An ASCO guideline rapid update is revising recommendations for the management of locally advanced esophageal carcinoma to include provision of nivolumab following adjuvant chemoradiotherapy and surgery. The new guidance addresses treatment of patients with residual disease following resection and chemoradiotherapy—a population that was not included in the original guideline published in 2020.1
Wayne L. Hofstetter, MD
“There are new data pointing to the benefit of adjuvant nivolumab in patients who have had a complete resection after neoadjuvant chemoradiation but have residual viable cancer in the resected specimen on pathologic analysis,” said Wayne L. Hofstetter, MD, of The University of Texas MD Anderson Cancer Center, and guideline expert panel co-chair. “This is a deviation from our recently published ASCO guideline in that this population was previously recommended to undergo surveillance instead of considering adjuvant therapy. Our expert panel wanted to come out quickly with an update to bring attention to this potentially beneficial treatment.”
The update recommends that patients with locally advanced esophageal carcinoma who were treated with preoperative chemoradiation followed by a complete resection but did not experience a pathologic complete response (ie, with residual, viable tumor in resected specimens) and are Eastern Cooperative Oncology Group Performance Status 0 or 1 be considered for adjuvant nivolumab. Dr. Hofstetter noted that the level of evidence in support of this change was moderate.
This new direction comes on the heels of the publication of results from CheckMate 577.2 This phase III, randomized controlled trial found adjuvant nivolumab plus adjuvant chemoradiotherapy and surgery led to better disease-free survival compared with chemoradiotherapy and surgery plus placebo (hazard ratio [HR] = 0.69) among patients with esophageal or gastroesophageal junction adenocarcinoma or esophageal squamous cell carcinoma (794 patients). Findings were impressive enough to warrant updating the 2020 ASCO guideline and help advance the standard of care for patients with residual disease, who, up until now, were treated mainly through watchful waiting.
Dr. Hofstetter noted that these recommendations represent a paradigm shift in the postoperative management of patients with esophageal cancer successfully treated with chemoradiotherapy and surgery and could inform better treatment decision-making by oncologists and better outcomes among patients. However, more work is needed to clarify the potential benefits of nivolumab.
“Data from CheckMate 577 indicate that disease-free survival was improved in patients who received nivolumab therapy compared to those who did not, suggesting this therapy can potentially prolong the time from initial therapy to [disease] recurrence,” he said. “Whether this will translate into prolonged overall survival—and determining which subgroup of patients will ultimately benefit from this adjuvant therapy—is the topic of future research and long-term outcomes from this single study.”
1. Shah MA, Kennedy EB, Catenacci DV, et al: Treatment of locally advanced esophageal carcinoma: ASCO Guideline. J Clin Oncol 38:2677-2694, 2020.
2. Kelly RJ, Ajani JA, Kuzdzal J, et al: Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer. N Engl J Med 384:1191-1203, 2021.
Originally published in ASCO Daily News. © American Society of Clinical Oncology. ASCO Daily News, August 20, 2021. All rights reserved.