Dennis Parenti, MD, vice president of Clinical Affairs for Therakos
In addition to the danger they pose, the cancerous red patches, plaques, and tumors that arise from cutaneous T-cell lymphoma (CTCL) represent an enormous quality-of-life issue for patients.
When it comes to alleviating the lesions caused by this group of non-Hodgkin lymphomas—in which malignant CD4- positive lymphocytes proliferate and infiltrate the skin—doctors can prescribe a number of therapies. The lesions can be treated topically, with retinoids and phototherapy, or with systemic therapies.
There’s also another option: Therakos photopheresis is indicated for the palliative treatment of skin manifestations of CTCL that are unresponsive to other therapies. The technique is intended to reduce redness, itching, and the size of the lesions; in some cases, it entirely clears the skin.
Headquartered in Raritan, New Jersey, Therakos is a division of Ortho Clinical Diagnostics, part of the Johnson & Johnson family of companies. Its first photopheresis machine became available in 1988, and since then the company’s technique for extracorporeal photopheresis (ECP) has been used in more than 700,000 treatments.
Therakos photopheresis has demonstrated efficacy and safety in CTCL patients, and has not been associated with secondary malignancies or opportunistic infections, according to a 1987 study and the company’s own data.1
To learn more about how photopheresis can help patients fight the symptoms of CTCL, OncologyLive
spoke with Dennis Parenti, MD, vice president of Clinical Affairs for Therakos.OncologyLive: What is extracorporeal photopheresis?Parenti:
ECP is an immune modulation therapy that was approved by the FDA for the palliative treatment of the skin manifestations of CTCL. ECP is also known as photoimmune therapy or immune cell therapy, and works by using either the integrated Therakos Uvar XTS or Cellex photopheresis systems to collect a small amount of whole blood from a patient connected to the system.
The system then separates the white blood cells; treats them with an exvivo methoxsalen (8-MOP) sterile solution, a photoactivable substance; activates the methoxsalen by UVA light; and reinfuses the white cells back into the patient. The treated white cells will start to undergo normal programmed cell death (apoptosis), which triggers a cascade of immunologic events. Less than 10% of all white cells are treated, yet some patients achieve a complete improvement in symptoms.Please explain more extensively the impact that ECP has on the immune system.
Although the exact mechanism of action is not known, photopheresis may activate the immune-mediated response to modulate malignant T lymphocytes. ECP helps to restore the body’s natural ability to maintain a balanced immune system by controlling the activity of overactive immune cells. Healthy immune systems maintain a balance between the effector cells that fight infection and the regulatory cells that prevent immune-mediated diseases like CTCL. Other therapies for restoring a balanced immune system have traditionally targeted the effector cells by suppressing their function, thus suppressing the immune system. However, ECP is believed to boost the number of the regulatory cells (T-regs) of the immune system, providing a novel approach that may have significant activity in the treatment of disease, including skin manifestations, without inducing generalized immunosuppression.
Why do patients need multiple treatments? What parameters do you use to determine when patients can stop treatment?
Patients receiving Therakos photopheresis may not see results right away. Patients are typically treated on two consecutive days each month for several months. If that doesn’t result in an improvement in skin findings, treatment can be accelerated to two consecutive days every two weeks for three months. If a response is maintained, the frequency of treatments can be gradually diminished or stopped. If the program of therapy has not stimulated an improvement after 20 treatments, healthcare practitioners should use their judgment in determining whether to continue.2How are some of the adverse events with this technology managed?