Research Paper on Results from an Italian Phase IIIb Study show that subcutaneous Rituximab is safe and effective in previously untreated patients with CD20+ diffuse large B-cell lymphoma or follicular lymphoma.

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Title: Results from an Italian Phase IIIb Study show that subcutaneous Rituximab is safe and effective in previously untreated patients with CD20+ diffuse large B-cell lymphoma or follicular lymphoma.

Abstract: When compared to the intravenous (IV) form, subcutaneous (SC) rituximab may be more convenient and tolerable with potential for fewer and milder administration-related reactions (ARRs). The findings of a phase IIIb study carried out in Italy are presented in the IS report. Adult patients with CD20+ DLBCL or FL who had received at least one complete dose of IV RTX 375 mg/m2 during induction or maintenance were included in the study. Patients on induction received RTX SC 1400 mg plus standard chemotherapy for approximately 4 cycles, and FL patients on maintenance received RTX SC for approximately 6 cycles. A total of 159 patients (73 DLBCL and 86 FL) were enrolled; 103 (54 DLBCL and 49 FL) successfully completed the induction phase, and 42 patients with FL successfully completed 12 maintenance cycles. ARRs were reported in 10 patients (6.3%), of whom 7 (8.1%) had FL and 3 (4.2%) had DLBCL. All of the mildly severe ARRs were resolved without the need for dose adjustments or discontinuation. 41 patients (25.9%) experienced treatment-emergent adverse events (TEAEs), and 14 patients (8.9%) experienced serious adverse events. Two DLBCL patients died as a result of septic shock and a rituximab-related Klebsiella infection (related to chemotherapy). The most frequent TEAE associated with treatment was neutropenia (14 patients, 8.9%). Six FL patients (7.0%) and two DLBCL patients (2.8%) stopped taking rituximab because of TEAEs. Complete response (CR) and CR unconfirmed were observed in 65.2% and 69.7% of DLBCL patients and 67.9% and 73.6% of FL patients, respectively. Due to the low rate of events, it was impossible to estimate the median time to events (EFS, PFS, and OS). EFS, PFS, and OS were respectively 70.8%, 70.8%, and 80.6% in patients with DLBCL and 77.9%, 77.9%, and 95.3% in patients with FL at a median follow-up of 29.5 and 47.8 months in those with DLBCL and FL, respectively. In patients with DLBCL and FL, switching from IV to SC rituximab was associated with a low risk of ARRs and a good response in both groups. The trial was cataloged as NCT01987505.

Paper Quality: SCOPUS / Web of Science Level Research Paper

Subject: Medicine

Sub Category: Hematology

Writer Experience: 20+ Years

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