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.

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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.”

Reference

  1. 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