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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)
- Source :
- Annals of Oncology. 28:836-842
- Publication Year :
- 2017
- Publisher :
- Elsevier BV, 2017.
-
Abstract
- 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).
- Subjects :
- Adult
Male
Oncology
Bendamustine
medicine.medical_specialty
Vincristine
Population
Follicular lymphoma
Antineoplastic Agents
Pharmacology
CHOP
Infusions, Subcutaneous
03 medical and health sciences
0302 clinical medicine
immune system diseases
Prednisone
hemic and lymphatic diseases
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Prospective Studies
030212 general & internal medicine
Infusions, Intravenous
education
Lymphoma, Follicular
Aged
education.field_of_study
Cross-Over Studies
business.industry
Patient Preference
Hematology
Middle Aged
medicine.disease
030220 oncology & carcinogenesis
Female
Rituximab
Lymphoma, Large B-Cell, Diffuse
business
Diffuse large B-cell lymphoma
medicine.drug
Subjects
Details
- ISSN :
- 09237534
- Volume :
- 28
- Database :
- OpenAIRE
- Journal :
- Annals of Oncology
- Accession number :
- edsair.doi.dedup.....4270cefabcac7cf5547af06b43cb9b65