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


CONCLUSIONS
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.
Lin
Tong-Yu
TY
Skate Key Laboratory of Oncology in Southern China, Guangzhou, Guangdong 510060, P. R. China.
Zhang
Hong-Yu
HY
Huang
Yan
Y
Guan
Zhong-Zhen
ZZ
Shen
Ti
T
Shi
Yuan-Kai
YK
Zhu
Jun
J
Ke
Xiao-Yan
XY
Wang
Hua-Qing
HQ
Shen
Zhi-Xiang
ZX
Yu
Shi-Ying
SY
Liu
Ting
T
Shi
Xiao-Li
XL
D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D058846:Antibodies, Monoclonal, Murine-Derived; D018951:Antigens, CD20 / Q000378:metabolism; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D016393:Lymphoma, B-Cell / Q000188:drug therapy* / Q000276:immunology; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy* / Q000276:immunology; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects; D012074:Remission Induction; D000069283:Rituximab; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D018951:Antigens, CD20; D000970:Antineoplastic Agents; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011239:Prednisolone