Front-Line Rituximab Plus Gemcitabine–Oxaliplatin Proposed For Elderly DLBCL Patient

Gemictabine–oxaliplatin given alongside rituximab may be suitable for treatment-naive patients with diffuse large B-cell lymphoma who are elderly or have a poor performance status

medwireNews: Preliminary findings suggest elderly patients with diffuse large B-cell lymphoma (DLBCL), including those with comorbidities, may be able to tolerate first-line rituximab in combination with gemcitabine and oxaliplatin (R-GemOx).

In light of the high efficacy and low toxicity demonstrated for R-GemOx in elderly patients with relapsed or refractory DLBCL, Wei Xu, from the First Affiliated Hospital of Nanjing Medical University in China, and co-workers investigated its front-line use in patients aged at least 70 years or aged 60–69 years with an ECOG performance status of 2 or higher.

The median age of the 60 patients enrolled in the study  was 75 years and 45% had a poor performance status, with 28% of patients aged at least 70 years having a poor ECOG performance score of 2 or higher. Sixty percent of the patients had Ann Arbor stage III or IV DLBCL, and the most common comorbidities were coronary artery disease (17%) and diabetes (15%).

The patients were given a regimen of rituximab 375 mg/m2 on day 1 of a 14-day cycle, with gemcitabine 1 g/m2 and oxaliplatin 100 mg/m2, both administered on day 2.

Over half (53%) of the patients achieved at least partial remission by the third cycle and went on to complete the full six cycles of treatment planned, the team reports in The Lancet Haematology.

The overall rate of complete or partial responses in the intention-to-treat group was 75%, with a complete response achieved by 47% of patients.

The proportion of patients achieving an overall response did not vary significantly by age, sex or DLBCL subtype, the researchers say, noting that 81% of the 16 participants aged over 80 years met this outcome.

However, patients with an International Prognostic Index (IPI) score for non-Hodgkin’s lymphoma of 0–2 were significantly more likely to achieve an overall response than those with an IPI score of 3–5, at 86% versus 60%.

After a median of 45 months, 3-year progression-free survival (PFS) and overall survival (OS) were achieved by 49% and 65% of patients, respectively, and there was no significant difference in these rates for patients aged 60–69 years versus those aged at least 70 years.

In multivariate analysis, PFS was significantly poorer in patients with an IPI score of 3–5 or a β2-microglobulin concentration above 2.5 mg/L, while only IPI score predicted OS. Specifically, the 3-year OS rate was 38% for those with an IPI score of 3–5 versus 85% for patients with an IPI score of 0–2, the researchers note.

The most common grade 3–4 haematological adverse events were neutropenia (15%), thrombocytopenia (8%) and anaemia (7%) but none of the patients required prophylactic antimicrobial therapy. A further 8% developed febrile neutropenia and 8% required a blood transfusion.

Nausea (8%), vomiting (5%), neurological toxicity (3%) and diarrhoea (2%) were the most common grade 3–4 non-haematological adverse events and these improved with supportive care, the investigators say. There were no treatment-related deaths.

“Our results are in line with previous findings suggesting that the R-GemOx regimen can show promising clinical activity with good tolerability in elderly and frail patients with diffuse large B-cell lymphoma”, write Wei Xu et al.

They conclude that their findings “provide a rationale for the design of further randomised controlled trials of the R-GemOx regimen versus conventional anthracycline-containing regimens” in this population.

 

Reference

Shen Q-D, Zhu H-Y, 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 . Lancet Haematol; Advance online publication 8 May 2018.
DOI: https://doi.org/10.1016/S2352-3026(18)30054-1

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