Rituximab plus chemotherapy as first-line treatment in Chinese patients with diffuse large B-cell lymphoma in routine practice: a prospective, multicentre, non-interventional study

Abstract

Background: The efficacy and safety of rituximab-based chemotherapy (R-chemo), the standard regimen for patients with diffuse large B-cell lymphoma (DLBCL), which is more common in Asia than in Western countries, are well confirmed in randomized controlled trials (RCTs). However, the safety and effectiveness of R-chemo in patients who are largely excluded from RCTs have not been well characterized. This real-world study investigated the safety and effectiveness of R-chemo as first-line treatment in Chinese patients with DLBCL.

Methods: Treatment-naive DLBCL patients who were CD20 positive and eligible to receive R-chemo were enrolled with no specific exclusion criteria. Data collected at baseline included age, gender, disease stage, international prognostic index (IPI), B symptoms, extranodal involvement, performance status, and medical history. In the present study, data on safety, treatment effectiveness, and HBV infection management were collected 120 days after the last R-chemo administration.

Results: Overall, R-chemo was well tolerated. The safety profile of R-chemo in patients with a history of heart or liver disease was well described without any additional unexpected safety concerns. The overall response rate (ORR) in the Chinese patients from this study was 94.2 % (complete response [CR], 55.0 %; CR unconfirmed [CRu] 18.2 %; and partial response [PR], 20.9 %). Compared to patients with no history of disease, the CR and PR rates of patients with a history of heart or liver disease were lower and higher, respectively; this tendency could be in part explained by treatment interruptions in patients with heart or liver diseases. HBsAg positivity and a maximum tumor diameter of ≥7.5 cm negatively correlated with CR + CRu, whereas age and HBsAg positivity negatively correlated with CR.

Conclusions: This study further validated the safety and effectiveness of R-chemo in Chinese patients with DLBCL. Patients with a history of heart or liver disease may further benefit from R-chemo if preventive measures are taken to reduce hepatic and cardiovascular toxicity. In addition to IPI and tumor diameter, HBsAg positivity could also be a poor prognostic factor for CR in Chinese patients with DLBCL.

Trial registration: ClinicalTrials.gov # NCT01340443 , April 20, 2011.

Keywords: Chemotherapy; DLBCL; HBV infection; HBsAg; R-CHOP.

Figures

Fig. 1

Treatment effectiveness of R-chemo in patients with a history of heart or liver disease (Patients who received ≥1 dose of R-chemo and underwent ≥1 tumor assessments after baseline were included in the analysis chemo, chemotherapy; CR, complete response; CRu, complete response unconfirmed; PR, partial response; ORR, overall response rate; R, rituximab)

Fig. 2

Multivariate logistic regression analyses of prognostic factors. Baseline factors were examined using multivariate logistic regression analyses to investigate prognostic factors of treatment responses. The baseline factors included IPI, age, HBsAg positivity, HBsAg negativity/HBcAb positivity, and maximum tumor diameter. IPI is an ordered categorical variable categorized as 1 for low risk, 2 for low-intermediate, 3 intermediate-high, and 4 for high. a Baseline prognostic factors correlated with CR + CRu. b Baseline prognostic factors correlated with the likelihood of achieving CR. CR, complete response; CRu, complete response unconfirmed

Fig. 3

Treatment effectiveness of R-chemo in patients with HBV infectious status (Patients who received ≥1 dose of R-chemo and underwent ≥1 tumor assessment after baseline were included in the analysis chemo, chemotherapy; CR, complete response; CRu, complete response unconfirmed; PR, partial response; ORR, overall response rate; R, rituximab)