Original articles

Efficacy and safety of the obinutuzumab-chlorambucil combination in the frontline treatment of elderly CLL patients with comorbidities – Polish Adult Leukemia Group (PALG) real-life analysis

Monika Długosz-Danecka, Wojciech Jurczak, Ewa Łątka-Cabała, Marta Morawska, Krzysztof Gawroński, Anna Wiśniewska, Marek Dudziński, Ewa Wąsik-Szczepanek, Ewa Chmielowska, Anna Łabędź, Kamil Wdowiak, Iwona Hus
Published online: July 11, 2018
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Introduction Fludarabine- or bendamustine‑based upfront immunochemotherapy is the current standard of care in fit patients with chronic lymphocytic leukemia (CLL). These regimens are poorly tolerated by patients with comorbidities, for whom the obinutuzumab–chlorambucil combination became the recommended first‑line treatment.
Objectives We aimed to analyze real‑life experience with the obinutuzumab–chlorambucil combination as the frontline treatment in elderly and unfit patients.
Patients and methods The retrospective analysis included 86 elderly patients (median age, 74 years) with CLL and a significant burden of comorbidities, treated with obinutuzumab–chlorambucil as the frontline regimen. All patients had a Cumulative Illness Rating Scale score greater than 6 and/or creatinine clearance of 30 to 69 ml/min.
Results Overall response rate at 2 months after treatment completion was 95.3%, with complete remission (CR) rate of 43% and partial remission (PR) rate of 52.3%. Stable disease rate was 4.7%. Progressive disease was not observed after treatment completion. The median progression‑free survival (PFS) was not reached after a median follow‑up of 18 months; estimated PFS at 30 months was 62%. We observed 6 relapses (7%), 3 (3.5%) in patients obtaining CR, and 3 (3.5%) in those with PR after immunochemotherapy. The most frequent adverse events were neutropenia and infusion‑related reactions (IRRs). Grade-3 neutropenia occurred in 11.6% of patients, and grade-3 IRRs, in 2.3%. There were no adverse events of grade 4 or 5.
Conclusions Our data confirm that the obinutuzumab–chlorambucil combination is an effective and well‑tolerated regimen in untreated CLL patients with comorbidities.

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