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[Comparison between R-CHOP regimen and CHOP regimen in treating naive diffuse large B-cell lymphoma in China--a multi-center randomized trail].

AbstractBACKGROUND & OBJECTIVE:
CHOP regimen is a standard treatment for patients with diffuse large B-cell non-Hodgkin's lymphoma (NHL), and its 5-year overall survival (OS) rate is 30%-40%. Rituximab is a chimeric monoclonal antibody (MoAb) directly against CD20-positive B cells, and has good effect on diffuse large B-cell NHL. Rituximab combined with standard chemotherapy has been approved for treating aggressive B-cell NHL in Europe and the US. This study was to determine efficacy and safety of the combination of Rituximab and CHOP regimen in treating Chinese patients with CD20-positive diffuse large B-cell NHL.
METHODS:
From Sep. 2003 to Nov. 2004, a total of 63 patients in 9 centers were enrolled. All the patients were randomized into 2 groups: 32 received CHOP regimen alone (CHOP group), and 31 received Rituximab and CHOP regimen (R-CHOP group). All patients signed informed consent. The complete response rates, overall response rates, and side events of the 2 groups were compared.
RESULTS:
The complete response rates were similar in R-CHOP and CHOP groups (41.9% vs. 37.5%, P=0.719); the overall response rates were slightly higher in R-CHOP group than in CHOP group (83.8% vs. 65.6%, P=0.096). Disease progression during treatment was reported for 7 (21.9%) patients in CHOP group and 1 (3.2%) patient in R-CHOP group (P=0.026). The occurrence rates of adverse events were similar in R-CHOP and CHOP groups (65.6% vs. 67.7%, P=0.859). The most common adverse event was leukopenia; fever and chills were rather common in R-CHOP group. Clinically relevant toxicity was similar in both groups.
CONCLUSION:
When compared with standard CHOP alone, the addition of Rituximab to standard CHOP regimen reduces the risk of treatment failure in patients with diffuse large B-cell NHL, and doesn't increase the occurrence of chemotherapy-related adverse events.
AuthorsTong-Yu Lin, Hong-Yu Zhang, Yan Huang, Zhong-Zhen Guan, Ti Shen, Yuan-Kai Shi, Jun Zhu, Xiao-Yan Ke, Hua-Qing Wang, Zhi-Xiang Shen, Shi-Ying Yu, Ting Liu, Xiao-Li Shi
JournalAi zheng = Aizheng = Chinese journal of cancer (Ai Zheng) Vol. 24 Issue 12 Pg. 1421-6 (Dec 2005) China
PMID16351785 (Publication Type: Comparative Study, English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Murine-Derived
  • Antigens, CD20
  • Antineoplastic Agents
  • Rituximab
  • Vincristine
  • Doxorubicin
  • Cyclophosphamide
  • Prednisolone
Topics
  • Adolescent
  • Adult
  • Aged
  • Antibodies, Monoclonal (administration & dosage, adverse effects)
  • Antibodies, Monoclonal, Murine-Derived
  • Antigens, CD20 (metabolism)
  • Antineoplastic Agents (administration & dosage, adverse effects)
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
  • China
  • Cyclophosphamide (administration & dosage, adverse effects)
  • Doxorubicin (administration & dosage, adverse effects)
  • Female
  • Humans
  • Leukopenia (chemically induced)
  • Lymphoma, B-Cell (drug therapy, immunology)
  • Lymphoma, Large B-Cell, Diffuse (drug therapy, immunology)
  • Male
  • Middle Aged
  • Prednisolone (administration & dosage, adverse effects)
  • Remission Induction
  • Rituximab
  • Vincristine (administration & dosage, adverse effects)

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