1.Preliminary study of autologous peripheral blood stem cell transplantation in patients with POEMS syndrome.
Ming-Hui DUAN ; Dao-Bin ZHOU ; Li JIAO ; Wei ZHANG ; Tie-Nan ZHU ; Jian LI ; Ti SHEN
Chinese Journal of Hematology 2010;31(11):744-747
OBJECTIVETo evaluate the efficacy and safety of autologous peripheral blood stem cell transplantation (auto-PBSCT) after high dose melphalan in patients with POEMS syndrome.
METHODSNine patients including 6 males and 3 females received 10 auto-PBSCT after high dose melphalan in our hospital from June 2005 to October 2009. The median age at transplantation was 44 (39 - 48) years. The median time from onset of disease to transplantation was 12 (5 - 60) months. Peripheral stem cells were mobilized by G-CSF alone in one patient and 8 patients by G-CSF plus chemotherapy. Two patients were conditioned by melphalan 140 mg/m(2) and 7 by melphalan 200 mg/m(2). The median number of MNC was 3.75 (1.05 - 8.33) × 10(8)/kg, and that of CD34(+) cell was 5.37 (1.32 - 10.90) × 10(6)/kg.
RESULTOne patient received tandem auto-PBSCT and others received single one. Stem cell engrafted in all but 1 patient who died of severe infection and acute renal failure on day 9 after transplantation. Eight patients were evaluable for response. The median time to ANC ≥ 0.5 × 10(9)/L and platelet ≥ 20 × 10(9)/L was 10 (9 - 11) and 11.5 (9 - 14) days respectively. Two patient reached negative immunofixation electrophoresis (IFE) after stem cell mobilization and transplantation respectively, and the other 6 remained IFE postive after auto-PBSCT. Skin changes and edema of lower extremities were improved in 5 of 6 patients, lymphadenopathy relieved in 1 and papilledema improved in 2 of 3 patients. All but 1 patient achieved gradual neurologic improvement after transplantation.
CONCLUSIONPBSCT is an effective and safe therapy for POEMS syndrome patients with low treatment related mortality.
Granulocyte Colony-Stimulating Factor ; therapeutic use ; Hematopoietic Stem Cell Mobilization ; Humans ; Melphalan ; therapeutic use ; POEMS Syndrome ; Peripheral Blood Stem Cell Transplantation
2.Photodynamic therapy mediated by 5-aminolevulinic acid suppresses gliomas growth by decreasing the microvessels.
Wei YI ; Hai-tao XU ; Dao-feng TIAN ; Li-quan WU ; Shen-qi ZHANG ; Long WANG ; Bao-wei JI ; Xiao-nan ZHU ; Humphrey OKECHI ; Gang LIU ; Qian-xue CHEN
Journal of Huazhong University of Science and Technology (Medical Sciences) 2015;35(2):259-264
Although 5-aminolevulinic acid (5-ALA)-mediated photodynamic therapy (PDT) has been demonstrated to be a novel and effective therapeutic modality for some human malignancies, its effect and mechanism on glioma are still controversial. Previous studies have reported that 5-ALA-PDT induced necrosis of C6 rat glioma cells in vitro. The aim of this study was to further investigate the effect and mechanism of 5-ALA-PDT on C6 gliomas implanted in rats in vivo. Twenty-four rats bearing similar size of subcutaneously implanted C6 rat glioma were randomly divided into 3 groups: receiving 5-ALA-PDT (group A), laser irradiation (group B), and mock procedures but without any treatment (group C), respectively. The growth, histology, microvessel density (MVD), and apoptosis of the grafts in each group were determined after the treatments. As compared with groups B and C, the volume of tumor grafts was significantly reduced (P<0.05), MVD was significantly decreased (P<0.001), and the cellular necrosis was obviously increased in group A. There was no significant difference in apoptosis among the three groups. The in vivo studies confirmed that 5-ALA-PDT may be an effective treatment for gliomas by inhibiting the tumor growth. The mechanism underlying may involve increasing the cellular necrosis but not inducing the cellular apoptosis, which may result from the destruction of the tumor microvessels.
Aminolevulinic Acid
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pharmacology
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therapeutic use
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Animals
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Brain Neoplasms
;
blood supply
;
drug therapy
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pathology
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Cell Line, Tumor
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Glioma
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blood supply
;
drug therapy
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pathology
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Microvessels
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drug effects
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Photochemotherapy
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Photosensitizing Agents
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pharmacology
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therapeutic use
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Rats
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Rats, Wistar
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Xenograft Model Antitumor Assays
3.Comparison of efficacy and adverse effects between arsenic trioxide and all-trans retinoic acid in patients with acute promyelocytic leukemia.
Li JIAO ; Shu-Jie WANG ; Jun-Ling ZHUANG ; Yong-Qiang ZHAO ; Dao-Bin ZHOU ; Ying XU ; Bing HAN ; Wei ZHANG ; Ming-Hui DUAN ; Nong ZOU ; Tie-Nan ZHU ; Ti SHEN
Acta Academiae Medicinae Sinicae 2009;31(5):555-558
OBJECTIVETo compare the efficacy and adverse effects between arsenic trioxide (ATO) and all-trans retinoic acid (ATRA) in patients with acute promyelocytic leukemia (APL).
METHODSThe clinical data of 71 patients with newly diagnosed APL were retrospectively analyzed. Two groups were classified according to the induction regimens, namely ATO group (n = 41) and ATRA group (n = 30). The complete remission (CR) rate and the time to CR were compared between these two groups.
RESULTSThe CR rate was 97.5% in ATO group and 93.3% in ATRA group (P > 0.05). The median time to CR was 29 days (21-45 days) in ATO group, which was significantly shorter than 38.5 days (24-63 days) in ATRA group (P < 0.001). Retinoic acid syndrome occurred in 52.9% of patients treated with ATRA, which affected the further use of ATRA.
CONCLUSIONSBoth ATO and ATRA have high response rates for newly diagnosed patients with APL. Compared with ATRA, ATO induction therapy has shorter time to achieve CR and less adverse effects, and therefore may be the first-line therapy for APL.
Adolescent ; Adult ; Aged ; Arsenicals ; adverse effects ; therapeutic use ; Female ; Humans ; Leukemia, Promyelocytic, Acute ; drug therapy ; Male ; Middle Aged ; Oxides ; adverse effects ; therapeutic use ; Remission Induction ; Retrospective Studies ; Treatment Outcome ; Tretinoin ; adverse effects ; therapeutic use ; Young Adult
4.Porcine anti-human lymphocyte globulin plus cyclosporine A therapy for severe aplastic anemia.
Bing HAN ; Si-yi YAN ; Nong ZOU ; Wei ZHANG ; Jian LI ; Ming-hui DUAN ; Li JIAO ; Jun-ling ZHUANG ; Shu-jie WANG ; Dao-bin ZHOU ; Tie-nan ZHU ; Ying XU ; Yong-qiang ZHAO ; Ti SHEN
Chinese Journal of Hematology 2011;32(4):241-244
OBJECTIVETo evaluate the efficacy of porcine anti-human lymphocyte globulin (P-ALG) plus cyclosporine A (CsA) therapy for severe aplastic anemia (SAA).
METHODSForty-eight SAA patients (31 males, 17 females) including 17 very severe aplastic anemias (vSAA) were treated with ALG plus CsA between 1999 to 2009 in our hospital and the outcomes were analyzed retrospectively for early mortality, response rate and quality, survival rate, toxicity and complications.
RESULTSThe median age was 28 (13 - 64) years. The interval from diagnosis to treatment was 45 days. The median neutrophil count at diagnosis was 0.178 × 10(9)/L. Overall response was 83.3% (54.2% complete, 29.2% partial) with a median time of 90 (23 - 380) days. 10.4% died of infection within 30 days mainly of fungi infection. Only 1 patient relapsed 2 years after treatment. No clonal disease was found. The 1.5-year survival rate was 87.5%. vSAAs had less response, higher early mortality and less survival (64.7%, 29.4% and 51.8%, respectively) compared to that of SAA (93.5%, 0, 100%, respectively, P < 0.05). Grouped patients with different age, gender, intervals between diagnosis and treatment and pre-existing infections had similar response. The main side effects were fever and skin rash (52.1%), serum sickness (16.7%), impaired liver function (60.4%) and hemorrhage (2.1%). No treatment-related mortality was found.
CONCLUSIONP-ALG plus CsA is an ideal and well tolerated treatment for SAA but not for vSAA.
Adolescent ; Adult ; Anemia, Aplastic ; drug therapy ; Animals ; Antilymphocyte Serum ; therapeutic use ; Cyclosporine ; therapeutic use ; Female ; Humans ; Immunosuppressive Agents ; therapeutic use ; Lymphocytes ; immunology ; Male ; Middle Aged ; Retrospective Studies ; Swine ; Treatment Outcome ; Young Adult
6.Bendamustine treatment of Chinese patients with relapsed indolent non-Hodgkin lymphoma: a multicenter, open-label, single-arm, phase 3 study.
Yuan-Kai SHI ; Xiao-Nan HONG ; Jian-Liang YANG ; Wei XU ; Hui-Qiang HUANG ; Xiu-Bin XIAO ; Jun ZHU ; Dao-Bin ZHOU ; Xiao-Hong HAN ; Jian-Qiu WU ; Ming-Zhi ZHANG ; Jie JIN ; Xiao-Yan KE ; Wei LI ; De-Pei WU ; Shen-Miao YANG ; Xin DU ; Yong-Qian JIA ; Ai-Chun LIU ; Dai-Hong LIU ; Zhi-Xiang SHEN ; Lian-Sheng ZHANG ; Leonard JAMES ; Edward HELLRIEGEL
Chinese Medical Journal 2021;134(11):1299-1309
BACKGROUND:
Bendamustine was approved in China on May 26th, 2019 by the National Medical Product Administration for the treatment of indolent B-cell non-Hodgkin lymphoma (NHL). The current study was the registration trial and the first reported evaluation of the efficacy, safety, and pharmacokinetics of bendamustine in Chinese adult patients with indolent B-cell NHL following relapse after chemotherapy and rituximab treatment.
METHODS:
This was a prospective, multicenter, open-label, single-arm, phase 3 study (NCT01596621; C18083/3076) with a 2-year follow-up period. Eligible patients received bendamustine hydrochloride 120 mg/m2 infused intravenously on days 1 and 2 of each 21-day treatment cycle for at least six planned cycles (and up to eight cycles). The primary endpoint was the overall response rate (ORR); and secondary endpoints were duration of response (DoR), progression-free survival (PFS), safety, and pharmacokinetics. Patients were classified according to their best overall response after initiation of therapy. Proportions of patients in each response category (complete response [CR], partial response [PR], stable disease, or progressive disease) were summarized along with a two-sided binomial exact 95% confidence intervals (CIs) for the ORR.
RESULTS:
A total of 102 patients were enrolled from 20 centers between August 6th, 2012, and June 18th, 2015. At the time of the primary analysis, the ORR was 73% (95% CI: 63%-81%) per Independent Review Committee (IRC) including 19% CR and 54% PR. With the follow-up period, the median DoR was 16.2 months by IRC and 13.4 months by investigator assessment; the median PFS was 18.6 months and 15.3 months, respectively. The most common non-hematologic adverse events (AEs) were gastrointestinal toxicity, pyrexia, and rash. Grade 3/4 neutropenia was reported in 76% of patients. Serious AEs were reported in 29 patients and five patients died during the study. Pharmacokinetic analysis indicated that the characteristics of bendamustine and its metabolites M3 and M4 were generally consistent with those reported for other ethnicities.
CONCLUSION:
Bendamustine is an active and effective therapy in Chinese patients with relapsed, indolent B-cell NHL, with a comparable risk/benefit relationship to that reported in North American patients.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, No. NCT01596621; https://clinicaltrials.gov/ct2/show/NCT01596621.
Adult
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Antineoplastic Combined Chemotherapy Protocols
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Bendamustine Hydrochloride/therapeutic use*
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China
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Humans
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Lymphoma, Non-Hodgkin/drug therapy*
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Neoplasm Recurrence, Local/drug therapy*
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Prospective Studies
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Rituximab/therapeutic use*