[Clinical features of rituximab plus chemotherapy as first-line treatment in patients with diffuse large B-cell lymphoma].
OBJECTIVE
A prospective, multicenter and non-interventional prospective study was conducted to evaluate the clinical features of rituximab combined with chemotherapy (R-Chemo) as first-line treatment on newly diagnosed Chinese patients with diffuse large B-cell lymphoma (DLBCL).


METHODS
This was a single arm, prospective, observational multicenter and phase IV clinical trial for 279 patients, who were newly diagnosed as CD20-positive DLBCL from 24 medical centers in China 2011 and 2012, no special exclusion criteria were used. All patients received rituximab based R-Chemo regimes, such as R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisolone) and other regimes as the first-line treatment. The treatment strategies were determined by physicians and patients without detailed description for treatment course, dose, interval time and examination. Clinical response and safety of all patients were investigated in 120 days after completion of last dose of rituximab.


RESULTS
Of 279 patients, 258 with stage I-IV who received at least 1 cycle of rituximab treatment and completed at least one time of tumor assessment were enrolled into intention-to-treat analysis, including 148 male and 110 female. The median age of all patients was 57.2(12.8-88.4) years. ECOG performance statuses of 0 or 1 were observed in 91.1% of patients, international prognostic index levels in the low-risk and low-middle-risk groups in 76.4% of patients, the tumor diameters smaller than 7.5 cm in 69.0% of patients. All patients received 6 median cycles of R-Chemo treatment every 24.4 days. R-CHOP treatment was shown to improve the clinical response with overall response rates of 94.2%. Common adverse events included anemia, marrow failure, leukopenia, thrombocytopenia, digestive diseases, infection and liver toxicity. All adverse events are manageable.


CONCLUSIONS
Non-interventional clinical trial of R-Chemo remains the standard first-line treatment for newly diagnosed patients with DLBCL in real clinical practice, which is consistent with international treatment recommendations for DLBCL patients. R-Chemo can provide the clinical evidence and benefit as the first-line standard treatment for Chinese patients with DLBCL.
Jiangsu Cancer Hospital, Nanjing 210000, China.
Jifeng
J
Feng
Jiangsu Cancer Hospital, Nanjing 210000, China.
Jianqiu
J
Wu
Jiangsu Cancer Hospital, Nanjing 210000, China.
Yongping
Y
Song
Jiangsu Cancer Hospital, Nanjing 210000, China.
Liping
L
Su
Jiangsu Cancer Hospital, Nanjing 210000, China.
Mingzhi
M
Zhang
Jiangsu Cancer Hospital, Nanjing 210000, China.
Wei
W
Li
Jiangsu Cancer Hospital, Nanjing 210000, China.
Yu
Y
Hu
Jiangsu Cancer Hospital, Nanjing 210000, China.
Xiaohong
X
Zhang
Jiangsu Cancer Hospital, Nanjing 210000, China.
Yuhuan
Y
Gao
Jiangsu Cancer Hospital, Nanjing 210000, China.
Zuoxing
Z
Niu
Jiangsu Cancer Hospital, Nanjing 210000, China.
Ru
R
Feng
Jiangsu Cancer Hospital, Nanjing 210000, China.
Wei
W
Wang
Jiangsu Cancer Hospital, Nanjing 210000, China.
Jiewen
J
Peng
Jiangsu Cancer Hospital, Nanjing 210000, China.
Xuenong
X
Ouyang
Jiangsu Cancer Hospital, Nanjing 210000, China.
Xiaolin
X
Li
Jiangsu Cancer Hospital, Nanjing 210000, China.
Changping
C
Wu
Jiangsu Cancer Hospital, Nanjing 210000, China.
Weijing
W
Zhang
Jiangsu Cancer Hospital, Nanjing 210000, China.
Yun
Y
Zeng
Jiangsu Cancer Hospital, Nanjing 210000, China.
Zhen
Z
Xiao
Jiangsu Cancer Hospital, Nanjing 210000, China.
Yingmin
Y
Liang
Jiangsu Cancer Hospital, Nanjing 210000, China.
Yongzhi
Y
Zhuang
Jiangsu Cancer Hospital, Nanjing 210000, China.
Jishi
J
Wang
Jiangsu Cancer Hospital, Nanjing 210000, China.
Zimin
Z
Sun
Jiangsu Cancer Hospital, Nanjing 210000, China.
Hai
H
Bai
Jiangsu Cancer Hospital, Nanjing 210000, China.
Tongjian
T
Cui
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002648:Child; D005260:Female; D006801:Humans; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000069283:Rituximab; D016896:Treatment Outcome
D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab