“ is the first and only therapy to improve DFS, along with a manageable safety profile, for patients with esophageal or GEJ cancer following neoadjuvant chemoradiation therapy and surgery,” Ian M.
Checkmate 577 trial#
Key secondary end points of the trial included OS of adjuvant nivolumab in this patient population, with a time frame of about 77 months following randomization, and the OS rate at 1, 2, and 3 years.Įnrollment was planned for 160 study sites throughout 27 countries including France, Germany, Belgium, the United Kingdom, Italy, Poland, Romania, Spain, Czech Republic, Hungary, Ireland, the Netherlands, Switzerland, Denmark, Israel, Russia, Canada, the United States, Japan, Taiwan, the Republic of Korea, Mexico, Puerto Rico, Brazil, Argentina, Peru, and Australia. The primary end point of the trial was DFS of adjuvant nivolumab in patients with resected esophageal or GEJ cancer who had received previous chemoradiation followed by surgery, with a time frame of about 58 months after the first patient underwent randomization. In the trial, patients were randomized to receive either nivolumab at 240 mg via intravenous infusion biweekly for the duration of 16 weeks followed by nivolumab at 480 mg every 4 weeks until progressive disease or intolerable toxicity, or placebo.
Moreover, patients who did not receive concurrent chemoradiation before surgery and those who had received an attenuated vaccine within 30 days of the first treatment, were also not permitted for inclusion. Patients with a diagnosis of cervical esophageal carcinoma or a diagnosis of stage IV resectable disease were not eligible for participation on the trial.
Checkmate 577 free#
To be eligible for enrollment, patients had to have been diagnosed with stage II/III carcinoma of the esophagus or GEJ, have completed preoperative treatment with chemoradiation followed by surgery, and have been diagnosed with residual pathologic disease after having been surgically rendered disease free with negative margins after complete resection. In the multicenter, double-blind, phase 3 CheckMate-577 trial, investigators set out to evaluate whether adjuvant nivolumab would improve overall survival (OS), DFS, or both when compared with placebo in patients with resected esophageal or GEJ cancer. 6 There is no postoperative adjuvant standard of care after chemoradiation and resection. 4,5 As such, the median OS in these patients is typically less than 2 years. 2,3 Notably, the majority of patients, or 70%, will not achieve a pCR following resection. “For the first time, we have a potential therapeutic option with nivolumab in the adjuvant setting for these patients.”Ĭhemoradiation followed by surgical resection is the current standard of care for this patient population, and 3- to 5-year survival rates following chemoradiation typically range from 30% to 40%. “Medical oncologists have had limited to no treatment options to offer esophageal cancer who undergo neoadjuvant chemoradiation therapy followed by surgery and fail to demonstrate a pathologic complete response (pCR),” Kelly added. Sammons Cancer Center at Baylor University Medical Center, stated in a press release. “Approximately 50% of patients with esophageal or gastroesophageal junction cancer who undergo neoadjuvant chemoradiation therapy followed by tumor resection will have disease recurrence within 4 years,” Ronan J. Moreover, the safety profile of nivolumab proved to be consistent with what has been demonstrated in previous studies.
Nivolumab (Opdivo), following neoadjuvant chemoradiation and complete surgical resection, resulted in a statistically significant improvement in disease-free survival (DFS) in patients with resected esophageal or gastroesophageal junction (GEJ) cancer, meeting the primary end point of the phase 3 CheckMate-577 trial (NCT02743494).
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