A pancreatic cancer is considered to be stage II if, following surgical removal of cancer in the pancreas, the final pathology report shows that the cancer has only spread locally. This means the cancer may extend to the duodenum, bile ducts or fat surrounding the pancreas, but does not invade any local lymph nodes and cannot be detected in other locations in the body. Most early pancreatic cancers can be removed by surgery. Unfortunately, early pancreatic cancer only accounts for a minority of newly diagnosed cases.

Currently, the best treatment for stage II adenocarcinoma of the pancreas is currently best managed by surgical removal of the cancer . Depending on the features of the cancer, approximately 10-35% of patients will be alive and without evidence of cancer 5 years after surgery. The most common surgical procedure is a pancreaticoduodenectomy, or Whipple procedure, which involves removal of a portion of the pancreas, small intestine (duodenum), stomach, and the entire gallbladder. The exact surgical procedure may differ based on the location and extent of the cancer within the pancreas.

Despite undergoing surgical removal of all visible cancer, approximately 60-70% of patients with stage II pancreatic cancer will experience recurrence of their cancer. A recurrence is caused by a small amount of cancer that spread outside the pancreas and therefore, was not removed by surgery. These cancer cells are referred to as micrometastases and cannot be detected with any of the currently available tests. The presence of micrometastases causes the relapses that follow treatment with surgery alone. In order to cleanse the body of micrometastases and reduce the risk of recurrence, it may be necessary to undergo additional systemic treatment after surgery.  This is called  adjuvant therapy and may consist of chemotherapy, radiation therapy, and/or biological therapy.

The following is a general overview of treatment for stage II pancreatic cancer. Treatment may consist of surgery, radiation, chemotherapy, biological therapy, or a combination of these treatment techniques. Multi-modality treatment, which utilizes two or more treatment techniques, is increasingly recognized as an important approach for improving a patient's chance of cure or prolonging survival. In some cases, participation in a clinical trial utilizing new, innovative therapies may provide the most promising treatment. Circumstances unique to each patient's situation may influence how these general treatment principles are applied. The potential benefits of multi-modality care, participation in a clinical trial, or standard treatment must be carefully balanced with the potential risks. The information on this website is intended to help educate patients about their treatment options and to facilitate a mutual or shared decision-making process with their treating cancer physician.

Adjuvant Therapy

The delivery of cancer treatment following surgery is referred to as "adjuvant" therapy. The purpose of adjuvant therapy for patients with stage II pancreatic cancer is to reduce cancer recurrences. Adjuvant therapy may include chemotherapy, radiation therapy and/or biologic therapy.

Long-term results from a large clinical trial conducted by the European Study Group for Pancreatic Cancer showed that adjuvant chemotherapy increased survival in patients with operable pancreatic cancer, while adjuvant chemoradiation had a detrimental effect . 1 This trial involved 289 patients who underwent surgery plus one of the following treatments:

• 5-FU Chemotherapy
• 5-FU Chemotherapy and radiation (chemoradiation)
• No additional treatment (surgery alone).

Patients with early stage pancreatic cancer who were treated with adjuvant chemotherapy after surgery lived longer than those who treated with surgery alone.  However, adjuvant treatment with chemotherapy plus radiation produced no benefit compared to surgery alone (see table 1).

Table 1 Adjuvant chemotherapy or adjuvant chemoradiation versus surgery alone in early stage pancreatic cancer

Chemotherapy

New chemotherapy drugs may be able to kill cancer cells more effectively than 5FU. Gemzar® is FDA-approved for the treatment of stages II, III, and IV pancreatic cancer and is now considered the standard chemotherapy drug for advanced disease. Gemzar® has been shown to improve response to treatment, time to cancer progression, and survival duration when compared with the older chemotherapy drug 5-fluorouracil. 2   In a clinical trial involving patients with advanced pancreatic cancer, patients who received Gemzar® experienced a significant improvement in disease-related symptoms as well as prolonged survival compared to patients who received 5-FU.

Strategies to Improve Treatment of Stage II Pancreatic Cancer

The development of more effective cancer treatments requires that new and innovative therapies be evaluated with cancer patients. Clinical trials are studies that evaluate the effectiveness of new drugs or treatment strategies. Future progress in the treatment of stage II pancreatic cancer will result from the continued evaluation of new treatments in clinical trials. Participation in a clinical trial may offer patients access to better treatments and advance the existing knowledge about treatment of this cancer. Patients who are interested in participating in a clinical trial should discuss the risks and benefits of clinical trials with their physician. Areas of active investigation aimed at improving the treatment of stage II pancreatic cancer include the following:

New Adjuvant Therapy

Researchers are actively investigating treatments that can be added to surgery to improve outcomes.

Combination chemotherapy (regimens): Each chemotherapy drug works in a slightly different way. Therefore, administering a combination of two or more chemotherapy drugs, also known as a regimen, may kill more cancer cells than treatment with a single drug. Gemzar®-based chemotherapy regimens have been evaluated in patients with advanced pancreatic cancer and may be available to patients with early stage disease.

Biological therapy: Biological therapies are naturally occurring or synthesized substances that direct, facilitate, or enhance the body's normal immune defenses. Biologic therapies include interferons, interleukins, monoclonal antibodies, and vaccines.

A cancer vaccine is a type of biologic therapy that is made from proteins on the patient's own cancer cells. Every cell in the body displays specific antigens (small carbohydrates and/or proteins) on their surface. These antigens are used by researchers to make a cancer vaccine. The immune system relies on differences in antigens to distinguish between healthy cells and non-healthy cells or “foreign” material, such as bacteria, viruses or cancer cells. Dendritic cells are specific immune cells that “present” or display antigens of non-healthy cells or foreign material to other cells in the immune system. Antigen's presented on dendritic cells are then recognized by the body as foreign or non-healthy and are destroyed by the body's immune system.

Oncophage® (HSPPC-96) is a vaccine that is composed of proteins from the patient's own cancer cells, including antigens and heat shock protein (HSP). HSPs exist in every cell in the body and one of their important roles is to form a complex with antigens from a cell that is considered not healthy, such as a cancer cell. Clinical studies have revealed that when this HSP/antigen complex from a cancer cell binds with dendritic cells, the immune system is stimulated to attack the cancer.

The Oncophage® vaccine is prepared by isolating HSPs/antigen complexes from cancer cells that are obtained during surgical removal of the cancer. The vaccine is then administered to the individual patient that it was prepared for. Patients typically receive Oncophage® once a week on an outpatient basis. Oncophage® is being evaluated in early clinical trials for the treatment of pancreatic cancer.

Researchers have reported that the use of Oncophage® with surgery improves survival in patients with operable pancreatic cancer. This small trial included 10 patients with pancreatic cancer that had not spread to distant sites in the body. Each patient underwent surgery to remove part of the pancreas, and within 8 weeks of surgery was treated with Oncophage®. On average, the patients in this study lived 2.5 years, which is longer than the usual average survival for patients with this type of pancreatic cancer, 16 months. One patient was alive and cancer free for more than 5 years following therapy, and 2 other patients were alive and cancer-free at 2.5 and 2.2 years following therapy. Treatment with Oncophage® in this trial consisted of one vaccination per week for a duration of 4 weeks. There were no significant side effects associated with Oncophage®.

New Surgical Procedures

Extended pancreaticoduodenectomy: More extensive operations for pancreatic cancer have been advocated by some surgeons to obtain wider surgical margins with the goal of removing all cancer cells in the area and preventing cancer recurrences in the area of the surgery. Regional or extended pancreaticoduodenectomy involves removal of surrounding veins and wider dissection of lymph nodes around the pancreas. This procedure has been popularized by some institutions in the United States and surgeons from Japan. The use of extended lymph node dissection is being tested in a clinical trial at the Mayo Clinic Cancer Center.

Pylorus-preserving surgery: During a standard Whipple resection, the pylorus, or "valve" that controls emptying of the stomach, is removed. This can cause "dumping syndromes" and difficulty with the absorption of nutrition from the gastrointestinal tract. By preserving the pylorus, gastric dumping can be reduced; however, it is important that adequate surgical removal of the cancer is not compromised by this procedure.