TY - JOUR
T1 - Ofatumumab is safe and effective as front-line treatment in older patients with chronic lymphocytic leukemia and severe co-morbidities, including other malignancies
AU - Vitale, Candida
AU - Falchi, Lorenzo
AU - Ciccone, Maria
AU - Burger, Jan
AU - Pemmaraju, Naveen
AU - Borthakur, Gautam
AU - Wierda, William G.
AU - Keating, Michael J.
AU - Ferrajoli, Alessandra
N1 - Publisher Copyright:
© 2019
PY - 2020/1
Y1 - 2020/1
N2 - 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.
AB - 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.
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U2 - 10.1016/j.jgo.2019.04.002
DO - 10.1016/j.jgo.2019.04.002
M3 - Article
C2 - 31005650
AN - SCOPUS:85064323505
SN - 1879-4068
VL - 11
SP - 19
EP - 23
JO - Journal of Geriatric Oncology
JF - Journal of Geriatric Oncology
IS - 1
ER -