Combination therapy with rituximab, gemcitabine, and oxaliplatin (R-GemOx) demonstrated efficacy and tolerability in the first-line setting among elderly patients with diffuse large B-cell lymphoma (DLBCL), according to a study published in The Lancet Haematology.1
Treatment with the current standard of care (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP) leads to good response rates and prolongs survival among elderly patients with DLBCL, but is associated with increased rates of treatment-related death, adverse events, and comorbidities. R-GemOx has shown high efficacy with low toxicity among elderly patients with relapsed/refractory DLBCL in previous studies.
In this open-label phase 2 study (ClinicalTrials.gov Identifier: NCT01670370), researchers enrolled 60 previously untreated frail or elderly patients with CD20-positive DLBCL. Patients received intravenous (IV) rituximab 375 mg/m2 on day 0 and gemcitabine 1 g/m2 plus oxaliplatin 100 mg/m2 on day 1, every 2 weeks; the planned treatment duration was 6 cycles if patients had at least a partial remission after the interim assessment. The median age of the study participants was 75 years, and nearly half had poor performance statuses.
Results showed that the overall response rate was 75% (45), and 47% (28) of patients achieved a complete response.
The most frequently reported grade 3 to 4 adverse events (AE) were hematologic or gastrointestinal in nature; thrombocytopenia, anemia, and neutropenia occurred in 8%, 7%, and 15% of patients respectively, and patients also experienced nausea (8%), vomiting (5%), and diarrhea (2%). No treatment-related deaths were observed.
The authors concluded that “R-GemOx could be a possible therapeutic option for this subpopulation. These results provide a rationale for the design of further randomised controlled trials of the R-GemOx regimen versus conventional anthracycline-containing regimens in previously untreated elderly patients with diffuse large B-cell lymphoma.”
- Shen QD, Zhu HY, Wang L, et al. Gemcitabine-oxaliplatin plus rituximab (R-GemOx) as first-line treatment in elderly patients with diffuse large B-cell lymphoma: a single-arm, open-label, phase 2 trial [published online May 8, 2018]. Lancet Haematol. doi: 10.1016/S2352-3026(18)30054-1