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Ofatumumab is safe and effective as front-line treatment in older patients with chronic lymphocytic leukemia and severe co-morbidities, including other malignancies.

Abstract：

BACKGROUND:The majority of patients with chronic lymphocytic leukemia (CLL) are older and have multiple comorbidities, including other cancer diagnoses. These patients are routinely excluded from participation in clinical trials. OBJECTIVE:In this phase II study, we determined the activity and toxicity of ofatumumab, a fully human anti-CD20 monoclonal antibody, in older patients with CLL, poor performance status and comorbidities. METHODS:Treatment-naïve patients with CLL aged ≥65 years with an ECOG performance status of 2-3 or Charlson comorbidity index ≥2 were eligible. Ofatumumab was administered intravenously weekly for the first month, then monthly for a total of 12 months. RESULTS:Thirty-four patients were enrolled. Median age was 73 years, and 29% had another cancer diagnosis. Among 32 patients evaluable for response, the overall response rate was 72%. We observed complete responses in 19% of patients and partial responses in 53%. The median progression-free survival duration was 21 months, and the estimated proportion of patients alive at 36 months was 87%. All 34 patients were evaluable for toxicity. Treatment was well tolerated, with infusion-related reactions being the most common treatment-related adverse event. Only one patient had a grade 3 infection. Additional grade 3 adverse events that may have been related to ofatumumab were diarrhea, nausea/vomiting, hyperglycemia, pulmonary embolism, and hypersensitivity reaction, each in one patient. No grade 4 adverse events were observed. CONCLUSION:Single-agent ofatumumab is a well-tolerated and effective therapeutic approach for treatment-naïve older patients with CLL; it can be safely administered to patients with significant comorbidities and other cancer diagnoses.

journal_name

J Geriatr Oncol

journal_title

Journal of geriatric oncology

authors

Vitale C,Falchi L,Ciccone M,Burger J,Pemmaraju N,Borthakur G,Wierda WG,Keating MJ,Ferrajoli A

doi

10.1016/j.jgo.2019.04.002

subject

Has Abstract

pub_date

2020-01-01 00:00:00

pages

19-23

issue

eissn

1879-4068

issn

1879-4076

pii

S1879-4068(19)30033-5

journal_volume

pub_type

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Ofatumumab is safe and effective as front-line treatment in older patients with chronic lymphocytic leukemia and severe co-morbidities, including other malignancies.