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ABSTRACT: Docetaxel lipid microsphere (DT-LM), an intravenous lipid emulsion for docetaxel without Tween 80, has demonstrated significant advantage over other conventional docetaxel formulations with respect to keeping sustained release, reducing irritation or toxicity of drug, sterile for intravenous injection and presenting targeting. A rapid, sensitive and reproducible ultra high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for determination of total docetaxel from a lipid microsphere formulation in human plasma using paclitaxel as internal standard (IS) has been developed and validated. The analytes and IS were extracted from plasma by simple liquid-liquid extraction and separated on ACQUITY UPLC BEH C18 column at a flow rate of 0.3ml/min using gradient elution mode. The total analytical time was only 2.5min. Detection and quantitation were performed by electrospray ionization (ESI) in the positive ionization mode by multiple reaction monitoring (MRM) of the transitions at m/z 808.3→527.1 for docetaxel and 854.0→285.9 for IS. The assay was linear over the concentration range of 2-5000ng/ml (r(2)>0.99) with the lower limit of quantification (LLOQ) of 2ng/ml. The intra- and inter-day precision in terms of relative standard deviation (RSD%) was within 9% and accuracy in terms of relative error (RE%) was within 12%. The rapid, sensitive and reproducible UPLC-MS/MS method is now used to support clinical pharmacologic studies with DT-LM injection in patients with advanced cancer.
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences 03/2013; 926C:101-107. · 2.78 Impact Factor
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Mei Dong,
Xiao-Hui He,
Peng Liu,
Yan Qin,
Jian-Liang Yang,
Sheng-Yu Zhou, Sheng Yang,
Chang-Gong Zhang,
Lin Gui,
Li-Qiang Zhou,
Yuan-Kai Shi
[show abstract]
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ABSTRACT: This study was conducted to evaluate the efficacy and safety of gemcitabine-based combination regimen in patients with peripheral T-cell lymphoma (PTCL). Between May 2007 and August 2011, 26 consecutive patients with PTCL were enrolled in this study. Of these 26 patients, histology was extranodal NK/T-cell lymphoma, nasal type in 14 (53.9 %), peripheral T-cell lymphoma, not otherwise specified in nine (34.6 %), anaplastic large cell lymphoma, ALK negative in three (11.5 %). The majority of patients had newly diagnosed (65.4 %) and advanced (80.8 %) diseases. Treatment regimen was DIMG (dexamethasone, ifosfamide, methotrexate, and gemcitabine) given to the first 6 patients, and GDP (gemcitabine, dexamethasone, and cisplatin) given to the remaining 20 patients. The median follow-up time was 25 (range 7-60) months. The overall response rate was 88.5 %. Twelve (46.2 %) patients achieved complete remission, 11 (42.3 %) patients achieved partial remission, and 1 (3.8 %) patient had stable disease (SD), two (7.7 %) patients had progressive diseases. The 1- and 2-year progression-free survival rates were 58.7 and 45.9 %, while 1- and 2-year overall survival rates for all patients were 80.6 and 63.7 %, respectively. Adverse events included grade 3 or 4 neutropenia (35.0 %) and thrombocytopenia (15.0 %) from patients treated with GDP. Grade 3 or 4 neutropenia and thrombocytopenia were 100.0 and 66.7 %, respectively, for patients who received DIMG regimen. Our study has demonstrated that the gemcitabine-based combination regimen, especially GDP regimen, is safe and well tolerated with promising clinical activity in patients with PTCLs.
Medical Oncology 03/2013; 30(1):351. · 2.14 Impact Factor
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Xiao-Hui He,
Bo Li,
Shuang-Mei Zou,
Mei Dong,
Sheng-Yu Zhou,
Jian-Liang Yang,
Li-Yan Xue, Sheng Yang,
Peng Liu,
Yan Qin,
Chang-Gong Zhang,
Xiao-Hong Han,
Yuan-Kai Shi
[show abstract]
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ABSTRACT: Anaplastic large-cell lymphoma (ALCL) is characterized by frequently presenting adverse factors at diagnosis. Many groups believed aggressive treatment strategies such as autologous stem cell transplantation brought survival benefit for ALCL patients. However, few compared these approaches with conventional chemotherapy to validate their superiority. Here, we report a study comparing the efficacy of peripheral blood stem cell transplantation (PBSCT) and conventional chemotherapy in the treatment of ALCL. A total of 64 patients with primary systemic ALCL were studied retrospectively. The median follow-up period was 51 months (range, 1-167 months). For 48 patients receiving conventional chemotherapy only, the 4-year event-free survival (EFS) and overall survival (OS) were 70.7% and 88.3%, respectively. Altogether, 16 patients received PBSCT, including 11 at first remission (CR1/PR1), 3 at second remission, and 2 for disease progression during first-line chemotherapy. The 4-year EFS and OS for patients transplanted at first remission were 81.8% and 90.9%, respectively. Compared with conventional chemotherapy, PBSCT did not show superiority either in EFS (P = 0.240) or in OS (P = 0.580) when applied at first remission. Univariate analysis showed that patients with B symptoms (P = 0.001), stage III/IV disease (P = 0.0083), bulky disease (P = 0.075), negative anaplastic lymphoma kinase (ALK) expression (P = 0.059), and age ≤ 60 years (P = 0.054) had lower EFS. Furthermore, PBSCT significantly improved EFS in patients with B symptoms (100% vs. 50.8%, P = 0.027) or bulky disease (100% vs. 52.8%, P = 0.045) when applied as an up-front strategy. Based on these results, we conclude that, for patients with specific adverse factors such as B symptoms or bulky disease, PBSCT was superior to conventional chemotherapy in terms of EFS.
Chinese journal of cancer 08/2012;
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Jian-liang Yang,
Yuan-kai Shi,
Xiao-hui He,
Mei Dong,
Sheng-yu Zhou,
Peng Liu,
Chang-gong Zhang,
Xiao-hong Han, Sheng Yang,
Lin Gui,
Yan Qin
[show abstract]
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ABSTRACT: To evaluate the effect of recombinant human interleukin 11 (rhIL-11) on hematological recovery after autologous hematopoietic stem cell transplantation (AHSCT) in patients with lymphoma.
A retrospective study was carried out on 73 patients with lymphoma after AHSCT. The patients were divided into two groups. The study group (n = 35) received rhIL-11 1.5 mg daily from the fifth day after AHSCT to the day when platelets recovering to 80.0×10⁹/L. The control group (n = 38) did not receive rhIL-11 after AHSCT.
All the 73 patients finished AHSCT from Mar 2003 to Dec 2008 in our department. Thirty-five patients received rhIL-11 and 38 patients did not. In the rhIL-11 group and control group, the nadir of platelet was (18.9 ± 5.0)×10⁹/L and (21.5 ± 6.0)×10⁹/L, respectively, with a significant difference (P = 0.04). The median time of platelet recovering to 50.0×10⁹/L was (14.3 ± 5.5) d and (13.2 ± 4.5) d (P = 0.37) in the two groups. There was no significant difference (P = 0.82) in the median numbers of platelet transfusion in the two groups. The curves of the mean of daily absolute platelet counts of the two groups were similar (P = 0.22). Adverse events related to rhIL-11 were not found in the rhIL-11 group.
The results of this study do not show obviously accelerating effect of rhIL-11 on the platelet recovery in lymphoma patients after AHSCT and obvious increase of adverse events after rhIL-11 administration.
Zhonghua zhong liu za zhi [Chinese journal of oncology] 06/2012; 34(6):469-72.
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Xiao-Hui He,
Bo Li, Sheng Yang,
Ning Lu,
Xun Zhang,
Shuang-Mei Zou,
Ye-Xiong Li,
Yong-Wen Song,
Shan Zheng,
Mei Dong,
Sheng-Yu Zhou,
Jian-Liang Yang,
Peng Liu,
Chang-Gong Zhang,
Yan Qin,
Feng-Yi Feng,
Yuan-Kai Shi
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ABSTRACT: To further explore the role of rituximab when added to the CHOP-like regimen in the treatment of immunohistochemically defined non-germinal center B-cell subtype (non-GCB) diffuse large B-cell lymphoma(DLBCL), 159 newly diagnosed DLBCL patients were studied retrospectively based on the immunohistochemical evaluation of CD10, Bcl-6, MUM-1, and Bcl-2. Altogether, 110 patients underwent the CHOP-like regimen, and rituximab was added for the other 49 patients. Cox regression analysis showed that compared with the CHOP-like regimen, the rituximab-based regimen(R-CHOP regimen) significantly decreased the risk of disease relapse and progression in CD10-negative patients (P=0.001), Bcl-6-negative patients (P=0.01), and MUM-1-positive patients (P=0.003). The risk of disease relapse in patients with non-GCB subtype (P=0.002) also decreased. In contrast, patients with the opposite immunohistochemical marker expression profile and GCB subtype did not benefit from treatment with the R-CHOP regimen. In addition, non-GCB subtype patients had a significantly higher expression rate of Bcl-2 than GCB subtype patients (P=0.042). Although univariate analysis found that both Bcl-2-positive and -negative patients had significantly higher event-free survival rates with the R-CHOP regimen, only Bcl-2 positivity (P=0.004) maintained significance in the Cox regression analysis. We conclude that the addition of rituximab can significantly improve the prognosis of patients with non-GCB subtype DLBCL, which is closely related to the expression of CD10, Bcl-6, MUM-1, and Bcl-2.
Chinese journal of cancer 05/2012; 31(6):306-14.
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Yan-hua Huang,
Xiao-hui He,
Yan Qin, Sheng Yang,
Zheng Lü,
Mei Dong,
Sheng-yu Zhou,
Peng Liu,
Chang-gong Zhang,
Jian-liang Yang,
Yuan-kai Shi
[show abstract]
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ABSTRACT: To analyze the liver function in patients with diffuse large B-cell lymphoma(DLBCL), who are hepatitis B surface antigen negative/antibody to hepatitis B core antigen positive (HBsAg-/HBcAb+), treated with CHOP and R-CHOP regimens.
In this retrospective study, 86 DLBCL patients, who were HBsAg-/HBcAb+, were collected from Cancer Hospital of Chinese Academy of Medical Sciences between January 2005 and December 2008. The patients were given at least two cycles of chemotherapy using CHOP-like or R-CHOP-like regimen without anti-HBV treatment, and followed-up for at least 12 months after completion of therapy.
Forty-seven patients received CHOP-like regimen while 39 patients received R-CHOP-like regimen. There were no significant differences in the degree of liver dysfunction between CHOP group and R-CHOP group after the 1st, 2nd, 3rd, 4th and 6th cycles (22.7% - 46.7% with CHOP and 17.6% - 34.2% with R-CHOP, respectively, (all P > 0.05), except for the 5th cycles (28.6% vs. 6.2%, P = 0.026). Liver function in most patients in CHOP group and R-CHOP group was normal after every cycle (53.3% - 77.3% and 65.8%-93.8%, respectively). Meanwhile, there were no significant differences in the degree of liver dysfunction between CHOP group and R-CHOP group in the 1st-3rd month, 4th-6th month, 7th-9th month and 10th-12th month after completion of therapy (7.7% - 40.0% with CHOP and 7.4% - 32.0% with R-CHOP, respectively, all P > 0.05).
The present study reveals a low incidence of liver dysfunction in HBsAg-/HBcAb+ DLBCL patients, both in CHOP group and in R-CHOP group. It may indicate a potential low incidence of HBV reactivation in these groups, and Rituximab do not increase the rate of liver dysfunction. Therefore, these data may not support regularly prophylactic antiviral therapy during chemotherapy, but close monitoring of liver function, HBV serum markers and HBV DNA level are demanded.
Zhonghua zhong liu za zhi [Chinese journal of oncology] 05/2012; 34(5):385-9.
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Xiaohong Han,
Li Ma,
Lingdi Zhao,
Xiaohui He,
Peng Liu,
Shengyu Zhou,
Jianliang Yang,
Yan Qin, Sheng Yang,
Jiarui Yao,
Yuankai Shi
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ABSTRACT: Factors affecting progenitor cell mobilization in patients with non-Hodgkin's lymphoma (NHL) and Hodgkin's lymphoma (HL) are incompletely understood. The aim of this retrospective study was to determine which factors are crucial for effective mobilization and collection of autologous peripheral blood stem cells (PBSC) prior to transplantation in Chinese patients.
A total of 239 patients with lymphoma (198 NHL and 41 HL patients) underwent PBSC collection after mobilization with granulocyte-colony-stimulating factor (G-CSF) or G-CSF plus chemotherapy priming.
Patient characteristics at diagnosis and transplant, including low Eastern Cooperative Oncology Group score (P = 0.013), lack of extranodal invasion (P = 0.034), previously administered radiotherapy regimens (P = 0.040), treatment with platinum prior to mobilization (P = 0.042), previous chemotherapy regimens (P = 0.001) and cycles (P < 0.001), and chemotherapy regimens (P < 0.001) were statistically significant for successful mobilization in multivariate analysis. Premobilization factors, including previous radiotherapy (P = 0.009), previous chemotherapy regimens (P = 0.043) and cycles (P = 0.039), low platelet count prior to mobilization (P = 0.042), and lower CD34+ cells in peripheral blood (PB) (P = 0.050) or bone marrow (BM) (P = 0.007) were considered possibly predictive of poor mobilization. We found the patients who had chemosensitive lymphoma had worse progress-free survival (PFS) than the patients with initial treatment and high risks (P = 0.017).
Our analysis showed that high amounts of chemotherapy, radiotherapy, low platelet count, chemosensitive recurrent patients, combination chemotherapy plus G-CSF and low CD34+ cells in BM prior to mobilization could emerged as important predictive factors for mobilization failure in Chinese patients with NHL and HL.
Journal of Clinical Apheresis 02/2012; 27(2):64-74. · 1.93 Impact Factor
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ABSTRACT: To characterize the safety profiles and serum pharmacokinetic effects of anti-epidermal growth factor receptor monoclonal antibody (CMAB009) in advanced cancer patients and evaluate the preliminary evidence of its anti-tumor activity.
This phase I, single-center clinical trial had 2 phases of treatment: single-dose phase, followed by a fixed weekly dose. Subjects meeting the inclusion criteria were enrolled. The subjects were randomly assigned to receive 1 of 3 initial doses of CMAB009 (100, 250 & 400 mg/m(2)) for the purpose of single-dose pharmacokinetic evaluation. After a 28-day washout period of allowing for the characterization of pharmacokinetic end points, the eligible patients were permitted to undergo a successive multi-dose phase study. They were divided into 2 dose groups, group A with 4 weekly doses of 250 mg/m(2), group B with the initial dose of 400 mg/m(2), followed by 3 weekly doses of 250 mg/m(2). The subjects were closely monitored for adverse events throughout the trial.
A total of 18 subjects were recruited, including colorectal cancer (n = 10), non-small cell lung cancer (n = 7) and gastric cancer (n = 1). CMAB009-associated toxicity was minimal. And the most commonly reported Grade 1/2 adverse events were skin rashes, fever, nausea and headache. Two patients with colorectal cancer achieved partial remission and the time to progression (TTP) was 24 and 16 weeks respectively.
As a well-tolerated antitumor agent, CMAB009 may be safely administered by the above multi-dosing protocol.
Zhonghua yi xue za zhi 09/2011; 91(33):2333-5.
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ABSTRACT: Aurora-A, encoding serine/threonine kinases with a key role in mitosis has been demonstrated to be involved in tumor progression. Hematogenous and lymphatic metastasis are also involved in cancer progression. Vascular endothelial growth factors (VEGFs) and their receptors (VEGFRs) have been implicated in tumor-related angiogenesis and lymphagenesis. The purpose of this study was to analyze the expression and prognostic significance of Aurora-A, VEGFs and VEGFRs in gastric cancer. The expression profiles of Aurora-A, VEGF-A and VEGF-D in gastric cancer cell lines were detected employing real-time reverse transcription polymerase chain reaction and Western blot analysis. The expression levels of Aurora-A, VEGF-A/VEGFR-2, VEGF-D/VEGFR-3 and clinicopathological characteristics were analyzed in 89 gastric cancer patients treated with curative surgery. Univariate analysis demonstrated that histological grade (P=0.052), TNM stage (P<0.001), lymphovascular involvement (P<0.001), Aurora-A (P<0.001) and VEGF-D (P=0.048) were prognostic factors. The presence of Aurora-A was correlated with tumor progression (P=0.053) and shorter survival (P=0.001). Cox multivariate regression analysis demonstrated that Aurora-A positive expression, stage III-IV and lymphovascular involvement were independent unfavorable prognostic factors in gastric cancer. Aurora-A positive expression was predictive for worse outcome in patients without lymph node metastasis (P<0.05) and in patients with stage III-IV (P<0.001). Aurora-A could serve as an independent prognostic marker in gastric cancer and could identify patients with worse outcome even in a relatively early and local disease, thus offering valuable information for administering individualized treatment and/or surveillance for these patients.
Oncology Reports 07/2011; 26(1):23-32. · 1.84 Impact Factor
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Yan Qin,
Yuan-Kai Shi,
Xiao-Hui He,
Jian-Liang Yang,
Chang-Gong Zhang,
Sheng-Yu Zhou,
Xin-Fan Liu,
Peng Liu, Sheng Yang,
Li-Qiang Zhou,
Xiao-Hong Han,
Jia-Rui Yao
[show abstract]
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ABSTRACT: To retrospectively analyze the clinical features and prognostic factors of patients with angioimmunoblastic T-cell lymphoma (AITL).
The clinicopathological and follow-up data of 18 AITL patients undergoing integrated treatment from Feb. 1998 to April 2009 in our department were retrospectively analyzed. All of the patients received CHOP-like regimens as initial chemotherapy, including 4 once treated with radiotherapy and 1 with high dose therapy followed by autologous stem cell transplantation (HDT-ASCT) as upfront consolidation therapy. B-cell, T-cell and NK-cell subgroup proportions in the peripheral blood were tested by flow cytometry in 6 patients.
The median age of the 18 patients was 55 years, male and female ratio was 2.6:1. Seventy-two percent of the patients were in an advanced stage. 72% of them had B symptoms, 69% hypergammaglobulinemia, 60% elevated LDH and 47% anemia. Forty-four percent achieved CR after initial treatment with CHOP-like regimens. With the median follow-up of 26 months, the overall 2-year survival and disease free survival (DFS) rates were 62.2% and 44.4%, respectively. In the univariate analysis, only age > 30 years and primary refractory disease adversely affected overall survival (OS); age > 30 years, advanced stage, B symptoms and splenomegaly adversely affected DFS. Four patients suffered from severe pneumonia during treatment, 2 of them died of respiratory failure. Flow cytometry of peripheral blood lymphocytes showed that 5 of the 6 tested cases had decreasing proportion of CD3(+)CD4(+) T cells, B cells and NK cells but elevated CD3(+)CD8(+) T cells. Two heavily treated patients achieved partial and complete response by thalidomide therapy, with a progression free survival (PFS) of 2 and 6+ months, respectively.
AITL patients do not response well to CHOP-like regimens chemotherapy. Age < 30 years and sensitive to initial chemotherapy are associated with prolonged OS. Effectiveness of thalidomide in the treatment of AITL deserves further investigation. Peripheral blood lymphocytes test indicates that AITL patients suffered from both natural and acquired immune defects.
Zhonghua zhong liu za zhi [Chinese journal of oncology] 06/2010; 32(6):448-51.
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Wei Shi,
Yuan-kai Shi,
Xiao-hui He,
Sheng-yu Zhou,
Mei Dong,
Chang-gong Zhang,
Jian-liang Yang,
Peng Liu,
Yan Qin, Sheng Yang,
Lin Gui
[show abstract]
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ABSTRACT: The efficacy of standard chemotherapy regimen on lymphoblastic lymphoma (LBL) is unsatisfied. This study was to evaluate the efficacy and safety of modified Hyper-CVAD regimen on Chinese patients with LBL.
Clinical records of 20 LBL patients who received modified Hyper-CVAD regimen in Cancer Hospital of Chinese Academy of Medical Sciences, from June 2004 to June 2008, were retrospectively analyzed in terms of response and toxicity.
By May. 2009, the median follow-up time was 17 (4-36) months. The 20 patients totally received 62 cycles regimen A and 29 cycles regimen B. 17 patients were assessable in efficacy, the total response rate (RR) was 88.2% with complete response (CR) rate of 41.2%. 15 patients received modified Hyper-CVAD regimen as first-line therapy (75.0%), and RR was 100% with CR rate of 50.0% (7/14). The RR of salvage therapy was 33% without CR achieved. The major toxicity was myelosuppression, the incidence of grades 3-4 neutropenia, thrombocytopenia and anemia was 95.0%, 75.0% and 40.0%, respectively. No treatment-related death was observed.
Modified Hyper-CVAD regimen was a promising regimen for the patients with LBL, and toxicity was within acceptable limits.
Zhonghua yi xue za zhi 04/2010; 90(14):978-81.
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Wei Shi,
Yuan-Kai Shi,
Xiao-Hui He,
Jian-Liang Yang,
Chang-Gong Zhang,
Sheng-Yu Zhou,
Mei Dong,
Peng Liu,
Yan Qin, Sheng Yang,
Lin Gui,
Zheng Lv
[show abstract]
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ABSTRACT: The efficacy of standard chemotherapy regimen on aggressive non-Hodgkin's lymphoma (NHL) of certain pathologic types is unsatisfied. This study was to evaluate the safety and efficacy of modified Hyper-CVAD regimen on Chinese patients with aggressive NHL.
Clinical records of 31 NHL patients who received modified Hyper-CVAD regimen in Cancer Hospital of Chinese Academy of Medical Sciences from June 2004 to June 2008 were analyzed in terms of toxicity and response.
The 31 patients totally received 91 cycles of regimen A and 41 cycles of regimen B with a median of 4 cycles (ranged 1-7 cycles). The major toxicity was myelosuppresion: the occurrence rates of neutropenia of grades III-IV, thrombocytopenia and febrile neutropenia were 49.5%, 3.3% and 12.1% during treatment of regimen A, and were 80.5%, 82.9% and 46.3% during treatment of regimen B. No treatment-related death was observed. The responses were assessable in 26 patients. The total response rate was 80.8%, and 12 patients achieved complete response (46.2%).
Modified Hyper-CVAD regimen is a promising regimen for the patients with intermediate and high grade NHL.
Ai zheng = Aizheng = Chinese journal of cancer 10/2009; 28(10):1083-7.
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Yuan-kai Shi, Sheng Yang,
Xiao-hong Han,
Jun Ma,
Han-yun Ren,
Xi-nan Cen,
Shu-yun Zhou,
Chun Wang,
Wen-qi Jiang,
Hui-qiang Huang,
Jian-ming Wang,
Jun Zhu,
Hu Chen,
Ming-zhe Han,
He Huang,
Xiao-mei Shen,
Peng Liu,
Xiao-hui He
[show abstract]
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ABSTRACT: To investigate the feasibility and efficacy of rituximab combined with high-dose chemotherapy supported by autologous peripheral blood stem cell transplantation (ASCT) in patients with aggressive B-cell non-Hodgkin lymphoma (NHL).
Twenty-eight patients with aggressive B-cell NHL (22 newly diagnosed, 6 relapsed) were enrolled in this study. The high-dose chemotherapy included CHOP regimen (CTX + ADM + VCR + PDN) for the newly diagnosed patients and DICE (DEX + IFO + DDP + VP-16) or EPOCH (VP-16 + PDN + VCR + CTX + ADM) for the relapsed patients. Each patient received infusion of rituximab at a dose of 375 mg/m(2) for four times, on D1 before and on D7 of peripheral blood stem cell mobilization, and on D1 before and D8 after stem cell reinfusion.
Complete remission was achieved in all patients after high dose chemotherapy and ASCT. At a median follow-up of 37 months, the estimated overall 4-year survival and progression-free survival rate for all patients were 75.0% and 70.3%, respectively, while both were 72.7% for the previously untreated patients. The therapy was generally well tolerated with few side-effects attributable to rituximab.
These results suggest that adding rituximab to high-dose chemotherapy with peripheral blood stem cell transplantation is feasible and may be beneficial for patients with aggressive B-cell non-Hodgkin lymphoma.
Zhonghua zhong liu za zhi [Chinese journal of oncology] 08/2009; 31(8):592-6.
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Yan Qin,
Yuan-Kai Shi,
Xiao-Hui He,
Xiao-Hong Han,
Sheng-Yu Zhou,
Peng Liu,
Jian-Liang Yang, Sheng Yang,
Chang-Gong Zhang,
Mei Dong,
Li-Qiang Zhou,
Jin-Wan Wang,
Feng-Yi Feng,
Yan Sun
[show abstract]
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ABSTRACT: To retrospectively analyze and compare the treatment efficiency of CHOP-based regimens with or without high-dose consolidation treatment combined with hematopoietic stem cell transplantation (HDT-HSCT) in the patients with lymphoblastic lymphoma (LBL).
From 1989 to 2004, totally 63 patients with LBL were initially treated with a standard CHOP-based regimen. Forty-two of the 63 patients achieved complete response (CR), 26 of those subsequently received consolidation HDT-HSCT, while the other 16 had 6-8 cycles of standard CHOP-based treatment only.
Of the 63 patients, 57 had a T-LBL and 6 B-LBL, with a median age of 20 years, 19 (30.2%) had a stage I-II diseases and 44 (69.8%) stage III-IV diseases, 61.9% presented with a mediastinal mass. Bone marrow involvement presented in 28.6% of the patients. Fourteen percent had central nervous system involvement. The median follow-up period was 24 months, and the estimated 5-year overall survival and disease-free survival of this series was 31.2% and 29.3%, respectively. Of the 42 patients who achieved CR, the 5-year OS rate of the patients who received HDT-HSCT as a consolidation therapy was 59.8% versus 14.6% of the patients treated by CHOP-based regimens alone (P=0.004). Bone marrow involvement, age > or =20 years, short response duration and primary refractory disease were factors significantly associated with poor outcome. Among the 18 patients with bone marrow involvement, 3 received allogeneic HSCT and were all still alive at the follow up time of 22, 32 and 37 months, respectively, while another 4 received auto-HSCT and all died of the disease within 14 months.
Short term treatment with a CHOP-based regimen is not sufficient for the patients with lymphoblastic lymphoma. High-dose consolidation treatment and hematopoietic stem cell transplantation may improve overall survival and disease free survival. Bone marrow involvement, age >20 years, and short response duration and primary refractory disease are all the factors significantly associated with poor outcome. For the patients with bone marrow involvement, allohematopoietic stem cell transplantation is superior to auto-hematopoietic stem cell transplantation.
Zhonghua zhong liu za zhi [Chinese journal of oncology] 06/2009; 31(6):469-73.
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ABSTRACT: This study observed and compared the preventive effects of ramosetron and ondansetron on gastrointestinal side effects caused by cisplatin-containing chemotherapy.
Fifty patients with malignant tumors undergoing their first chemotherapy were randomly divided into two groups, and each group received 0.3 mg of ramosetron and 16 mg of ondansetron in a prospective crossover comparison study.
Data were collected for analysis of the therapeutic effect in 47 cases and for adverse events in 50 cases. Both drugs showed similar results in regard to chemotherapy-induced gastrointestinal side effects, emesis and appetite loss on day 1, but by day 5, ramosetron was significantly better than ondansetron in terms of controlling appetite loss. From days 3-5, ramosetron tended to be more effective than ondansetron in its antiemetic action. The incidence of headache, fatigue and constipation was the same for both drugs.
Ramosetron is a long-lasting and safe antiemetic agent.
Chemotherapy 02/2007; 53(1):44-50. · 1.82 Impact Factor
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Yuan-kai Shi,
Xiao-hui He, Sheng Yang,
Hua-qing Wang,
Ze-fei Jiang,
Yun-zhong Zhu,
Xiao-yan Ke,
Yang Zhang,
Yun-peng Liu,
Wei-jing Zhang,
Zhao Wang,
Qing-zhi Shi,
Xiao-dong Xie,
He-long Zhang,
Jie-jun Wang,
De-yun Luo,
Qing-shan Zheng,
Rui-yuan Sun
[show abstract]
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ABSTRACT: To compare the efficacy and safety of daily administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF), and a single subcutaneous injection of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF), a sustained-duration rhG-CSF, in chemotherapy-induced neutropenia.
In the present randomized, open-label, match and cross-over study, enrolled 104 patients with previously untreated non-small cell lung cancer (NSCLC), breast cancer or non-Hodgkin's lymphoma and with normal bone marrow function from 13 centers were randomly divided into 2 matched groups, AB and BA group. Each patient received two cycles of chemotherapy of identical regimen. In the study cycle, the patients received a single subcutaneous injection of PEG-rhG-CSF 100 microg/kg on day 3; and in control cycle, daily subcutaneous infection of rhG-CSF 5 microg x kg(-1) x d(-1) began on day 3 and continued for 14 days or until the absolute neutrophil count (ANC) became > or = 5.0 x 10(9)/L twice after it decreased to the nadir. Efficacy and safety parameters were monitored.
The incidence rates of ANC < 1.5 x 10(9)/L in the 103 evaluable study cycles and 100 evaluable control cycles were 30.00% and 20.00% with the duration of 2.39 days and 2.35 days respectively. The incidence rates of grade 3 neutropenia were 7.77% and 7.00%; and that of grade 4 neutropenia were 5.80% and 4.00% respectively in the trial and control cycles. However, all the difference mentioned above did not reached statistical significance. None of the patients experienced febrile neutropenia. The ANC nadir was (7.55 +/- 5.25) x 10(9)/L and (8.42 +/- 5.57) x 10(9)/L (P = 0.257) respectively after receiving PEG-rhG-CSF and rhG-CSF. Compared with that of rhG-CSF group, the ANC profile of PEG-rhG-CSF group exhibited limited "overshoot" of neutrophils after the nadir. Subgroup analysis according to disease type yielded similar results. The safety profiles of the PEG-rhG-CSF and rhG-CSF groups were similar. Musculoskeletal pain or arthralgia occurred in 16.5% of the study cycles and 26.00% of the control cycles (P = 0.963), mostly mild or moderate. Other adverse effects such as fever, fatigue, dizziness, gastrointestinal effects and injection-site pain, were transient and easily manageable.
A single subcutaneous injection of PEG-rhG-CSF 100 microg/kg provides neutrophil support and a safety profile comparable to regimen of daily subcutaneous injection of rhG-CSF 5 microg x kg(-1) x d(-1) in Chinese patients receiving a variety of myelosuppressive chemotherapy regimens.
Zhonghua yi xue za zhi 12/2006; 86(48):3414-9.
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ABSTRACT: To explore the efficacy of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in the prophylaxis of chemotherapy-induced neutropenia.
Patients with previously untreated non-small cell lung cancer or breast cancer and with normal bone marrow function were eligible for the trial. In the phase I trial, patients were to treated with two cycles of paclitaxel/carboplatin chemotherapy every 21 days. In cycle 1, if absolute neutrophil count (ANC) dropped below 1.0 x 10(9)/ L with fever and/or ANC dropped below 0.5 x 10(9)/L, rhG-CSF 150 microg/d was administrated until WBC > or = 10 x 10(9)/L or ANC > or = 5.0 x 10(9)/L. In cycle 2, patients were to receive a single injection of PEG-rhG-CSF (30, 60, 100, or 200 microg/kg) 48 hours after chemotherapy. Pharmacodynamic analyses were performed.
All the 16 patients enrolled (4 in each group) were eligible for efficacy evaluation. In cycle 1, 7 patients received rhG-CSF administration because of grade 4 neutropenia, while in cycle 2, there was only 1 episode of grade 4 neutropenia, which were in the 30 microg/kg group. In cycle 1, the mean ANC nadir of 1.37 x 10(9)/L occurred on day 13 in the 9 patients who received no rhG-CSF administration. In cycle 2, the mean ANC nadirs were 0.77 x 10(9)/L, 4.54 x 10(9)/L, 3.00 x 10(9)/L, and 5.56 x 10(9)/L, respectively, in 30, 60, 100, or 200 microg/kg group. The nadirs of the first two groups occurred on day 8 of cycle 2, while those of the other two groups appeared on day 7. After PEG-rhG-CSF administration, two mean ANC peaks were observed. The first one ranging from 20.87 x 10(9)/L to 33.61 x 10(9)/L in the 4 groups appeared on day 3 to day 4. In the 30 microg/ kg group, the mean ANC reached the second peak at 5.03 x 10(9)/L on day 14. The second peaks on day 10 in the other groups were 12.42 x 10(9)/L, 11.59 x 10(9)/L, and 18.92 x 10(9)/L, respectively. Pharmacodynamic analyses showed sustained serum concentrations of PEG-rhG-CSF during the period of neutropenia.
PEG-rhG-CSF administration may decrease the incidence of grade 4 neutopenia and result in earlier and higher nadir ANCs. PEG-rhG-CSF has a potential of once-per-cycle administration. The ANC and serum concentration of PEG-rhG-CSF are consistent with neutrophil receptor-mediated clearance.
Zhongguo yi xue ke xue yuan xue bao. Acta Academiae Medicinae Sinicae 07/2006; 28(3):339-44.
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ABSTRACT: Head and neck lymphoma develops predominantly in the tonsil. This study was to investigate the clinical features of primary non-Hodgkin's lymphoma (NHL) of the tonsil, and to explore possible ways to improve the prognosis and quality of life of the patients after treatment.
Clinical data of 89 naive patients with NHL of the tonsil, treated from May 1990 to Jan. 2003, were retrospectively reviewed. All patients were confirmed pathologically and classified according to revised European-American Lymphoid Neoplasms and World Health Organization Classification, and staged according to the Ann Arbor classification. Stage I-II patients received radiochemotherapy-predominant treatment, whereas stage III-IV patients received chemotherapy-predominant treatment.
Of the 89 cases, 60 (67%) were diffuse large B-cell subtype, 11 (12%) were peripheral T-cell subtype, 5 (6%) were indolent lymphoma, 1 was anaplastic large T-cell lymphoma, and 1 was T lymphoblastic lymphoma; 81 (91%) were stage I-II disease. Of the 89 patients, 58 (72%) received radiochemotherapy, 19 (21%) received radiotherapy alone, 3 received chemotherapy alone, and 1 received radiochemotherapy combined with rituximab. The 5-year overall survival rate was 80%, that of stage I-II patients was 84%. Cox regression multivariate analysis showed that the survival rate was correlated to the value of international prognostic index (IPI), and whether the patient had primary refractory or relapsed disease, but was not correlated to sex, age, pathologic subtype, B symptoms, and bulky disease.
Most patients with NHL of the tonsil are at early stages, with good prognosis. Diffuse large B-cell lymphoma is the most common pathologic subtype. Primary refractory, relapse, and IPI>1 are independent prognostic factors.
Ai zheng = Aizheng = Chinese journal of cancer 05/2006; 25(4):481-5.
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Yuan-Kai Shi,
Peng Liu, Sheng Yang,
Xiao-Hong Han,
Xiao-Hui He,
Bin Ai,
Yan Qin,
Bo Li,
Ding-Zhi Huang,
Chang-Gong Zhang,
Yan Sun
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ABSTRACT: Recombinant human granulocyte colony-stimulating factor (rhG-CSF) is effective in the prophylaxis and management of chemotherapy-induced neutropenia, but requires daily administration because of its short half-life. Pegylated rhG-CSF (PEG-rhG-CSF) is a long-acting reagent that permits less frequent injection. This study was to evaluate the safety and tolerance of PEG-rhG-CSF in Chinese patients, and to explore its efficacy of enhancing absolute neutrophil count (ANC) and CD34+ cell count in peripheral blood.
Naïve non-small lung cancer or breast cancer patients with normal bone marrow function were eligible for this open-labeled, dose-escalation trial. All patients received 2 cycles of chemotherapy of identical regimen. In cycle 1, rhG-CSF (150 microg/day) was administrated in case of febrile neutropenia or grade 4 neutropenia; in cycle 2, patients received a single injection of PEG-rhG-CSF (30 microg/kg, 60 microg/kg, 100 microg/kg, or 200 microg/kg) 48 h after administration of paclitaxel and carboplatin.
All the 16 patients enrolled (4 in each dose group) were evaluable for safety and efficacy of PEG-rhG-CSF. Main adverse events related to PEG-rhG-CSF were musculoskeletal pain or arthralgia (13/16), fatigue (10/16), dizziness (2/16), and injection-site pain (1/16). All adverse events were mild to moderate, and most of them were reversible without treatment. PEG-rhG-CSF enhanced ANC in a dose-dependent manner to some extent, and PEG-rhG-CSF at 60 microg/kg or higher doses prevented chemotherapy-induced neutropenia with sustained effect; CD34+ cells in peripheral blood were also increased.
PEG-rhG-CSF is well tolerated, with no serious adverse event in this trial. The recommended dose of PEG-rhG-CSF for phase II trial is 100 microg/kg because of its adequate efficacy and less adverse events than those of 200 microg/kg.
Ai zheng = Aizheng = Chinese journal of cancer 05/2006; 25(4):495-500.
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Bin Ai,
Yuan-kai Shi,
Xiao-hui He,
Xiao-hong Han,
Li-ya Zhao,
Sheng-yu Zhou,
Peng Liu,
Jian-liang Yang,
Chang-gong Zhang,
Ding-zhi Huang,
Yan Qin, Sheng Yang
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ABSTRACT: To investigate the quality of life of Chinese malignant patients who treated with the high dose chemoradiotherapy combined with autologous stem cell transplantation (ASCT).
The data of 89 patients who answer the EORTC QLQ-C30 Chinese version 3.0 after finished ASCT and disease free were analyzed using SPSS 10.0.
The score of global health status and functional assessment were near or over 80, more than 80 percent of patient had good or very good global health status or function, the patients who were experiencing moderate or severe financial dysfunction, fatigue, dyspnea, sleeping disturbance and diarrhea were in 72.5% (65/89), 50.6% (45/89), 42.7% (38/89), 33.7% (30/89) and 32.5% (29/89) respectively. The score of dyspnea in female patients was significant higher than male patients (P = 0.024). The score of global health status (P = 0.000), physical function (P = 0.000), role function (P = 0.031) and social function (P = 0.029) became higher significantly with time from transplantation and the score of fatigue became lower (P = 0.020). The Hodgkin's lymphoma patients had higher score significantly in nausea & vomiting (P = 0.002) and dyspnea (P = 0.006) than NHL. The age at transplantation and evaluation took none effect on the score.
Most patient have good global health status and function after autologous stem cell transplantation, they are more suffered from financial dysfunction, fatigue, dyspnea, sleeping disturbance and diarrhea. Females have more dyspnea symptoms, the quality of life of patient will improve gradually with the time from transplantation, the Hodgkin's lymphoma patients have more symptoms than non-Hodgkin's lymphoma patients, we do not find any effect of age at transplantation and assessment on the quality of life.
Zhonghua yi xue za zhi 09/2005; 85(37):2640-3.
