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What is Stelfonta? A Breakthrough in Non-Surgical Tumor Treatment

4 min read

In a pivotal clinical trial, a single injection of Stelfonta led to complete tumor resolution in 75% of treated dogs within 28 days. What is Stelfonta? This injectable medication, also known as tigilanol tiglate, is a veterinary treatment option for certain non-metastatic mast cell tumors (MCTs) in dogs, offering a non-surgical alternative for hard-to-reach or difficult-to-excise tumors.

Quick Summary

Stelfonta is an injectable veterinary drug containing tigilanol tiglate, designed to treat non-metastatic mast cell tumors in dogs by destroying tumor cells and cutting off their blood supply. This results in the formation of a healing wound where the tumor was located, offering a non-surgical treatment alternative.

Key Points

  • Non-Surgical Option: Stelfonta provides a non-surgical alternative for treating non-metastatic mast cell tumors (MCTs) in dogs.

  • Injected Directly into the Tumor: The medication, tigilanol tiglate, is injected intratumorally to trigger a localized and targeted immune and inflammatory response.

  • Destroys Tumor and Blood Supply: The drug works by destroying the tumor cells and disrupting the blood vessels feeding the tumor, causing it to die and slough off.

  • Causes a Healing Wound: The tumor's removal results in a temporary open wound that typically heals on its own over several weeks without complex surgical closure.

  • Requires Pre- and Post-treatment Medication: To manage side effects from inflammatory substances released by the tumor, dogs must be given prescribed oral medications around the time of injection.

  • High Success Rate for Specific Tumors: Clinical trials show an 87% complete response rate with one or two injections for non-metastatic cutaneous MCTs and subcutaneous MCTs on the legs.

  • May Not Be Suitable for All Tumors: It is not recommended for tumors that have spread to other parts of the body (metastatic disease) or for subcutaneous tumors above the elbow or hock.

In This Article

The Science Behind Stelfonta

Stelfonta's active ingredient is tigilanol tiglate, a small molecule derived from the seeds of the rainforest plant Fontainea picrosperma. The drug is delivered via an intratumoral injection, meaning it is injected directly into the tumor mass. This method ensures the drug's effects are highly localized and concentrated where they are needed most.

Once injected, tigilanol tiglate triggers a multifaceted mechanism of action that leads to the tumor's destruction. This process includes several key steps:

  • Activation of Protein Kinase C (PKC): Tigilanol tiglate activates protein kinase C, an enzyme involved in cellular growth and survival.
  • Localized Inflammatory Response: The activation of PKC leads to a rapid, localized immune and inflammatory response within the tumor.
  • Vascular Disruption: This localized inflammation causes a severe and rapid disruption of the blood vessels supplying the tumor, effectively starving it of oxygen and nutrients.
  • Tumor Cell Death: The combination of vascular disruption and cellular signalling culminates in the death of the cancer cells and necrosis of the tumor tissue.
  • Immune System Modulation: The death of the tumor cells also stimulates a systemic anti-tumor immune response, which can help prevent recurrence.

The Stelfonta Treatment Process

Administering Stelfonta is a multi-step process carefully managed by a veterinarian to ensure patient safety and efficacy. The procedure is typically performed in the veterinary clinic and does not require general anesthesia, though mild sedation may be used.

  1. Pre-treatment: To minimize the risk of severe reactions from the release of inflammatory substances by the dying mast cells (degranulation), dogs are prescribed oral medications. This includes corticosteroids, antihistamines (H1 and H2 blockers), and sometimes pain medication, and is administered for several days before and after the injection.
  2. Injection: The veterinarian injects Stelfonta directly into the mast cell tumor. The dosage is determined by the tumor's size.
  3. Post-injection Changes: In the hours and days following the injection, visible changes in the tumor occur, including swelling, bruising, and darkening of the tissue.
  4. Wound Formation and Healing: Over the next 3 to 7 days, the necrotic tumor tissue detaches and sloughs off, leaving an open wound. The wound is typically left to heal on its own (secondary intention healing) and does not require bandaging unless there is excessive licking or drainage. The healing process usually takes 4 to 6 weeks, although some larger wounds may require more time.

Efficacy and Potential Risks

Clinical trials have demonstrated Stelfonta's high efficacy and favorable safety profile when used in appropriate cases. However, like any medication, it does come with potential risks and considerations.

  • High Response Rate: In a key study, 75% of dogs had a complete response (full tumor disappearance) after one injection. This rate rose to 87% for dogs receiving one or two injections.
  • Sustained Remission: For those with a complete response, 89% of dogs remained free of the tumor at the injection site one year later.
  • Side Effects: The most common adverse reactions are related to the injection site and the body's response to the tumor destruction. These can include pain, swelling, bruising, and lameness if a leg tumor was treated. Gastrointestinal issues like vomiting and diarrhea are also possible.
  • Serious Complications: In rare cases, severe wound formation, infections, and systemic mast cell degranulation leading to shock or death can occur, emphasizing the importance of following the vet's instructions for pre- and post-treatment medication.

Stelfonta vs. Surgical Excision

Choosing between Stelfonta and traditional surgery for a dog's mast cell tumor depends on several factors, including the tumor's location and size, the dog's overall health, and the owner's preferences. The following table compares key aspects of both treatments:

Feature Stelfonta (Tigilanol Tiglate Injection) Surgical Excision
Procedure Intratumoral injection, generally using mild sedation Requires general anesthesia to ensure proper excision
Suitability Best for non-metastatic cutaneous tumors anywhere on the body and specific subcutaneous tumors on the legs, with volumes typically <10 cm³ Recommended for accessible tumors where wide margins can be achieved without significant cosmetic or functional impact
Success Rate High success (87% complete response in trials), with low local recurrence rates High success rate if clean surgical margins are achieved; higher recurrence if margins are insufficient
Tumor Grading Biopsy for cytological grading can be performed before or shortly after injection; histopathological grading is not possible Excised tumor can be sent for histopathological grading to confirm complete removal and assess malignancy
Recovery Temporary open wound forms as the tumor sloughs off, which heals over 4-6 weeks with minimal intervention Recovery time varies, and may involve stitches, bandages, and restricted movement

Conclusion

Stelfonta offers a valuable and effective non-surgical treatment option for non-metastatic mast cell tumors in dogs, particularly for those located in areas where surgery would be difficult or disfiguring. The treatment's ability to destroy the tumor and promote natural healing with minimal intervention is a significant advantage for many dogs and their owners. However, as the tumor is destroyed in place, histopathological grading is not possible, which can be a key consideration for high-grade tumors where understanding malignancy is crucial. A detailed discussion with a veterinarian is essential to determine if Stelfonta is the right treatment for your dog's specific condition.

Disclaimer: This article provides general information and should not be considered medical advice. Always consult a qualified veterinary professional for diagnosis and treatment of your pet.

Frequently Asked Questions

Stelfonta is approved to treat non-metastatic cutaneous (skin-based) mast cell tumors (MCTs) located anywhere on the body, as well as specific non-metastatic subcutaneous (under the skin) MCTs on a dog's legs.

The active ingredient, tigilanol tiglate, is injected directly into the tumor. It causes a localized inflammatory response that destroys tumor cells and cuts off the tumor's blood supply, leading to tumor necrosis and sloughing.

No, general anesthesia is not typically required. The procedure involves a simple injection and can often be performed with the dog awake, though some dogs may need mild sedation for proper restraint.

The tumor will swell, bruise, and eventually die, sloughing off and leaving an open wound. This wound heals naturally over 4 to 6 weeks, with veterinarians managing any discomfort with pain medication and monitoring the site for healing progress.

Common side effects include pain, bruising, and swelling at the injection site, lameness (if a tumor on a limb was treated), and temporary gastrointestinal upset like vomiting or diarrhea.

Pre-treatment medications, including corticosteroids and antihistamines, are crucial because they help mitigate the effects of mast cell degranulation. As the tumor dies, it releases inflammatory substances, and these medications help prevent potentially severe systemic reactions.

No, because the tumor is destroyed in place, it is not available for histopathological grading after treatment. A veterinarian may perform a fine needle aspirate for cytological grading before the injection to assess the tumor's malignancy.

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.