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The allowance of randomization up to 16 weeks after surgery allows patients the time to recover from the unique physiological challenges of esophagectomy. We agree that adjuvant nivolumab has little impact for surgeons on the perioperative care of their patients, making this approach quite attractive.
#Checkmate 577 trial#
The results of the trial were outstanding, with a 31% reduction (hazard ratio, 0.69 confidence interval, 0.56-0.86) in the risk of recurrence/death and a doubling of disease-free survival (DFS 22.4 vs 11.0 months) for patients randomized to nivolumab. Patients with multiple myeloma may also have increased mortality when Opdivo is added to dexamethasone and a thalidomide analogue, which is not recommended for patients not currently enrolled in controlled clinical trials.įor more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.Do an excellent job describing the CheckMate 577 trial and how it easily fits into the typical paradigm of treatment for these patients. In addition, Opdivo may cause complications of allogenic hematopoietic stem cell transplantation, according to the release.
#Checkmate 577 skin#
Several precautions and warnings are linked to Opdivo due to severe and fatal immune-mediated side effects including colitis, lung tissue inflammation, a disease affecting the endocrine gland, liver inflammation, liver damage or injury, skin side effects, inflamed nephrons (which are part of the kidneys) and renal dysfunction, infusion-related reactions and other immune-mediated side effects. “Today’s news marks an important step for patients as well as meaningful progress toward our commitment to pioneering immunotherapy treatment options in early stages of disease where there is the potential to reduce the risk of recurrence.” Cardiovascular, Immunology and Oncology at Bristol Myers Squibb, in a press release. “Esophageal and (gastroesophageal junction) cancer patients with residual pathologic disease following neoadjuvant (chemoradiotherapy) and complete resection face a higher risk of disease recurrence however, the predominant option for these patients has been surveillance,” said Adam Lenkowsky, senior vice president and general manager of U.S. The FDA approval of Opdivo for these patients is a major step from its original treatment approach, which is surveillance in certain instances. “This is exciting news, providing renewed hope.” “In the CheckMate-577 trial, we saw a doubling in median disease-free survival compared to placebo, which suggests that Opdivo could become a new standard of care for these patients,” Dr. This was also observed in patients with squamous cell carcinoma (29.7 months versus 11 months) and those with adenocarcinoma (19.4 months versus 11 months). Findings demonstrated that median disease-free survival was greater in patients treated with Opdivo versus those treated with placebo (22.4 months versus 11 months). This FDA approval was based on findings from CheckMate-577, a phase 3 trial in which researchers compared Opdivo (532 patients) with placebo (262 patients) in patients with esophageal or gastroesophageal junction cancer with residual disease after neoadjuvant chemoradiotherapy and complete resection, according to the release. “Even after neoadjuvant (chemoradiotherapy) followed by surgery, there may be a high risk of recurrence for patients who do not achieve a pathologic complete response.” Sammons Cancer Center in Dallas, Texas, in the release. Kelly, director of Baylor Scott and White Charles A. “Locally advanced esophageal and gastroesophageal junction cancers are aggressive tumor types that often require multiple approaches to address the disease including chemotherapy, radiation and surgery,” said Dr.
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Bristol Myers Squibb announced that Opdivo (nivolumab) has been approved by the Food and Drug Administration (FDA) for the adjuvant treatment of patients with completely resected esophageal or gastroesophageal junction cancer who still had residual disease after undergoing neoadjuvant chemoradiotherapy.