Frequently Asked Questions

SKIN LESIONS

  • What is electrochemotherapy?

    Electrochemotherapy is a treatment combining a low dose of a chemotherapy drug and an electrical pulse (electroporation) applied directly to the cancer cells using an electrode.

    This low-level dose of chemotherapy drug is not normally effective against the cancer, as it is difficult to get inside the cells. When the electric pulse is applied, the cells form pores allowing the drug to enter and be active against the cancer.
     

  • Who is suitable for treatment?

    Electrochemotherapy is suitable for patients presenting with:

    - Metastatic melanoma on the skin
    - In transit metastases irrespective of pathologies
    - Squamous cell carcinomas
    - Basal cell carcinomas
    - Kaposi’s sarcomas
    - Head and neck cancers
    - Gynaecological cancers
    - Breast cancers that are affecting the skin

  • What about bleomycin toxicity and lung fibrosis?

    The following checks need to be carried out before the electrochemotherapy procedure is performed:

    - Check that the patient is fit for general anaesthetic
    - Perform a lung function test, as a potential side effect of Bleomycin is lung fibrosis

  • Can electrochemotherapy patients be treated as day case patients?

    Patients are often treated as a day case, and treatment with electrochemotherapy does not usually involve an overnight stay in hospital.

    Of course, this must be assessed on a patient-by-patient basis and in some cases it may be more appropriate to keep the patient under surveillance for the night after the operation.

  • What side effects are there?

    Some patients may experience a mild fever following the treatment, but medication can be prescribed to relieve this. On rare occasions, the wound site may become infected. Signs to look out for around the wound site include increased redness and pain, discharge or fluid leakage.

    Serious side effects are extremely rare but, as with all medical interventions, can happen. In very few cases, patients may have an allergic reaction to the chemotherapy drug or may experience shortness of breath. This is why it is important to have any relevant investigations completed prior to the day of treatment.

  • Is it purely palliative?

    This is dependent upon the size of tumours that the patient is presenting with.

    With tumours that are presenting as less than 3 cm there is a good chance that electrochemotherapy treatment can shrink these completely leaving the patient's skin disease-free.

    However, with patients who present with larger bleeding or fungating wounds, the treatment is then to provide comfort and a greater quality of life.
     

  • How many Worldwide centres do you have?

    There are currently 150 centres in the world (most of them in Europe) that offer electrochemotherapy treatment. 

    Since 2007 over 6000 people have been treated  world-wide with electrochemotherapy.
     

  • Why use bleomycin? Can you use other more effective drugs?

    During the development of the electroporation treatment, a number of cancer drugs were considered and trialled.

    Bleomycin with electroporation gave a 1000-fold increase in effect, making it the most effective choice for electrochemotherapy treatment.

    It works as a strong DNA cutting agent making it a very effective anti-cancer drug with a strong defence against its own resistance. Bleomycin is also active against cancers of any histology providing it can get into the cell, which electroporation allows it to do.

    Bleomycin is not a costly cancer drug and this makes electrochemotherapy a cost-effective cancer treatment.

    Cisplatin can be used if Bleomycin is unsuitable, for example if the maximum safe dose of bleomycin has been exceeded or if there have been unacceptable side effects from bleomycin,
     

  • Is there a thermal effect from the needles? Does it burn the patient?

    As a bi-polar needle is used during the electroporation process, the electricity flows in and out through the electrode. Therefore, whilst you will initially see some discolouration marks on the skin, these should fade during the healing process.

    During the healing phase, you will see a mark on the skin where the needles have entered. However, these normally fade over time and long term scarring from the needles is not expected.

  • Do you have published clincal data?

    There is a plethora of clinical papers that support our 85% objective response rate following the treatment. Please go to "References" to find out more.

  • Do you have long-term results?

    We do have local tumour control data showing a progression-free survival rate at 81% at 3 years in a phase II study.

    Long-term results are ongoing and the InspECT Registry (International Network for Sharing Practices on Electrochemotherapy) Network are currently collating this very data.

BONE

  • Who is suitable for electrochemotherapy?

    Electrochemotherapy is indicated in patients where surgery is not an option and radiotherapy is not indicated or has already been used at the maximum allowed dose.  

  • For which skeletal sites?

    The clinical experience gained so far is on the treatment of long bones, pelvis, scapula, sacrum and foot.

  • How long it takes to perform the procedure?

    Once the patient has entered the operating room, the time may vary from 20 minutes to 40 minutes, depending on the number of electrodes to be placed at the treatment site.

  • What kind of anesthesia is used?

    When treating long bones, a loco-regional anesthesia and a sedation during the delivery of electrical impulses are often the best choice.

    When treating other skeletal segments or when the patient's condition requires it, the anesthesiologist can opt for general anesthesia with curarization.

  • How is electrode insertion performed?

    The electrode insertion is performed percutaneously and in most cases the procedure is guided through an image intensifier.

    To treat more complex areas such as the hip and pelvis, guidance with Computerised Axial Tomography (TAC) is preferred.

  • Is there published data on treatment of bone metastases with electrochemotherapy?

    Bianchi G and colleagues (Rizzoli Orthopedic Institute, Bologna, Italy) reported their experience on 29 patients. A significant pain reduction was achieved in 84% of the patients with a functional recovery ranging from 55 to 73%. Disease progression was observed (TAC evaluation) only in 10% of patients.

    Gasbarrini A and colleagues (Rizzoli Orthopedic Institute, Bologna, Italy) reported on the treatment of a patient with melanoma metastases at the L5 level of the spine achieving a complete remission and this was also confirmed four years after electrochemotherapy.

    A register promoted by the Bone Metastases Group Study of the Italian Society of Orthopedics and Traumatology (SIOT), called ReinBONE (Registry on Electrochemotherapy in Bone), is collecting clinical data on patients with bone metastases that is being treated with electrochemotherapy.
     

  • Is there experience in the treatment of spine bone metastases?

    Gasbarrini A and colleagues (Rizzoli Orthopedic Institute, Bologna, Italy) report on the treatment of a patient with melanoma metastases at L5 level of the spine and achieving a complete remission that was also confirmed four years after electrochemotherapy.

  • How many electrodes are used for a single procedure?

    A minimum of 2 to a maximum of 6 electrodes for each treatment. Depending on the size of the lesion, you may need to place or reposition the electrodes to better cover the entire volume of the tumour.

    A dedicated software package (Pulsar) helps optimisation of the positioning of each single electrode.

LIVER AND PANCREAS

  • What are the advantages of electrochemotherapy on visceral tumours?

    Electrochemotherapy as a non-thermal ablation allows the preservation of normal tissue and organs surrounding the tumoral lesions. 

    It has a high selectivity, and, in fact produces a mitotic cell death caused by the single or double stranded DNA rupture. This so-called "mitotic catastrophe" selectively affects cells in active replication, such as neoplastic ones.

    Electrochemotherapy is repeatable, independent of histology and feasible after previous treatments.

  • Is electrochemotherapy safe?

    Cliniporator® and Cliniporator® VITAE are CE marked equipments.

    The safety of the techinique has been evidenced in the publications on early clincal experiences of the treatment of liver and pancreas tumours.  

  • How do you position the electrodes?

    PERCUTANEOUS MODE

    The percutaneous treatment can only be performed with the Cliniporator® VITAE and planned with the Pulsar software which shows where to position the electrodes as well as the required electrical field amplitude to effectively electroporate tumour cells.

    In the case of percutaneous access, using VGD series electrodes, 2 to 6 electrodes can be inserted for each placement. The maximum distance between the 2 needles is 3 cm and the electrodes must be parallel to each other.

    In the case of large lesions, multiple electrode placement is possible in order to electroporate the entire volume of the lesion.

    LAPAROTOMIC MODE

    The laparotomic treatment can be performed with either the Cliniporator® using EPSA or NF series electrodes (up to the depth of 3 cm) or with the Cliniporator® VITAE using VGD series electrodes (more than depth of 3 cm).

    In the case of laparotomic access using EPSA or NF series electrodes, it is necessary to cover the entire volume to be treated with subsequent electrode applications.

  • When is it possible to know if the treatment has involved the whole lesion?

    Within 24 hours from the electrochemotherapy of the liver it is possible to perform a liver contrast-enhanced ultrasound that will show a non-vascularized area caused by the "vascular lock" effect of electrochemotherapy.

    In thecase of other treatment sites, a safe method of assessing the treated volume has not yet been identified.

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