A new study suggests that it may be safet to reduce the standard course of treatment for younger patients with low-risk diffuse large B-cell lymphoma (DLBCL) by two cycles of chemotherapy. The trial, which tracked patients for a median of more than 5 years and up to 11 years, showed 4 cycles of chemotherapy to be as effective as 6 cycles in terms of eradicating cancer and preventing relapse. These findings were presented by Poeschel et al the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 781).
Under the reduced 4-cycle regimen, chemotherapy would last a total of 84 days, compared with 126 days with the 6-cycle regimen. “With a shorter duration of chemotherapy, patients are back to daily life with their families and back to work more quickly,” said lead study author Viola Poeschel, MD, of Saarland University Medical School in Homburg/Saar, Germany, in a statement. “Our study shows you can spare two cycles of chemotherapy and it is equally effective. We think this will be the new standard treatment for this patient population.”
Most patients with DLBCL receive treatment in 6 cycles, spaced 3 weeks apart. Each treatment cycle includes CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) along with rituximab.
For the study, researchers enrolled nearly 600 patients between the ages of 18 and 60 treated for DLBCL at institutions in Germany, Denmark, Norway, Italy, and Israel. All patients had stage I or II cancer and were considered to be at low risk. Half of the patients were randomly assigned to receive six cycles of CHOP, and half received four cycles of CHOP. All patients received the standard six cycles of rituximab. There were no relevant differences in demographics, protocol adherence, and toxicity between the two arms.
There were no statistically significant differences between the two groups in terms of overall survival, relapse, or disease progression. The 3-year progression-free survival rate of the patients receiving the reduced regimen was 96% vs 94% of patients receiving the standard regimen (P = .760). The 3-year event-free survival rate was identical (89%) in both treatment arms. The 3-year overall survival rate was 99% in patients receiving the reduced regimen vs 98% in patients receiving the standard regimen. Four percent (95% confidence interval [CI] = 2%–7%) of the patients in the 4-cycle arm relapsed vs 5% (95% CI = 3%–8%) of the patients in the 6-cycle arm.
In addition, the data suggest that reducing the number of chemotherapy cycles also reduces the number of adverse events by one-third. Altogether, 1,295 adverse events occurred in the 295 patients who underwent 6 cycles of chemotherapy compared with 835 adverse events in the 293 patients who received 4 cycles of chemotherapy. “This is an important and meaningful benefit to patients,” Dr. Poeschel added.
The researchers will continue to track the health of study participants for an additional 5 years to determine whether decreasing the number of chemotherapy cycles may help reduce the long-term side effects of chemotherapy.
Disclosure: See the study authors’ full disclosures at ash.confex.com.
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