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Title: Zevalin Used in Abbreviated Chemotherapy Regimen Shows Efficacy for Follicular Non-Hodgkin's Lymphoma: Presented at ASH

"Zevalin Used in Abbreviated Chemotherapy Regimen Shows Efficacy for Follicular Non-Hodgkin's Lymphoma: Presented at ASH"

By Bruce Sylvester ATLANTA, GA -- December 16, 2005 -- Three cycles of CHOP-rituximab (CHOP-R) followed by ibritumomab tiuxetan (Zevalin) and rituximab induces a high rate of clinical remission (CR/CRu) among patients with previously untreated follicular non-Hodgkin's lymphoma (NHL). CHOP-R comprises a combination of rituximab (Mabthera), cyclophosphamide, doxorubicin, (Adriamycin), vincristine (Oncovin), and prednisolone. At the 47[^th Annual Meeting of the American Society of Hematology (ASH), study researcher Samuel Jacobs, MD, clinical professor of medicine, University of Pennsylvania, Pittsburgh, Pennsylvania, reported the phase 2 study that evaluated the abbreviated regimen.

"This trial suggests that this new regimen could become successful as an initial therapy," Dr. Jacobs said in his poster presentation here on December 11^th.

Previous research demonstrated that CHOP-R and radioimmunotherapy (RIT) is effective in the treatment of follicular NHL. The combination of these agents as initial therapy has shown promising results (Hainsworth et al. Proc ASCO. 2005;23:Abstract 6577).

In their single-institution, nonrandomized, phase 2 study, Dr. Jacobs and colleagues evaluated the safety and efficacy of abbreviated CHOP-R followed by Zevalin and rituximab as initial therapy. "The rationale for following Zevalin with additional rituximab includes the potential beneficial effect of extended therapy and the possible vaccinal effect (Cartron et al. Blood. 2004;104:2635)," the researchers explained in their poster.

Subjects were eligible for enrollment in the study if they had CD20-positive follicular NHL, grade 1 to 3, stage II to IV, no prior treatment with monoclonal antibody or chemotherapy, and symptomatic disease.

CHOP-R was given in standard doses every 21 days for 3 cycles. Four weeks after the last dose of CHOP-R, investigators administered the Zevalin regimen. One week after Zevalin treatment, the subjects receive rituximab 375 mg/m² 4 times weekly for 4 doses.

Bone marrow examination and fusion positron emission tomography -- computed tomography CT scans were performed at baseline, after CHOP-R, and 12 weeks after RIT.

At the planned interim analysis after accrual of 19 patients, 8 patients with follicular NHL had completed therapy and follow-up studies and were evaluable. Of these, 2 were grade 1, 3 were grade 2, and 3 were grade 3. Four subjects had stage III disease and half had stage IV. Median age was 59 (range 45-77).

After 3 cycles of CHOP-R, the overall response rate was 75%, with a complete remission in 2 of the 8 subjects. After treatment with Zevalin and rituximab, 7 of 8 subjects (87.5%) achieved a complete remission (CR/CRu with negative PET scan).

"If remission sticks, radioimmunotherapy will be used earlier and not just on relapsed or refractory patients," Dr. Jacobs said.

"This trial continues to accrue patients, and additional time is needed to determine the duration of response and time to next therapy," the authors noted.

The study was supported by Biogen Idec, Inc.

[Presentation title: Phase II Trial of Abbreviated CHOP-Rituximab Followed by 90Y Ibritumomab Tiuxetan (Zevalin) and Rituximab in Patients With Previously-Untreated Follicular Non-Hodgkin Lymphoma (NHL). Abstract 2449]

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