A clinical study prematurely interrupted due to the excellent results of the drug tested is about to deliver us a new standard of therapy for patients with Hodgkin’s lymphoma. The combination of immunotherapy with chemotherapy has in fact been shown to block the progression of the disease increase survival up to 92% (compared to 83% of the already very effective traditional treatment protocol), as well as reducing important side effects on patients. The results of the trial were published in New England Journal of Medicine.
Tumors: Hodgkin’s lymphoma
Il Hodgkin’s lymphoma And a tumor of the lymphatic system which generally presents with enlargement of the lymph nodes in the upper part of the body (such as the neck, armpits and groin) and which leads to an abnormal proliferation of B lymphocyteswhite blood cells present in the blood, spleen, lymph nodes, bone marrow and all tissues of the lymphatic system. Treatment depends on the stage of the disease (to learn more), but generally involve cycles of chemotherapy combined with possible radiotherapy.
Hodgkin’s lymphoma is a relatively rare tumor (it affects approximately 3-4 people per 100,000 inhabitants every year), but it is among the most frequent in the population between 15 and 35 years. Hence the need to think about new treatments that reduce the long-term side effects of treatments. Historically, in fact, this patient population has often received radiotherapy together with chemoa highly effective treatment in eliminating diseased cells and bringing the disease into remission, but which can later lead to the onset of secondary tumors, infertility, heart and lung problems.
The trial, coordinated by the SWOG Cancer Research Network, a global community of scientists engaged in cancer research funded by the US National Cancer Institute, had the dual objective of improve the standard of care for Hodgkin’s lymphoma, linked to a survival rate already above 80, and of at the same time minimize the long-term toxicity of the drugs necessary for recovery on the patients’ organism.
Hodgkin’s lymphoma: a clinical study destined to enter the annals
The phase 3 trial involved almost a thousand patients followed in hundreds of clinics and academic institutions across the United States. The scientists attempted an exceptional approach – involving, in the same clinical study, pediatric patients (constituting a third of the participants: the youngest were 12 years old) and elderly patients (10% of the participants were over 60 years old). The median age of the subjects was 30 years.
The study also sought to be as inclusive as possibleinvolving a high number of patients – 25% – belonging to groups and minorities usually poorly represented in oncology research.
Half of the patients followed the latest standard of therapy used against Hodgkin’s lymphoma, a combination of AVD chemotherapy (doxorubicin, vinblastine, dacarbazine) combined with brentuximab vedotina monoclonal antibody drug conjugate.
The other half received chemotherapy combined with a type of immunotherapybased on the drug nivolumabwhich targets a genetic alteration characteristic of Hodgkin lymphoma, known to facilitate tumor proliferation. Nivolumab reactivates the immune defenses knocked out by lymphoma and makes tumor cells visible again to immune sentinels.
The results: a leap forward in survival
The trial went so well that the National Cancer Institute ordered its suspensionso as to apply more quickly to the US Food and Drug Administration than nivolumab be added to standard therapies for third or fourth stage Hodgkin lymphoma (the most advanced). Since the immunotherapy is already used in other areas, approval is expected to proceed quickly and smoothly.
