Low-dose fludarabine and cyclophosphamide combined with rituximab (FCR) was found to be safe and effective as first-line treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in elderly patients or those with comorbid conditions, according to the results of a prospective observational study published in the British Journal of Haematology.
A total of 107 patients with CLL or SLL who could not receive full-dose FCR participated in the study (ClinicalTrials.gov Identifier: NCT02156726), which was conducted by the Czech CLL Study Group. Low-dose FCR was administered to 107 patients; 102 had CLL and 5 had SLL.
The study population had a median age of 70 years, median Cumulative Illness Rating Scale score of 5, and median creatinine clearance of 69 mL/min. Most patients (77%) had unfavorable biological prognostic factors.
Overall, 56% of patients had grade 3 or 4 neutropenia, and a minority had grade 3 or 4 thrombocytopenia (10%) or anemia (7%). Grade 3 to 5 infections were seen in 15% of patients. Most patients finished at least 4 treatment cycles; the median number of cycles completed was 6 (range, 1-6).
Patients lived for a median of 29 months without disease progression, and patients with favorable biologic prognostic factors lived even longer without disease progression. Specifically, patients with a mutated immunoglobulin heavy-chain variable-region gene (IGHV) lived a median of 53 months without disease progression, and patients without del(11q) or del(17p) lived a median of 74 months.
The study population had a median overall survival of 59 months and an overall response rate of 81%.
The study authors concluded that low-dose FCR is a “well-tolerated” and “effective” first-line regimen for CLL or SLL in selected elderly patients and those with comorbid conditions with favorable biologic prognostic factors.
Smolej L, Brychtová Y, Cmunt E, et al. Low-dose fludarabine and cyclophosphamide combined with rituximab in the first-line treatment of elderly/comorbid patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL): long-term results of project Q-lite by the Czech CLL Study Group. Br J Haematol. Published online February 22, 2021. doi:10.1111/bjh.17373