The risk of recurrence after neoadjuvant chemoradiotherapy followed by surgery (called trimodal therapy) remains high in cancer of the esophagus (EC) or esophageal-gastric junction (EGT). There is still no treatment in this scenario. CheckMate 577 is the first global, randomized, double-blind, phase 3 study to report the efficacy and safety of a checkpoint inhibitor in the adjuvant setting following trimodal treatment for CE/TEG.
In Renata D’Alpino Peixoto’s opinion, a clinical oncologist specializing in gastrointestinal and neuroendocrine tumors who works at the Centro Paulista de Oncologia (CPO), of the Oncoclínicas Group, the results exceeded expectations. “This is the first tumor, after melanoma, where adjuvant immunotherapy has been shown to be beneficial,” she says. “Although relapse rates are high (greater than 50%), no one knows for sure the best way to follow up such patients, or even if any follow-up (by imaging and/or laboratory tests) brings any reduction in the risk of dying from the disease. disease,” he says.
The management for this type of patient before CheckMate 577 was only clinical observation. “In my view, given the efficacy demonstrated so far, with the use of nivolumab being able to double the median disease-free survival (DFS) and with an acceptable profile of clinical toxicities, the therapy has the potential to be incorporated as a new therapy. standard treatment”, comments Bruno Protásio, oncologist at the NOB clinic, Grupo Oncoclínicas, in Salvador (BA).
CheckMate-577 included nearly 800 patients with SCC/TEG, stages II or III, treated with trimodality and who had residual disease in the esophagectomy specimen. They were randomized to observation or to treatment with the immunotherapy, nivolumab, for up to one year. Groups received either placebo or nivolumab 240 mg by intravenous infusion every two weeks for 16 weeks, followed by nivolumab 480 mg every four weeks until disease progression or unacceptable toxicity. At the end of the study, the authors demonstrated a statistically significant benefit in disease-free survival (DFS) in favor of immunotherapy treatment, even doubling the median DFS in the immunotherapy arm, from 11 months to 22.4 months.
Regarding the safety of using nivolumab, CkeckMate 577 reported, in most cases, manageable toxicities, in agreement with previous studies involving this medication.
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