Cutaneous T-cell lymphoma (CTCL) is a rare type of cancer with its origin (pathogenesis) found in white blood cells (T lymphocytes). The disease is incurable and debilitating.
A recent article in the Cancer Therapy Advisor explains that CTCL is one of several types of lymphoma that collectively are named non-Hodgkin’s lymphoma. When functioning normally, T cells assist the immune system in fighting germs. But in CTCL, the T cells develop abnormalities that cause them to attack the skin.
The most common type of CTCL is mycosis fungoides (MF) that initially forms on the skin but may spread to other organs or lymph nodes.
A less common type of CTCL is Sezary syndrome. It is aggressive cancer that affects the blood, skin, and may affect the lymph nodes.
The investigational drug being studied is Brentuximab vedotin. It is an antibody-drug compound that can be used singularly or combined with other drugs. It is classified as a chemotherapy drug and treats such disorders as peripheral T-cell lymphoma, MF, or Hodgkin lymphoma. Brentuximab vedotin is its generic name while its trade name is Adcetris.
The Phase 3 ALCANZA Trial
The ALCANZA trial began in 2012 with a total enrollment of 131 patients.
Patients with primary cutaneous anaplastic (abnormal) large cell lymphoma (C-ALCL) or MF were eligible for enrollment in the trial if they had been treated previously with any type of therapy or radiotherapy that targets the entire body (systemic).
ALCL can begin in the skin, lymph nodes, or other organs in the body. The type of ALCL that appears in the skin (cutaneous) is usually less aggressive than the systemic type.
The trial was conducted worldwide over a period of six years. Trial results were just published in Blood Advances.
Trial Results
Final results of the ALCANZA study at the one-year mark showed that 65.5 percent of patients in the Brentuximab vedotin arm may not require subsequent antineoplastic therapy versus 13.4 percent for bexarotene or oral methotrexate (Physician’s choice). The results referred to patients who have CD30-expressing CTCL.
Gene expression refers to the conversion of information contained in our DNA that provides instructions to make various molecules or proteins.
At 37.3 Months
Interim results at the 37.3-month follow-up showed a longer PFS (14.2 months) for the brentuximab vedotin arm than for the physician’s choice (5.6 months).
At the 45.9 month follow-up, there was virtually no difference in OS rates between the two drugs.
However, there was an improvement in OS for brentuximab vedotin against physician’s choice when testing patients with advanced-stage MF.
Adverse Events
Peripheral neuropathy, affecting the central nervous system, occurred in sixty-seven percent of patients being treated with brentuximab vedotin. Six percent of patients were affected in the physician’s choice arm.
Symptoms, mostly pain in the hands and feet, are usually resolved when the cause is removed. At the final cutoff of trial data, 86% of cases in the brentuximab vedotin arm had been resolved.
Looking Forward
The study authors concluded that results of the ALCANZA trial showed that the time period between treatments was substantially longer with brentuximab vedotin in patients previously treated with CD30 expressing MF or C-ALCL as opposed to physician’s choice.
