The study "shows that neoadjuvant chemoradiotherapy followed by minimally invasive esophagectomy has similar safety and better histopathological outcome than neoadjuvant chemotherapy for the treatment of locally advanced esophageal squamous-cell carcinoma," Dr. Lille Tan of Fudan University, in Shanghai, told Reuters Health by email.
In a paper in JAMA Surgery, Dr. Tan and colleagues note that although there is evidence of benefit with such an approach, studies have focused predominantly of adenocarcinoma in the distal esophagus or esophagogastric junction.
"Thus," they say, "whether the results could be extrapolated for patients with esophageal squamous cell carcinoma remains to be validated."
To investigate, the researchers conducted a multicenter randomized controlled trial including 264 patients, 86% of whom were men. Their average age was 61 years and they were assigned to receive neoadjuvant chemoradiotherapy (nCRT) or neoadjuvant chemotherapy (nCT). About six weeks later, patients in both groups underwent minimally invasive esophagectomy via thoracoscopy and laparoscopy.
The total postoperative complications rate was 47% in the nCRT group, not significantly different from the 43% seen in the nCT group. The distribution of severity was also similar between groups.
At 90 days, the perioperative mortality rate was 3.5% for the nCRT group, which again was not significantly more than the 2.8% in the nCT group.
However, although R0 resection rates were also similar between groups, the nCRT group had a significantly higher pathologic complete response rate. This was in 35.7% in the nCRT patients compared to only 3.8% of the nCT group (P<0.001). The negative lymph node rate was also significantly higher at 66.1% versus 46.2% (P=0.03).
The end of the trial will be at least three years after the treatment of the last patient, say the investigators, but at one year using intention-to-treat analysis, overall survival was not significantly different between groups. However, deaths caused by tumor progression or recurrence were significantly less common in the nCRT group (6.8% vs. 14.4%).
Dr. Marco G. Patti of the University of North Carolina at Chapel Hill, co-author of an accompanying editorial, told Reuters Health by email that this was a "very important study."
"We look forward to the 3-year survival data to see whether they will confirm the results of this interim analysis at one year," he said.
SOURCE: https://bit.ly/3lLppwQ and https://bit.ly/2Qp2dZF JAMA Surgery, online March 17, 2021.
By David Douglas
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