Massimo Federico, MD, director of the medical oncology unit at the University of Modena and Reggio Emilia, Italy, was quoted in Cancer Network as saying that “Achieving a complete clinical and molecular response in 100% of cases, in a prospective and multicentric [involving multiple lymph nodes] setting is impressive and should represent the basis for additional clinical and biologic studies aimed at better understanding the mechanisms of the extraordinary synergistic effect of three ingredients that, used alone, have demonstrated so far only a limited, although significant, efficacy.”
About Follicular Lymphoma (FL)
Follicular lymphoma is a form of non-Hodgkin lymphoma exhibiting a large number of B cells whose nodular structure of follicular architecture is preserved. Approximately one in three thousand people may be affected by FL at a median age of between 60 and 65 years. It rarely affects children.
Clinical description of FL
Lymph nodes are the primary location of FL. It may also be found in the bone marrow, spleen, peripheral blood and Waldeyer’s ring (the lymphoid tissues of the nasopharynx, tonsils, and base of the tongue.) In rare cases, the skin and central nervous system may be affected.
Symptoms of FL
Symptoms may include weight loss, night sweats, and fever. They generally appear in late stages of the disease. Additional information about Fl may be found here.
Final Results
The British Journal of Haematology recently published final results of the LNH-PRO-05 study previously referred to by Federico. These impressive results were achieved in patients with high-risk follicular lymphoma (FL) through the use of a combination of rituximab, Interferon alfa-2b, and dose-dense CVP (cyclophosphamide/vincristine/prednisone).
Combining drugs with both antiproliferative and immune effects in the treatment of FL patients has improved survival and disease control to a great extent. It has become one of the most effective treatments for FL.
The research team was led by Jimena Cannata-Ortiz, who is based out of the Hospital Universitario La Princesca in Madrid. They reported that their primary focus is to minimize early and long-term toxicity, while at the same time striving to maintain efficacy. With this in mind, they expect to achieve long-term survival.
Their report stated that “The use of two antiproliferative and immunomodulatory agents in combination with anthracycline-free chemotherapy can achieve excellent complete response rates in FL patients with a FLIPI score > 2, which translates into excellent progression-free survival and overall survival at 8 years.”
A Brief History
Two decades ago, alfa-2b combined with dose-dense CVP was introduced as a treatment for FL. At the ten-year mark data showed a progression-free survival rate of 57% and an overall survival rate of 79%.
The researchers started a clinical trial for 50 FLIPI ≥ 2 patients from five centers when rituximab became available. The efficacy/toxicity plus the outcome as compared to historical data was reported by the researchers. The study ran from 2005 through 2013 and ended in 2016.
Upon evaluating all participants, it was determined that 82% achieved a complete response at the fourth cycle. At cycle 8 the investigators reported a 100% response.
There was a median follow-up at 6.2 years showing a 91% progression-free survival rate while the overall survival rate was 98%. The researchers found the outcome to be superior to results of the prior study but noted that the difference may have been a result of the longer period of follow-up of the former trial. Additional information about this phase II trial is available here.