Abstract
Anthracycline-containing regimens (CHOP and CHOP-like regimens) are still the cornerstone of elderly patients with diffuse large B-cell lymphoma (DLBCL), although the therapeutic response is acceptable, high incidence of co-morbidities and treatment-related adverse effects including cardiac and hematologic toxicities are major obstacle in clinical practice, and management of elderly DLBCL patients remains a great challenge. We employed a platinum-based regimen (oxaliplatin-gemcitabine) which is widely used to treat solid tumors plus anti-CD20 antibody rituximab(R-GemOx) as first-line treatment in elderly patients with DLBCL. We have performed an interim analysis of this ongoing Phase 2 study and evaluated safety and efficacy of this regimen.
This study was a prospective, multicenter, single-arm phase 2 clinical trial (NCT01670370). Eligible patients included those with previously untreated, CD20 positive DLBCL, ≥70 years of age or ≥60 years with ECOG performance status score ≥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. Interim evaluation was conducted after 3 cycles of treatment, patients who responded to the treatment and did not have disease progression received up to six cycles of R-GemOx treatment.
At the time of interim analysis, 25 patients were enrolled between July 2010 and March 2013 and 22 patients were eligible to evaluate. Patients were 50.0% (11/22) male with median age 74 (range: 61-85) yrs, four patients (18.2%) were <age 70. ECOG PS ≥2 was 16/22 and the international prognostic score (IPI) enrolled to study was low risk group (0-1 score) 4/22, low intermediate group (2 score) 7/22, high intermediate/ high risk group (3-5 score) 11/22. The median number of cycles of therapy was 5, three pts have discontinued study due to progression. Evaluation of response was according to response criteria for lymphoma: The overall response rate (ORR) among treated pts was 81.8%, with 63.6% of patients achieving CR/CRu and 18.2% achieving PR, one patient (4.5%) had SD and 3 patients (13.3%) had PD. With the median follow-up of 15 months (4-34), progression-free survival rate was 50.6% (Fig. 1), and overall survival rate was 67.2% (Fig. 2). In terms of toxicities, most treatment-related adverse events (AEs) were mild or moderate in severity. The most common grade ≥3 AEs were gastrointestinal complications including diarrhea and vomiting (18.2%) and bone marrow suppression (13.6%), other nonserious AEs observed included hypodynamia, mild paresthesia and hepatic injury. No clinical impairment of cardiac and nephrotoxicity were observed.
Progression-free survival
Overall survival
R-GemOx immunochemotherapy regimen is highly active and well-tolerated in previously untreated elderly patients with DLBCL, gastrointestinal complications and hematologic toxicities can occur and should be carefully monitored, the encouraging interim data suggest R-GemOx is a promising first-line regimen for this subgroup of patients, Longer follow-up and further evaluation are required to evaluate efficacy and safety of this regimen.
No relevant conflicts of interest to declare.
This feature is available to Subscribers Only
Sign In or Create an Account Close Modal