Three-year Follow-up on the Safety and Effectiveness of Rituximab Plus Chemotherapy as First-Line Treatment of Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in Real-World Clinical Settings in China

Abstract

Background:Prospective real-life data on the safety and effectiveness of rituximab in Chinese patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) are limited. This real-world study aimed to evaluate long-term safety and effectiveness outcomes of rituximab plus chemotherapy (R-chemo) as first-line treatment in Chinese patients with DLBCL or FL. Hepatitis B virus (HBV) reactivation management was also investigated.Methods:A prospective, multicenter, single-arm, noninterventional study of previously untreated CD20-positive DLBCL or FL patients receiving first-line R-chemo treatment at 24 centers in China was conducted between January 17, 2011 and October 31, 2016. Enrolled patients underwent safety and effectiveness assessments after the last rituximab dose and were followed up for 3 years. Effectiveness endpoints included progression-free survival (PFS) and overall survival (OS). Safety endpoints were adverse events (AEs), serious AEs, drug-related AEs, and AEs of special interest. We also reported data on the incidence of HBV reactivation.Results:In total, 283 previously untreated CD20-positive DLBCL and 31 FL patients from 24 centers were enrolled. Three-year PFS was 59% (95% confidence interval [CI]: 50–67%) for DLBCL patients and 46% (95% CI: 20–69%) for FL patients. For DLBCL patients, multivariate analyses showed that PFS was not associated with international prognostic index, tumor maximum diameter, HBV infection status, or number of rituximab treatment cycles, and OS was only associated with age >60 years (P < 0.05). R-chemo was well tolerated. The incidence of HBV reactivation in hepatitis B surface antigen (HBsAg)-positive and HBsAg-negative/hepatitis B core antibody-positive patients was 13% (3/24) and 4% (3/69), respectively.Conclusions:R-chemo is effective and safe in real-world clinical practice as first-line treatment for DLBCL and FL in China, and that HBV reactivation during R-chemo is manageable with preventive measures and treatment.Trial Registration:ClinicalTrials.gov, NCT01340443; https://clinicaltrials.gov/ct2/show/NCT01340443.

Ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone in patients with previously untreated non‐germinal centre B‐cell‐like diffuse large B‐cell lymphoma: A Chinese subgroup analysis of the phase III PHOENIX trial

“…Additionally, some previous findings have suggested that BCL2 overexpression might be more common in Chinese versus Western patients with DLBCL[5]. In this subgroup analysis of Chinese patients in the PHOENIX study, R-CHOP efficacy was consistent with previous clinical study results and real-world data in Chinese patients with DLBCL[10][11][12][13]. In addition, ibrutinib+R-CHOP significantly improved PFS in Chinese patients aged <60 years with BCL2-high/MYC-high co-expression.…”

“…In another study of 411 patients with previously untreated DLBCL, R‐CHOP significantly improved ORR (95.19% vs. 87.95%, p = 0·007), CR (77.01% vs. 71.43%), progression‐free survival (PFS; P = 0·018) and overall survival (OS; p = 0.034) [11]. Real‐world analyses for first‐line R‐CHOP in Chinese patients with DLBCL have shown CR rates of 55%–77%, 3‐year PFS/event‐free survival (EFS) rates of 59%–75% and 3‐year OS rates of 76%–90% [12, 13]. However, consistent with data in Western patients [14], high MYC / BCL2 co‐expression, which has been observed in 18·4% of patients in China, has been associated with inferior survival in R‐CHOP‐treated Chinese patients with DLBCL [15, 16].…”

Improving survival of 3760 patients with lymphoma: Experience of an academic center over two decades

“…Immunochemotherapy containing rituximab and anthracyclines not only led to improvement of mature BCL prognosis, 16,17 but also was proven to be cost-effective. 18,19 A study 20 from SEER database indicated that there were 279 704 cumulative life years saved after introducing rituximab into clinical practice, with 200 278 for DLBCL, 68 177 for FL, and 12 363 for chronic lymphocytic leukemia.…”

Real-world use and acceptance of biosimilar rituximab in oncology practice in India

“…The use of rituximab has substantially improved the outcome of patients with FL in recent years. 20 MCL is an aggressive NHL and accounts for ~5% of the NHL patients. 21 The clinicopathological characterization of MCL is not optimal in India with only few reports available.…”