Participants were randomly assigned to receive pembrolizumab or a placebo in addition to standard therapy. This global studyĮnrolled a total of 434 participants, some of which were enrolled by Dana-Farber’s Center for Esophageal and Gastric Cancer. The Keynote 811 study examined the addition of immunotherapy drug pembrolizumab (Keytruda®) to the current standard of care, trastuzumab and chemotherapy, and showed notable improvement in overall treatment response rates in patients. For more information, view the results of the study. Peter Enzinger, MD, Director of our Center for Esophageal and Gastric Cancer, was one of the principal investigators of the trial. In a recent breakthrough trial, Keynote 590, conducted at our Center and other sites around the world, investigators demonstrated that the addition of an immunotherapy drug, pembrolizumab (Keytruda ®), significantly improved survival compared Until recently, the standard treatment for patients with metastatic (inoperable) esophageal cancer was chemotherapy, most commonly the combination of fluorouracil, oxaliplatin and leucovorin (FOLFOX).Īlthough effective in most patients, resistance eventually developed, and patients had to seek alternative treatment options. Learn more about the results of the study in the American Nivolumab has been approved by the US Food and Drug Administration. This combination represents a new first line standard of care for patients with advanced esophageal squamous cell carcinoma. This treatment combination resulted inĪ 6.3-month improvement in survival and prevented progression of cancer at one year in 25% of patients, a 50% improvement over chemotherapy alone. The CheckMate 648 study examined the efficacy and safety of combining nivolumab, a drug that binds to the protein PD-1 to help immune cells kill cancer cells, with the current standard treatment of chemotherapy. ![]() Learn more about the results in the New England Journal of Medicine. The Center for Esophageal and Gastric Cancer, under principal investigator James Cleary, MD, enrolled the largest number of patients to this study. However, a 2021 breakthrough study, CheckMate 577, proved that one year of immunotherapy (nivolumab) added after surgery doubles the disease-free survival for patients receiving this additional treatment. Until recently, the standard treatment for locally advanced esophageal and gastro-esophageal junction cancer was chemotherapy plus radiation therapy followed by surgery. Learn about our recent breakthrough trials and their impactful findings below. The treatment of esophageal and gastric cancer. Our physicians lead and participate in revolutionary worldwide clinical trials to constantly improve Trials are a crucial way that advancements in treatment are made, and allow physicians to research answers to questions that arise in the clinic. We show that adding pembrolizumab to trastuzumab and chemotherapy markedly reduces tumour size, induces complete responses in some participants, and significantly improves objective response rate.Dana-Farber Cancer Institute and our Center for Esophageal and Gastric Cancer remain as dedicated to discoveries in cancer research as to delivering compassionate, patient-centered care. Here we describe results of the protocol-specified first interim analysis of the randomized, double-blind, placebo-controlled phase III KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for unresectable or metastatic, HER2-positive gastric or gastro-oesophageal junction adenocarcinoma (, NCT03615326). ![]() Although adding the anti-programmed death 1 (PD-1) antibody pembrolizumab to chemotherapy does not significantly improve efficacy in advanced HER2-negative gastric cancer, there are preclinical and clinical rationales for adding pembrolizumab in HER2-positive disease. ![]() ![]() More than a decade ago, combination therapy with the anti-HER2 antibody trastuzumab and chemotherapy became the standard first-line treatment for patients with these types of tumours. Human epidermal growth factor receptor 2 (HER2, also known as ERBB2) amplification or overexpression occurs in approximately 20% of advanced gastric or gastro-oesophageal junction adenocarcinomas.
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