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Rituximab versus obinutuzumab-based first-line chemoimmunotherapy for follicular lymphoma—a real-world multicenter retrospective cohort study

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Abstract

The GALLIUM study showed a progression-free survival advantage of 7% in favor of obinutuzumab vs. rituximab-based immunochemotherapies as first-line therapy in follicular lymphoma (FL) patients. Yet, the toxicity appears to be increased with obinutuzumab-based therapy. This is a multicenter retrospective-cohort study including adult FL patients comparing the toxicity of first-line rituximab vs. obinutuzumab-based chemo-immunotherapies (R and O groups, respectively). We compared the best standard-of-care therapy used per time period, before and after obinutuzumab approval. The primary outcome was any infection during induction and 6 months post-induction. Secondary outcomes included rates of febrile neutropenia, severe and fatal infections, other adverse events, and all-cause mortality. Outcomes were compared between groups. A total of 156 patients were included in the analysis, 78 patients per group. Most patients received bendamustine (59%) or CHOP (31.4%) as adjacent chemotherapy. Half of the patients received growth-factor prophylaxis. Overall, 69 patients (44.2%) experienced infections, and a total of 106 infectious episodes were recorded. Patients in the R and O groups had similar rates of any infection (44.8% and 43.5%, p = 1), severe infections (43.3% vs. 47.8%, p = 0.844), febrile neutropenia (15% vs. 19.6%, p = 0.606), and treatment discontinuation, as well as similar types of infections. No covariate was associated with infection in multivariable analysis. No statistically significant difference was evident in adverse events of grades 3–5 (76.9% vs. 82%, p = 0.427). To conclude, in this largest real-life study of first-line treated FL patients comparing R- to O-based therapy, we did not observe any difference in toxicity during the induction and 6 months post-induction period.

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Data availability

The data supporting this study’s findings are available from the corresponding author, TB, upon reasonable request.

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Authors and Affiliations

  1. Institute of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah-Tikva, Israel

    Tamar Berger, Shai Shimony, Pia Raanani, Anat Gafter‑Gvili & Ronit Gurion

  2. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

    Tamar Berger, Ella Shmerts, Uri Abadi, Shai Shimony, Pia Raanani, Anat Gafter‑Gvili & Ronit Gurion

  3. Laboratory of Genome Maintenance, The Rockefeller University, New York, NY, USA

    Tamar Berger

  4. Rabin Medical Center, Bio-Statistical Unit, Beilinson Campus, Petah-Tikva, Israel

    Tzippy Shochat

  5. Department of Hematology, Hadassah Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel

    Shlomzion Aumann, Boaz Nachmias & Neta Goldschmidt

  6. Department of Hematology and Bone Marrow Transplantation, Rambam Health Care Campus, Haifa, Israel

    Nurit Horesh

  7. Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel

    Reut Harel & Ariel Aviv

  8. Hematology Unit, HaEmek Medical Center, Afula, Israel

    Reut Harel & Ariel Aviv

  9. Department of Hematology, Meir Medical Center, Kfar Saba, Israel

    Uri Abadi

  10. Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA

    Shai Shimony

  11. Department of Medicine A, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel

    Anat Gafter‑Gvili

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  1. Tamar Berger
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Contributions

TB, AGG, and RG conceived the presented idea for the study and designed the research study. TB, SA, BN, NG, NH, RH, AA, ES, and UA identified through databases follicular lymphoma patients as potential candidates for the study and collected the data. TB, AGG, RG, and TS analyzed the data. TB, AGG, and RG drafted the manuscript. TB, SS, AGG, and RG contributed to the interpretation of results and, along with AA, PR, and TS, critically revised the paper. All authors approved the submitted and final version of the manuscript.

Corresponding author

Correspondence to Tamar Berger.

Ethics declarations

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Approval was obtained from Rabin Medical Center (RMC) Institutional Review Board (IRB) ethics committee.

Consent to participate

Informed consent was waived due to the retrospective design of the study.

Competing interests

Tamar Berger—Janseen (honoraria, advisory committee), Neopharm (advisory committee).

Boaz Nachmias—AbbVie (consultant, honoraria, research funding).

Pia Raanani—Pfizer (advisory board, consultancy, research support, speaker’s bureau); Novartis (consultancy, research support); BMS (consultancy); Janssen (speaker’s bureau).

Ronit Gurion—Roche, Gilead, Medison Ltd, Novartis, and Takeda (honoraria and advisory committee).

All other authors have no relevant financial or non-financial interests to disclose.

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Berger, T., Shochat, T., Aumann, S. et al. Rituximab versus obinutuzumab-based first-line chemoimmunotherapy for follicular lymphoma—a real-world multicenter retrospective cohort study. Ann Hematol 102, 2127–2136 (2023). https://doi.org/10.1007/s00277-023-05306-2

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