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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)
Open accessAbstract
Background The aim of this study was to evaluate patient preference and satisfaction for the subcutaneous (s.c.) versus intravenous (i.v.) formulation of rituximab given with chemotherapy in previously untreated patients with CD20+ diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL).Patients and methods Patients received eight cycles of rituximab according to 2 schedules: Arm A received 1 cycle rituximab i.v. (375 mg/m2) and 3 cycles rituximab s.c. (1400 mg) then 4 cycles rituximab i.v.; Arm B received 4 cycles rituximab i.v. (375 mg/m2) then 4 cycles rituximab s.c. (1400 mg). Alongside rituximab, both arms received 6-8 cycles of chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP), cyclophosphamide, vincristine, prednisone (CVP), or bendamustine as per standard local practice). Preference for s.c. or i.v. administration was evaluated using the Patient Preference Questionnaire (PPQ) at cycles 6 and 8. Patient satisfaction and convenience were assessed using the Cancer Therapy Satisfaction Questionnaire (CTSQ), and Rituximab Administration Satisfaction Questionnaire (RASQ) at cycles 4 and 8.Results At the primary data cut-off (19 January 2015), the intent-to-treat population comprised 743 patients. The majority had DLBCL (63%) and baseline characteristics were balanced between arms. At cycle 8, 81% of patients completing the PPQ preferred rituximab s.c. Preference was not impacted by treatment sequence or disease type. Patient satisfaction as measured by RASQ was higher for s.c. versus i.v. CTSQ scores were similar between arms. Adverse events were generally balanced between administration routes and no new safety signals were detected.Conclusion Most previously untreated patients with CD20+ DLBCL or FL preferred s.c. to i.v. rituximab administration. Patient satisfaction with rituximab treatment was generally greater with s.c. administration.Registered clinical trial number NCT01724021 (ClinicalTrials.gov).
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“The most common reasons for the preference were less time required in the clinic and increased comfort with subcutaneous administration [55].”
From Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities (2018) · cites this paper as [55]
In the citing paper
“The majority of patients preferred subcutaneous over intravenous rituximab therapy, regardless of whether they received subcutaneous rituximab during the first or second part of the study; 79–81% expressed an overall preference for subcutaneous administration at cycle 6 and 77–84% at cycle 8.”
From Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities (2018) · cites this paper as [55]
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Research works printed but not linked: 2
- Lugtenburg, 2015, Subcutaneous versus intravenous rituximab in combination with CHOP for previously untreated diffuse large B-cell lymphoma: efficacy and safety results from the phase IIIB MABEASE study, Haematologica, 100, S483
- Lugtenburg, 2015, Patient preference with subcutaneous vs intravenous rituximab combined with CHOP for untreated diffuse large B-cell lymphoma: results from the phase IIIb MABEASE study, Hematol Oncol, 33, A383
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Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities
Bittner, B., Richter, W., & Schmidt, J. (2018) · BioDrugs · doi:10.1007/s40259-018-0295-0 · Cited by 447
Tan, A. R., Im, S., Mattar, A. P. L., Colomer, R., Stroyakovskiy, D., Nowecki, Z. I., Laurentiis, M. D., Pierga, J., Jung, K. H., Schem, C., et al. (2020) · The Lancet Oncology · doi:10.1016/s1470-2045(20)30536-2 · Cited by 186
Locke, K. W., Maneval, D. C., & LaBarre, M. J. (2019) · Drug Delivery · doi:10.1080/10717544.2018.1551442 · Cited by 177
Anti-CD20 monoclonal antibodies: reviewing a revolution
Casan, J. M. L., Wong, J., Northcott, M., & Opat, S. (2018) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2018.1508624 · Cited by 139
Badkar, A. V., Gandhi, R. B., Davis, S. P., & LaBarre, M. J. (2021) · Drug Design Development and Therapy · doi:10.2147/dddt.s287323 · Cited by 133
Metadata
- Authors
- Rummel, M., Kim, T. M., Aversa, F., Brugger, W., Capochiani, E., Plenteda, C., Re, F., Trask, P., Osborne, S., Smith, R., & Grigg, A.
- Affiliations
- Universitätsklinikum Gießen und Marburg (DE)
- Seoul National University Hospital (KR)
- University of Parma (IT)
- University of Freiburg (DE)
- Ospedale di Livorno (IT)
- Genentech (US)
- F. Hoffmann-La Roche AG (CH)
- Austin Hospital (AU)
- Corresponding author
- Rummel, M.
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2017-04
- Volume
- 28
- Issue
- 4
- Pages
- 836-842
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2566995909
- Cited by
- 154
- References
- 15
- Citations by year
- 2026: 16 · 2025: 30 · 2024: 20 · 2023: 18 · 2022: 10 · 2021: 22 · 2020: 9 · 2019: 11 · 2018: 10 · 2017: 7
- FWCI
- 8.77
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- F. Hoffmann-La Roche Ltd
- Topics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
- Health Sciences › Medicine › Hematology › Chronic Lymphocytic Leukemia Research
- Health Sciences › Medicine › Oncology › Neutropenia and Cancer Infections
- Keywords
- rituximab, subcutaneous administration, intravenous administration, patient preferences, patient satisfaction, diffuse large B-cell lymphoma, follicular lymphoma, CD20-positive lymphoma, CHOP chemotherapy, bendamustine, treatment-naive patients, crossover trial, adverse events
- MeSH terms
- Rituximab, Adult, Aged, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Infusions, Intravenous, Lymphoma, Follicular, Male, Middle Aged, Prospective Studies, Lymphoma, Large B-Cell, Diffuse, Cross-Over Studies, Infusions, Subcutaneous, Patient Preference
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