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1 Pancreatic Cancer NCCN Guidelines for Patients Dedicated to the memory of Randy Pausch Also available at NCCN.com

2 About this booklet Its purpose Learning that you have cancer can be overwhelming. The goal of this booklet is to help you get the best cancer treatment. It has a special step-by-step guide of the cancer tests and treatments recommended by experts in pancreatic cancer. Supported by the NCCN Foundation The NCCN Foundation supports the mission of the National Comprehensive Cancer Network (NCCN ) to improve the care of patients with cancer. One of its aims is to raise funds to create a library of booklets for patients. Learn more about the NCCN Foundation at The source of the information NCCN is a not-for-profit network of 21 of the world s leading cancer centers. Pancreatic cancer experts from NCCN have written treatment guidelines for doctors taking care of patients with pancreatic cancer. These treatment guidelines suggest what the best practice is for cancer care. The information in this booklet is based on these guidelines. For more information This booklet focuses on the treatment of pancreatic cancer. More information on NCCN, pancreatic cancer, and other cancers can be found on NCCN.com National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines for Patients and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. 2

3 Part Table 1: of About contents pancreatic cancer How to use this booklet Part 1 About pancreatic cancer Explains the growth and spread of pancreatic cancer. Part 2 Cancer tests Describes the suggested tests in Part 5 used to plan treatment. Part 3 Cancer treatments Describes the suggested treatments in Part 5 for pancreatic cancer. Part 4 Clinical trials Explains a type of research that is a treatment option in Part 5. Part 5 A step-by-step treatment guide Presents the recommended course of action from diagnosis to after cancer treatment Part 6 Beyond cancer treatment Presents supportive care for the physical and emotional challenges of cancer. Part 7 Treatment planning Offers information to help you get a good treatment plan. Part 8 Dictionary The definitions of medical and other terms are listed. Credits Index 3

4 How to use this booklet Who should read this booklet? This booklet is about treatment for ductal adenocarcinoma of the pancreas. About 90 out of 100 people with pancreatic cancer have ductal adenocarcinoma. This booklet may be helpful for patients, caregivers, and other family and friends dealing with this cancer. Where should I start reading? Reading the booklet in order from the beginning to the end may be the most helpful if you do not know much about pancreatic cancer. The first parts of the booklet provide basic information that will make it easier to understand the latter parts. As you read through this booklet, you may find it helpful to create a list of questions to ask your doctor. Does the whole booklet apply to me? There is important information in this booklet for many situations. Thus, not everyone will get every test and treatment listed in this booklet. The treatment guide in Part 5 covers what the NCCN doctors feel is the most useful based on science and their experience. However, the suggestions in Part 5 may not be the right for you. Your doctor may suggest other tests or treatments based on your medical history and other factors. This booklet does not replace the knowledge and suggestions of your doctors. What pages should I read? To help you use this booklet, each topic is described at the start of Parts 1 7. Page numbers are listed so you can flip right to the topic of interest. Your treatment team can also point out the parts that apply to you and give you more information. Reading this booklet at home may help you absorb what your doctors have said and prepare for treatment. Help! I don t know these words! In this booklet, many medical words are included that describe cancer, tests, and treatments. These are words that you will likely hear your treatment team use in the months and years ahead. Most of the information may be new to you, and it may be a lot to learn. Don t be discouraged as you read. Keep reading and review the information. Words that you may not know are defined in the text or the sidebar. Words with sidebar definitions are underlined when first used on a page. All definitions are listed in the Dictionary in Part 8. Acronyms are also listed in the text or the sidebar. Acronyms are words formed from the first letters of other words. One example is U.S. for United States. 4

5 Part 1: About pancreatic cancer Part 1 You ve learned that you have pancreatic cancer. It s common to feel shocked and confused. Part 1 reviews some basics about pancreatic cancer that may help you start to cope. These basics may also help you start planning for treatment What is the pancreas? Explains where the pancreas is and what it does. 1.2 How does pancreatic cancer start? Describes the types of pancreatic cells where cancer begins. 1.3 How does pancreatic cancer spread? Explains the body systems by which pancreatic cancer spreads. 1.4 Tools Webpages with basics about pancreatic cancer are listed. Part 2 Part 3 Part 4 Part 5 Part 6 Part 7 5 Part 8

6 1.1 What is the pancreas? The pancreas is a gland found behind the stomach. It is about 6 inches long and has three main parts. The widest part is called the head. The middle of the gland is the body. The narrow end is called the tail. The pancreas makes hormones, such as insulin. It also makes proteins, called enzymes, that help to digest food. Enzymes are made in the small ducts of the pancreas. The small ducts connect to the main duct that extends from the tail to the head of the pancreas. Near the pancreas under the liver is the gallbladder. The gallbladder makes bile that also helps to digest food. Bile flows through the common bile duct into the main pancreatic duct. From the main pancreatic duct, bile and enzymes empty into the duodenum. See Figure 1. Figure 1. Pancreas and nearby organs Illustration Copyright 2012 Nucleus Medical Media, All rights reserved. 6

7 Part 1.2 How 1: About does pancreatic cancer start? Part 1 Cells are the building blocks that form tissue in the body. Normal cells grow and then divide to form new cells. New cells are formed as the body needs them. When normal cells grow old or get damaged, they die. Cancer cells don t do this. Cancer cells make new cells that aren t needed and don t die quickly when old or damaged. See Figure 2. Over time, cancer cells grow and divide enough to form a primary tumor. Primary tumors can grow large and invade nearby tissues. Figure 2. Normal versus cancer cell growth Illustration Copyright 2012 Nucleus Medical Media, All rights reserved. Genes are instructions in cells for making new cells and controlling how cells behave. Changes in genes turn normal cells into cancer cells. Within the pancreas, exocrine or endocrine cells become cancer cells. Endocrine cells make hormones. Exocrine cells make enzymes. There is more than one type of exocrine cell. About 90 out of 100 pancreatic cancers start in exocrine cells that line the ducts. This type of pancreatic cancer is called ductal adenocarcinoma and is the focus of this booklet. Definitions: Common bile duct: A tube-shaped organ that transports digestive fluid from the liver into the gut Duodenum: First part of the small intestine, which absorbs nutrients from eaten food Hormones: Chemicals in the body that activate cells or organs Insulin: A chemical that controls the amount of sugar in the blood Liver: An organ that removes waste from the blood Main pancreatic duct: A tube-shaped vessel that drains digestive fluids from the pancreas into the gut Primary tumor: First mass of cancer cells in the body Part 2 Part 3 Part 4 Part 5 Part 6 Part 7 7 Part 8

8 1.3 How does pancreatic cancer spread? Unlike normal cells, cancer cells can spread and form tumors in other parts of the body. The spread of cancer makes it dangerous. Cancer can take over vital organs and cause them to stop working. Cancer that has spread is called a metastasis. Cancer in a nearby body part is called a local metastasis. Cancer in a body part far from the primary tumor is called a distant metastasis. Cancer can spread to distant sites through blood. Two major blood vessels lie behind the pancreas. The superior mesenteric artery supplies the intestines with blood. The superior mesenteric vein returns blood to the heart. Cancer can also spread through lymph. Lymph is a clear fluid that gives cells water and food. It also has white blood cells that fight germs. Lymph nodes filter lymph and remove the germs. Lymph travels throughout the body in vessels like blood does. As seen in Figure 3, lymph vessels and nodes are found everywhere in the body. Figure 3. Lymph nodes and vessels Illustration Copyright 2012 Nucleus Medical Media, All rights reserved. 8

9 1.4 Tools Part 1 Webpages American Cancer Society National Cancer Institute NCCN Pancreatic Cancer Action Network Review of Part 1 Part 2 Part 3 Part 4 Part 5 The pancreas helps digest food. Pancreatic cancer often starts in the cells that line the ducts. Cancer cells form a tumor since they don t die as they should. Cancer cells can spread to other body parts through lymph or blood. Part 6 Part 7 9 Part 8

10 Part 2: Cancer tests Treatment planning starts with testing. The tests used for pancreatic cancer are described on the next pages. This information can help you use the treatment guide in Part 5. It may also help you know what to expect during testing. Not every person with pancreatic cancer will receive every test listed General health tests A medical history and body exam are described. 2.2 Imaging tests The tests that take pictures of the insides of the body are described. 2.3 Blood tests Common signs of disease that are found in blood are described. 2.4 Tissue tests The tests of body tissue or fluid for cancer cells are described. 2.5 Tools Questions to ask your doctor about testing are listed along with helpful webpages. 10

11 2.1 General health tests Part 1 Medical history Before and after cancer treatment, your doctor will assess your medical history. Your medical history includes any health events in your life and any medications you ve taken. This information may affect which cancer treatment is best for you. It may help to make a list of old and new medications while at home to bring to your doctor s office. Since some health problems run in families, your doctor may want to ask about the medical history of your blood relatives. Physical exam Doctors often give a physical exam along with taking a medical history. A physical exam is a review of your body for signs of disease. During this exam, your doctor will listen to your lungs, heart, and gut. Parts of your body will likely be felt to see if organs are of normal size, are soft or hard, or cause pain when touched. Your doctor will also check for jaundice. Jaundice is a yellowing of the skin and eyes. See Figure 4. It can be caused by a tumor blocking a duct that drains bile from the liver. Figure 4. Jaundice of the eyes Cholangitis Jaundice by Bobjgalindo available at commons.wikimedia.org/wiki/file:cholangitis_jaundice.jpg under a Creative Commons Attribution-Share Alike 3.0 Unported license. Notes: Part 2 Part 3 Part 4 Part 5 Part 6 Part 7 11 Part 8

12 2.2 Imaging tests Imaging tests allow your doctors to see inside your body. Pictures (images) are made with scanning machines or scoping tools. The images may show if you have a tumor and its size. Imaging tests are often easy to undergo. Before the test, you may be asked to stop eating or drinking for several hours. You also should remove any metal objects that are on your body. It may be helpful to have a loved one come with you for the test. You may want someone to drive you home after the test. Scans Scanning machines are large and have a tunnel in the middle. During the test, you will need to lie on a table that moves slowly through the tunnel. Pillows or straps may be used to keep you still during the test. You will be alone, but a technician will operate the machine in a nearby room. He or she will be able to see, hear, and speak with you at all times. radiologist needs to see the pictures. The scanning tests recommended in Part 5 include: CT. The first test for pancreatic cancer is often a CT (computed tomography) scan. A CT scan takes many pictures of a body part from different angles using x-rays. See Figure 5. A pancreatic protocol CT allows doctors to see the pancreas, blood vessels, and very tiny tumors. Before the test, you may be given a contrast dye to make the pictures clearer. The dye will be injected into your vein. It may cause you to feel flushed or get hives. Rarely, serious allergic reactions occur. Tell your doctor if you have had bad reactions before. As the machine takes pictures, you may hear buzzing, clicking, or whirring sounds. Earplugs are sometimes worn to block these sounds. A computer combines all pictures into one detailed picture. An imaging test can take between 30 to 60 minutes to complete. Often, there are no side effects. If radiation is used, the amount is small. You will likely be able to resume your activities right away unless you took a sedative. You may not learn of the results for a few days since a Figure 5. CT scan 12

13 2.2 Imaging tests Part 1 MRI. An MRI (magnetic resonance imaging) scan uses radio waves and powerful magnets to take pictures inside the body. It does not use x-rays. An MRI may cause your body to feel a bit warm. Like a CT scan, a contrast dye may be used. A pancreatic protocol MRI may be used instead of CT to view the pancreas. MRCP. MRCP (magnetic resonance cholangiopancreatography) is an MRI scan that makes very clear images of the pancreas and bile ducts. No contrast dye is used because bile and other fluids serve as contrast. An MRCP takes about 10 minutes, but it is often done along with a normal MRI scan. Scopes Some imaging tests insert a tool into the body to search for disease. An endoscope is a tool commonly used. An endoscope has a thin, long tube that can be guided into the body, often through the mouth. At the end of the tube is a very small light and camera lens. At the other end of the endoscope is an eyepiece that your doctor looks through to see the images shown by the camera. To use the endoscope, your doctor will give you a sedative. After the test, your throat may feel sore. You may also feel bloated from air that was pumped into your body for better viewing. EUS. EUS (endoscopic ultrasound) uses an endoscope that is fitted with a small ultrasound probe. The ultrasound probe bounces sound waves off your pancreas and other organs to make images. This test takes about 15 to 45 minutes. This test is often done to get a close look at your pancreas and any tumor that might be in it. Your doctors can also do a tissue test (see Part 2.4) at the same time to confirm if a tumor is cancer. Definitions: Allergic reaction: Symptoms caused when the body is trying to rid itself of outside agents Bile: Yellowish-brown fluid made by the liver Bile ducts: Small tubeshaped organs that drain bile from the liver Hives: Itchy, swollen, and red skin caused by the body ridding itself of an invader Pancreas protocol MRI: Imaging methods using MRI that clearly show the pancreas and nearby organs Radiologist: A doctor who s an expert in reading imaging tests Sedative: A drug that helps a person to relax or go to sleep Part 2 Part 3 Part 4 Part 5 Part 6 Part 7 13 Part 8

14 2.2 Imaging tests ERCP. An ERCP (endoscopic retrograde cholangiopancreatography) uses an endoscope and x-rays to make images. First, a tube is passed through the open channel of the endoscope to inject contrast into the pancreatic and bile ducts. See Figure 6. The contrast allows the pancreas and ducts to be seen on x-rays. Next, images of the pancreas and bile ducts are made using an x-ray machine. An ERCP takes about 30 to 90 minutes to complete. Laparoscopy. This test is a type of surgery that allows your doctors to see organs in the abdomen. It uses a laparoscope a tool like an endoscope. Unlike EUS and ERCP, laparoscopy requires the laparoscope be inserted through a tiny cut in the abdomen. Laparoscopy is done under general anesthesia in the operating room and takes about 30 minutes. After the surgery, you may feel tired and may have pain. You may have a small scar after the cut has healed. Cancer staging Cancer staging is a way to rate the extent of the cancer. Pancreatic cancer has five stages (stage 0 stage IV). The stages are defined by the growth of the primary tumor and its spread to other sites in the body. Sometimes, cancer is staged twice. The first stage is based on tests before surgery. The second stage is based on tests of the tissue removed during surgical treatment for patients who have surgery. Figure 6. ERCP Illustration Copyright 2012 Nucleus Medical Media, All rights reserved. Some doctors use cancer staging to plan treatment. In Part 5 A step-by-step treatment guide, cancer staging isn t used to recommend which tests and treatments to receive. Rather, recommendations are based on three potential categories of pancreatic cancer: localized cancer that can be treated with surgery, locally advanced cancer, and distant metastases. 14

15 2.3 Blood tests Part 1 Blood tests are used to check for diseases, how well organs are working, and treatment results. One common blood test is a complete blood cell count. This test counts the number of blood cells in a blood sample. Too few or too many cells may signal there s a problem. Another common test is measurement of blood chemistry levels. This test assesses if chemicals in the blood are too low or high. Abnormal levels can be caused by cancer or other diseases. One example is liver function tests. These blood tests assess for chemicals that are made or processed by the liver. Levels that are too high or low signal that the liver is not working well. CA 19-9 is a blood protein that is often high in people with pancreatic cancer. High levels can be caused by pancreatic cancer or other health problems. It is not used to confirm that you have pancreatic cancer but is used to check results of cancer treatment. Bilirubin gives bile its color. There may be too much bilirubin in the blood if a tumor is blocking a bile duct. Too much bilirubin causes a yellowing of the skin and eyes, a condition called jaundice. It also increases CA 19-9 blood levels. Your doctor may change your treatment plan based on blood tests. How many times your blood will be tested depends on your cancer treatments and other factors. Common side effects of blood tests are bruising and dizziness. Definitions: Abdomen: The belly area Bile ducts: Small tubeshaped organs that drain digestive fluid from the liver Distant metastasis: The spread of cancer cells from the first tumor to a far site Endoscope: A thin, long tube with a light and camera General anesthesia: A controlled loss of wakefulness from drugs Localized cancer: A tumor that hasn t grown outside the pancreas Locally advanced cancer: A tumor that has grown outside the pancreas into nearby structures Part 2 Part 3 Part 4 Part 5 Part 6 Primary tumor: First mass of cancer cells in the body Acronyms Part 7 15 EUS = Endoscopic ultrasound Part 8

16 2.4 Tissue tests Imaging tests may fail to show cancer. Thus, your doctor may want you to have a biopsy. A biopsy is the removal of a tissue or fluid sample from the body for testing. The sample is sent to a lab and examined with a microscope for cancer cells. Lab tests will find cancer cells if any are present in a tissue sample. If no cancer is found, a different spot of the pancreas may be biopsied if your doctors still think there s cancer. Before a biopsy, you may be asked to stop eating, stop taking some medicines, or stop smoking. FNA (fine-needle aspiration) is the most common biopsy for pancreatic cancer. FNA can be done during EUS with a needle attached to the endoscope. The needle is inserted through the stomach or duodenum into the tumor. A second FNA method is to insert a thin needle through the skin and guide it into the tumor using a CT scan for guidance. This method is called a percutaneous FNA. For this FNA, you will be given local anesthesia. Besides FNA, a biopsy may be done during surgery or a laparoscopy. A biopsy is often done in less than 1 hour. It is generally a safe test. You may have some pain after a percutaneous FNA. After EUS-FNA, your throat may be sore and you may feel bloated from air pumped into your body. Definitions: Duodenum: First part of the small intestine, which absorbs nutrients from food Endoscope: A thin tube with a light and camera to see inside the body EUS: A test that uses a thin, lighted tube to see inside the body Laparoscopy: A surgical test that inserts a thin, lighted tube into a small cut to see inside the belly area Local anesthesia: A loss of feeling in a small area of the body from the injection of drugs Microscope: A tool that uses lenses to see things the eyes can t Acronyms CT = Computed tomography EUS = Endoscopic ultrasound 16

17 2.5 Tools Part 1 Questions about testing to ask your doctor What tests will I have? Do you recommend that I have a biopsy? If so, why? Where will the tests take place? Will I have to go to the hospital? How long will it take? Will I be awake? Will it hurt? Will I need anesthesia? What are the risks? How do I prepare for testing? Should I bring someone with me? How soon will I know the results and who will explain them to me? If a biopsy is done, will I get a copy of the results? Who will talk with me about the next steps? When? Part 2 Part 3 Part 4 Part 5 Part 6 Part 7 17 Part 8

18 2.5 Tools Webpages American Cancer Society National Cancer Institute NCCN Pancreatic Cancer Action Network Review of Part 2 Tests are used to find cancer and plan treatment. Your health history and a body exam inform your doctor about your health. Blood tests check for signs of disease. Tests that take pictures of the inside of your body may show cancer. Tests of tissue or fluid from your body may find cancer. 18

19 Part 3: Cancer treatments Part 1 There is more than one treatment for pancreatic cancer. The main types are described on the next pages. This information may help you use the treatment guide in Part 5. It may also help you know what to expect during treatment. Not every person with pancreatic cancer will receive every treatment listed Surgery The operations used to remove pancreatic tumors from the body are described. 3.2 Radiation therapy The uses of radiation to treat pancreatic cancer are described. 3.3 Chemotherapy Chemotherapy drugs for pancreatic cancer are described. 3.4 Targeted therapy Targeted drugs for pancreatic cancer are described. 3.5 Tools Questions to ask your doctor about treatments are listed along with helpful webpages. Part 2 Part 3 Part 4 Part 5 Part 6 Part 7 19 Part 8

20 3.1 Surgery There are three types of surgery used for pancreatic cancer. The type of surgery you receive depends on where the tumor is in the pancreas. The goal of surgery is to remove all of the cancer. To do so, the tumor and some normal-looking tissue around its edge are removed. The normal-looking tissue is called the surgical margin. The surgery for a tumor in the head of the pancreas is called a pancreaticoduodectomy, also known as a Whipple procedure. This surgery removes the pancreatic head, the gallbladder, duodenum, part of the bile duct, and often part of the stomach. Some of the lymph nodes near your pancreas are often removed to test for cancer. Once the cancer has been removed, your surgeons will connect your organs so you can digest food. The surgery for a tumor in the body or tail of the pancreas is called a distal pancreatectomy. This surgery removes both the body and tail and some nearby lymph nodes. Sometimes, the spleen and its blood vessels are removed as well. The surgery for cancer in a large portion of the pancreas is called a total pancreatectomy. This surgery removes the entire pancreas. Also removed are the gallbladder, duodenum, part of the bile duct and stomach, nearby lymph nodes, and sometimes the spleen. This surgery isn t done often. Order of treatments When and why treatments are given can be hard to understand. Part 5 gives full details. Here, the terms that describe the order of treatments are explained. The main treatment used to rid your body of cancer is called the primary treatment. For pancreatic cancer, surgery can be used to remove the cancer. Chemotherapy with or without targeted therapy may be used as a primary treatment to control cancer growth for cancer that has spread outside the pancreas. Radiation therapy can also be given as a primary treatment for locally advanced tumors. Neoadjuvant treatment may be given to shrink the tumor before surgery. Adjuvant treatment is given after surgery to try to kill any remaining cancer cells and reduce the chance of the cancer returning. For pancreatic cancer, chemotherapy and radiation therapy can be used as neoadjuvant or adjuvant treatments. First-line treatment is the first set of treatments given. If first-line treatment fails, second-line treatment is the next treatment or set of treatments given. 20

21 3.2 Radiation therapy Part 1 Radiation therapy uses high-energy rays to treat cancer. The rays damage a cell s instructions for creating and controlling cells. This either kills the cancer cells or stops new cancer cells from being made. More research is needed to know the best practice for treating pancreatic cancer with radiation. In this section, the methods of radiation therapy that are now used are explained. For pancreatic cancer, radiation is often given with chemotherapy. Chemotherapy may improve how well radiation works. This combined treatment is called chemoradiation. Radiation may be given before, during, or after surgery or without any surgery. External radiation For pancreatic cancer, radiation is often given using a machine outside the body. This method is called EBRT (external beam radiation therapy). Before treatment, images of the tumor are taken with a CT scan using contrast. This process is called simulation. Your doctors use the images to decide the radiation dose and to shape the radiation beams. Beams are shaped with computer software and hardware added to the radiation machine. During treatment, you will lie on a table in the same position as done during simulation. Devices may be used to keep you from moving so that the radiation targets the tumor. Likewise, methods may be applied to control breathing. Radiation beams are aimed at the tumor with help from ink marks on the skin or tiny, gold seeds placed in the tumor. Definitions:! See pages 6 7 for details of organs near the pancreas. Bile ducts: Small tubeshaped organs that drain digestive fluid from the liver Contrast: A dye put into your body to make pictures from imaging tests clearer Duodenum: First part of the small intestine, which absorbs nutrients from food Gallbladder: A small organ that holds digestive fluid from the liver Lymph nodes: Diseasefighting cells located throughout the body Part 2 Part 3 Part 4 Part 5 Part 6 You will be alone while the technician operates the machine from a nearby room. He or she will be able to see, hear, and speak with you at all times. As treatment is given, you may hear noises. A session can take between 30 to 60 minutes. The types of EBRT used for pancreatic cancer include: 3D-CRT (three-dimensional conformal radiation therapy) Radiation is given in small doses for a few weeks with beams that match the shape of the tumor, 21 Spleen: An organ near the stomach that helps protect the body against disease Acronyms CT = Computed tomography Part 7 Part 8

22 3.2 Radiation therapy IMRT (intensity-modulated radiation therapy) Radiation is given in small doses for a few weeks with beams of different strengths based on the thickness of the tumor, and SABR (stereotactic ablative radiotherapy) Radiation is given in high doses within a few visits and precisely targets the tumor. Internal radiation The other radiation method is internal radiation therapy (also called brachytherapy). Internal radiation therapy involves placing a radioactive object in or near the tumor. For pancreatic cancer, internal radiation is given during surgery through a plastic tube that is removed before the surgical cuts are sewn closed. Treatment side effects Side effects are new or worse physical or emotional conditions caused by cancer treatment. Each treatment for pancreatic cancer can cause side effects, but how your body will respond can t be fully known. You may have different side effects than someone else. Common side effects of treatments are listed below. Surgery. You may experience weakness, tiredness, and pain after the surgery. Other common side effects are difficulty digesting food, diabetes, leakage of pancreatic fluids, and surgical scars. Radiation therapy. Side effects of radiation therapy may not occur in the first few visits. Over time, you may have discomfort in your abdomen. Other common side effects are not feeling hungry, nausea, diarrhea, and fatigue. Chemotherapy. Side effects of chemotherapy depend on the drug, amount taken, length of treatment, and the person. In general, side effects are caused by the death of fast growing cells, which are found in the gut, mouth, and blood. As a result, common side effects include diarrhea, nausea, vomiting, mouth sores, tiredness or weakness, numbness or tingling of hands or feet, skin and nail changes, hair loss, swelling, and not feeling hungry. Targeted therapy. Erlotinib is a targeted therapy for pancreatic cancer. Common side effects include skin rash, diarrhea, feeling tired, not feeling hungry, and nausea. The rash may appear on the face, neck, or trunk of the body within the first 2 weeks of treatment. Controlling side effects is important for your quality of life. There are many ways to limit these problems. However, listing all the ways is beyond the scope of this booklet. In general, changes in behavior, diet, or medications may help. Don t wait to tell your treatment team about side effects. If you don t tell your treatment team, they may not know how you are feeling. 22

23 3.3 Chemotherapy Part 1 Chemotherapy is the use of drugs to treat cancer. Many people refer to this treatment as chemo. Chemotherapy stops the growth process of cells in an active growth phase. It doesn t work on cells in a resting phase. Cancer cells grow fast, so chemotherapy works well to stop new cancer cells from being made. When only one drug is used, it is called a single agent. However, chemotherapy drugs differ in the way they work, so often more than one drug is used. A combination regimen is the use of two or more chemotherapy drugs. The chemotherapy drugs used for pancreatic cancer are: Capecitabine sold as Xeloda, Cisplatin sold as Platinol and Platinol AQ, Docetaxel sold as Taxotere, 5-FU (5-fluorouracil), Gemcitabine sold as Gemzar, Irinotecan hydrochloride sold as Camptosar, Oxaliplatin sold as Eloxatin, and Definitions: Diabetes: A disease that causes high levels of blood sugar Fatigue: Severe tiredness despite getting enough sleep that limits one s ability to function Targeted therapy: Drugs that stop the growth process specific to cancer cells Part 2 Part 3 Part 4 Part 5 Nab-Paclitaxel sold as Abraxane Chemotherapy for pancreatic cancer can be given as a pill taken by mouth or as a liquid that is slowly injected into a vein. Most of the chemotherapy drugs listed above are given as injections. These injections are often given as outpatient treatment at a hospital, clinic, or doctor s office. The length of the outpatient visit depends on which chemotherapy you receive. Chemotherapy is given in cycles of treatment days followed by days of rest. These cycles vary in length depending on which drugs are used. Often, the cycles are 14, 21, or 28 days long. These cycles give the body a chance to recover before the next treatment. Thus, chemotherapy treatment includes some days without treatment. 23 Part 6 Part 7 Part 8

24 3.4 Targeted therapy Targeted therapy is the use of drugs to treat cancer. It stops the growth process that is very specific to cancer cells. It is less likely to harm normal cells than chemotherapy, which stops any cells in a growth phase. Erlotinib hydrochloride (sold as Tarceva ) is a targeted therapy used for pancreatic cancer. It treats cancer by blocking a growth signal that is sent from the edge of a cell to the cell s control center (nucleus). Erlotinib is used with chemotherapy. It is a pill that when digested travels in the bloodstream to treat cancer throughout the body. Complementary and alternative medicine You may hear about other treatments from your family and friends. They may suggest using CAM (complementary and alternative medicine). CAM is a group of treatments that aren t often given by doctors. There is much interest today in CAM for cancer. Many CAMs are being studied to see if they are truly helpful. Complementary medicines are treatments given along with usual medical treatments. While CAMs aren t known to kill cancer cells, they may improve your comfort and well-being. Two examples are acupuncture for pain management and yoga for relaxation. Alternative medicine is used in place of usual medicine. Some alternative medicines are sold as cures even though they haven t been proven to work. If there was good proof that CAMs or other treatments cured cancer, they would be included in this booklet. It is important to tell your treatment team if you are using any CAMs. They can tell you which CAMs may be helpful and which CAMs may limit how well treatments work. 24

25 3.5 Tools Part 1 Questions about treatment to ask your doctor Are there any clinical trials that are appropriate for me? Is pancreatic cancer surgery a major part of your practice? Part 2 What are the treatments for pancreatic cancer? What are the risks and benefits for each treatment of pancreatic cancer? Will my age, general health, and stage of pancreatic cancer limit my treatment choices? How soon should I start treatment? How long does treatment take? How much will the treatment cost? How can I find out how much my insurance company will cover? How likely is it that I ll be cancer-free after treatment? Part 3 Part 4 Do I have to get treated? What symptoms should I look out for during treatment? Part 5 Where will I be treated? Will I have to stay in the hospital or can I go home after each treatment? When will I be able to return to my normal activities? What can I do to prepare for treatment? Should I stop taking my medications? Should I store my blood in case I need a transfusion? What is the chance that my cancer will return and/or spread? Part 6 How many pancreatic cancer surgeries have you done? How many of your patients have had complications? 25 What should I do after I finish treatment? Are there supportive services that I can get involved in? Support groups? Part 7 Part 8

26 3.5 Tools Webpages American Cancer Society National Cancer Institute NCCN Pancreatic Cancer Action Network Review of Part 3 Surgery removes the tumor with some normal tissue around its edge. Surgery may also remove lymph nodes. Radiation kills cancer cells or stops new cancer cells from being made. Drugs can be used to kill cancer cells anywhere in the body. Chemotherapy drugs stop the growth process of cells in a growth phase. Targeted therapy drugs stop cancer cells from getting signals to grow. 26

27 Part 4: Clinical trials Part 1 Part 4 describes a type of research called clinical trials. Taking part in a clinical trial may be a good treatment option. Talking with your treatment team, family, and friends can help you decide if a clinical trial is right for you What are clinical trials? This type of research is described. 4.2 The purpose of clinical trials The different aims of clinical trials are listed. 4.3 Phases of clinical trials The four phases of clinical trials are described. 4.4 Joining a clinical trial The first steps to take part in a trial are reviewed. 4.5 Tools Questions to ask your doctor about clinical trials are listed along with helpful webpages. Part 2 Part 3 Part 4 Part 5 Part 6 Part 7 27 Part 8

28 4.1 What are clinical trials? A clinical trial is a type of research that studies a test or treatment. Because of clinical trials, the tests and treatments in this booklet are now widely used to help patients. There may be an open clinical trial that you can join. Clinical trials are an important treatment option for people with pancreatic cancer. Until recently, not many clinical trials had been done to find tests and treatments for pancreatic cancer. Thus, doctors are still studying what tests and treatments work best. NCCN experts recommend that you talk with your treatment team about joining a clinical trial. Joining a clinical trial has benefits. First, you ll have access to the most current cancer care. Second, you will be treated by experts. Third, the results of your treatment both good and bad are carefully tracked. Fourth, you may help other patients with cancer. Clinical trials have risks too. Like any test or treatment, there may be side effects. Also, new tests or treatments may not help. Another downside may be that paperwork or more trips to the hospital are needed. 4.2 The purpose of clinical trials Clinical trials study how safe and helpful new tests or treatments are. When found to be safe and helpful, they may become tomorrow s standard of care. However, there is no way to know this before the trial is done. Clinical trials can study many things, such as: New drugs not yet approved by the U.S. FDA (Food and Drug Administration), New uses of drugs already approved by the FDA, New ways to give drugs, such as in pill form, Use of alternative medicines, such as herbs and vitamins, New tests to find and track disease, and Drugs or procedures that relieve symptoms. New clinical trials of pancreatic cancer aim to study: Better ways to identify who is at risk for pancreatic cancer, Early signs of pancreatic cancer so it can be cured, Better ways to image pancreatic cancers, 28

29 4.2 The purpose of clinical trials Part 1 New systemic therapy drugs to treat pancreatic cancer, New methods of giving radiation therapy, Which treatments work best to shrink a tumor for surgery, and Which treatments work best to kill cancer cells after surgery. 4.3 Phases of clinical trials Tests and treatments aren t offered to the public as soon as they re made. They need to go through a series of trials to make sure they re safe and work. Clinical trials have four phases. They are labeled with Roman numerals I IV. The phases are described next using the example of a new drug treatment: Phase I Phase I trials aim to find the best dose of a new drug with the fewest side effects. The drug has already been tested in lab and animal studies, but it now needs to be tested in patients. Doctors start by giving very low doses of the drug to the first group of patients. Higher doses are given to the next groups until side effects become too severe or the desired effect is seen. The drug may help patients, but Phase I trials are to test a drug s safety. If a drug is found to be safe enough, it can be tested in a phase II clinical trial. Phase II Phase II trials assess if a drug works for a specific type of cancer. They are done in larger groups of patients compared to Phase I trials. Often, new combinations of drugs are tested. Patients are closely watched to see if the Definitions: Alternative medicine: Treatments used in place of standard treatments FDA: A federal government agency that regulates drugs and food Radiation therapy: The use of radiation to treat cancer Side effect: An unplanned physical or emotional response to treatment Systemic therapy: Medicine that affects cancer cells throughout the body Part 2 Part 3 Part 4 Part 5 Part 6 Part 7 29 Part 8

30 4.3 Phases of clinical trials drug works. The treatment team also looks for unplanned responses to treatment. If a drug is found to work, it can be tested in a phase III clinical trial. Phase III Phase III trials include large numbers of patients. Often, these trials are randomized. This means that patients are put into a treatment group by chance. There can be more than two treatment groups in phase III trials. The control group gets the standard treatment and the other groups get a new treatment. Neither you nor your doctor can choose your group. Every patient in phase III studies is watched closely. The study will be stopped early if the side effects of the new drug are too severe or if one group has much better results. Phase III clinical trials are often needed before the FDA will approve the use of a new drug for the general public. Phase IV Phase IV trials test new drugs approved by the FDA. The drug is tested in many patients with different types of cancer. This allows for better research on short-lived and long-lasting side effects and safety. For instance, some rare side effects may only be found in large groups of people. Doctors can also learn more about how well the drug works and if it s helpful when used with other treatments. 4.4 Joining a clinical trial If you would like to join a clinical trial, talk with your doctor. There may be clinical trials where you re getting treatment. To join, you must meet the conditions of the study. Patients in a clinical trial are often alike in terms of their tumor and general health. This is to know that any progress is because of the treatment and not because of differences between patients. Even if you qualify for the study, it is still your choice to join. To join, you ll need to review a paper called an informed consent form. This form describes the study in detail, including the risks and benefits. Also, your doctor will explain why the clinical trial may be right for you. You will be able to fully read the entire form and have all your questions answered. Afterward, you may decide to sign the form and start in the study. 30

31 4.5 Tools Part 1 Questions about clinical trials to ask your doctor Is there a clinical trial that I could take part in? How might the study change my daily life? Part 2 What is the purpose of the study? What kinds of tests and treatments does the study involve? What does the treatment do? Has the treatment been used before? Has it been used for other types of cancers? Will I know which treatment I receive? What is likely to happen to me with, or without, this new treatment? What side effects can I expect from the study? Can the side effects be controlled? Will I have to stay in the hospital? If so, how often and for how long? Will the study cost me anything? Will any of the treatment be free? If I m harmed as a result of the research, what treatment might I get? What type of long-term follow-up care is part of the study? Part 3 Part 4 Part 5 Part 6 What are my other choices? What are their benefits and risks? Part 7 31 Part 8

32 4.5 Tools List of clinical trials National Cancer Institute CANCER ( ) Pancreatic Cancer Action Network Webpages National Cancer Institute NCCN Pancreatic Cancer Action Network Review of Part 4 A clinical trial is a type of research that studies a test or treatment. Clinical trials are an important treatment option for patients with pancreatic cancer. Four research phases are done to fully study how safe and how well the tests or treatments work. There may be open clinical trials that you can take part in. 32

33 Part 5: A step-by-step treatment guide Part 1 Part 5 is a guide through treatment for people dealing with pancreatic cancer. It shows what tests and treatments are recommended under which conditions. This information is taken from the treatment guidelines written by NCCN experts for pancreatic cancer doctors. Much effort has been made to make this guide easy to read. Charts are used to list treatment options and map the steps through the treatment process. This information is also described in the text. Some words that you may not know are defined on the page and in the Dictionary in Part 8. This guide can help you talk with your doctors about treatment options. It is organized by how much the cancer has grown. Follow the Contents to find the recommended care for you Pancreatic cancer testing Read about the initial tests used to confirm pancreatic cancer and plan treatment. 5.2 Local pancreatic cancer Learn about treatment for cancer that hasn t grown beyond the pancreas. 5.3 Locally advanced pancreatic cancer 38 Surgery an option? Yes, for some tumors with minor growth to blood vessels. 41 Other options? Yes, for any tumors that have grown into nearby structures. 5.4 Metastatic pancreatic cancer Learn about treatments for pancreatic cancer that has spread far from the pancreas. Part 2 Part 3 Part 4 Part 5 Part 6 Part 7 33 Part 8

34 5.1 Pancreatic cancer testing 5.1 Pancreatic cancer testing Imaging tests Special CT or MRI of the pancreas Imaging results No signs of cancer but cancer is still suspected Tumor in pancreas but no metastases Metastases Next tests Liver function tests, Chest CT, and EUS, ERCP, EUS/ERCP, or MRI/MRCP Review by team of experts, Liver function tests, Chest CT, and Consider EUS Biopsy The first test for pancreatic cancer is usually either a CT or MRI. The pictures made by these tests may show if you have a tumor. It is suggested that the CT or MRI be done with standard protocols that clearly show tumor growth in and near the pancreas. These methods are called a pancreatic protocol CT or pancreatic protocol MRI. Even when a tumor isn t found, your doctors may still think that you may have cancer. In this case, more testing is needed. Many patients have an EUS next. An EUS lets your doctors see your pancreas more clearly and remove tissue with FNA for diagnosis. If a pancreatic tumor is found, results from liver function tests, chest CT, and other imaging tests may be used by your doctors to plan cancer treatment. For possible metastases, a biopsy of the site may be done to confirm that there s cancer. A team of cancer experts should review test results and plan treatment. Experts in imaging tests, laboratory tests, surgery, cancer drugs, and radiation therapy are recommended. Part 5.1 shows the recommended tests for pancreatic cancer. Your doctors will use these tests to decide if you have cancer and to plan treatment. Testing is started when signs of pancreatic cancer are found by your doctors. Next steps: For cancer found only in the pancreas, see Part 5.2 for treatment options. If the cancer has spread only to nearby sites, see Part 5.3. Part 5.4 lists the treatment options for metastases. 34

35 5.2 Local pancreatic cancer Part Treatment with surgery Tests and symptom control Possible biliary stent + antibiotic drugs, CA 19-9, and Consider laparoscopy Primary treatment Surgery Tests CT and CA Adjuvant treatment Clinical trial (preferred), Chemotherapy + chemoradiation, or Chemotherapy alone Part shows the recommended care for cancer that is in your pancreas only. Your doctors may want you to have tests to confirm surgery is the best treatment for you. Before surgery, your doctors may also treat symptoms of cancer that may cause serious health problems. Cancer can cause high CA 19-9 levels in the blood. As a result, your doctors may order CA 19-9 blood tests before and after surgery to check surgery results. Lower CA 19-9 levels after surgery suggest that the cancer was mostly or fully removed. However, CA 19-9 levels are also high when too much bilirubin is in the blood because of a blocked bile duct. Too much bilirubin causes jaundice. You may have jaundice because a tumor has blocked your bile duct. In this case, your CA 19-9 levels shouldn t be tested before surgery. Your doctors won t know if the high CA 19-9 level is caused by cancer or bilirubin. Your doctors may unblock your bile duct with a stent if you have jaundice and symptoms of cholangitis or fever. If so, antibiotic drugs are also needed. You may also get a stent if you are very itchy from jaundice or won t have surgery within a week. If bilirubin levels return to normal before surgery, a CA 19-9 test can be done. Your doctors may want you to have a laparoscopy before surgery. This surgical test may find cancer that was not found by other tests. It is suggested for people at higher risk of having metastases. Definitions:! See pages for test information. Bile duct: Small tubeshaped organs that drain digestive fluid from the liver Cholangitis: An infection of bile ducts Metastases: Cancer that has spread from the first tumor to another body part Stent: A tiny tube used to unblock a duct Acronyms CT = Computed tomography ERCP = Endoscopic retrograde cholangiopancreatography EUS = Endoscopic ultrasound FNA = Fine-needle aspiration MRCP = Magnetic resonance cholangiopancreatography MRI = Magnetic resonance imaging Part 2 Part 3 Part 4 Part 5 Part 6 Part 7 Part 8

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