The quality of evidence is downgraded by indirectness (direct comparisons not available) and imprecise results.
A Cochrane review [Abstract] 1 included 5 RCTs with a total of 1343 patients to evaluate the efficacy of bendamustine therapy for patients with indolent B cell lymphoid malignancies including chronic lymphatic leukaemia (CLL). Three trials include patients with follicular lymphoma, mantle cell lymphoma and other indolent lymphomas, while 2 trials included only patients with CLL. A meta-analysis could not be performed due to clinical heterogeneity among the trials.
Bendamustine had no statistically significant effect on overall survival (OS) of patients with indolent B cell lymphoid malignancies in three trials (HR 0.93 (95% CI 0.61 to 1.44), HR 0.69 (95% CI 0.43 to 1.11),HR 0.82 (95% CI 0.47 to 1.42) respectively).
Progression-free survival (PFS) was statistically significantly improved with bendamustine treatment compared to other chemotherapy in three of four trials (HR 0.28, 95% CI 0.19 to 0.42 (n = 319); HR 0.91, 95% CI 0.50 to 1.64 (n = 92); HR 0.58, 95% CI 0.43 to 0.77 (n = 513); HR 0.51, 95% CI 0.37 to 0.71 (n = 208), respectively). One trial demonstrated a statistically not significant improvement of PFS. The risk of grade 3 or 4 adverse events was similar when bendamustine was compared to CHOP and fludarabine, and higher when compared to chlorambucil. Compared to chlorambucil quality of life was unaffected by bendamustine treatment (one trial, no meta-analysis).
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