of care for the treatment of early-stage non-small cell lung cancer (NSCLC) because of equivalent long-term survival. OBJECTIVES:To evaluate whether the improved perioperative outcomes associated with VATS lobectomy are explained by surgeon characteristics, including case volume and specialty training. METHODS:We analyzed the Surveillance, Epidemiology, and End Results-Medicare-linked registry to identify stage I-II NSCLC in patients above 65 years of age. We used a propensity score model to adjust for differences in patient characteristics undergoing VATS versus open lobectomy. Perioperative complications, extended length of stay, and perioperative mortality among patients were compared after adjustment for surgeon's volume and specialty using linear mixed models. We compared survival using a Cox model with robust standard errors. RESULTS:We identified 9,508 patients in the registry who underwent lobectomy for early-stage NSCLC. VATS lobectomies were more commonly performed by high-volume surgeons (P?<?0.001) and thoracic surgeons (P?=?0.01). VATS lobectomy was associated with decreased adjusted odds of cardiovascular complications (odds ratio [OR]?=?0.65; 95% confidence interval [CI]?=?0.47-0.90), thromboembolic complications (OR?=?0.47; 95% CI?=?0.38-0.58), extrapulmonary infections (OR?=?0.75; 95% CI?=?0.61-0.94), extended length of stay (OR?=?0.47; 95% CI?=?0.40-0.56), and perioperative mortality (OR?=?0.33; 95% CI?=?0.23-0.48) even after controlling for differences in surgeon volume and specialty. Long-term survival was equivalent for VATS and open lobectomy (hazard ratio?=?0.95; 95% CI?=?0.85-1.08) after controlling for patient and tumor characteristics, surgeon volume, and specialization. CONCLUSIONS:VATS lobectomy for NSCLC is associated with better postoperative outcomes, but similar long-term survival, compared with open lobectomy among older adults, even after controlling for surgeon experience.

Project description:Background At present, the clinical conclusion that robotic-assisted thoracic surgery (RATS) and video-assisted thoracic surgery (VATS), which is better for patients with non-small cell lung cancer (NSCLC) is not clear. Therefore, this meta-analysis aimed to compare the perioperative outcomes between RATS and VATS for NSCLC. Methods The Population, Interventions, Comparators, Outcomes, and Study design (PICOS) framework was employed to develop the search strategy, and the findings was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. We searched EMbase, The Cochrane Library, PubMed, Web of Science, CNKI, and Wan Fang Data to collect clinical studies about RATS vs. VATS for patients with NSCLC from inception to October 2019. The following outcomes were measured: rate of conversion to thoracotomy, postoperative complications, postoperative hospital mortality, lymph node dissection, hospitalization time, operating time, and postoperative drainage days. Estimation of potential publication bias was conducted by Begg’s test and Egger’s test. The Standardized Mean Difference (SMD) and Odds Ratio (OR) with 95% confidence intervals (CI) were pooled using Stata 15.0 software. Results A total of 18 studies involving 60,349 patients were included. Among them, 8,726 cases were in the RATS group, and 51,623 were in the VATS group. The results of meta-analysis showed that the operation time of RATS group was longer than that of VATS group (SMD=0.532, 95% CI: 0.391–0.674, P=0.000). And the further meta-analysis suggested that the incidence of postoperative complications was lower in patients who underwent RATS after 2015 (OR=0.848, 95% CI: 0.748–0.962, P=0.010). Meanwhile, there was no significant difference between both groups in postoperative hospitalization time (SMD=0.003, 95% CI: −0.104–0.110, P=0.957). In addition, more lymph nodes were retrieved in RATS group than VATS (SMD=0.308, 95% CI: 0.131–0.486, P=0.001). However, the conversion rate, retrieved lymph node station, days to tube removal and in-hospital mortality rate have no significant differences between both groups. Discussion The current meta-analysis indicates that the perioperative outcomes of RATS and VATS for NSCLC are equivalence. Due to the limited quantity and quality of included studies, the above conclusions still need to be verified by more high-quality studies.

Project description:BACKGROUND:The morbidity of lung cancer has long been the highest in cancer. Stage I, stage II and partly of stage III non-small cell lung cancer (NSCLC) are mainly treated by surgery. Lobectomy and segmentectomy both are common lung resection methods. Video-assisted thoracoscopic surgery (VATS) has been widely used in clinical, and the application of single-portvideo-assisted thoracoscopic surgery (SP VATS) has gradually been recognized and accepted by professors. With increasing degree of eldly in society, eldly patients already have become inceasingly difficulties in the diagnosis and treatment of NSCLC. The aim of this study is to explore and analyze clinical value of SP VATS lobectomy and segmentectomy in elderly patients with NSCLC. METHODS:In this retrospective observational study, the outcomes of 417 consecutive patients who had undergone SP VATS anatomic segmentectomy or lobectomy for NSCLC from May 2014 to December 2016 on department of thoracic surgery in Fujian Medical University Affiliated Union Hospital were examined, including 139 elderly-case (lobectomy vs segmentectomy: 124 vs 15) and 278 nonelderly-case (lobectomy vs segmentectomy: 248 vs 30). The condition of perioperative period and postoperative short-time recovery could be compared with lobectomy and segmentectomy between elderly and nonelderly cases and lobectomy and segmentectomy in elderly cases. RESULTS:The morbidty of preoperative complications was significant difference (P<0.05) in comparing with elderly and non-elderly patients with NSCLC either in SP VATS anatomic segmentectomy orlobectomy, except others is no significant difference (P>0.05). Numbers of dissected lymph nodes and mediastinal nodal stations of SP VATS lobectomy in elderly patients with NSCLC were more than segmentectomy (P<0.05), which were (7.61±0.21) vs (20.39±0.97) and (5.60±0.35) vs (15.40±2.64). But there was not significant difference between two elderly groups of SP VATS lobectomy and anatomic segmentectomy in age, morbidty of preoperative complications, average operation time and intraoperative blood loss (P>0.05). Postoperative drainage volume [(1,150.15±140.02) mL vs (853.53±177.04) mL] and duration [(7.00±1.31) d vs (5.00±0.74) d], duration of postoperative hospital stay [(3.18±1.32) d vs (5.04±1.30) d], costs [(70.06±5.23) thousands yuan vs (61.20±5.22) thousands yuan ] or postoperative complications (5.97% vs 20.00%)(P>0.05). Notwithstanding, group of SP VATS anatomic segmentectomy found more postoperative atrialfibrillation and the vein thrombosis of lower limbs (P<0.05). CONCLUSIONS:Elderly patients having more basic diseases and taking increasely risk of postoperative complications. SP VATS anatomic segmentectomy andlobectomy do not increase the risk of elderly patients with surgery. SP VATS segmentectomy is as safe and effective as SP VATS lobectomy in elderly patients, who fit to undergo SP VATS segmentectomy seem to get as same short-time effect as SP VATS lobectomy.

Dataset Information

Mortality for Robotic- vs Video-Assisted Lobectomy-Treated Stage I Non-Small Cell Lung Cancer Patients.

Publications

Mortality for Robotic- vs Video-Assisted Lobectomy-Treated Stage I Non-Small Cell Lung Cancer Patients.

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