title: Phase II multicenter study of oblimersen sodium, a Bcl-2 antisense oligonucleotide, in combination with rituximab in patients with recurrent B-cell non-Hodgkin lymphoma.
abstract: Oblimersen sodium plus rituximab was evaluated in relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) patients. Oblimersen was administered as a continuous intravenous infusion at a daily dose of 3 mg/kg/d for 7 d on alternate weeks for 3 weeks. Rituximab was given at a weekly dose of 375 mg/m(2) for six doses. Patients with stable disease or objective response were allowed to receive a second course of treatment. The overall response rate (ORR) was 42% with 10 complete responses (CR) and eight partial responses (PR). Twelve (28%) patients achieved a minimal response or stable disease. Among the 20 patients with follicular lymphoma the ORR was 60% (eight CR, four PR). Three of the responders were refractory to prior treatment with rituximab, and two of the responses occurred in patients who had failed an autologous stem cell transplant. Median duration of response was 12 months. Most toxicities were low grade and reversible. In conclusion, oblimersen sodium can be safely combined with rituximab. The combination appears to be most beneficial in patients with indolent NHL and warrants further investigation in a large randomized trial.
authors.affiliation: Department of Lymphoma/Myeloma, MD Anderson Cancer Center, Houston, TX, USA. bpro@mdanderson.org
authors.forename: Barbara
authors.initials: B
authors.lastname: Pro
authors.forename: Brian
authors.initials: B
authors.lastname: Leber
authors.forename: Mitchell
authors.initials: M
authors.lastname: Smith
authors.forename: Luis
authors.initials: L
authors.lastname: Fayad
authors.forename: Jorge
authors.initials: J
authors.lastname: Romaguera
authors.forename: Fredrick
authors.initials: F
authors.lastname: Hagemeister
authors.forename: Alma
authors.initials: A
authors.lastname: Rodriguez
authors.forename: Peter
authors.initials: P
authors.lastname: McLaughlin
authors.forename: Felipe
authors.initials: F
authors.lastname: Samaniego
authors.forename: James
authors.initials: J
authors.lastname: Zwiebel
authors.forename: Adriana
authors.initials: A
authors.lastname: Lopez
authors.forename: Larry
authors.initials: L
authors.lastname: Kwak
authors.forename: Anas
authors.initials: A
authors.lastname: Younes