A presentation of updated results from the VIOLET study comparing video-assisted thoracoscopic surgery (VATS) with open lobectomy showed that improvements in pain, in-hospital complications, and shorter hospital stay previously reported after VATS were achieved without any compromise to oncologic outcomes at 1 year. In addition, patients who underwent VATS had significantly improved physical function at 5 weeks.
Eric Lim, MD, MBBS, of Royal Brompton and Harefield Hospitals, presented results of the primary endpoint analysis at the 2021 ASCO Annual Meeting.
VIOLET included 503 patients with known or suspected primary lung cancer within cT1-3, cN0-1, M0 stage. Patients were randomly assigned 1:1 to VATS or open lobectomy. The primary outcome was physical function at 5 weeks.
In-hospital outcomes of VIOLET were presented at the 2019 World Conference of Lung Cancer in Barcelona. Those results showed that VATS lobectomy was associated with less pain, significantly lower complication rate, and shorter hospital stay achieved without any compromise to early oncologic outcomes or serious adverse events.
In an intention-to-treat analysis, the authors found a 4.65-point improvement in physical function at 5 weeks for patients randomized to VATS (P = 0.09), “confirming better functional recovery in participants randomized to VATS,” Dr. Lim said. (it lacks explanation of this scale)
The difference in recovery in favor of VATS was most marked at the 2-week timepoint, he said.
Physical function did not return to baseline for patients in either group. According to Dr. Lim, this was likely due to lung function lost due to lobectomy. However, function achieved a final state by 3 months in VATS group compared to 6 months in the open group.
Discussant Valerie W. Rusch, MD, FACS, of Memorial Sloan Kettering Cancer Center, said the study results inform the future management of patients with NSCLC and definitely establishes the standard of care for early-stage resectable NSCLC.
“Minimally invasive surgical approaches—VATS and robotic VATS—to lung resection represent a paradigm shift in surgical technique,” Dr. Rusch said. “It has often been difficult for surgeons in practice to learn this technique and incorporate it into practice. During the past 25 years, however, there has been gradual adoption of minimally invasive technique across the global thoracic surgical community.”
Pain, Complications, and Readmission
The results of VIOLET, she said, include endpoints that are highly meaningful to patients and health care systems, as well as to surgical and oncology data.
This includes the results of an economic analysis that showed that patients who were assigned to VATS had lower overall hospital costs out to 1 year compared with open lobectomy when taking into account costs of surgery, complications, hospital stay, and readmissions.
Previously reported in-hospital pain was lower for patients assigned to VATS and this was achieved despite 10% less analgesic use compared with open surgery. According to Dr. Lim, the researchers optimistically defined prolonged pain as analgesics required more than 5 weeks after surgery. Prolonged pain was significantly lower in VATS compared with the open arm.
“We learned that on average pain was experienced for 3 months after surgery, not 5 weeks,” Dr. Lim said. Patients assigned to VATS experienced much lower levels of pain compared with open surgery and this was a consistent finding in other measures of pain like quality-of-life scales, he said.
The researchers also previously reported 26% lower in-hospital complications for patients assigned to VATS and no difference in in-hospital serious complications. After discharge, patients assigned to VATS continued to experience a 19% lower rate of readmissions out to 1 year.
Dr. Lim said that while lower in-hospital complications were driven by less infection and kidney complications, postdischarge complications in favor of VATS were driven by lower blood, heart, and gastrointestinal complications.
In addition, fewer patients were readmitted to the hospital in the VATS group. The main reasons for re-admission in both arms were infection, medical procedures (?), and shortness of breath. Among the causes of death in the first year, disease progression was the most common.
Finally, Dr. Lim and colleagues previously reported that there was no difference in the quality of lymph node dissection between the two arms measured by total number or median number of mediastinal lymph nodes harvested. There was also no difference in attainment of complete resection with either technique.
After discharge, the researchers observed no differences in time to uptake for adjuvant chemotherapy. A similar number of patients experienced disease recurrence in both arms, as well as development of new cancers.
“We concluded no difference in survival despite an approximately 30% reduction in the hazard ratio for death for those randomized to VATS because we were not powered to analyze this outcome,” Dr. Lim said.
Lim EKS, et al. Video-assisted thoracoscopic versus open lobectomy in patients with early-stage lung cancer: one-year results from a randomized controlled trial (VIOLET). Abstract 8504. Presented at: 2021 ASCO Annual Meeting.