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 for anaplastic large cell lymphoma.
Fei DONG ; Yan LIU ; Qihui LI ; Jijun WANG ; Hongmei JING ; Xiaoyan KE
Journal of Central South University(Medical Sciences) 2018;43(6):631-637
To determine clinical and pathologic profiles for anaplastic large cell lymphoma (ALCL).
Methods: The clinical data of 22 patients with ALCL were analyzed retrospectively. Therapentie effect of different treatment strategies on ALCL was evaluated.
Results: The median age for these patients was 32(9-70) years old and the patients with positive ALK accounted for 68.2% (15/22). All patients underwent chemotherapy, including regiments of CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), CHOPE (CHOP plus etoposide) or BEACOP (CHOP plus etoposide and bleomycin). Fourteen (63.6%) patients achieved initial complete remission (CR) and the CR rate for patients with ALK+ was significantly higher than that of patients with ALK- (P<0.05), while the age, gender, stage, beta 2-microglobulin (2-MG) level, lactate dehydrogenase (LDH) level, B symptoms had no significant effect on the rate of CR (P>0.05). After a median follow-up of 41 (2-150) months, 12 patients were overall survival, the median progression free time was 22.5 (2-150) months, and the age, gender, stage, IPI index, ALK expression level, beta 2-MG level, LDH level, and B symptoms had no significant effect on the rate of overall survival (P>0.05).
Conclusion: ALK-positive occurs mainly in ALCL patients. The chemotherapy is still the main treatment, and CHOPE regimen is a better initial treatment scheme because the most patients show good prognosis.
Adolescent
;
Adult
;
Age Factors
;
Aged
;
Alkaline Phosphatase
;
Antineoplastic Combined Chemotherapy Protocols
;
administration & dosage
;
therapeutic use
;
Bleomycin
;
administration & dosage
;
Child
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Cyclophosphamide
;
administration & dosage
;
Doxorubicin
;
administration & dosage
;
Etoposide
;
administration & dosage
;
Female
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Humans
;
Lymphoma, Large-Cell, Anaplastic
;
drug therapy
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enzymology
;
mortality
;
Male
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Middle Aged
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Prednisone
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administration & dosage
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Prognosis
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Retrospective Studies
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Sex Factors
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Treatment Outcome
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Vincristine
;
administration & dosage
;
Young Adult
3.Efficacy Comparison of Low dose Thalidomide Combined with Modified VCMP and VAD regimens for Treatment of Aged MM Patients.
Journal of Experimental Hematology 2016;24(3):765-768
OBJECTIVETo evaluate the efficacy and adverse effects of low dose thalidomide (TD) combined with modified VCMP (vincristine+cyclophosphamide+melphalan+prednisone) (TD+mVCMP) and VAD (vincristine+doxorubicin+dexamethsone) (TD+VAD) regimens for treating aged patients with MM.
METHODSA total of 47 patients with newly diagnosed MM were enrolled in this study. Among them 27 cases were treated with TD+mVCMP regimen (TD+mVCMP group), 20 cases were treated with TD+VAD regimen (TD+VAD group). The dose of TD in 2 groups all was 100 mg/d. Each patient received 4 or more courses of treatment.
RESULTSOut of 27 cases in TD+mVCMP group, 9 cases achieved complete remission (CR), 5 cases-very good partial remission (VGPR), 6 cases-partial remission (PR); among 20 cases in TD+VAD group, 3 cases achieved CR, 3 cases achieved VGPR, 4 cases achieved PR. The total effective rate in 2 group was 74.1% and 50% respectively, there was statistical difference between 2 groups (P<0.05). The differences of Hb level, plasmocytic ratio of bone marrow and M protein level in 2 groups before and after treatment were significant (P<0.05). The 5 years survival rate of patients in TD+mVCMP and TD+VAD group was 72.8% and 66.9% respectively, there was no statistical difference (P>0.05). The incidence of adverse reactions including caxdiac toxicity, severe leucopenia and thrombocytopenia in TD+mVCMP group was lower than that in TD+VAD group.
CONCLUSIONLow dose TD combined with modified VCMP regimen for treatment of newly diagnosed aged patients with MM is safe and effective, which may be used as the first line treatment regimen for population in aged MM patients.
Antineoplastic Combined Chemotherapy Protocols ; administration & dosage ; therapeutic use ; Cyclophosphamide ; administration & dosage ; therapeutic use ; Cytarabine ; administration & dosage ; therapeutic use ; Dexamethasone ; administration & dosage ; therapeutic use ; Humans ; Melphalan ; administration & dosage ; therapeutic use ; Multiple Myeloma ; drug therapy ; Prednisone ; administration & dosage ; therapeutic use ; Remission Induction ; Survival Rate ; Thalidomide ; administration & dosage ; therapeutic use ; Thrombocytopenia ; Vincristine ; administration & dosage ; therapeutic use
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.Application of vincristine-loaded platelet therapy in three dogs with refractory immune-mediated thrombocytopenia.
Hyung Jin PARK ; Ja Won KIM ; Kun Ho SONG ; Kyoung Won SEO
Journal of Veterinary Science 2015;16(1):127-130
Three dogs presented with refractory immune-mediated thrombocytopenia (IMT). All patients failed to respond to prednisone, which is considered a mainstay of immunosuppressive therapy. Vincristine-loaded platelets (VLPs), which act selectively on mononuclear phagocytes,were introduced. After the VLPs were transfused, two dogs responded quickly withimproved clinical signs while the third dogwith recurrent IMT was euthanized due to its deteriorating condition. This case report describesthe efficacy of VLP therapy in refractory IMT patients.
Animals
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Antineoplastic Agents, Phytogenic/administration & dosage/*therapeutic use
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Dog Diseases/*therapy
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Dogs
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Female
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Male
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Platelet Transfusion/methods/*veterinary
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Purpura, Thrombocytopenic, Idiopathic/therapy/*veterinary
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Vincristine/administration & dosage/*therapeutic use
6.Comprehensive therapy for infant vascular tumor associated with Kasabach-Merritt phenomenon.
Xu MIAO ; OuYang TIANXIANG ; Xiao YAN ; Huang YINGYING ; Chen HUIPING ; Yu JIE ; Ma XIAORONG ; Zhao TINGHUI ; Chang MENGLING ; Lin JUN ; Liu JUN
Chinese Journal of Plastic Surgery 2015;31(4):263-268
OBJECTIVETo summarize the management of infant vascular tumors with Kasabach-Merritt phenomenon (KMP) and to evaluate the effect of drug combined with sclerotherapy.
METHODSFrom Feb. 2007 to Nov. 2014, 25 cases with KMP, who underwent drug therapy combined with sclerotherapy, were retrospectively studied. Oral corticosteroids (2 mg/kg per day) was used as the first-line therapy on all of the patients and intravenous vincristine (1.5 mg/m2 every week) was added when the platelet counts didn't recover obviously after 2-3 weeks. After the recovery of the platelet counts, the patients were admitted for sclerotherapy (average, 4.56 sessions per case) with 100% alcohol (1-3 ml per session), Lauromacrogol (1.25-5 ml per session) and betamethasone (0.25-1 ml per session). All the patients were followed up for 42 months ( range, 9 months to 6.5 years). Therapeutic outcomes were assessed by evaluating platelet counts, size of lesion, function of trunk and limb.
RESULTSAll the 25 cases got obvious recovery in the platelet counts [average, (94.3 ± 18.5) x 10(9)/L] after drug therapy, of which 16 were treated by single oral corticosteroids for 4-7 weeks and 9 were treated by corticosteroids plus intravenous vincristine for 2-5 weeks. Meantime, 11 cases received platelet transfusions, of which 3 were coupled with gamma globulin intramuscularly. During the first admission, each of the 25 cases received 1-4 sessions of sclerotherapy (average, 2.6 sessions each case). One week after the sclerotherapy, the platelet counts returned to (167-312) x 10(9)/L (average, (258.5 ± 34.4) x 10(9)/L). The hemoglobin and blood coagulation function returned to normal within 1-5 weeks. Meanwhile the mental condition, appetite, body weight, sleeping were greatly improved. The size of the lesions decreased gradually after the combined therapy including 13 cases within 3-12 months and 13 cases within 13-36 months. Long term follow-up indicated that only 1 case need treatment for recurrent decrease of platelet counts, and all of the 25 cases kept the normal weight, height, immunity as well as the growing development.
CONCLUSIONSOral corticosteroids plus intravenous vincristine combined with sclerotherapy is a reliable management with high cure rate, short course and minor side-effect.
Administration, Oral ; Betamethasone ; administration & dosage ; Combined Modality Therapy ; methods ; Ethanol ; administration & dosage ; Glucocorticoids ; administration & dosage ; Humans ; Infant ; Injections, Intravenous ; Kasabach-Merritt Syndrome ; blood ; therapy ; Platelet Count ; Polyethylene Glycols ; administration & dosage ; Retrospective Studies ; Sclerotherapy ; methods ; Vincristine ; administration & dosage
7.Outcome of hepatoblastoma: experience with 63 patients received chemotherapy with the regimen C5V.
Gongbao LIU ; Baihui LIU ; Kai LI ; Kuiran DONG ; Xianmin XIAO
Chinese Journal of Pediatrics 2015;53(2):119-123
OBJECTIVETo summarize the experience of the chemotherapy regimen cisplatin + fluorouracil + vincristine (C5V) for hepatoblastoma, and analyze the factors associated the outcome.
METHODA retrospective analysis was conducted for the outcome of hepatoblastoma. Sixty-three patients who received the regimen of C5V as the first choice of chemotherapy were reviewed, including 37 males and 26 females. The age at diagnosis ranged from 2 days after birth to 124 months, median 15 months. Four patients with stage I, 16 patients with stage II, 28 patients with stage III, 15 patients with stage IV disease were enrolled in the study. Nine patients had primary tumor resection while the remain by 54 received neoadjuvant chemotherapy. The median follow-up time was 30 months.
RESULTForty patients had delayed surgery, including 35 patients with regimen C5V alone, the others were treated with regimen C5V and cisplatin + adriamycin (CITA). The mean time of neojuvant chemotherapy was (3.4 ± 1.7) cycles. The mean time of chemotherapy after surgery was (5.3 ± 2.0) cycles. In 12 cases the (24.5%) tumor recurred after surgery. The margin of resection less than 0.5 cm , vascular invasion, stage III or IV disease were all the high risks of relapse (P = 0.049,0.001,0.022, respectively). Two-year overall survival (OS) and 5-year OS of the study was 61.1% and 58.7%, respectively. The 2-year OS and 5-year OS of stage I to III were 75.0% and 75.0%, 100.0% and 100.0%, 65.8% and 61.4%. The 1-year OS and 3-year OS of stage IV was 20.0%, 13.3%, respectively. Univariate analysis showed that age at diagnosis less than 60 months, vascular invasion, thrombocythemia at diagnosis, stage III or IV, tumor resection was the prognostic factor (P = 0.019, <0.001,0.011, <0.001, respectively). Multivariate analysis showed that tumor resection and age at diagnosis less than 60 months were both the prognostic factor (P < 0.001, 0.004, respectively ).
CONCLUSIONThe regimen of C5V is useful for hepatoblastoma. Tumor resection is the key factor of treatment. Prognostic factor is composed of age, stage, and clinical sign at diagnosis.
Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Child ; Child, Preschool ; Cisplatin ; administration & dosage ; Doxorubicin ; administration & dosage ; Female ; Fluorouracil ; administration & dosage ; Hepatoblastoma ; drug therapy ; Humans ; Infant ; Infant, Newborn ; Liver Neoplasms ; drug therapy ; Male ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Retrospective Studies ; Vincristine ; administration & dosage
8.Chronic myeloid leukemia as a secondary malignancy after diffuse large B-cell lymphoma.
Ha Young LEE ; Kyung Hee LEE ; Myung Soo HYUN ; Min Kyoung KIM ; Sung Ae KOH ; Hee Soon CHO
The Korean Journal of Internal Medicine 2014;29(2):250-252
No abstract available.
Adult
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Antineoplastic Combined Chemotherapy Protocols/therapeutic use
;
Benzamides/therapeutic use
;
Bone Marrow Examination
;
Chemoradiotherapy
;
Cyclophosphamide/administration & dosage
;
Doxorubicin/administration & dosage
;
Humans
;
Karyotyping
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive/*diagnosis/drug therapy/genetics/pathology
;
Lymphoma, Large B-Cell, Diffuse/*diagnosis/pathology/therapy
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Male
;
*Neoplasms, Second Primary
;
Piperazines/therapeutic use
;
Positron-Emission Tomography
;
Prednisolone/administration & dosage
;
Protein Kinase Inhibitors/therapeutic use
;
Pyrimidines/therapeutic use
;
Time Factors
;
Tomography, X-Ray Computed
;
Treatment Outcome
;
Vincristine/administration & dosage
;
Whole Body Imaging/methods
9.A multi-center retrospective study of L-asparaginase-based regimens as first-line treatment in newly diagnosed extranodal NK/T-cell lymphoma.
Fangfang YUAN ; Xudong WEI ; Qingsong YIN ; Yufu LI ; Ruihua MI ; Hao AI ; Haiping YANG ; Hongyi LI ; Shoubei GE ; Yanyan LIU ; Yongping SONG
Chinese Journal of Hematology 2014;35(7):614-618
OBJECTIVETo analyze the short-term efficacy, overall survival (OS), and safety in newly diagnosed extranodal NK/T-cell lymphoma (ENKTL) patients with L-asparaginase based regimens or CHOP regimen in combination with radiotherapy as first-line treatment.
METHODSOf the total 181 patients diagnosed by imaging and pathology, 69 patients received CHOP regimen and 112 patients received L-asparaginase based regimens. All the patients received radical radiotherapy(RT)after 6 cycles of chemotherapy.
RESULTSThe overall response rates of L-asparaginase-based group and CHOP group were 90.2% and 72.5%, respectively (P=0.002). The 1, 2, 5-year OS and progression-free survival (PFS) in L-asparaginase-based group were 96.0%, 88.3%, 65.1% and 94.2%, 79.8%, 50.0%, respectively. The 1, 2, 5-year OS and PFS in CHOP group were 82.6%, 61.9%, 28.4% and 63.8%, 44.0%, 21.0% (P=0.000).
CONCLUSIONCompared with CHOP regimen, L-asparaginase-based chemotherapy is more effective and safe for newly diagnosed nasal-type ENKTL.
Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Asparaginase ; administration & dosage ; Cyclophosphamide ; therapeutic use ; Doxorubicin ; therapeutic use ; Female ; Humans ; Lymphoma, Extranodal NK-T-Cell ; drug therapy ; Male ; Middle Aged ; Prednisone ; therapeutic use ; Retrospective Studies ; Treatment Outcome ; Vincristine ; therapeutic use
10.SLCO1B1c. 521T>C gene polymorphisms are associated with high-dose methotrexate pharmacokinetics and clinical outcome of pediatric acute lymphoblastic leukemia.
Huanian ZHANG ; Xuelian HE ; Jianxin LI ; Yang WANG ; Cheng WANG ; Yujun CHEN ; Changhe NIU ; Ping GAO
Chinese Journal of Pediatrics 2014;52(10):770-776
OBJECTIVETo provide guidance for the high-dose methotrexate (HD-MTX) treatment of pediatric acute lymphoblastic leukemia (ALL), and to understand the impact of SLCO1B1c.521T>C (rs4149056) variant on methotrexate (MTX) pharmacokinetics and clinical outcome in children with ALL.
METHODEighty-two children with ALL in Division of Hematology of Wuhan Children's Hospital from January 2008 to February 2013 were enrolled. All patients were genotyped for rs4149056 single nucleotide polymorphism (SNP) into wild-type group (TT genotype) and variant group (TC/CC genotype). According to the ALL-BFM 2000 protocol, all patients received intravenous infusion of MTX every ten days at 3 to 5 g/m(2). Leucovorin rescue was performed after 36 hours of the MTX administration and its dose was adjusted according to the MTX plasma concentration at 48 hours. The concentrations of MTX and its metabolite at 24, 48 and 72 h were determined by high performance liquid chromatography with solid phase extraction. Population pharmacokinetic parameters were estimated by the NLME software. The pharmacokinetics, toxicity and leucovorin rescue was compared. The relapse rate within 5 years and event-free survival were followed up.
RESULTEighty-two pediatric patients were classified into two groups: variant group including 20 TC genotype carriers and one CC genotype carrier, wild-type group included 61 patients with TT genotype. Compared with wild-type group, plasma concentration of MTX at 48 and 72 h increased significantly [48 h: (1.00±1.41) vs.(0.34±0.17) µmol/L, t=2.131, P=0.046; 72 h: (0.31±0.26) vs.(0.08±0.04) µmol/L; t=3.995, P=0.001]. Area under the concentration time curve (AUC48-∝) of MTX significantly increased in variant group [(23.18±19.91) vs.(5.66±2.01) h·µmol/L] (t=4.025, P=0.001). Time above the MTX safety threshold (TC>0.1 µmol/L) increased significantly in variant group [(95.3±22.0) vs.(67.1±7.5) h, t=5.880, P<0.001]. Rescue dosage of leucovorin in variant group was higher than that in wild-type group [(312.7±287.8) vs.(140.6±27.5) mg/m2, t=2.614, P=0.017]. The children carrying rs4149056 C allele suffered from a higher frequency of serious adverse effect [gastrointestinal toxicity: 33% (7/21) vs. 5% (3/61);hepatic toxicity: 24% (5/21) vs. 2% (1/61)]. The difference was statistically significant (χ2=9.275, 8.289, all P<0.05). Hospital stay of variant group was significantly longer than that of wild-type [(4.95±1.43) vs. (4.05±0.22) d, t=2.881, P=0.009]. The relapse rate within 5 years of variant group and wild-type group were 9% (2/21) and 13% (8/61), respectively. There were no significant differences in the event-free survival between the two groups (χ2=0.001, P=0.971).
CONCLUSIONThe SLCO1B1 c.521T>C variant was an important determinant of MTX pharmacokinetics. An appropriate leucovorin dose raise in variant group was beneficial to reducing the serious toxicity and did not affect the long-term clinical outcome.
Alleles ; Antineoplastic Combined Chemotherapy Protocols ; Asparaginase ; Child ; Daunorubicin ; Disease-Free Survival ; Genotype ; Humans ; Leucovorin ; administration & dosage ; Methotrexate ; administration & dosage ; pharmacokinetics ; Organic Anion Transporters ; genetics ; Polymorphism, Genetic ; Polymorphism, Single Nucleotide ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; drug therapy ; genetics ; Prednisone ; Solute Carrier Organic Anion Transporter Family Member 1b1 ; Treatment Outcome ; Vincristine

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