Intralesional Bleomycin Injection

What is intralesional bleomycin injection treatment?

Bleomycin treatment

This treatment involves the injection of bleomycin through the skin into a vascular malformation or haemangioma. Bleomycin has been successfully used in treatment of haemangiomas and all types of vascular malformations. The only exception is port wine stains (capillary malformations), where laser is a better treatment as it is difficult to inject into the fine hair vessels. Thick port wine stains, or where there is an associated thickened lip, can be considered for bleomycin injection.

The trust was the first in Western Europe to offer bleomycin injections. Although this is a fairly new treatment, the effectiveness and safety of the drug has been widely studied and published and the treatment has been shown to have a high success rate.

Bleomycin treatment has been offered to patients within South Tees since 2004. Our experts have performed more than1,000 bleomycin treatments over the past seven years.

Patients who receive this treatment are closely followed, and all their details are entered into a database. As this is a new treatment, long-term follow-up information (more than 15 years) is not available at present.

Results from around the world have been published in medical journals and there have been no reports of patients suffering serious complications.

Before this treatment was introduced to the plastic surgery department at the trust approval had to be given by sought the South Tees Clinical Effectiveness Subcommittee and Drug and Safety Committee. The treatment is monitored and results are regularly audited.

How does the treatment work?

The injection contains a drug called bleomycin. It affects the vessel lining cells, and causes them to disappear, or decrease in number. If the lesion responds to the treatment, it will become smaller in size, less raised, and lighter in colour.

The aim of the treatment is to shrink the lesion without the need for surgery, scars, or systemic medication, which is sometimes used as treatment.

What is the success rate of the treatment?

To date the trust has treated more than 620 patients and has achieved a 93% response rate with 83% seeing a significant improvement. No serious complications have been reported. The recurrence rate is extremely low at just 8%.

How is bleomycin treatment performed?

The procedure is performed as a day case, and in most cases patients leave the hospital a few hours after the procedure. A response to the injection is usually only seen after the second or third injection.

Children undergoing treatment are admitted on a children’s unit or ward on the morning of the treatment. The unit is specifically designed to provide a comfortable and re-assuring environment. You or your spouse/partner can accompany your child to the theatre.

Adult patients are either admitted on the surgical admissions unit at The James Cook University Hospital, or on the Friarage surgical day unit. You will be given a direct contact number to ring should you have any concerns after you have been discharged.

A series of injections is usually needed, (four on average), although this varies according to the size of the lesion. The time period between treatments is usually 3-4 weeks.

A colour photograph will be taken before and after treatment to objectively show the progress and response to the treatment. Consent for photographs taken will be asked from each patient/patient’s parent or guardian. The photographs will be stored as part of their medical records.

As a safeguard, we will perform a urine pregnancy test on all female patients before each treatment to ensure that you are not treated with the drug during the early pregnancy stage.

Detailed notes will be kept at each treatment session to ensure that we are aware of all effects of the injection. Details of treatment are kept on a non-identifiable, password protected database which is registered and compliant with information governance guidelines.

Due to the potential lung effects of bleomycin treatment (see below), all children under the age of 16 will be seen for a consultation by a paediatric lung specialist before, during and after treatment. In adults over the age of 16 a lung test and chest x-ray will be done before starting treatment. To date no lung effects or serious systemic side effects have occurred in any of the patients undergoing treatment at the trust.

What are the risks?

Of the patients already treated with intralesional bleomycin injection in our unit (after 3,000 treatments), minimal side effects occurred.

Most patients will experience some swelling of the birthmark after treatment. This is not usually excessive and settles in the days following treatment. Some patients have a fever or elevated temperature on the first night after treatment. There is some discomfort after the injection, but significant pain is rare. Three patients developed

Three patients developed infection (0.5%) where the injection was performed, which we treated with antibiotics. Colouration of the skin occurred in six patients (1%), and ulceration of the skin occurred in two patients (0.3%) Six patients (1%) experienced a skin rash which disappeared after treatment with steroid medication

Only one patient (0.001%) developed a serious complication; following treatment of a very complex malformation of the tongue, face and airways which was related to the complexity of the underlying malformation.

The following side-effects have not been present in patients treated, but are listed as potential side effects of bleomycin treatment: nausea, tenderness and redness of the injected skin, loss of appetite and skin colour darkening over joints, or on the back.

Lung damage by bleomycin has been reported, associated with large amounts (more than 250mg) given via a drip. At this dosage, the incidence of lung damage is 4%. The highest total dose injected into a birthmark at The James Cook University Hospital is 85mg, well below this level. Of more than 2,500 patients treated in the world, this complication only occurred in one case where a much higher dose was used compared to our treatment standard. The patient made a full recovery. A study has been performed to measure the amount of bleomycin that spills into the circulation during and after injection and extremely low levels were detected.

There is a theoretical risk to infertility due to the drug being a chemotherapy agent, although this is usually associated with a different group of chemotherapy drugs, and will be related to the administered dose. No firm evidence exists to show that this is a major concern. In addition there is always the risk of very uncommon or previously unknown side-effects occurring.

We will be monitoring you/your child closely to see if any of these side-effects occur. Side-effects will be treated if possible, or the injection treatment stopped if there is any concern over safety. If you have any concerns regarding complications shown in patients undergoing treatment for vascular birthmarks, or of potential side-effects of the drug, you are welcome to discuss these with us.

What are the benefits?

Bleomycin is a localized treatment, unlike some of the alternative treatments used. It is a non-surgical and scarless treatment with a high success rate, especially in vascular malformations. Some patients respond better to the treatment than others. In about 20% of patients the response is moderate.

What are the alternatives?

Because a percentage of hemangiomas disappear over time, one option is to leave lesions to resolve on their own. Not all haemangiomas disappear, and it often happens only after school going age. In the early stages haemangiomas can enlarge if not treated.

Hemangiomas can be treated with topical skin gel or systemic propranolol given over 6-8 months and has been very effective in treating hemangiomas, especially flat lesions and if affecting the airway. Surgery is a treatment option of hemangiomas. It has the advantage of treating the lesion in a single session but will leave a permanent skin scar, and is usually best used if the hemangioma does not completely disappear.

Surgery is a treatment option of haemangiomas. It has the advantage of treating the lesion in a single session but will leave a permanent skin scar.

Laser is the first choice for port wine stain (capillary malformation) lesions. Surgery is possible for small or non-complex vascular malformations and other injectable drugs such as alcohol are sometimes used.

All the possible treatment options will be considered and discussed with you to ensure you can make an informed choice. Please feel free to discuss any questions or concerns you may have with us.