May 2013, Vol 4 No 3
Safety of Bendamustine in Chronic Lymphocytic Leukemia and Non-Hodgkin LymphomaUncategorized
The previous articles have outlined the clinical outcomes of clinical trials evaluating bendamustine in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). The third in the series of articles discusses the short-term toxicities of bendamustine from these clinical trials.
Patients with CLL are always a challenge to treat due to their underlying immune suppression. Compared with chlorambucil, patients receiving bendamustine had higher rate of grade 3/4 neutropenia – 43% versus 21%. Grade 3/4 thrombocytopenia was almost identical – 10% for chlorambucil and 11% for bendamustine, and the infection rate was similar in the 2 arms. Nonhematologic toxicities were also similar between the arms. With similar toxicities but an improved response rate, bendamustine has become a frequently used alternative for patients with CLL.
In patients with indolent NHL, the pooled safety data showed the most common serious adverse events to be febrile neutropenia and pneumonia. Other grade 3/4 adverse events of note were fatigue (11%), hypokalemia (5%), and dehydration (5%). Varicella zoster reactivation was seen in 11% of patients who did not take antiviral prophylaxis but was controlled in those who did take it. Patients with prior purine analogue therapy had an increased risk of grade 3/4 neutropenia (41% vs 29%). Appropriate prophylactic antibiotics do need to be used in patients receiving bendamustine.
Infections are common in patients with CLL and NHL despite aggressive supportive care such as neupogen or neulasta and prophylactic antibiotics. If a patient has been heavily pretreated, has a lower neutrophil count, or has a bad performance status, a first-cycle dose reduction of bendamustine should be considered. A high level of suspicion for cytopenias and infectious complications should be maintained for patients receiving bendamustine. Other more rare complications include infusion reaction, rash, or tumor lysis. Because bendamustine does damage DNA, there is the potential for secondary malignancies as well. However, when weighing the risk/benefit ratio, bendamustine is a beneficial drug for many patients with CLL and NHL.
Chronic Lymphocytic Leukemia Bendamustine is approved for single-agent use in chronic lymphocytic leukemia (CLL) based on the result from a phase 3 trial comparing bendamustine and chlorambucil.1 Progression-free survival was 18 months in the bendamustine group versus 6 months in the chlorambucil group. Bendamustine 100 mg/m2 was administered on days [ Read More ]
This is the third article in a 4-part series on bendamustine. While the previous article discussed the efficacy of bendamustine for patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) in the registration studies cited in the US product labeling, this article discusses its safety.1 The next article in [ Read More ]