Surgery is the most effective way to achieve long-term survival and has improved significantly over the past two decades. Nonetheless, surgery to remove a pancreatic tumor is complicated and difficult to undergo. Patients need to assess the risks and benefits of this type of surgery. Patients should find a surgeon and a facility with a great deal of experience in performing this procedure. Some complications of surgery include digestive difficulties, insufficient pancreatic enzymes or hormones, leaking, infections and bleeding.
Surgery is performed when the surgeon believes all of the cancer can be removed safely or sometimes to relieve symptoms or prevent problems. Surgery generally applies to patients who are in the early stages of pancreatic cancer. Other surgery candidates are patients with locally advanced cancer or borderline resectable cancer who have a good response to neoadjuvant therapy(treatment before surgery). Our recent research suggests that many patients benefit from neoadjuvant treatment.
Other types of surgical procedures may be performed in patients who are in later stages of pancreatic cancer to relieve symptoms such as pain and obstructions of the bile or pancreatic ducts or of the intestines.
Whipple procedure or pancreaticoduodenectomy is the most common surgery performed to remove tumors in the head of the pancreas. The two basic types of Whipple procedures are the pylorus-preserving Whipple procedure — where the entire stomach and first portion of the duodenum are spared -or the less common approach where the lower part of the stomach is removed. For the pylorus-preserving procedure the surgeon removes most of the duodenum (the beginning of the small intestine), the head of pancreas, part of the bile duct, the gallbladder and lymph nodes located in the area of the pancreas.
After these organs are removed, the stomach or the remaining part of the duodenum, pancreas and remaining part of the bile duct are joined to the small intestine. This allows bile and pancreatic enzymes to enter the digestive system normally and mix with ingested food. In some patients, laparoscopy can be used to perform the surgery, which is less invasive.
Total Pancreatectomy is a seldom-used procedure that removes the entire pancreas, usually together with the spleen. When the entire pancreas is removed, the endocrine cells in it are also removed, leaving you with no islet cells. Because islet cells make insulin, which controls blood sugar levels in the body, removal of the entire pancreas will result in diabetes. You will then be dependent on insulin injections.
Distal Pancreatectomy is where the bottom half (tail and body) of the pancreas is removed, usually, but not always, along with the entire spleen. Sometimes, part of the body of the pancreas can be preserved. This procedure can sometimes be done using laparoscopic or robotic techniques.
When the cancer has spread and surgical removal of the tumor is not an option, other surgical procedures may be used. These surgeries help relieve symptoms such as jaundice, nausea, vomiting and pain in order to improve quality of life. Surgeons can bypass blockages of the pancreatic or bile ducts or gastrointestinal tract to relieve these symptoms. Surgeons can also cut nerves or perform nerve blocks to reduce pain.
QUESTIONS TO ASK ABOUT SURGERY
- The amount of expertise your surgeon has may add months or years to your life. In fact, an experienced surgeon may operate on pancreatic tumors that a less-experienced surgeon might declare inoperable.
- Why will I have this surgery?
- What are the risks and benefits of this surgery?
- How many pancreatic surgical procedures have you done, and how often do you do them?
- How many resections with no residual disease do you perform each year?
- How many pancreatic surgical procedures are done at this hospital, and how often?
- How long will the surgery take?
- How long will I be in the hospital?
- What are all of the complications that can occur?
- How much time do I have to get a second opinion, think about other options, and make a decision?
Drug Treatment for Pancreatic Cancer
If you are not a candidate for surgery, other treatment options that are available to you include chemotherapy, immunotherapy and newer types of radiation. There are also many ongoing clinical trials involving immunotherapy and targeted therapy.
Chemotherapy is the use of drugs to kill cancer cells and is a systemic treatment, meaning that the drug enters the bloodstream and travels throughout the body to reach the tumor cells. It may be given orally or by injection, or may be delivered through a catheter in a vein. Chemotherapy may be used alone or may be combined with either radiation therapy or surgery.
Types of Chemotherapies
The choice of which treatment to use depends on your health and the location and size of the tumor. Additionally, certain characteristics of the tumor may make it suitable for treatment with specific drugs. Therapy is usually given as a combination of drugs that have been tested and validated in clinical trials. Having your blood tested for inherited mutations such as mutations in the BRCA2 gene, and tissue from your tumor sequenced to determine if specific genetic mutations are present, may be beneficial. Specific treatments that target some genetic mutations are available, and could be an appropriate choice of treatment for you.
Chemotherapies for patients with nonresectable tumors commonly include gemcitabine with nab-Paclitaxel (Abraxane) or FOLFIRINOX, which is the combination of four chemotherapies in one (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin). Additional strategies include fewer drugs, or the addition of cisplatin.
Side Effects of Chemotherapy
- Hair loss or thinning of hair
- Loss of appetite
- Mouth sores
- Chemo brain, which is the mental cloudiness that patients sometimes notice before, during and after cancer treatment, affecting daily life.
- Bleeding or bruising
- Low blood cell counts
- Peripheral neuropathy, which isweakness, numbness and pain, typically in the hands and feet, and is a result of damage to peripheral nerves
Why doesn’t chemotherapy kill all cancer cells?
- Tumors are often surrounded by a stroma.
- The stroma is made up of normal cells called fibroblasts as well as immune cells and a sticky substance called the extracellular matrix.
- The stroma around the tumor seems to protect it from chemotherapy; however, on the positive side it may also prevent the cancer from metastasizing.
Targeted therapy targets the changes in cancer cells that help them grow, divide and spread. Most targeted therapies are either small-molecule drugs or monoclonal antibodies. Small-molecule drugs are small and can easily enter cells. These drugs have targets that are inside the cells. Monoclonal antibodies are large molecules that attach to specific targets on the outside of cancer cells. Monoclonal antibodies may have a direct effect on cancer cells, but they can also mark cancer cells so that a patient’s immune system destroys the cancer cells. There are many targeted therapies and monoclonal antibodies currently being investigated in clinical trials to determine if they can benefit patients with pancreatic cancer.
The immune system protects people against infections and usually gets rid of mutated cells in the body. However, cancer cells are able to hide from the immune system, preventing the immune system from destroying them. Immunotherapies are types of biological therapies that use substances to stimulate the immune system to help the body fight cancer, infection and other diseases. Currently, the only immunotherapy approved for pancreatic cancer is pembrolizumab (Keytruda®). This treatment has proven effective for patients whose tumors are mismatch repair deficient. This deficiency is found in 1 in 50 advanced pancreatic cancers. The study leading to its approval was funded by the Lustgarten Foundation.
Radiation therapy, also called radiotherapy, uses high-energy X-rays to shrink tumors by killing cancer cells. External beam radiation therapy is the type used most often to treat pancreatic cancer. A beam of radiation from outside of the body is focused on the tumor, similarly to what is done during a diagnostic X-ray, only at much higher doses of radiation.
Radiation is often given at the same time as chemotherapy (chemoradiation therapy), but may be given by itself before or after completing chemotherapy.
Common Side Effects of Radiation Therapy
- Skin changes
- Loss of appetite
- Weight loss
- Worsening of chemotherapy side effects
Finding a Clinical Trial
Research is changing the way patients are being treated. If you have pancreatic cancer, a clinical trial may be your best option. Talk to your doctor to find out if a clinical trial might be right for you. Our partner at Emerging Med provides free and unlimited access to current, verified clinical trial information. They provide direct and ongoing telephone support throughout the clinical trial search process and can be reached at 1-800-535-1867. Calls will be returned promptly.
A clinical trial is the scientific term for the study of a drug, procedure or medical device. A clinical trial is a research study designed to explore innovative and potentially life-saving new treatments. The goal of a clinical trial is to find treatments that are better than what is currently available. The approved treatments that we have today were made possible because patients participated in clinical trials. Through clinical trials, doctors find new and better ways to prevent, detect, diagnose, control and treat illnesses.
The goal of clinical trials is to determine if these potential new treatments are safe and effective. They have already been studied in the lab (clinical research) for many years before being given to participants in the next phase of testing, the clinical trial. Volunteers take part to help others, but to also possibly receive the newest treatment available for their illness or disease.
Clinical trials are run by doctors, healthcare professionals and research scientists according to strict FDA guidelines to ensure that participants are treated as safely as possible. There are many different types of clinical trials; these are used to find better ways to prevent, screen, diagnose and treat disease, and can help improve patients’ quality of life.
Clinical trials can be sponsored by governmental agencies or by pharmaceutical companies that make new drugs. The National Cancer Institute’s National Clinical Trials Network is currently conducting many pancreatic cancer clinical trials, with more being added all the time. The Lustgarten Foundation also sponsors and supports clinical trials. Drug companies often partner with universities and cancer centers to conduct these trials.
People who participate in clinical trials are not guinea pigs. Clinical trials are not a “last resort.” There are trials looking for patients at almost every stage. By participating in a trial, patients have access to the most cutting-edge treatment and receive excellent care. Participating is not without risks, but it opens you up to treatment that’s not otherwise available. The new treatment being offered during the clinical trial might be safer and work better than the current treatment options that are part of the standard of care.
Currently less than 5 percent of pancreatic cancer patients are enrolled in clinical trials. Because there are few effective treatments for patients with tumors that cannot be removed surgically and for patients who have metastatic disease, clinical trials of pancreatic cancer treatments are important. They should be discussed with your oncologist and seriously considered in cases where other treatments are not effective. Today, people are living longer from successful pancreatic cancer treatments that are the result of past clinical trials.
Types of clinical trials
- Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent it from returning. These trials may include medicines, cancer vaccines, lifestyle changes, or close monitoring.
- Screening trials test new ways for detecting pancreatic cancer or health conditions. One trial that is undergoing development is our Cancer SEEK early detection test.
- Diagnostic trials study or compare tests or procedures to better understand how to diagnose a particular disease or condition.
- Treatment trials test new treatments, novel drug combinations or new approaches to surgery or radiation therapies.
- Quality of life trials (or supportive/ palliative care trials) explore and measure ways to improve the comfort and quality of life of people who are living with pancreatic cancer.
Phases of clinical trials
Phase 1: A phase 1 clinical trial attempts to assess whether a new drug is safe for use in a small group of people (20-80) for the first time, determines the maximum dose that can be administered and identifies any side effects. Patient safety is the main concern in a phase 1 clinical trial. These trials usually take place in major cancer centers. Placebos are not part of phase 1 trials. Phase 1 trials carry the most potential risk. For patients with a life-threatening illness, weighing the potential risks and benefits carefully is key.
Phase 2: Phase 2 trials determine if the treatment works. If a new treatment is found to be reasonably safe during a phase 1 clinical trial, it can be tested in a phase 2 clinical trial. The benefit or response the doctors look for depends on the goal of the treatment set at the beginning of the trial. This could mean that a patient’s pancreatic cancer shrinks or disappears, that it doesn’t spread to other organs or that volunteers are eligible for surgery they might not have been eligible for before treatment. Many studies look to see if people receiving the new treatment live longer than they would have been expected to live without the treatment or using only standard of care.
Phase 3: Phase 3 clinical trials are designed to compare these new therapies with the current standard of care. This comparison is the real test of a potential new drug. Because doctors do not know yet which treatment is better, patients with similar characteristics are picked at random to receive the existing standard therapy or the new treatment (this is called a “randomized clinical trial”).
If the new agent shows similar or improved results as compared to existing therapy and an acceptable safety profile, it is often approved for general release by the FDA.
After a drug is approved by the FDA, researchers track its ongoing safety in the general population in Phase 4 trials, actively seeking more information about the drug’s treatment benefits and optimal use.
Who takes part in clinical trials?
All clinical trials have a set of rules about who can – or cannot – participate. This is called “eligibility.” Your eligibility may be based on your age, gender, overall health, type and stage of disease, your treatment history and other conditions.
Things that allow you to take part in clinical trials are called “inclusion criteria,” and things that disqualify you are called “exclusion criteria.”
How is my safety protected during a clinical trial?
As a participant, you will receive high-quality, individualized care. The research team will closely monitor your treatment response, your health and any side effects that you may have. Researchers will also follow strict scientific guidelines and ethical principals to protect participants.
You are protected in a clinical trial in three additional ways: by Institutional Review Boards (IRBs), Data Monitoring Committees, and FDA inspections. People from the local community, including doctors and clergy, serve on IRBs to review and monitor their facility’s medical research that involves people. They ensure that there is the least possible risk to participants and that the risks are reasonable in relation to the expected benefits.
The FDA inspects records, clinics and research sites involved in clinical trials. The FDA makes sure volunteers are being protected and that the studies are being done properly. The FDA requires that you be given complete information about the study before you agree to take part, which is known as informed consent. You will be asked to read and sign an Informed Consent Form and will be given a copy of the signed form to keep with your other medical records. This form must be written in an understandable way for you.
Signing the form for participation in a clinical trial shows that you have been given this information and that you understand it. However, when you sign the Informed Consent Form you are not signing a contract and you may leave the study at any time and for any reason. In addition, informed consent is an ongoing process. You have the right to be given all pertinent information and have your questions answered at any time during your participation in the clinical trial.
Will I still receive treatment if I am participating in a clinical trial?
Yes. Placebos are rarely used in pancreatic cancer clinical trials. If you are participating in a clinical trial and do not receive the study medication, you will be given the best available treatment currently available for your cancer, also known as the standard of care.
How do patients pay for costs associated with clinical trials?
Costs related to treating your cancer are often covered by health insurance. There are also research costs related to taking part in a clinical trial. Often these costs aren’t covered by health insurance, but may be covered by a trial sponsor. In many instances, there are no additional costs to participate in a clinical trial, and, at times, the institution running the clinical trial will cover the patients’ costs. Be sure you fully understand the financial implications before beginning the trial.
What questions should I ask if I qualify for a clinical trial?
If you are considering taking part in a clinical trial, you should ask any questions or bring up any issues concerning the trial at any time before, or during, the trial. Refer to the following suggestions to help you develop your own questions and remember that participation in a clinical trial is always voluntary and you can withdraw at any time.
Questions about the study
- What is the purpose of the study?
- Why do researchers think the approach may be effective?
- Who will fund the study?
- Who has reviewed and approved the study?
- How are study results and safety of participants being monitored?
- How long will the study last?
- What are my responsibilities if I take part?
- Who will tell me about the results of the study and how will I be informed?
Questions about the benefits and risks
- What are the possible short-and long-term benefits?
- What are my risks and possible side effects?
- What are my long-term risks?
- What other options are available?
- How do the risks and possible benefits of this trial compare with other treatment options?
Questions about participation and care
- What kinds of therapies, procedures and/or tests will I have during the trial?
- Will they hurt, and if so, for how long?
- How do the tests in the study compare with those I would have outside of the trial?
- Will I be able to take my regular medications while taking part in the clinical trial?
- Where will the trial take place?
- Who will be in charge of my care?
- Can I talk to other people in the study?
- What happens when the trial is over?
- Will I have to pay for any part of the trial, such as tests or the study drug? If so, what will the charges likely be?
- If so, what will the charges likely be?
- What is my health insurance likely to cover?
- Who can help answer any questions from my insurance company or health plan?
- Will there be any travel costs that I need to consider while I am in the trial?
Complementary And Alternative Methods
Complementary therapies are added to conventional treatments to ease the side effects of standard treatment and provide physical or mental benefits to patients with cancer. Meditation to relieve stress and acupuncture to relieve pain are examples of complementary therapies.
Studies show that more than 65 percent of patients who have cancer use complementary or alternative methods. The use of complementary or alternative methods may make patients feel that they are taking an active part in their own treatment and care, and that they have more control over their disease.
Some complementary methods that have been shown to be helpful to patients with cancer include:
- Acupuncture for pain or for nausea and vomiting from chemotherapy
- Massage therapy for anxiety or pain
- Mind-body-spirit therapies such as yoga, hypnosis, relaxation training, imagery and music therapy
- Medical marijuana. The FDA does not recognize marijuana as medicine, but many states have approved marijuana for medical use. Ask your health-care team if medical marijuana is something you should consider, if it is available in your area, and what steps you would need to take to obtain a prescription.
However, complementary and alternative therapies can have risks. Just because a product claims to be “natural” does not necessarily mean that it is safe. Most dietary supplements, vitamins and herbs are not approved by the FDA because they have not been tested. These products may contain contaminants, or they may interact with prescription drugs. Some products can be very potent and may have unpredictable effects. Some alternative therapies may counteract the effects of chemotherapy or be harmful in other ways. Patients with pancreatic cancer who are considering the use of complementary therapy or alternative treatments should always discuss these methods with their healthcare team before they starting to use them.