Berend van der Wilk, MD, Erasmus University Medical Center, Rotterdam, Netherlands, shares the results of the phase 3 SANO trial, evaluating an organ-sparing, active surveillance approach after neoadjuvant chemoradiotherapy among patients with esophageal cancer.

Dr Van der Wilk stated, “People undergoing active surveillance have non-inferior overall survival, could be operated safely after a local regional regrowth which resulted in an improved global health-related quality of life.”

These results were first presented at the 2023 European Society for Medical Oncology Annual Congress in Madrid, Spain.

Transcript:

Good afternoon, my name is Berend van der Wilk, I'm a medical doctor at Erasmus Medical Center University in Rotterdam in the Netherlands and I'm a surgical trainee. I had the privilege to present the results of the SANO trial, which is a phase 3 cluster randomized trial.

We see that patients with esophageal cancer are being treated with neoadjuvant chemoradiotherapy followed by an esophagectomy. We also see that an esophagectomy is a major surgical procedure resulting in mortality, morbidity and a decrease in health-related quality of life. And we also know from the CROSS trial that nearly 1/3 of the patients have a pathologically complete response after neoadjuvant chemoradiotherapy that means that no vital tumor cells are found in the esophageal resection specimen anymore after neoadjuvant chemo radiotherapy. This imposed us with a dilemma whether we need surgery for all those patients or should we be willing to perform an organ-sparing active surveillance strategy for patients who respond well to neoadjuvant chemo radiotherapy.

That's the rationale behind the SANO study in which we aim to compare the efficacy of neoadjuvant chemoradiotherapy followed by active surveillance versus standard surgery for patients with locally advanced esophageal cancer. As I said, it's a phase 3 cluster randomized trial including patients undergoing neoadjuvant chemoradiotherapy who reach the clinically complete response 12 weeks after the completion of neoadjuvant chemo radiotherapy. We define the clinically complete response according to the absence of vital tumor cells using diagnostics which we reported earlier in the preSANO trial. And we used endoscopic bite-on-bite biopsies, endoscopic ultrasonography and PET-CT scans. The primary end point was overall survival and the secondary end points included disease-free survival, operative and pathological outcomes, and health-related quality of life.

The main results were that at 2 years, overall survival was non-inferior for patients undergoing active surveillance compared to patients undergoing standard surgery. And the same was true for the disease-free survival and the rate of distant metastasis between both groups. We saw that nearly half of the patients still needed a postponed esophagectomy during active surveillance, but we also saw that it could be performed safely and timely for those patients.

Lastly, we saw that patients who underwent active surveillance had an improved global health-related quality of life 6 and 9 months after the completion of neoadjuvant chemotherapy compared to patients undergoing standard surgery.

To summarize, people undergoing active surveillance have non-inferior overall survival, could be operated safely after a local regional regrowth which resulted in an improved global health-related quality of life. We still need longer term data as well to conclude on the long-term efficacy of the trial and we will publish that in a few years. Thank you.

Source:

Van der Wilk BJ, Eyck BM, Wijnhoven BPL, et al. Neoadjuvant chemoradiotherapy followed by surgery versus active surveillance for oesophageal cancer (SANO-trial): A phase-III stepped-wedge cluster randomised trial. Presented at ESMO Annual Congress; October 20-24, 2023; Madrid, Spain. LBA75