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Efficacy and safety of obinutuzumab in the frontline treatment of CLL patients with comorbidities: The real-world results of Polish Adult Leukemia Group (PALG) retrospective analysis.

Abstract

e19513
Background: The current first-line treatment for fit chronic lymphocytic leukemia (CLL) patients remains fludarabine-based therapy. Elderly patients with numerous comorbidities, poorly tolerate such regimen and pose a huge challenge. In our analysis, we investigated the efficacy and safety obinutuzumab-chlorambucil combination in elderly and unfit patients. Methods: We include in our analysis 86 elderly (median age 74), treatment-naïve CLL patients with significant burden of coexisting comorbidities. All patients presented the Cumulative Illness Rating Scale (CIRS) score greater than 6 and/or creatinine clearance (CrCl) of 30–69 ml/min. Obinutuzumab was infused intravenously at 1000 mg on days 1, 8 and 15 of cycle 1 and on day 1 of cycles 2–6 (28-day cycles) with first infusion split over 2 days for patients’ safety. Chlorambucil was administered orally at a dose of 0.5 mg per kilogram of body weight on days 1 and 15 of each cycle. Results: Overall response rate (ORR) at 2 months after treatment completion was 95,35% with CR rate of 43,02 % and partial remission (PR) rate of 56,98%. Stable disease (SD) or progressive disease (PD) were not observed after the end of therapy. The median progression free survival (PFS) was 13,05 months. The relapses occurred in 9 patients (10,46%) with 3 patients (3,49%) completing treatment with CR, 3 (3,49%) with PR and another 3 (3,49%) with SD. The most frequent adverse events (AE) were infusion-related reactions (IRR) and neutropenia. Grade 3 IRR occurred in 2,3 % of patients, grade 2 in 12,8% (in 81,8% of patients only during the first infusion of monoclonal antibody). Grade 3 neutropenia was reported in 11,6% of patients, grade 2 in 22,1% with any incidence of febrile neutropenia. There were no AE of grade 4 and 5 or related deaths. Conclusions: Our data confirms that obinutuzumab-chlorambucil is an effective and well-tollerated regimen in untreated CLL patients with coexisting comorbidities.

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Journal of Clinical Oncology
Pages: e19513

History

Published in print: May 20, 2018
Published online: June 01, 2018

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Monika Dlugosz-Danecka
Department of Hematology, Jagiellonian University, Krakow, Poland;
Wojciech Jurczak
Department of Hematology, Jagiellonian University, Krakow, Poland;
Ewa Łątka
Department of Hematology, Jagiellonian University, Krakow, Poland;
Marta Morawska
Exparimental Hematooncology Department, Medical University of Lublin, Lublin, Poland;
Krzysztof Gawroński
Department of Hematology, Military Institute of Medicine, Warsaw, Poland;
Anna Wiśniewska
Department of Oncology and Chemotherapy, Kopernik Memorial Specialist District Hospital, Koszalin, Poland;
Marek Dudziński
Department of Hematology, Clinical District Chopin Memorial Hospital, Rzeszow, Poland;
Ewa Wąsik-Szczepanek
Department of Hematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland;
Ewa Chmielowska
Department of Clinical Oncology, Oncology Centre, Bydgoszcz, UMK in Torun, Bydgoszcz, Poland;
Anna Łabędź
Department of Hematology, Rydygier Memorial Hospital, Krakow, Poland;
Kamil Wdowiak
Department of Internal Medicine and Oncology, Silesian Medical University, Katowice, Poland;
Iwona Hus
Department of Clinical Transplantology, Medical University of Lublin, Lublin, Poland;
Department of Hematology, Jagiellonian University, Krakow, Poland; Exparimental Hematooncology Department, Medical University of Lublin, Lublin, Poland; Department of Hematology, Military Institute of Medicine, Warsaw, Poland; Department of Oncology and Chemotherapy, Kopernik Memorial Specialist District Hospital, Koszalin, Poland; Department of Hematology, Clinical District Chopin Memorial Hospital, Rzeszow, Poland; Department of Hematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland; Department of Clinical Oncology, Oncology Centre, Bydgoszcz, UMK in Torun, Bydgoszcz, Poland; Department of Hematology, Rydygier Memorial Hospital, Krakow, Poland; Department of Internal Medicine and Oncology, Silesian Medical University, Katowice, Poland; Department of Clinical Transplantology, Medical University of Lublin, Lublin, Poland

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Monika Dlugosz-Danecka, Wojciech Jurczak, Ewa Łątka, Marta Morawska, Krzysztof Gawroński, Anna Wiśniewska, Marek Dudziński, Ewa Wąsik-Szczepanek, Ewa Chmielowska, Anna Łabędź, Kamil Wdowiak, Iwona Hus, ASCO Authors' Group.
Journal of Clinical Oncology 2018 36:15_suppl, e19513-e19513

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