1.Three-year Follow-up on the Safety and Effectiveness of Rituximab Plus Chemotherapy as First-Line Treatment of Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in Real-World Clinical Settings in China: A Prospective, Multicenter, Noninterventional Study.
Jian-Qiu WU ; Yong-Ping SONG ; Li-Ping SU ; Ming-Zhi ZHANG ; Wei LI ; Yu HU ; Xiao-Hong ZHANG ; Yu-Huan GAO ; Zuo-Xing NIU ; Ru FENG ; Wei WANG ; Jie-Wen PENG ; Xiao-Lin LI ; Xue-Nong OUYANG ; Chang-Ping WU ; Wei-Jing ZHANG ; Yun ZENG ; Zhen XIAO ; Ying-Min LIANG ; Yong-Zhi ZHUANG ; Ji-Shi WANG ; Zi-Min SUN ; Hai BAI ; Tong-Jian CUI ; Ji-Feng FENG
Chinese Medical Journal 2018;131(15):1767-1775
Background:
Prospective real-life data on the safety and effectiveness of rituximab in Chinese patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) are limited. This real-world study aimed to evaluate long-term safety and effectiveness outcomes of rituximab plus chemotherapy (R-chemo) as first-line treatment in Chinese patients with DLBCL or FL. Hepatitis B virus (HBV) reactivation management was also investigated.
Methods:
A prospective, multicenter, single-arm, noninterventional study of previously untreated CD20-positive DLBCL or FL patients receiving first-line R-chemo treatment at 24 centers in China was conducted between January 17, 2011 and October 31, 2016. Enrolled patients underwent safety and effectiveness assessments after the last rituximab dose and were followed up for 3 years. Effectiveness endpoints included progression-free survival (PFS) and overall survival (OS). Safety endpoints were adverse events (AEs), serious AEs, drug-related AEs, and AEs of special interest. We also reported data on the incidence of HBV reactivation.
Results:
In total, 283 previously untreated CD20-positive DLBCL and 31 FL patients from 24 centers were enrolled. Three-year PFS was 59% (95% confidence interval [CI]: 50-67%) for DLBCL patients and 46% (95% CI: 20-69%) for FL patients. For DLBCL patients, multivariate analyses showed that PFS was not associated with international prognostic index, tumor maximum diameter, HBV infection status, or number of rituximab treatment cycles, and OS was only associated with age >60 years (P < 0.05). R-chemo was well tolerated. The incidence of HBV reactivation in hepatitis B surface antigen (HBsAg)-positive and HBsAg-negative/hepatitis B core antibody-positive patients was 13% (3/24) and 4% (3/69), respectively.
Conclusions:
R-chemo is effective and safe in real-world clinical practice as first-line treatment for DLBCL and FL in China, and that HBV reactivation during R-chemo is manageable with preventive measures and treatment.
Trial Registration
ClinicalTrials.gov, NCT01340443; https://clinicaltrials.gov/ct2/show/NCT01340443.
Aged
;
Aged, 80 and over
;
Antineoplastic Combined Chemotherapy Protocols
;
therapeutic use
;
China
;
Cyclophosphamide
;
administration & dosage
;
Doxorubicin
;
administration & dosage
;
Female
;
Follow-Up Studies
;
Humans
;
Lymphoma, Follicular
;
drug therapy
;
Lymphoma, Large B-Cell, Diffuse
;
drug therapy
;
Male
;
Middle Aged
;
Prospective Studies
;
Rituximab
;
therapeutic use
;
Vincristine
;
administration & dosage
2.Clinical features and prognosis of children with mature B-cell non-Hodgkin's lymphoma: an analysis of 28 cases.
Zai-Sheng CHEN ; Yong-Zhi ZHENG ; Yi-Qiao CHEN ; Qin-Li GAO ; Jian LI ; Jian-Zhen SHEN
Chinese Journal of Contemporary Pediatrics 2018;20(6):470-474
OBJECTIVETo study the clinical features and treatment outcome of children with mature B-cell non-Hodgkin's lymphoma (B-NHL).
METHODSA total of 28 previously untreated children with mature B-NHL were enrolled and given the chemotherapy regimen of CCCG-B-NHL-2010. Among them, 20 were given rituximab in addition to chemotherapy. The children were followed up for 31 months (ranged 4-70 months). A retrospective analysis was performed for the clinical features of these children. The Kaplan-Meier method was used for survival analysis. A univariate analysis was performed to investigate the prognostic factors.
RESULTSAmong the 28 children, 17 (61%) had Burkitt lymphoma, 8 (29%) had diffuse large B-cell lymphoma (DLBCL), and 3 (11%) had unclassifiable B-cell lymphoma. As for the initial symptom, 13 (46%) had cervical mass, 10 (36%) had maxillofacial mass, 9 (32%) had hepatosplenomegaly, 5 (18%) had abdominal mass, and 5 (18%) had exophthalmos. Of all children, 14 had a lactate dehydrogenase (LDH) level of <500 IU/L, 3 had a level of 500-1 000 IU/L, and 11 had a level of ≥ 1 000 IU/L. After two courses of chemotherapy, 21 children achieved complete remission and 7 achieved partial remission. At the end of follow-up, 24 achieved continuous complete remission and 4 experienced recurrence. The 2-year event-free survival rate was (85.7± 6.6)%. The children with bone marrow infiltration suggested by bone marrow biopsy, serum LDH ≥500 IU/L, and bone marrow tumor cells >25% had a low 2-year cumulative survival rate.
CONCLUSIONSThe CCCG-B-NHL 2010 chemotherapy regimen combined with rituximab has a satisfactory effect in the treatment of children with B-NHL. Bone marrow infiltration on bone marrow biopsy is associated with poor prognosis.
Antineoplastic Combined Chemotherapy Protocols ; administration & dosage ; Bone Marrow ; pathology ; Child ; Child, Preschool ; Female ; Humans ; Infant ; Lymphoma, B-Cell ; diagnosis ; drug therapy ; mortality ; pathology ; Male ; Prognosis ; Progression-Free Survival ; Retrospective Studies ; Rituximab ; administration & dosage ; Treatment Outcome
3.A Case of Therapy-Related Acute Leukemia With Mixed Phenotype With BCR-ABL1 After Treatment of Diffuse Large B-Cell Lymphoma.
Dahae YANG ; Sung Ran CHO ; Seri JUNG ; Woonhyoung LEE ; Hyun Yong HWANG ; Ho Seop LEE ; Yang Soo KIM ; Jong Rak CHOI ; Mi Hyang KIM
Annals of Laboratory Medicine 2017;37(2):166-168
No abstract available.
Aged
;
Antineoplastic Combined Chemotherapy Protocols/adverse effects
;
Bone Marrow Cells/cytology/pathology
;
Female
;
Flow Cytometry
;
Fusion Proteins, bcr-abl/*genetics
;
Granulocyte Colony-Stimulating Factor/therapeutic use
;
Humans
;
Immunophenotyping
;
Leukemia/*diagnosis/etiology
;
Lymphoma, Large B-Cell, Diffuse/*drug therapy
;
Phenotype
;
Rituximab/administration & dosage
4.Clinical Efficacy and Safety of Rituximab Combined with Fludarabine and Cyclophosphamide for Treatment of Chronic Lymphocytic Leukemia.
Hui-Jie HAN ; Yue-Wu LU ; Rui-Xiang XIA
Journal of Experimental Hematology 2016;24(1):25-29
OBJECTIVETo explore the clinical efficacy and safety of rituximab combined with fludarabine and cyclophosphamide for the treatment of the chronic lymphocytic leukemia (CLL).
METHODSForty cases of CLL patients treated in our hospital from March 2010 to March 2014 years were selected and divided into the observation group (20 cases) and control group (20 cases) by random number table method. The patients in control group were treated with CHOP chemotherapy, the patients in observation group were treated with rituximab combined with fludarabine, cyclophosphamide treatment. The therapeutic efficacy of patients in 2 groups was analyzed according to the peripheral hemogram indexes, symptom and sign disappeared time as well as adverse reaction incidence.
RESULTSthe remission rate in observation group was 90.00%, which was significantly higher than that in control group (70.00%) (P < 0.05); the peripheral hemogram indexes in 2 groups before treatment showed no significant difference (P > 0.05), and were significantly improved after treatment, but the white blood cell count and lymphocyte absolute number were significantly lower in observation group as compared to the control group (P < 0.05); symptom and sign disappeared time in observation group were significantly shorter as compared with the control group (P < 0.05); adverse reaction incidence in obseovation group was significantly lower as compared with control group (P < 0.05).
CONCLUSIONapplication of rituximab combined with fludarabine and cyclophosphamide in the treatment of CLL shows the higher curative effect, can effectively improve the symptoms and reduce the incidence of adverse reactions. It is worthy to be popularized.
Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Cyclophosphamide ; administration & dosage ; therapeutic use ; Doxorubicin ; therapeutic use ; Humans ; Leukemia, Lymphocytic, Chronic, B-Cell ; drug therapy ; Prednisone ; therapeutic use ; Rituximab ; administration & dosage ; therapeutic use ; Treatment Outcome ; Vidarabine ; administration & dosage ; analogs & derivatives ; therapeutic use ; Vincristine ; therapeutic use
5.Imaging findings for intravascular large B-cell lymphoma of the liver.
Jungmin BAE ; Hyo Keun LIM ; Ha Young PARK
Clinical and Molecular Hepatology 2015;21(3):295-299
Intravascular large B-cell lymphoma (IVLBCL) is a rare subtype of extranodal diffuse large B-cell lymphoma that most commonly involves the central nervous system and skin. To our knowledge, no state-of-the art imaging findings have been reported for hepatic IVLBCL in the English literature. We report the first case of hepatic involvement of IVLBCL along with a literature review.
Antigens, CD20/metabolism
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use
;
Humans
;
Liver Neoplasms/drug therapy/*pathology/radiography
;
Lymphoma, Large B-Cell, Diffuse/drug therapy/*pathology/radiography
;
Magnetic Resonance Imaging
;
Male
;
Middle Aged
;
Remission Induction
;
Rituximab/administration & dosage
;
Tomography, X-Ray Computed
6.FcγRIII a polymorphisms and efficacy of Rituximab combined chemotherapy for diffuse large B-cell lymphoma in Chinese patients.
Yun ZHUANG ; Chun QIAO ; Guohua YANG ; Yunfeng SHEN ; Xifeng QIAN ; Lei YANG ; Wei XU ; Jianyong LI
Chinese Journal of Hematology 2014;35(9):816-821
OBJECTIVETo evaluate the impact of Fc gamma receptor IIIa (FcγR IIIa) polymorphisms on the efficacy of rituximab (RTX) combined chemotherapy for patients with diffuse large B-cell lymphoma (DLBCL).
METHODSFcγRIIIa polymorphisms were analyzed by PCR in 122 patients and 100 healthy controls. All patients received 8(4-12) cycles of RTX combined chemotherapy.
RESULTS78(63.93%) patients with F/F, 5(4.10%) with V/V, and 39(31.97%) with V/F were identified, which were not different compared to controls. Patients with different FcγRIIIa genotypes did not have any difference in terms of gender, age, molecular subtypes, lactate dehydrogenase (LDH) or international prognostic index (IPI). The overall response rate (ORR) was 89.35% with a complete response (CR) of 80.33% and a partial response (PR) of 9.02%. The ORR was 83.33%, 100.00% and 100.00% in F/F, V/V and V/F, respectively. A higher response rate was observed in V/V and V/F as compared with F/F (P<0.05). With a median follow-up of 35 months (range: 12-62 months), 46(37.71%) patients had relapsed and 40 (32.79%) cases progressed and ended in death. The 3-year progress-free survival (PFS) rate was 41.03%, 100.00%, 100.00% in F/F, V/V and V/F, respectively. The 3-year overall survival (OS) rate was 48.72%, 100.00% and 100.00% in patients with three genotypes. The PFS and OS rate were significantly higher in V/V and V/F as compared with F/F (P<0.05).
CONCLUSIONFcγR III a polymorphisms could predict response and prognosis of RTX combined chemotherapy for patients with DLBCL.
Antibodies, Monoclonal, Murine-Derived ; administration & dosage ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Asian Continental Ancestry Group ; genetics ; Disease-Free Survival ; GPI-Linked Proteins ; Humans ; Lymphoma, Large B-Cell, Diffuse ; drug therapy ; genetics ; Polymorphism, Genetic ; Prognosis ; Receptors, IgG ; genetics ; Remission Induction ; Rituximab
7.Treatment of children with steroid-dependent nephrotic syndrome with rituximab.
Jianping HUANG ; Juan DU ; Shuo WANG ; Lili XIAO ; Xiaoyan ZHAO
Chinese Journal of Pediatrics 2014;52(7):521-524
OBJECTIVETo investigate the effects of rituximab (RTX) in children with steroid-dependent nephrotic syndrome.
METHODFive cases of children with steroid-dependent nephrotic syndrome seen from May 2012 to February 2013 in whom only steroid plus calcineurin inhibitor was effective and the disease recurred on reduction of dose were enrolled into this study, including 3 males and 2 females. Calcineurin inhibitors were stopped and steroids was changed to full dose. After the general condition improved, RTX was given at a dose of 375 mg/m(2), once a week for a total of three times for one course. After urine protein became negative for five days, the dose of steroid was changed to 2 mg/kg every other day, thereafter the dose was reduced by 5 mg per every 2 weeks, until discontinuation. After regular monitoring, when peripheral blood B cells were ≥ 3%, a second RTX was added.
RESULTUrine protein was negative in 2-7 days in 5 patients after the first RTX treatment. Before treatment B lymphocytes in peripheral blood was 7.8% to 13.0% and after the first course of RTX treatment decreased to 0 in the first 6 to 8 months at the beginning of recovery, while in the first 7 to 10 months to 3.3%-6.1%, after a second RTX was given, B lymphocytes were reduced to 0, but in two cases (cases 1 and 3) B lymphocytes rose again at 16 and 17 months, in the first 17 and 18 months rose to 4.16% and 4.17%, RTX was given once again respectively. B lymphocytes were reduced to 0 again. Currently the 5 patients continued to be negative for urine protein, maintaining remission for 12 to 20 months.RTX infusion had no significant side effects, and side effects of steroid and calcineurin inhibitor disappeared.
CONCLUSIONIn children with steroid-dependent and only calcineurin inhibitor effective nephritic syndrome, relapse may still occur after improvement of nephrotic syndrome, after the first RTX treatment, regular monitoring of B lymphocytes, RTX supplementary treatment in advance can help discontinuation of steroids and immunosuppressive agents and maintain remission.
Anti-Inflammatory Agents ; administration & dosage ; therapeutic use ; Antibodies, Monoclonal, Murine-Derived ; administration & dosage ; therapeutic use ; Antigens, CD19 ; metabolism ; B-Lymphocytes ; drug effects ; metabolism ; Calcineurin Inhibitors ; administration & dosage ; therapeutic use ; Child ; Child, Preschool ; Drug Administration Schedule ; Female ; Follow-Up Studies ; Humans ; Immunosuppressive Agents ; administration & dosage ; therapeutic use ; Lymphocyte Count ; Male ; Nephrotic Syndrome ; drug therapy ; metabolism ; Proteinuria ; urine ; Recurrence ; Remission Induction ; Rituximab ; Treatment Outcome
8.Lower dose of rituximab in the treatment of elderly autoimmune hemolytic anemia.
Chinese Journal of Hematology 2014;35(3):236-238
OBJECTIVETo explore the safety and efficacy of lower dose of rituximab in the treatment of elderly autoimmune hemolytic anemia (AIHA).
METHODSFrom May 2008 to February 2013, a total of 37 patients with newly diagnosed elderly AIHA patients were enrolled in the study, including 25 cases treated with prednisone 1 mg · kg⁻¹ · d⁻¹ for 4 weeks and 12 cases ineligible for glucocorticoid receiving rituximab (100 mg/week for 4 times).
RESULTSOf the 25 patients with conventional glucocorticoid, 5 cases (20.0%) were complete remission (CR), 15 cases with partial remission (PR) and 5 cases without response. The overall response rate was 80.0%. Of the 12 cases with rituximab, 8 cases (66.7%) were CR, 3 cases with PR and 1 without response. The overall response rate was 91.7%. A significantly higher CR rate was seen in lower dose of rituximab, as compared to that in conventional glucocorticoid (P=0.038).
CONCLUSIONA lower dose of rituximab, with satisfactory safety and efficacy, was better than the conventional glucocorticoid in the treatment of elderly AIHA patients.
Aged ; Aged, 80 and over ; Anemia, Hemolytic, Autoimmune ; drug therapy ; Antibodies, Monoclonal, Murine-Derived ; administration & dosage ; adverse effects ; therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Prednisone ; therapeutic use ; Rituximab ; Treatment Outcome
9.High-dose methotrexate plus hematopoietic stem cell transplantation supplemented by rituximab intrathecal injection for primary central nervous system lymphoma:two cases report and literature review.
Jin-hong JIANG ; Bing-mu FANG ; Ye-hui XU
Chinese Journal of Hematology 2013;34(2):162-163
Adult
;
Antibodies, Monoclonal, Murine-Derived
;
therapeutic use
;
Central Nervous System Neoplasms
;
therapy
;
Female
;
Hematopoietic Stem Cell Transplantation
;
Humans
;
Injections, Spinal
;
Lymphoma, Non-Hodgkin
;
therapy
;
Male
;
Methotrexate
;
administration & dosage
;
therapeutic use
;
Middle Aged
;
Rituximab
10.Efficacy and safety of low-dose rituximab combined with different dosage of glucocorticoids for immune thrombocytopenia.
Wei-wei XING ; Zhen-yu LI ; Zhi-ling YAN ; Kai-ge LIU ; Ning LI ; Jiang CAO ; Xiu-ying PAN ; Xu-peng HE ; Kai-lin XU
Chinese Journal of Hematology 2013;34(5):409-412
OBJECTIVETo compare the efficacy and safety of low-dose rituximab combined with different dosage of glucocorticoids for immune thrombocytopenia (ITP).
METHODSSeventy-four patients (35 male, median age 34 years, range 18-70 years) including 60 newly-diagnosed, 6 persistent, 5 chronic and 3 refractory patients were enrolled in this study, and separated into control (36 cases) and experimental (38 cases) groups according to the dosage of glucocorticoids. Patients in both groups received dexamethasone 40 mg/day on days 1-4, followed by rituximab 100 mg on days 7, 14, 21, 28. The patients in experimental group also received decrements of prednisone 60, 30, 20, 10 mg/day on days 5-7, 8-14, 15-21, 22-28. The initial, long-term efficacy and safety were evaluated.
RESULTSPlatelet counts of all patients at day 4 remarkably increased, with the median platelet count from 11(1-26) × 10⁹/L to 84(23-132) × 10⁹/L in control group, and 10(2-20) × 10⁹/L to 80(22-115) × 10⁹/L in experimental group; the platelet counts of patients at day 14 in experimental group [163(19-262) × 10⁹/L] was higher than that of control group [98(18-238) × 10⁹/L] (P<0.05). The overall response (OR) rates at day 28 in experimental group (84.21%) was significantly higher than that of control group (66.67%, P = 0.03). There was no significant difference of sustained response (SR) rates in two groups (63.89%vs 65.79%, 58.33%vs 60.53%, P > 0.05) at six and twelve months follow-up points. Both groups showed similar incidence of adverse events, and no patients discontinued the treatment due to side effects.
CONCLUSIONLow-dose rituximab and glucocorticoids was an effective method for ITP patients, and maintenance treatment with decrements of prednisone contributed to improving earlier CR rate.
Adolescent ; Adult ; Aged ; Antibodies, Monoclonal, Murine-Derived ; therapeutic use ; Female ; Follow-Up Studies ; Glucocorticoids ; administration & dosage ; therapeutic use ; Humans ; Male ; Middle Aged ; Rituximab ; Thrombocytopenia ; drug therapy ; Treatment Outcome ; Young Adult

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