Post-Surgery Concerns: Using Denosumab for Giant Cell Tumors

What are the issues related to the use of Denosumab after surgery for giant cell tumor of bone?

I have a giant cell tumor on the third lumbar vertebra, and later I consulted a neurosurgeon who performed surgery.
The doctor mentioned that for tumors located on the spine, a Total En Bloc Resection is necessary to reduce the recurrence rate.
(The operational definition of this procedure is that the specimen removed during the spinal tumor resection is enveloped by a layer of healthy tissue that is intact and continuous, which we refer to as the margin; furthermore, throughout the surgical process, the spinal tumor tissue remains intact and is not ruptured or exposed in the surgical field.) The doctor stated that the surgery was very successful and cleanly executed, but I still need to receive Denosumab to lower the recurrence rate.

I had my surgery on February 3rd, and I have not yet received Denosumab because I had my wisdom teeth extracted.
My attending physician advised me to address the oral issues before starting the medication, and I can begin the treatment in mid-April (one month after the extraction).
However, will this delay affect my treatment? Although it’s too late now since the teeth have already been removed.
Denosumab seems unable to kill any potentially remaining tumor cells; can it really reduce the recurrence rate? How long after surgery is Denosumab typically administered, and is there a standard duration for this treatment? This medication is quite expensive...
Should I consult an orthopedic surgeon for clearer answers to these questions?

Ming, 20~29 year old female. Ask Date: 2021/03/23

Dr. Chen Sirong reply Oncology

Ming, 23 years old, male.
1.
The doctor said the surgery was very successful and the tumor was completely removed, but I still need to take Denosumab to reduce the recurrence rate.
A: Essentially, Denosumab is used to treat tumors by shrinking them before surgery or for patients who are not operable.
However, some doctors also use it postoperatively to prevent recurrence, including physicians at major medical centers like National Taiwan University Hospital.
2.
But will this delay treatment or something similar? Although it’s too late now since the tooth has already been extracted.
A: 2.1 The treatment has undergone clinical trials by the pharmaceutical company and has been proven effective, while postoperative prevention has not gone through such trials.
2.2 You should be aware that its side effects can severely damage the gums with a probability of 3%, so you should not take the risk of using it prematurely.
You must wait until your tooth is completely healed before using it; otherwise, you may not achieve the preventive effect and suffer from the drug's side effects, which is not worth it.
3.
Denosumab seems unable to kill any potentially remaining tumor cells, so can it really reduce the recurrence rate? A: The treatment has undergone clinical trials by the pharmaceutical company and has been proven effective, while postoperative prevention has not gone through such trials.
However, some doctors do use it for postoperative recurrence prevention, including physicians at major medical centers like National Taiwan University Hospital.
4.
How long after surgery should Denosumab be administered? Is there a standard duration? This injection is somewhat expensive...
A: Because postoperative prevention has not undergone clinical trials by the pharmaceutical company, no one can accurately tell you how long to use it.
5.
Should I consult an orthopedic surgeon for clearer answers on these issues? A: It’s advisable to seek multiple consultations.
6.
My personal thoughts: 6.1 I have a good friend who had a giant cell tumor in his upper limb before marriage and has been married with children for over 12 years after surgery at Chang Gung Memorial Hospital.
His doctor did not recommend him to take it.
It’s normal to be more concerned now that you are recovering from a serious illness, and I wish you well ten years from now as you look back on this experience.
6.2 I think you are young, and the location of the tumor is more challenging to manage, so the doctor may recommend you take it.
6.3 Due to the drug's side effects that can harm the gums, you should pause the injections if you notice any issues with your teeth.
Wishing you good health.
Taoyuan Hospital, Chen Si-Rong.

Reply Date: 2021/03/23

More Info

After undergoing surgery for a giant cell tumor (GCT) of the spine, your concerns regarding the use of Denosumab are quite valid and reflect the complexities involved in post-operative care for such tumors. Let’s break down your questions and concerns systematically.

Denosumab and Its Role Post-Surgery
Denosumab is a monoclonal antibody that inhibits RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand), which plays a crucial role in the formation, function, and survival of osteoclasts (the cells responsible for bone resorption). In the context of giant cell tumors, Denosumab is primarily used to manage tumors that are unresectable or to shrink tumors before surgery. However, its use in the post-operative setting is becoming more common, particularly in preventing recurrence.

1. Timing of Denosumab Administration:
- It is understandable that you delayed the initiation of Denosumab due to your dental procedure. While it is crucial to address any oral health issues before starting Denosumab—since it can increase the risk of osteonecrosis of the jaw—delaying treatment for a month post-surgery may raise concerns about the potential for tumor recurrence. However, the immediate risk of recurrence is often assessed based on the completeness of the surgical resection and the histological characteristics of the tumor.

2. Effectiveness in Reducing Recurrence:
- While Denosumab does not directly kill residual tumor cells, it can help in reducing the risk of recurrence by inhibiting osteoclast activity and potentially altering the tumor microenvironment. The effectiveness of Denosumab in preventing recurrence post-surgery is still under investigation, and while some studies support its use, it is not universally accepted as a standard post-operative treatment.

3. Duration of Treatment:
- There is no universally accepted duration for Denosumab treatment after surgery for GCTs. Some protocols suggest continuing treatment for a period of 1-2 years, especially in cases with a high risk of recurrence. The decision on how long to continue Denosumab should be made collaboratively with your healthcare team, taking into account your specific case, the characteristics of the tumor, and any side effects you may experience.

4. Consulting with Specialists:
- It is advisable to discuss your concerns with an orthopedic oncologist or a specialist in bone tumors. They can provide insights tailored to your situation and help you weigh the benefits and risks of starting Denosumab at this stage. They can also address any concerns about the cost and insurance coverage for the medication.

Additional Considerations
- Monitoring for Side Effects:
- As you consider starting Denosumab, be aware of potential side effects, including the risk of osteonecrosis of the jaw, hypocalcemia, and skin reactions. Regular follow-ups and monitoring are essential to manage any adverse effects effectively.

- Psychological Impact:
- It is natural to feel anxious about the possibility of recurrence, especially after a significant surgery. Engaging in discussions with your healthcare providers about your concerns can help alleviate some anxiety and provide clarity on the next steps.

- Long-term Follow-up:
- Regular imaging and clinical evaluations will be necessary to monitor for any signs of recurrence. Your healthcare team will likely recommend a follow-up schedule based on your individual risk factors.

In conclusion, while the delay in starting Denosumab may raise concerns, it is essential to focus on the overall treatment plan and maintain open communication with your healthcare team. They will guide you through the decision-making process regarding the initiation and duration of Denosumab therapy, ensuring that you receive the best possible care tailored to your needs.

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