Bendamustine Plus Rituximab Offers New Standard of Care for Treatment of NHL and Indolent Lymphoma

NEW ORLEANS—There was good news at ASH 2009 on promising treatments for indolent lymphoma and aggressive non-Hodgkin's lymphoma. Also, a separate poster presentation showed that even just one cycle of postremission therapy extended survival in elderly patients with acute myeloid leukemia.

Bendamustine/Rituximab for Indolent Lymphoma

Bendamustine (Treanda) plus rituximab(Drug information on rituximab) (Rituxan) was better tolerated and improved progression-free survival (PFS) compared with standard CHOP plus rituximab (CHOP-R) as first-line therapy for indolent lymphoma in a multicenter, randomized, controlled trial conducted by the German Study Group on Indolent Lymphoma (StiL).

“This study is potentially practice-changing,” said Mathias J. Rummel, MD, head of the department of hematology at Hospital of the Justus-Liebig, University of Giessen in Giessen, Germany.

The study included 549 symptomatic patients (splenomegaly, pain, large tumor burden) enrolled at 82 centers, with a median age of 64 years. Patients were randomized to either bendamustine plus rituximab (B/R) or CHOP-R. Of these, 513 patients were evaluable for toxicity and efficacy. Histologies were distributed equally between B/R and CHOP-R:

B/R

• 55% had follicular lymphoma

• 18% had mantle cell lymphoma (MCL)

• 27% had other indolent lymphomas

CHOP-R

• 56% had follicular lymphoma

• 19% had MCL

• 24% had other indolent lymphomas

MCL is not considered indolent but was included because it is not curable with standard therapy, according to Dr. Rummel's group (abstract 405).

B/R caused significantly less hematologic toxicity (grades 3 and 4 leukocytopenia, neutropenia, and need for growth factor support with granulocyte colony-stimulating factor; P < .0001 for all comparisons). Alopecia did not occur in patients treated with bendamustine, whereas most patients treated with CHOP-R lost their hair. A much smaller percentage of patients in the B/R arm than in the CHOP-R arm experienced paresthesias, stomatitis, skin reactions, infectious complications, and sepsis.

Overall response rate (ORR) was similar for the two regimens: 92.7% for B/R and 91% for CHOP-R. Complete response (CR) occurred in more patients in the B/R arm than in the CHOP-R arm (39.6% vs 30%, respectively), and this translated to significantly better PFS at a median of 54.9 months for B/R vs 34.8 months for CHOP-R (P = .00012). Median follow up in this study thus far is 34 months.