Rituximab subcutaneous in B-cell non-Hodgkin lymphoma: clinical experience in a single center

Sánchez‐González, Blanca; Torres, Eduardo Mateos; Rosset, Mariana Paola Ferraro; Calafell, Montserrat; Gale, Carmen; Martínez, L.; Sancho, Esther; García, P. Peña; Gimeno, Eva; García-Pallarols, Francesc; Salar, Antonio

doi:10.1080/10428194.2017.1349906

Cited by 3 publications

(2 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…With regard to maintenance treatment for FL, the SparkThera trial also supported an acceptable and manageable safety profile, with 31% of patients experiencing ARRs after subcutaneous rituximab injection for up to 2 years, which were mainly mild to moderate, rarely required treatment, and most commonly included erythema (13%), injection site erythema (5%) and myalgia (5%) (Salar et al , ). In addition, a post‐marketing single‐centre assessment of the safety profile of subcutaneous rituximab for B‐cell NHL also supported that most subcutaneous injections administered in daily practice were well‐tolerated, with 39% of patients developing ARRs over 1–7 injections per patient; these were mainly mild reactions that generally resolved without treatment, and included erythema, local pain, haematoma, cellulitis, pruritus and dizziness (Sanchez‐Gonzalez et al, ).…”

Section: Discussionmentioning

confidence: 92%

Safety of switching from intravenous to subcutaneous rituximab during first‐line treatment of patients with non‐Hodgkin lymphoma: the Spanish population of the MabRella study

García‐Muñoz¹,

Quero²,

Pérez‐Persona³

et al. 2019

Br J Haematol

View full text Add to dashboard Cite

Summary Rituximab is a standard treatment for non‐Hodgkin diffuse large B‐cell (DLBCL) and follicular (FL) lymphomas. A subcutaneous formulation was developed to improve the resource use of intravenous rituximab, with comparable efficacy and safety profiles except for increased administration‐related reactions (ARRs). MabRella was a phase IIIb trial to assess the safety of switching from intravenous to subcutaneous administration of rituximab during first‐line induction/maintenance for DLBCL or FL, focusing on ARRs. Efficacy, satisfaction and quality of life were also assessed. Patients received subcutaneous rituximab plus standard induction chemotherapy for DLBCL or FL for 4–7 cycles, and/or every 2 months maintenance monotherapy for FL for 6–12 cycles. The study included 140 patients: DLBCL, n = 29; FL, n = 111. Ninety‐five percent of patients experienced adverse events, reaching grade ≥3 in 38·6% and were serious in 30·0%. AARs occurred in 48·6%, mostly (84·9%) at the injection site, with only 2·1% of patients reaching grade 3. The end‐of‐induction complete/unconfirmed complete response rate was 69·6%. After a median follow‐up of 33·5 months, median disease‐/event‐/progression‐free and overall survivals were not attained. The Rituximab Administration Satisfaction Questionnaire showed improvements in overall satisfaction and the EuroQoL‐5D a good quality‐of‐life perception at induction/maintenance end. Therefore, switching to subcutaneous rituximab showed no new safety issues and maintained efficacy with improved satisfaction and quality of life.

show abstract

Section: Discussionmentioning

confidence: 92%

Safety of switching from intravenous to subcutaneous rituximab during first‐line treatment of patients with non‐Hodgkin lymphoma: the Spanish population of the MabRella study

García‐Muñoz¹,

Quero²,

Pérez‐Persona³

et al. 2019

Br J Haematol

View full text Add to dashboard Cite

show abstract

“…The incidence of ARRs was very low, with 6.3% of patients overall, 4.2% of patients with DLBCL, and 8.1% patients with FL that reported ARRs, which mainly consisted of local adverse effects at the site of injection. This rate was lower than that reported in previous clinical trials with SC rituximab in patients with DLBCL [ 12 ] and FL [ 13 , 14 ], as well as in the postmarketing setting [ 15 ]. Furthermore, all ARRs were of mild intensity and spontaneously resolved without any requirement of changes in rituximab dose or frequency of administration.…”

Section: Discussionmentioning

confidence: 57%

Safety and Efficacy of Subcutaneous Rituximab in Previously Untreated Patients with CD20+ Diffuse Large B-Cell Lymphoma or Follicular Lymphoma: Results from an Italian Phase IIIb Study

Petrini

Gaïdano

Mengarelli

et al. 2022

Advances in Hematology

View full text Add to dashboard Cite

Subcutaneous (SC) rituximab may be beneficial in terms of convenience and tolerability, with potentially fewer and less severe administration-related reactions (ARRs) compared to the intravenous (IV) form. This report presents the results of a phase IIIb study conducted in Italy. The study included adult patients with CD20+ DLBCL or FL having received at least one full dose of IV RTX 375 mg/m2 during induction or maintenance. Patients on induction received ≥4 cycles of RTX SC 1400 mg plus standard chemotherapy and FL patients on maintenance received ≥6 cycles of RTX SC. Overall, 159 patients (73 DLBCL, 86 FL) were enrolled: 103 (54 DLBCL, 49 FL) completed induction and 42 patients with FL completed 12 maintenance cycles. ARRs were reported in 10 patients (6.3%), 3 (4.2%) with DLBCL and 7 (8.1%) with FL, all of mild severity, and resolved without dose delay/discontinuation. Treatment-emergent adverse events (TEAEs) and serious adverse events occurred in 41 (25.9%) and 14 patients (8.9%), respectively. Two patients with DLBCL had fatal events: Klebsiella infection (related to rituximab) and septic shock (related to chemotherapy). Neutropenia (14 patients, 8.9%) was the most common treatment-related TEAE. Two patients with DLBCL (2.8%) and 6 with FL (7.0%) discontinued rituximab due to TEAEs. 65.2% and 69.7% of patients with DLBCL and 67.9% and 73.6% of patients with FL had complete response (CR) and CR unconfirmed, respectively. The median time to events (EFS, PFS, and OS) was not estimable due to the low rate of events. At a median follow-up of 29.5 and 47.8 months in patients with DLBCL and FL, respectively, EFS, PFS, and OS were 70.8%, 70.8%, and 80.6% in patients with DLBCL and 77.9%, 77.9%, and 95.3% in patients with FL, respectively. The switch from IV to SC rituximab in patients with DLBCL and FL was associated with low risk of ARRs and satisfactory response in both groups. This trial was registered with NCT01987505.

show abstract

Rituximab

2019

Reactions Weekly

View full text Add to dashboard Cite

Rituximab subcutaneous in B-cell non-Hodgkin lymphoma: clinical experience in a single center

Cited by 3 publications

References 11 publications

Safety of switching from intravenous to subcutaneous rituximab during first‐line treatment of patients with non‐Hodgkin lymphoma: the Spanish population of the MabRella study

Safety of switching from intravenous to subcutaneous rituximab during first‐line treatment of patients with non‐Hodgkin lymphoma: the Spanish population of the MabRella study

Safety and Efficacy of Subcutaneous Rituximab in Previously Untreated Patients with CD20+ Diffuse Large B-Cell Lymphoma or Follicular Lymphoma: Results from an Italian Phase IIIb Study

Rituximab

Contact Info

Product

Resources

About