Is Xofigo A Chemotherapy Drug
No, Xofigo isnt a chemotherapy drug. Its a type of drug called a radiopharmaceutical. This is a form of radiation therapy. Xofigo is absorbed into your bones like calcium. The drug gives off a small amount of radiation that kills the cancer cells in your bones.
Talk with your doctor or pharmacist if you have questions about this type of therapy.
How You Have Radium 223
You have radium 223 as an injection into a vein. Usually this is through a thin short tube which is put into a vein in your arm or hand each time you have treatment. The injection takes around a minute.
You normally have the injection every 4 weeks. You usually have it up to 6 times. You might have a blood test in between injections to make sure it is safe for you to have your next one. You have the treatment as an outpatient and can go home afterwards.
Who Is Eligible To Take Radium
Xofigo is intended to treat symptomatic bone metastases in patients whose prostate cancer is hormone-resistant, meaning the patients PSA levels do not respond to Lupron. To be eligible, the patient should not have any cancer in the soft tissues such as the liver or lung. Small amounts of metastatic disease in the lymph nodes is permissible, however, because limited disease in the nodes is nowhere near as dangerous as bone disease. The reason Xofigo is withheld from men with liver or lung metastases is that radium-223 attacks only the bone metastases so it would not be expected to have any effect on cancer that is located in the liver or lung.
Given the risk of bone marrow suppression, it is not recommended that chemotherapy be administered concurrently with Xofigo, although clinical trials of the combination are currently underway. Prior chemotherapy does not preclude patients from receiving radium-223. In fact, the ALSYMPCA trial stratified its participants by their status and found that radium-223 has similar efficacy in patients who have, or have not received previous chemotherapy. Even people who were considered too frail to be treated with docetaxel were allowed to receive Xofigo. This means that although efficacy is demonstrated to be similar for pre- and post- chemotherapy patients, studies to determine the optimum sequencing of radium-223 are currently underway.
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Efficacy And Safety Data Supporting Xofigo Approval
The approval of Xofigo is based on data from the pivotal Phase III ALSYMPCA trial. At the interim analysis, radium 223 significantly improved overall survival median OS was 14.0 months with radium 223 plus best standard of care vs. 11.2 months with placebo plus best standard of care. Additionally, at the interim analysis there was a delay in the time to first symptomatic skeletal event for patients treated with radium 223 vs. placebo.
An updated analysis, conducted after the study was unblinded, showed a further improvement in overall survival for patients treated with radium 223 vs. placebo, with a median OS of 14.9 months vs. 11.3 months HR=0.695 .
The most common adverse reactions in patients receiving radium 223 in the ALSYMPCA trial were nausea, diarrhea, vomiting and peripheral edema. The most common hematologic laboratory abnormalities were anemia, lymphocytopenia, leukopenia, thrombocytopenia and neutropenia.
Overview Of Clinical Trial Data
Table 2 Key efficacy and safety data for radium-223 from phase 3 trialFig. 1: Prospective subgroup analysis of hazard ratios for death in the radium-223 ALSYMPCA trial
The Eastern Cooperative Oncology Group scores the performance status of patients with respect to activities of daily living as follows: 0, fully active and able to carry out all predisease activities without restriction 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light nature 2, ambulatory and up and about for more than 50% of waking hours and capable of self-care but unable to carry out work activities 3, capable of only limited self-care and confined to a bed or chair for more than 50% of waking hours 4, completely disabled and 5, dead. The category for use of opioids includes patients with a score of 2 or 3 on the World Health Organization âladderâ for cancer pain . The category for non-use of opioids includes patients without pain or opioid use at baseline and patients with a score of 1 on the WHO ladder for cancer pain. Superscan refers to a bone scan showing diffuse, intense skeletal uptake of the tracer without renal and background activity. ALP denotes alkaline phosphatase, and NE not evaluated. Reproduced with permission from Parker et al.
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Can There Be Any Complications Or Risks
Some patients find that the pain gets a bit worse before it gets better. If this does happen, the pain can be managed by pain medications including paracetamol. In addition, if it becomes unmanageable contact your doctor and discuss the options that may be available to you.
The most common side-effects after treatment with radium include:
At your hospital clinic appointment, your doctor will give you a prescription for medication which will help relieve these side effects if they do occur.
The radiation which attacks the cancer cells in the bone may also cause some temporary damage to your bone marrow, which may result in slower blood cell production. This may lead to the following side effects:
- Low white cell count which may make you susceptible to infection
- Drop in red blood cells causing anaemia, leading to tiredness
- Drop in platelets causing a tendency to bruising and bleeding
If you develop any of the following symptoms, contact your doctor immediately:
- Any unusual bruising.
- More bleeding than usual after an injury.
- If you seem to be catching a lot of colds or getting other infections.
- Symptoms of pain, swelling or numbness of the jaw, a heavy jaw feeling or loosening of a tooth.
What Is This Medicine
RADIUM-223 DICHLORIDE is a radiopharmaceutical drug. This medicine allows radiation to target bone metastases from prostate cancer and prevent fractures and other bone problems caused by cancer bone metastases.
This medicine may be used for other purposes ask your health care provider or pharmacist if you have questions.
COMMON BRAND NAME: Xofigo
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Drug Forms And Strengths
Xofigo comes as a liquid solution in single-dose vials. Each vial contains 1,100 kilobecquerel of radioactivity per milliliter of solution at the reference date.*
Your healthcare provider will administer Xofigo by injection into a vein. This takes about 1 minute.
* kBq is a measurement unit of radioactivity. The reference date refers to the date and time this measurement was taken. The radioactivity of Xofigo decreases over time. Your doctor will take this into account when calculating your dose.
If Treatment Does Not Work
Recovery from cancer is not always possible. If the cancer cannot be cured or controlled, the disease may be called advanced or terminal.
This diagnosis is stressful, and for some people, advanced cancer may be difficult to discuss. However, it is important to have open and honest conversations with your health care team to express your feelings, preferences, and concerns. The health care team has special skills, experience, and knowledge to support patients and their families and is there to help. Making sure a person is physically comfortable, free from pain, and emotionally supported is extremely important.
People who have advanced cancer and who are expected to live less than 6 months may want to consider hospice care. Hospice care is designed to provide the best possible quality of life for people who are near the end of life. You and your family are encouraged to talk with the health care team about hospice care options, which include hospice care at home, a special hospice center, or other health care locations. Nursing care and special equipment, including a hospital bed, can make staying at home a workable option for many families. Learn more about advanced cancer care planning.
After the death of a loved one, many people need support to help them cope with the loss. Learn more about grief and loss.
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What Are The Advantages And Disadvantages Of External Beam Radiotherapy
The advantages and disadvantages of radiotherapy depend on your general health, previous treatment and how far your cancer has spread. What may be important to one person might be less important to someone else. Talk to your doctor, radiographer or nurse about your own situation.
Advantages
- External beam radiotherapy to the prostate can help some men live longer if their cancer hasnt spread far from the prostate.
- External beam radiotherapy is painless, but you may find the treatment position uncomfortable if you have pain.
- Treatment sessions only last around 10 minutes, including the time it takes to get you into position. You dont need to stay in hospital overnight.
- Most men who have radiotherapy for pain find it helps control their pain.
- You might be able to reduce the dose of any pain-relieving drugs youre taking. This could be useful if they are causing side effects.
- Radiotherapy may control other symptoms, such as blood in the urine and bowel problems.
- If your pain comes back, you may be able to have more external beam radiotherapy to the same area. This will depend on the dose you’ve already had and how long ago you had it.
Disadvantages
The pain can come back after several months. If this happens, you might need further treatment with radiotherapy or other treatments.
Preparing for treatment
What does treatment involve?
Side Effects And Risks
Xofigo and Xtandi contain different types of drugs. These medications can cause some similar side effects, but some different ones as well. Below are examples of these side effects.
Mild side effects
These lists contain up to 10 of the most common mild side effects that can occur with either Xofigo or Xtandi, as well as mild side effects that both drugs may share.
- Can occur with Xofigo:
- pain, swelling, or redness at the site where Xofigo is injected
- falls that may lead to bone fractures
- posterior reversible encephalopathy syndrome , a condition that causes swelling in your brain
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What Happens After Radiotherapy
After you finish your radiotherapy, you will have regular appointments to check how well your treatment is working and monitor any side effects. Your doctor or nurse will let you know how often youll have appointments.
You will have regular blood tests to measure your level of PSA . Your doctor will also ask you about any side effects from your treatment and any symptoms you might have.
At some hospitals, you may have fewer follow-up appointments, and be encouraged to take greater control of your own health and wellbeing. You might hear this called supported self-management. Instead of having regular appointments at the hospital, you may talk to your doctor or nurse over the telephone.
If youve had external beam radiotherapy to treat bone pain, you may find the pain gets worse during treatment and for a few days afterwards this is called a pain flare. Your doctor might prescribe some pain-relieving drugs to help with the pain, or increase the dose that you already take.
You should notice that the pain gradually improves, though it might take a few weeks for the treatment to be most effective. The pain relief usually lasts for several months and you may be able to reduce the dose of any pain-relieving drugs you are taking. But speak to your hospital team or GP first you shouldnt reduce the dose suddenly. If your pain or other symptoms dont improve, talk to your doctor, radiographer or nurse.
Gut Microbiota Composition Of Prostate Cancer Patients And Healthy Individuals
To compare gut bacterial composition between healthy individuals and prostate cancer patients, we investigated the relative abundance of selected taxa in fecal samples collected from three prostate cancer patients and from two healthy males.
The relative abundances of the analysed phyla differed between the two groups. Proteobacteria in cancer patients was 11.37-fold higher than in healthy individuals , and Actinobacteria was 1.06-fold higher than that in healthy individuals. In contrast, Bacteroidetes and Firmicutes were 0.76-fold and 0.86-fold lower than those in healthy individuals. At the genus level, Prevotella, Bifidobacterium, and Atopobacter were increased in prostate cancer, whereas Lactobacillus was decreased . At the species level, Bacteroides fragilis was increased , whereas Clostridium coccoides and Clostridium leptum were found to be decreased in prostate cancer patients.
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What Are The Advantages And Disadvantages
The advantages and disadvantages of radiotherapy depend on your general health, previous treatment and how far your cancer has spread. What may be important to one person might not be so important to someone else. Talk to your doctor, radiographer or nurse about your own situation.
Advantages
- Radium-223 can help relieve bone pain.
- You might be able to reduce the dose of any pain-relieving drugs youre taking. This could be useful if they are causing side effects.
- Radium-223 can help relieve bone pain, helps some men with advanced prostate cancer to live longer and can improve your day-to-day life.
Disadvantages
- For a few men, radium-223 wont help to control their pain.
- Like all cancer treatments, radium-223 can cause side effects.
- You can only have one course of radium-223.
Preparing for treatment
Before having radium-223 there are things you should discuss with your doctor, radiographer or nurse.
- Let them know if you are taking any medicines. You cant have radium-223 if youre taking a drug called abiraterone. If you take calcium, phosphate or vitamin D supplements, you may need to stop taking these for a while.
- Tell them if you have a bowel condition, such as Crohns disease or ulcerative colitis, or leakage from the bowel. Radium-223 may make bowel inflammation worse.
- Your doctor or nurse may ask you to have a blood test before treatment to check your blood cell levels are high enough.
What does treatment involve?
What Precautions Do I Need To Follow After The Treatment
To protect others from the radium that is excreted from your body in the weeks following your treatment, you will need to be extra careful with bathroom hygiene . To avoid splashing, please sit on the toilet rather than standing and wipe up any spills immediately. If you use pads or have a catheter bag we will discuss with you how to manage and dispose of these items.
You can have sexual relations from 1 week after each injection of radium, but you must use effective barrier contraceptive methods during treatment and until six months after your last injection of radium.
You will be given a treatment record sheet after you have received the radium which will contain details of what treatment you have had and the radiation precautions you need to follow. Please carry this sheet with you until the date you will be told when you attend.
If you have any medical / dental appointments or are admitted to hospital during this time, please show the sheet to the healthcare professional dealing with you. This is especially important if you fall, develop a fracture or need any surgical treatment, as the doctors may need to take extra care because of the radioactivity in your bones.
It is important that you let the people close to you know that you have had this treatment so that they can tell the people who care for you. If you die in the months immediately after treatment, there may need to be a delay before your body can be buried, cremated or undergo a post-mortem examination.
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How Should I Use This Medicine
This medicine is for injection into a vein. It is given by a health care professional in a hospital or clinic setting.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
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Radiotherapy For Advanced Prostate Cancer
This page has information for people having radiotherapy for advanced prostate cancer.
We explain how radiotherapy can be used to treat advanced prostate cancer, what treatment involves, and the advantages and disadvantages of having radiotherapy for advanced prostate cancer.
If you’ve been diagnosed with localised prostate cancer that hasn’t spread outside the prostate, read our information on external beam radiotherapy for localised or locally advanced prostate cancer instead.
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Remission And The Chance Of Recurrence
A remission is when cancer cannot be detected in the body and there are no symptoms. This may also be called having no evidence of disease or NED.
A remission can be temporary or permanent. This uncertainty causes many people to worry that the cancer will come back. Although there are treatments to help prevent a recurrence, such as hormonal therapy and radiation therapy, it is important to talk with your doctor about the possibility of the cancer returning. There are tools your doctor can use, called nomograms, to estimate someoneâs risk of recurrence. Understanding your risk of recurrence and the treatment options may help you feel more prepared if the cancer does return. Learn more about coping with the fear of recurrence.
In general, following surgery or radiation therapy, the PSA level in the blood usually drops. If the PSA level starts to rise again, it may be a sign that the cancer has come back. If the cancer returns after the original treatment, it is called recurrent cancer.
When this occurs, a new cycle of testing will begin again to learn as much as possible about the recurrence, including where the recurrence is located. The cancer may come back in the prostate , in the tissues or lymph nodes near the prostate , or in another part of the body, such as the bones, lungs, or liver . Sometimes the doctor cannot find a tumor even though the PSA level has increased. This is known as a PSA recurrence or biochemical recurrence.