As researchers recently discovered, outcomes for patients with diffuse large B-cell lymphoma are just as good when the number of chemotherapy cycles is reduced.
In patients with diffuse large B-cell lymphoma (DLBCL), the current standard of care is six cycles of a specific type of chemotherapy plus Rituxan (rituximab). However, as researchers from Germany and Norway recently discovered, outcomes are just as good when the number of chemotherapy cycles is reduced.
According to the results of the international multicenter FLYER trial, which were presented at the 2018 American Society of Hematology (ASH) Annual Meeting from Dec. 1 to 4 in San Diego, patients from 18-60 years old experienced both similar survival rates and less adverse events (AEs) when they received four rounds of chemotherapy instead of six.
In this trial, which ran from December 2005 to October 2016, doctors randomized 592 patients to two arms. Of the total, 588 patients were evaluable for the final analysis. The median age of all patients was 48 years.
The standard-of-care arm consisted of 295 patients who received six cycles of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP), plus the monoclonal antibody Rituxan (6x R-CHOP). The experimental arm of 293 patients received four cycles of CHOP plus six applications of rituximab (4x R-CHOP+2xR). Treatment was given in 21-day cycles, and the final data was analyzed after three years of treatment.
The primary endpoint of the study was progression-free survival (PFS), with event-free survival and overall survival (OS) being monitored as well.
At three years, progression-free survival between the two groups was similar, with a rate of 96 percent in the (6x R-CHOP) arm and 94 percent in the (4x R-CHOP+2xR) arm. Event-free survival was identical in both groups at 89 percent, and overall survival was improved in the group that received less chemotherapy (99 percent vs. 98 percent in the standard six-cycle arm). There was no significant difference in relapse rates between the two arms.
In addition to the positive survival outcomes, patients who received less chemotherapy also experienced fewer adverse events. In the standard arm, leukocytopenia was reported 237 times, 172 cases of anemia were reported, and 17 patients experienced thrombocytopenia. When patients received two fewer doses of chemotherapy, the amount of times these events were reported dropped to 171, 107 and 16, respectively.
The researchers also noted that non-hematological adverse events were reduced by approximately a third in patients that received fewer cycles. The standard arm reported 1,295 counts of paresthesia, nausea, infection, vomiting and mucositis, while the experimental arm saw just 835 non-hematological adverse events.
If reducing the amount of chemotherapy in young patients with DLBCL provides the same survival benefits and fewer adverse events, this could be considered a viable option for some patients in the future. As the researchers concluded in their abstract on the study, “Chemotherapy can be spared without compromising prognosis in this population.”