9 Imaging was performed on tumors every nine weeks. Chemotherapy drugs were given to patients in the other group every two weeks, either with or without Zirabev or Erbitux. In the Keytruda group, patients received the medication once every three weeks for up to two years. 9 Patients (N = 307) were randomly chosen to receive either Keytruda or chemotherapy. Keynote 177 plus#Taking place at 192 cancer centers in 23 countries, the study examined how well Keytruda performed in these patients as a first-line therapy versus standard-of-care chemotherapy plus Zirabev or Erbitux. Keynote 177 trial#The KEYNOTE-177 study is a phase 3 trial composed of patients with microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer (MSI-H/dMMR mCRC). 8 Chemotherapy regimens included in the study were modified FOLFOX6 (leucovorin, fluorouracil and oxaliplatin) and FOLFIRI (leucovorin, fluorouracil and irinotecan). 7 The monoclonal antibody Erbitux (cetuximab) blocks epidermal growth factor receptors on cancer cells, reducing growth and division. Zirabev (bevacizumab), a vascular endothelial growth factor inhibitor, lowers the amount of microvascular growth of tumor blood vessels. Keytruda prevents PD-1 and PD-L1 from bonding, freeing T cells to continue killing cancer cells. If PD-1 and PD-L1 bond together, this interaction stops T cells from killing cancer cells and allows the cancer to spread. PD-L1 is found on cancer cells as well as other types of cells. PD-1 is found on the body’s T cells, a type of immune cell that normally attacks and kills invaders such as cancer cells. To understand how Keytruda works, it helps to first learn about two cell proteins called programmed death 1 (PD-1) and programmed death-ligand 1 (PD-L1). It is designed to prevent cancer cells from multiplying and spreading inside the body. Keytruda (pembrolizumab) is a type of immunotherapy called a monoclonal antibody. They are often combined with embolization, which involves injecting tiny particles to block or reduce blood flow to cancer cells.įOR YOUR REFERENCE: What Medications Were Investigated in the KEYNOTE-177 Trial? Interventional radiology treatments, such as ablation, which use highly focused energy to shrink or destroy tumors before or after surgery.Immunotherapy, which uses the body’s immune system to attack cancer cells and is an option for people with colon cancer whose cancer cells have a specific genetic makeup.Targeted therapies, which attack specific genes and proteins in cancer cells.4Īdditional treatment options for patients with metastatic colon cancer include the following 3,4: Waste is collected from the opening into a bag attached to the skin. The surgeon cuts the colon above the cancer and attaches the end to an opening in the belly. In some cases, it is necessary for the surgeon to perform a colostomy. Surgeons can remove colon and liver tumors during the same procedure to reduce pain and shorten recovery time. However, it can also spread to the lining of the abdomen (peritoneum), ovaries, brain or other organs. Colon cancer usually spreads to the liver because the blood supply from the colon is connected to the liver by a large blood vessel. Metastatic colon cancer (also known as advanced colon cancer or stage 4 colon cancer) is cancer that has spread beyond the colon to other organs. Phase 4: occurs after FDA approval monitors safety and effectiveness in large, diverse populations and collects information on long-term side effects.įOR YOUR REFERENCE: What Is Metastatic Colorectal Cancer?Ĭolorectal cancer starts in the colon or rectum and is often called colon cancer or rectal cancer depending on where it starts.Phase 3: gathers more information about safety and effectiveness, studies different populations and dosages and examines use of the drug in combination with other drugs.Phase 2: focuses on effectiveness and obtains preliminary data on whether the drug works in people who have a certain disease or condition.Phase 1: tests an experimental treatment on a small group of often healthy people to judge its safety and side effects and find the correct dosage.The number of participants increases in each phase, starting from 20 to 80 people for a phase 1 trial to up to 3,000 for a phase 3 trial (Figure 1). To find out whether a drug can be approved for use, the Food and Drug Administration (FDA) requires four phases of a clinical trial. The following information is for educational purposes and is not medical advice.įOR YOUR REFERENCE: What Are Clinical Trials?Ĭlinical trials determine whether a drug works in humans and if it is safe and effective. The Educated Patient ®: Research Updates provides current clinical updates for different disease states.
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