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S. Rule et al.
Ltd, Takeda, Celgene, Janssen, and Gilead. AMC does not declare any conflict of interest. OC declares honoraria from F. Hoffmann-La Roche Ltd, Takeda, BMS, Merck, Gilead, and Janssen; consultation or advisory role for F. Hoffmann-La Roche Ltd, Takeda, BMS, Merck, Gilead, and Janssen; research fund- ing from F. Hoffmann-La Roche Ltd, Takeda, Gilead, and AbbVie; and travel and/or accommodation expenses from F. Hoffmann-La Roche Ltd, Takeda, and Janssen. CP declares honoraria from Janssen and Gilead; consultancy or advisory role for Takeda and Celgene and travel and/or accommodation expenses from Gilead. C-MW declares honoraria from F. Hoffmann-La Roche Ltd, Janssen-Cilag, Gilead, and AbbVie; consultation or advisory role for F. Hoffmann-La Roche Ltd, Janssen-Cilag, Gilead, and AbbVie; research funding from F. Hoffmann-La Roche Ltd, Janssen-Cilag, Gilead, and AbbVie; and travel and/or accommodation expenses from F. Hoffmann-La Roche Ltd, Janssen-Cilag, Gilead, and AbbVie. FZ declares honoraria from F. Hoffmann-La Roche Ltd, Janssen-Cilag, Gilead, Celgene, AbbVie, Takeda, and Novartis; consultation or advisory role for Sandoz, F. Hoffmann-La Roche Ltd, Janssen- Cilag, Gilead, Celgene, AbbVie, Takeda, and Novartis; research funding from Celgene and Novartis; and travel and/or accommo- dation expenses from F. Hoffmann-La Roche Ltd, Celgene, AbbVie, Takeda, and Novartis. SR is employed by F. Hoffmann- La Roche Ltd. LMacG, RRT, and SN are employed by F. Hoffmann-La Roche Ltd. MD declares honoraria from Bayer, Celgene, Gilead, Janssen, and F. Hoffmann-La Roche Ltd; con- sultation or advisory role for Acerta, Bayer, Celgene, Gilead, Janssen, Novartis, F. Hoffmann La Roche Ltd, and Sandoz; and
research funding from Celgene, Janssen, Mundipharma, and F. Hoffmann-La Roche Ltd.
Contributions
SR, WGB, JB, AMC, OC, CP, C-MW, FZ and MD were involved in accrual and treatment of patients. SR analyzed data. All authors were involved in interpreting the data, critically reviewing the manuscript, approved the manuscript for submis- sion and agree to be accountable for the accuracy and integrity of the study.
Funding
MabCute was sponsored by F. Hoffmann-La Roche Ltd. Third-party medical writing assistance, under the direction of Simon Rule and Martin Dreyling, was provided by Christopher Dunn and Scott Malkin of Ashfield MedComms, an Ashfield Health company, and was funded by F. Hoffmann-La Roche Ltd.
Data-sharing statement
Qualified researchers may request access to individual patient level data through the clinical study data request platform (https://vivli.org/). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmem- bers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_a re_how_we_work/clinical_trials/our_commitment_to_data_shar ing.htm
References
1. Ninkovic S, Lambert J. Non-Hodgkin lym- phoma. Medicine. 2017;45(5):297-304.
2. Shankland KR, Armitage JO, Hancock BW. Non-Hodgkin lymphoma. Lancet. 2012;380 (9844):848-857.
3.Dreyling M, Ghielmini M, Rule S, et al. Newly diagnosed and relapsed follicular lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and fol- low-up. Ann Oncol. 2021;32(3):298-308.
4. Kastritis E, Leblond V, Dimopoulos MA, et al. Waldenström’s macroglobulinaemia: ESMO Clinical Practice Guidelines for diag- nosis, treatment and follow-up†. Ann Oncol. 2018;29(Suppl 4):iv41-iv50.
5. Tilly H, Gomes da Silva M, Vitolo U, et al. Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diag- nosis, treatment and follow-up. Ann Oncol. 2015;26(Suppl 5):v116-125.
6. Zelenetz AD, Gordon LI, Abramson JS, et al. NCCN guidelines insights: B-cell lym- phomas, version 3.2019. J Natl Compr Canc Netw. 2019;17(6):650-661.
7. Dreyling M, Campo E, Hermine O, et al. Newly diagnosed and relapsed mantle cell lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and fol- low-up. Ann Oncol. 2017;28(Suppl 4):iv62- iv71.
8. Salles G, Barrett M, Foa R, et al. Rituximab in B-cell hematologic malignancies: a review of 20 years of clinical experience. Adv Ther. 2017;34(10):2232-2273.
9. MabThera Summary of Product Characteristics. 2020. (Accessed 27 April, 2021, at https://www.ema.europa.eu/en/docu-
ments/product-information/mabthera-epar-
product-information_en.pdf).
10. Highlights of prescribing information.
Rituxan® (rituximab) injection, for intra- venous use. South San Francisco, CA: Biogen Idec, Inc. and Genentech USA, Inc.; 2019 September.
11. Yelvington BJ. Subcutaneous rituximab in follicular lymphoma, chronic lymphocytic leukemia, and diffuse large B-cell lym- phoma. J Adv Pract Oncol. 2018;9(5):530- 534.
12. Davies A, Berge C, Boehnke A, et al. Subcutaneous rituximab for the treatment of B-cell hematologic malignancies: a review of the scientific rationale and clinical develop- ment. Adv Ther. 2017;34(10):2210-2231.
13. Davies A, Merli F, Mihaljevic B, et al. Pharmacokinetics and safety of subcuta- neous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study. Lancet Oncol. 2014;15(3):343- 352.
14.Davies A, Merli F, Mihaljevic B, et al. Efficacy and safety of subcutaneous ritux- imab versus intravenous rituximab for first-line treatment of follicular lymphoma (SABRINA): a randomised, open-label, phase 3 trial. Lancet Haematol. 2017;4(6): e272-e282.
17.
18.
19.
lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non- inferiority trial. Lancet Haematol. 2016;3(3): e128-138.
Rummel M, Kim TM, Aversa F, et al. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017;28(4):836-842.
De Cock E, Kritikou P, Sandoval M, et al. Time savings with rituximab subcutaneous injection versus rituximab intravenous infu- sion: a time and motion study in eight coun- tries. PLoS One. 2016;11(6):e0157957. Highlights of prescribing information: Rituxan HycelaTM (rituximab and hyaluronidase human) injection, for subcu- taneous use. San Francisco, CA: Genentech, Inc. 2017.
15.
16.
Lugtenburg P, Avivi I, Berenschot H, et al. Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophos- phamide, doxorubicin, vincristine, and pred- nisone in first-line diffuse large B-cell lym- phoma: the randomized MabEase study. Haematologica. 2017;102(11):1913-1922. Assouline S, Buccheri V, Delmer A, et al. Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic
20.Schneider T, Rosta A, Losonczy H, et al. Efficacy and tolerability of a 2-year ritux- imab maintenance therapy in patients with advanced follicular lymphoma after induc- tion of response with rituximab-containing first line-regimens (HUSOM Study). Pathol Oncol Res. 2018;24(2):199-205.
21. Salles G, Seymour JF, Offner F, et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, ran- domised controlled trial. Lancet. 2011;377 (9759):42-51.
22. Forstpointner R, Dreyling M, Repp R, et al. The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitox- antrone (FCM) significantly increases the response rate and prolongs survival as com-
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