medwireNews: The combination of rituximab, gemcitabine, and oxaliplatin (R-GemOx) has potential for the treatment of older patients with a new diagnosis of diffuse large B-cell lymphoma (DLBCL), suggests a Chinese phase II trial.
The researchers explain that the regimen previously showed “high efficacy” and “good tolerability” in patients with relapsed and refractory disease, with similar findings now seen in the first-line setting.
They continue: “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.”
A total of 60 patients – aged at least 70 years or 60–69 years with an ECOG performance status of 2 or worse – were given rituximab 375 mg/m2 on day 0, followed by gemcitabine 1 g/m2 and oxaliplatin 100 mg/m2 on day 1, with the cycle repeated every 14 days for a maximum of six cycles.
Over a median follow-up of 45 months, the overall response rate was 75%, with a complete response in 47% and a partial response in 28%.
At 3 years 49% of the participants were progression-free and 65% were alive, with the median duration unreached for both outcomes.
Lead author Wei Xu, from the First Affiliated Hospital of Nanjing Medical University, and co-workers highlight the tolerability of the R-GemOx regimen in this population of patients, most of whom were elderly and had a poor performance status (45% with ECOG ≥2) or concomitant diseases (65% had a high and 35% had a very high Charlson Comorbidity Index score).
The most common adverse event of grade 3 or 4 was neutropenia, seen in 15% of participants, followed by thrombocytopenia and nausea, each in 8%, and anemia in 7%.
As reported in The Lancet Haematology, toxicities led to treatment discontinuation in seven patients, but no deaths were attributed to the study regimen.
Noting that the patients aged 60–69 years with a poor performance status and those who were 70 years or older could “have had different characteristics and responses to treatment,” the authors say that “[f]urther investigations are needed to confirm the findings of this study.”
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