What is TheraSphere and how does it work?
TheraSphere is a low-toxicity targeted therapy for liver cancer that consists of millions of tiny glass beads containing radioactive yttrium-90. The radioactive glass beads (20-30 micrometres in diameter - about one-third the width of a human hair) are sent directly to the liver tumour.
Your doctor injects TheraSphere into your liver's hepatic artery through a small flexible tube called a catheter. The tiny radioactive glass beads flow directly into the liver tumour through its own blood vessels and permanently attach themselves in the small blood vessels of the tumour. The radiation destroys the tumour cells from inside the tumour, with minimal effect on the surrounding healthy liver tissue. The radioactive microspheres will continue to emit radiation for several weeks after TheraSphere therapy and radiation levels will decrease to negligible levels. TheraSphere therapy is most commonly called radioembolization or Selective Internal Radiation Therapy (SIRT).
TheraSphere Microspheres as thin as a human’s hair. The doses are in vials.
TheraSphere treatment is usually an outpatient procedure that does not require hospitalization. It is well tolerated by patients, with side effects that are usually milder than many of the other cancer therapies. As the procedure targets the liver tumour, the impact on non-target tissue is minimal. After therapy, most TheraSphere patients are suitable for additional therapeutic options because the procedure does not block the vessels of the liver.
TheraSphere treatment has some common side effects, including mild to moderate fatigue, pain, and nausea for about a week. Doctors describe these symptoms as similar to those of the common flu. Some patients may experience loss of appetite and temporary changes in liver tests.
TheraSphere is a Human Use Device (HUD) for the treatment of cancer that has developed in your liver (hepatocellular carcinoma /HCC/). It can be used to shrink tumours to make them suitable for surgery or transplant.
It is also the only medical agent approved in the United States for the treatment of patients with primary liver cancer who have portal vein thrombosis.
TheraSphere is approved as a device for humanitarian use based on its safety and its possible benefits.
Over 5,000 therapies have been performed with TheraSphere, both in routine liver cancer treatment and in research centres of excellence around the world.
When Can My Doctor Use TheraSphere?
- Your doctor may use TheraSphere to treat your liver cancer if it cannot be removed with surgery.
- Your doctor may use TheraSphere to treat your liver cancer while you are waiting for a liver transplant. TheraSphere therapy has demonstrated the potential to shrink patients' tumours, thus making them suitable for radiofrequency ablation, surgery, or liver transplant.
Who is TheraSphere Suitable for?
TheraSphere is suitable for patients where either the liver is the only site of disease or the liver is the primary site of disease. TheraSphere has no effect on tumours that are outside the liver.
Before TheraSphere is offered as a treatment option, your doctor will consider several factors, such as the functional status of your liver, your medical history, and the blood flow to the liver, so as to minimize side effects and optimize therapy to your liver. Do not hesitate to ask your doctor or nurse about the tests they will perform.
How Can I Benefit from TheraSphere Therapy?
As every patient is different, it is difficult to determine how beneficial TheraSphere will be for you. If your doctor thinks TheraSphere may be right for you, he or she may treat your liver cancer with TheraSphere, possibly stabilizing your liver disease, increasing your chances of radiofrequency ablation or of surgery for removing the tumour, or of a liver transplant (some doctors call this shrinking to transplant).
What to Expect from a Typical TheraSphere Therapy?
You may expect different types of doctors to be involved in TheraSphere therapy. Interventional radiologists, radiation oncologists, and nuclear medicine doctors are some of the specialists who may work with you during treatment. You will usually continue to see your medical oncologist while your therapy is being performed.
The actual administration of TheraSphere is done by an interventional radiologist.
Although all treatments are performed on an outpatient basis, they require several hospital visits and follow-up of your treatment continues for several months.
Will I Have to Discontinue Other Therapies to Receive TheraSphere?
Generally, most of a patient's treatment is stopped prior to undergoing TheraSphere. However, your oncologist will determine if your treatment should be stopped during the therapy period.
TheraSphere Therapy Summary:
| Beginning | Angiogram for pre-planning |
| Week 2 | TheraSphere therapy within 2 weeks after the angiogram for pre-planning |
| Week 4 | Following the condition on the phone 2 weeks after the therapy |
| Week 6 | Repeated PET/CTs, MRIs, plus laboratory tests and physical encounter with your doctor a month after the TheraSphere therapy, if necessary |
If a second TheraSphere therapy is needed, the same schedule will be repeated. To maximize the safety of TheraSphere therapy, only one lobe of the liver is treated per administration. Therefore, if you have tumours in both liver lobes, you may need a second therapy.
Preparation and Angiogram for Pre-planning
This is the first preparatory step for your therapy (this is not radiotherapy). Angiogram helps determine if you are a candidate for TheraSphere. If you are suitable, you will return for your radiotherapy after 2 weeks. Once you are in the room for your procedure:
- you receive a medication for your pain and a sedative to make you relax;
- a small incision is performed, with the size of the tip of a pencil, in your hip, in order to insert the catheter for the application of the therapy;
- the catheter is inserted through your femoral artery and goes into your hepatic artery.
There are three important steps:
- Building a map of your hepatic arteries in order to identify the blood vessels that probably feed the tumour.
- It is possible to have coils inserted into your small blood vessels that go to the stomach or the intestines. This prevents radioactive microspheres from reaching your stomach and causing ulcer. This part of the procedure is not necessary for all patients.
- Finally, imaging spheres are injected into your liver. These spheres consist of harmless proteins that are similar in size to the Yttrium-90 microspheres of TheraSphere and will provide the attending physician with information about the blood flow in your liver. By using these imaging spheres, the doctor is able to ensure that TheraSpheres remain in your liver and do not spread to other organs, which would cause side effects. This may be called safety screening.
There may be a slight bruise or bump slightly larger than a pea at the site from which the catheter was inserted. You should inform your doctor if you notice any bleeding or additional swelling at the site.
An angiogram takes up to 2 hours. You will then be transferred to the Department of Nuclear Medicine for a scan to see the location of the spheres for diagnostic imaging. This may take approximately 2 hours. After your scan at the Department of Nuclear Medicine, you will usually be discharged.
Discharge Instructions
On the day of discharge, limit your activities:
- No exercise or weight lifting (more than 4.5 kg) for the next 3 days.
- Do not drive within 24 hours after the procedure.
- You may continue with all other daily activities 24 hours after the investigation.
- You should drink at least 6 glasses of water (x240 ml) in the next 24 hours. Water helps to clear the dye that was used during the pre-planning angiogram.
The Day of Application of TheraSphere Therapy
Typically, your therapeutic day will be within 1 or 2 weeks after your pre-planning angiogram. Your hospital stay will be approximately 4 to 6 hours. Therapy requires a repeat angiogram, but we usually do not need another scan at the Department of Nuclear Medicine.
What Will TheraSphere Therapy Be Like?
Once you enter the treatment room, the following steps will be taken:
- You will be given a painkiller and sedative to help you relax. You will feel sleepy but will be able to communicate with your doctor and the team if you wish.
- A local anaesthetic will be placed in your thigh, a small incision will be made, and a catheter will be inserted into the femoral artery.
- The catheter is guided to the hepatic artery using an X-ray method (fluoroscopy) so that it can be inserted.
- The TheraSphere is injected, blood flow guides the TheraSphere to the target tumour and radiation is emitted from the glass beads. The TheraSphere infusion takes a few minutes, but due to the time it takes to insert the catheter, your usual stay in the room will be about 1 hour.
- The catheter is removed and you are taken to a recovery room for approximately 2 - 6 hours.
Typical liver tumour with microspheres located in the small vessels (the catheter is inserted into the artery).
Will the incision site differ from that on the pre-planning angiogram?
The procedure for catheter placement is similar for both the TheraSphere infusion and the pre-planning angiogram.
Prescribed medications
On the day of therapy, you may be prescribed the following medications:
- A small dose of steroids (i.e., one standard Medrol pack) is given to address fatigue.
- Anti-ulcer medication is given to protect your stomach.
- An antibiotic is given for 5 days to reduce the chance of infection.
Not all patients need medication. All prescriptions will be reviewed prior to your discharge.
Please take your medication as prescribed.
On the day of therapy, you may be discharged with a packet of information containing scheduled check-ups, prescriptions, and emergency phone numbers. Please keep these well as you may need to bring them with you to your check-ups.
Discharge instructions after therapy
Discharge instructions will be similar to those on the pre-planning angiogram. Your medical team may add some changes.
Do I need to do anything different when I go home after therapy?
As with any surgical procedure, limit your activities on the day of discharge. You should not do any exercise or lift any weights (over 4.5 kg) for the next 3 days, but you may resume all of your daily activities within 24 hours after therapy.
When can I return to work?
Each patient has different recovery needs. Typically, patients who have no symptoms prior to the procedure recover faster. The type of activity should also be taken into consideration before returning to work, as exercise and weight lifting (over 4.5 kg) should be considered. Consult your doctor if you have any questions.
What side effects might I have?
Typical side effects after TheraSphere therapy are minimal to moderate. They may include abdominal pain/stomach pain, nausea, vomiting, fever or fatigue, which usually resolve within 48 hours. If these signs and symptoms persist for more than 7 - 10 days, notify your doctor. You may be prescribed additional medications to your treatment to minimize these side effects.
TheraSphere releases radiation that affects liver tissue. As a result, your doctor will test your blood regularly to monitor liver function and identify any potential risks that could occur. Rarely, a loss of liver function that leads to death may occur. Many side effects disappear shortly after therapy is given. Other side effects may last longer or become permanent.
Even after safety screening, there may still be a small risk of TheraSphere reaching your lungs and/or digestive tract, which is likely to result in:
- Damage to the lungs, which includes swelling, injury or shortness of breath
- Irritation of the gastrointestinal tract, which may lead to chronic pain, nausea, vomiting, ulcers, bleeding, or pancreatitis (swelling of the pancreas)
As with any therapy, rare, serious side effects may occur, and as each patient is different, your doctor can best describe the side effects you may experience.
What should I do if side effects occur?
It is important to contact your doctor or nurse in case you experience a side effect. Your doctor may prescribe medication to ease your discomfort. Although it is rare for side effects to be life-threatening, it is important to let your doctor know as soon as you feel side effects.
Does TheraSphere cause hair loss?
Hair loss has not been reported as a side effect during TheraSphere therapy.
CHECK-UPS
- Your doctor may give you a check-up 2 weeks after your treatment to assess how you feel after the procedure.
- Approximately 4 weeks after therapy, you will return to the hospital for a repeat CT/MRI or PET scan, if needed, as well as blood tests. After a month, you will have a post-treatment review with your doctor to review your imaging and blood test results.
- Usually, your post-therapy follow-up after a month will clarify if you need a second therapy. For maximum safety with TheraSphere treatment, only one lobe of the liver will be treated at a time. Therefore, if you have tumours on both lobes of the liver, you may need a second therapy.
- Your doctor or nurse will inform you of specific check-ups or routine follow-up. These are usually carried out at 3-month intervals.
Radiation safety precautions
Radiation safety is a normal concern for many patients who are discharged from the hospital after TheraSphere therapy, however, no special safety precautions are required. Patients leaving the hospital have been found to pose no risk to surrounding people; the radiation field outside their body is low enough to not be considered a radiation hazard. As a precaution, many hospitals have general instructions as suggested guidelines. When you leave the hospital, you will be provided with further information about these precautions.
If you anticipate traveling across international borders, safety check equipment may detect low radiation levels as a result of your TheraSphere therapy. Your physician can provide you with a letter describing the circumstances, which you may obtain upon request.
Please note: Although the radioactivity of TheraSphere continues to decrease over time, TheraSphere will remain permanently implanted in your liver tissue. Special care must be taken when handling the tissue during surgery, or if cremation is being considered.
The words "you have liver cancer" may be life changing and start a waterfall of emotions. By spending time researching treatment options for yourself or a loved one, you ensure you receive the best possible care based on individual needs. We hope the information provided about TheraSphere has been helpful. If you have any questions, feel free to contact a representative.