Early efficacy and safety of obinutuzumab with chemotherapy in previously untreated patients with follicular lymphoma: A real-world retrospective report of the Polish Lymphoma Research Group.


Journal

Advances in clinical and experimental medicine : official organ Wroclaw Medical University
ISSN: 1899-5276
Titre abrégé: Adv Clin Exp Med
Pays: Poland
ID NLM: 101138582

Informations de publication

Date de publication:
Jan 2023
Historique:
pubmed: 6 1 2023
medline: 2 2 2023
entrez: 5 1 2023
Statut: ppublish

Résumé

The first-line obinutuzumab-based immunochemotherapy improves the outcome of patients with follicular lymphoma (FL) compared with rituximab-based regimens. However, infusion-related reactions occur in almost half of patients during the 1st obinutuzumab administration. The study aimed to evaluate the early effectiveness and safety of obinutuzumab-based induction regimens in a real-world setting. Outcomes of patients diagnosed with FL and treated with obinutuzumab between January 2020 and September 2021 were analyzed. The study group included 143 treatment-naïve patients with FL. The median age was 52 years (range: 28-89 years); 45.1% of patients had a high-risk disease as assessed using the Follicular Lymphoma International Prognostic Index (FLIPI). Induction chemotherapy included: O-CVP (obinutuzumab, cyclophosphamide, vincristine, prednisolone) in 49.0% of patients, O-CHOP (O-CVP plus doxorubicin) in 28.7% and O-BENDA (obinutuzumab, bendamustine) in 22.4%. Complete response (CR) and partial response (PR) rates were 69.9% and 26.5%, respectively. There was no difference in response rates between different regimens (p = 0.309). Maintenance was started in 115 patients (85.2%). In the 1st cycle, obinutuzumab was administered as a single 1000-milligram infusion in 47.9% of patients, whereas in 52.1%, initial infusions were split over 2 days (100 mg/900 mg). Infusion-related reactions were reported only during the 1st administration of obinutuzumab in 9.1% of patients, with a similar incidence in those receiving the total dose on a single day or split over 2 days (p = 0.458). The most common adverse events were hematological. Five patients died from coronavirus disease 2019 (COVID-19). The early responses to induction regimens and adverse events profile were similar for every type of induction treatment. The infusion-related reactions were rare and limited to the 1st dose of obinutuzumab.

Sections du résumé

BACKGROUND BACKGROUND
The first-line obinutuzumab-based immunochemotherapy improves the outcome of patients with follicular lymphoma (FL) compared with rituximab-based regimens. However, infusion-related reactions occur in almost half of patients during the 1st obinutuzumab administration.
OBJECTIVES OBJECTIVE
The study aimed to evaluate the early effectiveness and safety of obinutuzumab-based induction regimens in a real-world setting.
MATERIAL AND METHODS METHODS
Outcomes of patients diagnosed with FL and treated with obinutuzumab between January 2020 and September 2021 were analyzed.
RESULTS RESULTS
The study group included 143 treatment-naïve patients with FL. The median age was 52 years (range: 28-89 years); 45.1% of patients had a high-risk disease as assessed using the Follicular Lymphoma International Prognostic Index (FLIPI). Induction chemotherapy included: O-CVP (obinutuzumab, cyclophosphamide, vincristine, prednisolone) in 49.0% of patients, O-CHOP (O-CVP plus doxorubicin) in 28.7% and O-BENDA (obinutuzumab, bendamustine) in 22.4%. Complete response (CR) and partial response (PR) rates were 69.9% and 26.5%, respectively. There was no difference in response rates between different regimens (p = 0.309). Maintenance was started in 115 patients (85.2%). In the 1st cycle, obinutuzumab was administered as a single 1000-milligram infusion in 47.9% of patients, whereas in 52.1%, initial infusions were split over 2 days (100 mg/900 mg). Infusion-related reactions were reported only during the 1st administration of obinutuzumab in 9.1% of patients, with a similar incidence in those receiving the total dose on a single day or split over 2 days (p = 0.458). The most common adverse events were hematological. Five patients died from coronavirus disease 2019 (COVID-19).
CONCLUSION CONCLUSIONS
The early responses to induction regimens and adverse events profile were similar for every type of induction treatment. The infusion-related reactions were rare and limited to the 1st dose of obinutuzumab.

Identifiants

pubmed: 36603138
doi: 10.17219/acem/157290
doi:

Substances chimiques

obinutuzumab O43472U9X8
Rituximab 4F4X42SYQ6
Cyclophosphamide 8N3DW7272P
Doxorubicin 80168379AG

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

131-136

Auteurs

Ewa Paszkiewicz-Kozik (E)

Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, Poland.

Iwona Hus (I)

Department of Hematology, Institute of Hematology and Transfusion Medicine, Warszawa, Poland.

Monika Palka (M)

Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology, Kraków, Poland.

Małgorzata Dębowska (M)

Department of Mathematical Modeling of Physiological Processes, Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences, Warszawa, Poland.
Department of Computational Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, Poland.

Agnieszka Końska (A)

Department of Hematology, Institute of Hematology and Transfusion Medicine, Warszawa, Poland.

Martyna Kotarska (M)

Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, Poland.

Agata Tyczyńska (A)

Department of Hematology and Transplantology, Medical University of Gdańsk, Poland.

Monika Joks (M)

Department of Hematology and Marrow Transplantation, Poznan University of Medical Sciences, Poland.

Maja Twardosz (M)

Department of Bone Marrow Transplantation and Oncohematology, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice, Poland.

Agnieszka Giza (A)

Department of Hematology, Jagiellonian University Medical College, Kraków, Poland.

Ewa Wąsik-Szczepanek (E)

Department of Hematooncology and Bone Marrow Transplantation, Medical University in Lublin, Poland.

Elżbieta Kalicińska (E)

Department of Hematology, Wroclaw Medical University, Poland.

Anna Wiśniewska (A)

Department of Oncology and Chemotherapy, Nicolas Copernicus State Hospital, Koszalin, Poland.

Marta Morawska (M)

Department of Hematology, St. John's Cancer Center, Lublin, Poland.

Barbara Lewicka (B)

Department of Hematology, Ludwik Rydygier Hospital, Kraków, Poland.

Marcin Szymański (M)

Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, Poland.

Łukasz Targoński (Ł)

Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, Poland.

Joanna Romejko-Jarosińska (J)

Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, Poland.

Joanna Drozd-Sokołowska (J)

Department of Hematology, Transplantation and Internal Diseases, Medical University of Warsaw, Poland.

Edyta Subocz (E)

Department of Hematology, Warmian-Masurian Cancer Center of the Ministry of the Interior and Administration Hospital, Olsztyn, Polan.

Ryszard Swoboda (R)

Department of Bone Marrow Transplantation and Oncohematology, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice, Poland.

Monika Długosz-Danecka (M)

Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology, Kraków, Poland.

Ewa Lech-Maranda (E)

Department of Hematology, Institute of Hematology and Transfusion Medicine, Warszawa, Poland.

Jan Walewski (J)

Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, Poland.

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