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

Candida Vitale, Lorenzo Falchi, Maria Ciccone, Jan Burger, Naveen Pemmaraju, Gautam Borthakur, William G. Wierda, Michael J. Keating, Alessandra Ferrajoli

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)19-23
Number of pages5
JournalJournal of Geriatric Oncology
Volume11
Issue number1
DOIs
StatePublished - Jan 2020

ASJC Scopus subject areas

  • Oncology
  • Geriatrics and Gerontology

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