Cancer Res Treat.  2023 Oct;55(4):1355-1362. 10.4143/crt.2023.271.

Intensified First Cycle of Rituximab Plus Eight Cycles of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone with Rituximab Chemotherapy for Advanced-Stage or Bulky Diffuse Large B-Cell Lymphoma: A Multicenter Phase II Consortium for Improving Survival of Lymphoma (CISL) Study

• Kim YR
• Kim JS
• Kim WS
• Eom HS
• Yang DH
• Bae SH
• Kim HJ
• Lee JH
• Oh SJ
• Yoon SS
• Kwak JY
• Choi CW
• Kim MK
• Oh SY
• Kang HJ
• Nam SH
• Shim H
• Park JS
• Mun YC
• Suh C
• the Korean Society of Hematology Lymphoma Working Party

• KMID: 2547809
• DOI: http://doi.org/10.4143/crt.2023.271

Abstract

Purpose
This phase II, open-label, multicenter study aimed to investigate the efficacy and safety of a rituximab intensification for the 1st cycle with every 21-day of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP-21) among patients with previously untreated advanced-stage or bulky diffuse large B-cell lymphoma (DLBCL).
Materials and Methods
Ninety-two patients with stage III/IV or bulky DLBCL from 21 institutions were administered 8 cycles of R-CHOP-21 with an additional one dose of rituximab intensification on day 0 of the 1st cycle (RR-CHOP). The primary endpoint was a complete response (CR) rate after 3 cycles of chemotherapy.
Results
Among the 92 DLBCL patients assessed herein, the response rate after 3 cycles of chemotherapy was 88.0% (38.0% CR+50.0% partial response [PR]). After the completion of 8 cycles of chemotherapy, the overall response rate was observed for 68.4% (58.7% CR+9.8% PR). The 3-year progression-free survival rate was 64.0%, and the 3-year overall survival rate was 70.4%. Febrile neutropenia was one of the most frequent grade 3 adverse events (40.0%) and 5 treatment-related deaths occurred. Compared with the clinical outcomes of patients who received R-CHOP chemotherapy as a historical control, the interim CR rate was higher in male patients with RR-CHOP (20.5% vs. 48.8%, p=0.016).
Conclusion
Rituximab intensification on days 0 to the 1st cycle of the standard 8 cycles R-CHOP-21 for advanced DLBCL yielded favorable response rates after the 3 cycles of chemotherapy and acceptable toxicities, especially for male patients. ClinicalTrials.gov ID: NCT01054781.

Keyword

Rituximab; Diffuse large B-cell lymphoma; R-CHOP; Response

Figure

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  Fig. 1 Diagram of the enrolled diffuse large B-cell lymphoma patients. DLBCL, diffuse large B-cell lymphoma; RR-CHOP, intensified the first cycle of rituximab plus eight cycles of cyclophosphamide, doxorubicin, vincristine, and prednisolone with rituximab; TRM, treatment-related mortality.

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  Fig. 2 Kaplan-Meier analyses of overall survival (A) and progression-free survival (B) of patients receiving RR-CHOP chemotherapy. RR-CHOP, intensified the first cycle of rituximab plus eight cycles of cyclophosphamide, doxorubicin, vincristine, and prednisolone with rituximab.

Reference

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