Video-assisted thoracoscopic versus open lobectomy in patients with early-stage lung cancer: One-year results from a randomized controlled trial (VIOLET).
2021; Lippincott Williams & Wilkins; Volume: 39; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2021.39.15_suppl.8504
ISSN1527-7755
AutoresEric Kian Saik Lim, Tim Batchelor, Joel Dunning, Michael Shackcloth, Vladimir Anikin, Babu Naidu, Elizabeth Belcher, Mahmoud Loubani, Vipin Zamvar, Rosie Harris, Lucy Dabner, Holly E. McKeon, Sangeetha Paramasivan, Alba Realpe, Daisy Elliot, Paulo De Sousa, Jane Blazeby, Chris Rogers,
Tópico(s)Pleural and Pulmonary Diseases
Resumo8504 Background: Video assisted thoracoscopic surgery (VATS) is a popular access for lung cancer resection. However, there is limited information from RCTs from in-hospital to one-year clinical efficacy, safety and oncologic outcomes of a minimal access approach. Methods: VIOLET is a parallel group multi-center RCT conducted in 9 centers in the United Kingdom that recruited participants with known or suspected (cT1-3, N0-1 and M0) lung cancer (ISRCTN13472721). Trial protocol: https://bmjopen.bmj.com/content/9/10/e029507.info. Results: From July 2015 to February 2019, 503 participants were randomized to VATS (n=247) or open (n=256) lobectomy. Patients allocated to VATS had less pain with a mean difference (MD) in visual analogue score of -0.54 (95%CI -0.99 to -0.10) despite less analgesic consumption (mean ratio 0.90, 95%CI 0.80 to 1.01). After discharge pain was consistent on multiple sub-scales including overall pain (MD -7.19, -10.59 to -3.80), chest pain (MD -4.66, -7.96 to -1.36) and an 18% relative risk (RR) reduction in incision pain (RR 0.82; 0.72 to 0.94) up to one-year. Better functional recovery continued in VATS arm after discharge with better physical function (primary outcome) with MD of 4.65 (1.69 to 7.61; P=0.002) at 5 weeks and overall improvement in global health status with a MD of 4.21 (1.62 to 6.79; P=0.001). In hospital, VATS arm had fewer complications (RR 0.74, 0.66 to 0.84; P<0.001) with no difference in serious adverse events (RR 0.98, 0.59 to 1.63; P=0.948). Median hospital stay was one day shorter in the VATS arm (4 vs 5 days) corresponding to hazard ratio (HR) for discharge of 1.34, 95%CI 1.09 to 1.65; P=0.006). After discharge VATS arm had 19% less serious adverse events (RR 0.81, 0.66 to 1.00; p=0.053) and lower readmission rates (29.0% vs. 35.9% respectively) to one-year. Of those with lymph node disease, 50.9% in the VATS and 45.9% in open arms received adjuvant treatment. There was no difference in the time to uptake of adjuvant chemotherapy (HR 1.12, 0.62 to 2.02; p=0.716). Recurrence with clinical follow up and CT at one-year was similar with 7.7% versus 8.1% in the VATS and open groups respectively. Progression-free survival (HR 0.74, 0.43 to 1.27; p=0.27) and overall survival HR 0.67, 0.32 to 1.40; p=0.282) was not significantly different. Conclusions: VATS lobectomy for lung cancer is associated with less pain, fewer in-hospital complications and shorter hospital stay, achieved without any compromise to early oncologic outcomes nor serious adverse events. Superior functional recovery continues in the post-operative period with improved physical function, lower re-admission rates and no difference in disease-free and overall survival up to one-year. Clinical trial information: ISRCTN13472721.
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