Clinical Phase II Study of a Non-Anthracycline-Based Immunochemotherapy Regimen(R-GemOx) As First-Line Treatment in Elderly Patients with Diffuse Large B-Cell Lymphoma

Anthracycline-based regimen(CHOP and CHOP-like regimens) is still the most widely used treatment of elderly patients with diffuse large B-cell lymphoma (DLBCL), but because of low rates of the overall response, high incidence of co-morbidities and treatment-related adverse effects, the prognosis of these patients remain dismal. Our aim was to develop a non-anthracycline-based immunochemotherapy regimen, rituximab combination with GemOx (gemcitabine and oxaliplatin) for elderly patients with DLBCL and investigate the safety and preliminary efficacy of this regimen.

This study was a prospective, single-arm clinical trial. Eligible patients was previously untreated, CD20 positive DLBCL patients diagnosed by biopsy, ≥70 years of age or ≥60 years with ECOG PS of ≥2. Therapeutic protocol of R-GemOx regimen was as follows: rituximab 375 mg/m² i.v. on day 1; gemcitabine 1 g/m² i.v. on day 2; oxaliplatin 100 mg/m² i.v. on day 2, each cycle of treatment was administered every 14 to 21 days according to recovery of toxicities. Patients who responded to the treatment and did not have disease progression received up to six cycles of R-GemOx treatment.

15 patients were enrolled between July 2010 and April 2012 and 12 patients were eligible to evaluate. Patients were 41.7% (5/12) male with median age 73(range: 61–85 yrs), three patients (25.0%) were <age 70. ECOG PS ≥2 was 11/12 and the international prognostic score (IPI) enrolled to study was low risk group (0–1 score) 0/12, low intermediate group (2 score) 4/12, high intermediate (3 score) 2/12 and high risk group (4–5 score) 6/12. Evaluation of response was according to response criteria for lymphoma: The overall response rate (ORR) among treated pts was 75.0% (CR/CRu, 5; PR, 4); one patient (8.3%) had SD and 2 patients (16.7%) had PD. With a median follow-up of 7 (4–26) months, the median overall survival (OS) and the progression-free survival (PFS) have not been achieved. In terms of toxicities, most treatment related adverse events (AEs) were mild or moderate in severity. The most common grade ≥3 AEs were bone marrow depression (25.0%) and gastrointestinal complications (16.7%), no impairment of kidney and heart were observed.

This is the first clinical study to investigate the safety and efficacy of R-GemOx regimen in elderly patients with DLBCL. Rituximab combination with GemOx appears highly active and favorable toxicity profiles in elderly patients with DLBCL requiring treatment, the encouraging preliminary data suggest R-GemOx is a promising first-line regimen for this subgroup of patients, and further evaluation is required.

No relevant conflicts of interest to declare.