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Bendamustine more effec.than chlorambucil for adv. Chronic Lymphocytic Leukemia (CLL)

Posted 08-21-2009 at 06:20 PM by admin
HemOnc today
August 20, 2009

Bendamustine treatment demonstrated better overall response rate and PFS than chlorambucil treatment in previously untreated patients with advanced CLL.

Researchers conducted a phase-3 multicenter study and randomly assigned 319 patients IV bendamustine (Treanda, Cephalon) 100 mg/m2 per day on days one to two, or chlorambucil (Leukeran, Smithkline Beecham) 0.8 mg/kg orally on days one and 15. Every four weeks, treatment cycles were repeated for a maximum of six cycles.

Overall, 68% of 162 patients in the bendamustine group and 31% of 157 patients in the chlorambucil group had complete or partial response (P<.0001).

More patients treated with bendamustine (31%) had complete response vs. patients treated with chlorambucil (2%). Additionally, 11% of patients in the bendamustine group had nodular partial response compared with 3% of patients in the chlorambucil group.

Among patients with Binet stage C disease, 20% treated with bendamustine demonstrated complete response, whereas no patients treated with chlorambucil did.

The bendamustine group demonstrated a higher median PFS rate (21.6 months) compared with the chlorambucil group (8.3 months; P<.0001); this difference was observed in patients with both Binet stage B and C disease.

The median duration of response was 21.8 months in patients treated with bendamustine and only eight months in patients treated with chlorambucil.

Grade-3 or -4 severe infections were noted in 8% of patients in the bendamustine group and in 3% of patients in the chlorambucil group.

Knauf WU. J Clin Oncol. 2009;doi:10.1200/JCO.2008.20.8389.


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