1.Phase Ⅱ clinical study of gemcitablineplus etoposite in treatment of advanced non-small-cell carcinoma
Li ZHANG ; Zhongjun XIA ; Yang ZHANG
China Oncology 1998;0(01):-
0.05). The maj or toxicity included Neutropenia, nausea and vomiting. The severity of these sid e effects was mild to moderate and well tolerated. No severe toxicity was observ ed. Conclusions:Gemcitabine plus etoposide (GV) and Gencitabine plus cisplatin were both active regimen for advanced NSCLC, with high efficecy but talerated toxicity.
2.Long-term Outcomes of Patients with Newly Diagnosed NK/T-cell Lymphoma Treated by EPOCH Regimen
Zexiao LIN ; Yan GAO ; Huiqiang HUANG ; Xubin LIN ; Qingqing CAI ; Zhongjun XIA ; Xiaoxiao WANG ; Wenqi JIANG
Journal of Sun Yat-sen University(Medical Sciences) 2010;31(2):274-277
[Objective]This study was aimed to evaluate treatment outcomes and toxicity of continuous-infusion EPOCH regimen for NK/T-cell lymphoma(NK/TCL).[Methods]From June 2003 to June 2008,34 patients including 30 nasal NK/TCL (88.2%)and 4 nasal type NK/TCL(11.8%)received doxorubicin,vincfistine,etoposide over 96 hours infusion with bolus eyelophosphamide and oral predinisone(EPOCH)chemotherapy as first-line treatment.Median cycles of EPOCH administered were 2.5(1-6 cycles).Additional involved field radiation therapy(IFRT)was administered to patients with localized nasal focus after chemotherapy.[Results]Among 34 patients,33 were eligible for response evaluation.The response rate(RR)was 60.6% (20/33)with complete remission(CR)rate of 45.5%(15/33).The RR of patients with nasal NK/TCL was 66.7%(20/30)with CR rate of 50%(15/30).Only one of the 3 nasal type NK/TCL patients achieved stable disease(SD),the other 2 had progressive disease(PD)during chemotherapy.After a median follow-up of 22(2-68)months,the estimated 3-year overall survival rate(OS)was 52.2%.For patients with nasal NK/TCL,the estimated median survival time was not reached,the 3-year OS was 59.4%.For patients with nasal type NK/TCL,the estimated median survival time was only 7 months.The CR rate was 75.0% for localized nasal NK/TCL who received initial EPOCH chemotherapy followed IFRT with the 3-year OS of 75.0%.Major adverse effect was myelosuppression.The incidence of grade Ⅲ~Ⅳ neutropenia was 30.9%.No treatment-related mortality occurred.[Conclusions]EPOCH regiment was effective and well tolerant for nasal NK/TCL.Combined EPOCH chemotherapy followed by IFRT produced promising outcome for patients with localized disease.However,patients with nasal type NK/TCL responded poorly and more efficacious treatment strategies are urgently needed.
3.Efficacy and safety evaluation for 28 Chinese non-Hodgkin lymphoma patients treated with Hyper-CVAD/MA regimen
Kaiyuan TENG ; Huiyan LUO ; Miaozhen QIU ; Fanghua LI ; Yanxia SHI ; Huiqiang HUANG ; Zhongjun XIA ; Wenqi JIANG ; Ruihua XU
Cancer Research and Clinic 2009;21(10):660-662,665
Objective To evaluate the efficacy and safety of the hyper-CVAD/MA regimen as an intensified treatment option for 28 T cell and aggressive/highly aggressive B cell NHL in Chinese patients. Methods Clinical data of 28 NHL patients treated with hyper-CVAD/MA regimen from Jan 2005 to Sep 2008 were retrospectively analyzed. Results 27 NHL patients were available for the efficacy analysis, with a response rate of 70.4 %. For the 13 B cell lymphoma cases, the response rate was 84.6 %. The main toxicity was Grade Ⅲ or Grade Ⅳ myelosuppression in all cases and 2 treatment related deaths. Conclusion Hyper-CVAD/MA regimen had a high response rate in T cell and aggressive /highly aggressive B cell NHL lymphoma, companied by significant toxicity when treating Chinese patients. Further clinical practices are needed to pick up a suitable dose which can balance efficacy and safety.
4.New risk factors and new tendency for central nervous system relapse in patients with diffuse large B-cell lymphoma:a retrospective study
Cai QINGQING ; Hu LIYANG ; Geng QIRONG ; Chen JIE ; Lu ZHENHAI ; Rao HUILAN ; Liu QING ; Jiang WENQI ; Huang HUIQIANG ; Lin TONGYU ; Xia ZHONGJUN
Chinese Journal of Cancer 2016;35(12):713-724
Background:In patients with diffuse large B?cell lymphoma (DLBCL), central nervous system (CNS) relapse is uncom?mon but is nearly always fatal. This study aimed to determine the risk factors for CNS relapse in DLBCL patients and to evaluate the effcacy of rituximab and intrathecal chemotherapy prophylaxis for CNS relapse reduction. Methods:A total of 511 patients with newly diagnosed DLBCL treated at the Sun Yat?sen University Cancer Center between January 2003 and December 2012 were included in the study. Among these patients, 376 received R?CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) as primary treatment, and 135 received CHOP regimen (cyclophosphamide, doxorubicin, vincristine, and prednisone) as primary treatment. Intrathe?cal chemotherapy prophylaxis (methotrexate plus cytarabine) was administered to those who were deemed at high risk for CNS relapse. In the entire cohort and in the R?CHOP set in particular, the Kaplan–Meier method coupled with the log?rank test was used for univariate analysis, and the Cox proportional hazards model was used for multivariate analysis. Differences were evaluated using a two?tailed test, andP<0.05 was considered signiifcant. Results:At a median follow?up of 46months, 25 (4.9%) patients experienced CNS relapse. There was a trend of reduced occurrence of CNS relapse in patients treated with rituximab; the 3?year cumulative CNS relapse rates were 7.1% in CHOP group and 2.7% in R?CHOP group (P=0.045). Intrathecal chemotherapy prophylaxis did not confer much beneift in terms of preventing CNS relapse. Bone involvement [hazard ratio (HR)=4.21, 95% conifdence interval (CI) 1.38–12.77], renal involvement (HR=3.85, 95% CI 1.05–14.19), alkaline phosphatase (ALP) >110U/L (HR=3.59, 95% CI 1.25–10.34), serum albumin (ALB) <35g/L (HR=3.63, 95% CI 1.25–10.51), treatment with rituxi?mab (HR=0.34, 95% CI 0.12–0.96), and a time to complete remission≤ 108days (HR=0.22, 95% CI 0.06–0.78) were independent predictive factors for CNS relapse in the entire cohort. Bone involvement (HR=4.44, 95% CI 1.08–18.35), bone marrow involvement (HR=11.70, 95% CI 2.24–60.99), and renal involvement (HR=10.83, 95% CI 2.27–51.65) were independent risk factors for CNS relapse in the R?CHOP set. Conclusions:In the present study, rituximab decreased the CNS relapse rate of DLBCL, whereas intrathecal chemo?therapy prophylaxis alone was not suffcient for preventing CNS relapse. Serum levels of ALB and ALP, and the time to complete remission were new independent predictive factors for CNS relapse in the patients with DLBCL. In the patients received R?CHOP regimen, a trend of increased CNS relapse was found to be associated with extranodal lesions.
5.A Modified NHL-BFM-95 Regimen Produces Better Outcome ThanHyperCVAD in Adult Patients with T-Lymphoblastic Lymphoma,a Two-Institution Experience
Chun LI ; Zhi-Jun WUXIAO ; Xiaoqin CHEN ; Guanjun CHEN ; Yue LU ; Zhongjun XIA ; Yang LIANG ; Hua WANG
Cancer Research and Treatment 2020;52(2):573-585
Purpose:
Lymphoblastic lymphoma (LBL) is an invasive neoplasm of precursor T-cell or B-cell lineage.A broadly accepted standard treatment for adult LBL has not yet been defined.
Materials and Methods:
To address this issue, we compared two chemotherapy regimens: a modified non-Hodgkinlymphoma Berlin–Frankfurt–Mu!nster-95 (NHL-BFM-95) regimen and HyperCVAD/MA. Thisretrospective study consecutively enrolled 207 adult LBL patients at two hospitals from2000 to 2018. Univariate and multivariate analysis were used to assess prognostic factors.
Results:
In the present study, most clinical characteristics were similar between the two treatmentgroups except for age and lactate dehydrogenase (LDH) level. Patients treated with modifiedNHL-BFM-95 regimen tended to be younger and with elevated LDH level. The modified NHLBFM-95 regimen produced better treatment outcomes than those with HyperCVAD/MA inpatients with T-LBL or patients < 40 years. Treatment with HyperCVAD/MA, high EasternCooperative Oncology Group scores, and bone marrow involvement were independent riskfactors in T-LBL. No patients interrupted treatment for severe adverse events.
Conclusion
The results suggested that the modified regimen is well-tolerated and can produce the promisingoutcomes in patients with T-LBL or patients < 40 years.
6. Application of pegylated recombinant human granulocyte colony-stimulating factor to prevent chemotherapy-induced neutropenia in patients with lymphoma: a prospective, multicenter, open-label clinical trial
Huiqiang HUANG ; Bing BAI ; Yuhuan GAO ; Dehui ZOU ; Shanhua ZOU ; Huo TAN ; Yongping SONG ; Zhenyu LI ; Jie JIN ; Wei LI ; Hang SU ; Yuping GONG ; Meizuo ZHONG ; Yuerong SHUANG ; Jun ZHU ; Jinqiao ZHANG ; Zhen CAI ; Qingliang TENG ; Wanjun SUN ; Yu YANG ; Zhongjun XIA ; Hailin CHEN ; Luoming HUA ; Yangyi BAO ; Ning WU
Chinese Journal of Hematology 2017;38(10):825-830
Objective:
To evaluate the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in prophylaxis neutropenia after chemotherapy in patients with lymphoma.
Methods:
This was a multicenter, single arm, open, phase Ⅳ clinical trial. Included 410 patients with lymphoma received multiple cycles of chemotherapy and PEG-rhG-CSF was administrated as prophylactic. The primary endpoint was the incidence of Ⅲ/Ⅳ grade neutropenia and febrile neutropenia (FN) after each chemotherapy cycle. Meanwhile the rate of antibiotics application during the whole period of chemotherapy was observed.
Results:
①Among the 410 patients, 8 cases (1.95%) were contrary to the selected criteria, 35 cases (8.54%) lost, 19 cases (4.63%) experienced adverse events, 12 cases (2.93%) were eligible for the termination criteria, 15 cases (3.66%) develpoed disease progression or recurrence, thus the rest 321 cases (78.29%) were into the Per Protocol Set. ②During the first to fourth treatment cycles, the incidences of grade Ⅳ neutropenia after prophylactic use of PEG-rhG-CSF were 19.14% (49/256) , 12.5% (32/256) , 12.18% (24/197) , 13.61% (20/147) , respectively. The incidences of FN were 3.52% (9/256) , 0.39% (1/256) , 2.54% (5/197) , 2.04% (3/147) , respectively. After secondary prophylactic use of PEG-rhG-CSF, the incidences of Ⅳ grade neutropenia decreased from 61.54% (40/65) in the screening cycle to 16.92% (11/65) , 18.46% (12/65) and 20.75% (11/53) in 1-3 cycles, respectively. The incidences of FN decreased from 16.92% (11/65) in the screening cycle to 1.54% (1/65) , 4.62% (3/65) , 3.77% (2/53) in 1-3 cycles, respectively. ③The proportion of patients who received antibiotic therapy during the whole period of chemotherapy was 34.39% (141/410) . ④The incidence of adverse events associated with PEG-rhG-CSF was 4.63% (19/410) . The most common adverse events were bone pain[3.90% (16/410) ], fatigue (0.49%) and fever (0.24%) .
Conclusion
During the chemotherapy in patients with lymphoma, the prophylactic use of PEG-rhG-CSF could effectively reduce the incidences of grade Ⅲ/Ⅳ neutropenia and FN, which ensures that patients with lymphoma receive standard-dose chemotherapy to improve its cure rate.
7.The efficacy and safety profile of ixazomib/lenalidomide/dexamethasone in relapsed/refractory multiple myeloma: a multicenter real-world study in China
Yang YANG ; Zhongjun XIA ; Wenhao ZHANG ; Chengcheng FU ; Li BAO ; Bing CHEN ; Kaiyang DING ; Sili WANG ; Jun LUO ; Bingzong LI ; Luoming HUA ; Wei YANG ; Xin ZHOU ; Liang WANG ; Tianhong XU ; Weida WANG ; Guolin WU ; Yun HUANG ; Jing LI ; Peng LIU
Chinese Journal of Hematology 2021;42(8):628-634
Objective:To evaluate the efficacy and safety profile of ixazomib/lenalidomide/dexamethasone (IRd) in Chinese patients with relapsed/refractory multiple myeloma (MM) .Methods:This study comprising 14 medical centers in China included patients with relapsed/refractory MM who received at least. Ixazomib at an initial oral dose of 4 mg was administered. Seven patients had dose adjustment to 3 mg at the time of first dose. The lenalidomide doses were adjusted according to creatinine clearance rate. The efficacy and safety were evaluated every cycle.Results:In the study cohort of 74 patients, the median age was 65 years and 11 (14.9% ) patients received over three lines of therapy. Overall response rate (ORR) was 54.1% (40/74) , and 7 (9.5% ) , 14 (18.9% ) , and 19 (25.7% ) patients achieved stringent complete response or complete response, very good partial response, and partial response, respectively. The median progression-free survival and overall survival were 9.9 and 20 months, respectively. The median time to response was 1 month. The efficacy and survival outcome were similar to those reported in the Tourmaline-MM1 China Continuous Study. The ORR of patients refractory to bortezomib, lenalidomide, and bortezomib plus lenalidomide were 52.0% (13/25) , 57.1% (4/7) , and 33.3% (6/18) , respectively. The rate of grade 3-4 adverse events was 36.5% (27/74) . Common hematological toxicities were anemia, thrombocytopenia, lymphopenia, and neutropenia. Common non-hematological toxicities were fatigue, gastrointestinal symptoms, and infections. Two cases of grade 3 peripheral neuropathy were reported. The patients eligible for the Tourmaline-MM1 China Continuous Study had a higher ORR than the ineligible patients [77.8% (14/18) vs 46.4% (26/56) , P=0.020]. There was no difference in the rate of grade 3-4 adverse events [33.3% (6/18) vs 37.5% (21/56) , P=0.749]. Conclusion:The IRd regimen had good efficacy and acceptable toxicity in Chinese patients with relapsed/refractory MM.
8.Clinical guideline for surgical treatment of symptomatic chronic osteoporotic vertebral fractures
Bohua CHEN ; Qixin CHEN ; Liming CHENG ; Tongwei CHU ; Zhongliang DENG ; Jian DONG ; Haoyu FENG ; Shiqing FENG ; Shunwu FAN ; Yanzheng GAO ; Zhong GUAN ; Yong HAI ; Dingjun HAO ; Baorong HE ; Dianming JIANG ; Jianyuan JIANG ; Chunde LI ; Fang LI ; Feng LI ; Li LI ; Weishi LI ; Zhongshi LI ; Qi LIAO ; Bin LIU ; Guodong LIU ; Xiaoguang LIU ; Zhongjun LIU ; Shibao LU ; Xinlong MA ; Limin RONG ; Huiyong SHEN ; Yong SHEN ; Jun SHU ; Yueming SONG ; Tiansheng SUN ; Jiwei TIAN ; Huan WANG ; Hong XIA ; Jianzhong XU ; Zhengwei XU ; Huilin YANG ; Jie ZHAO ; Yue ZHOU ; Yue ZHU
Chinese Journal of Trauma 2020;36(7):577-586
According to the pathological characteristics of symptomatic chronic thoracic and lumbar osteoporotic vertebral fracture (SCOVF), the different clinical treatment methods are selected, including vertebral augmentation, anterior-posterior fixation and fusion, posterior decompression fixation and fusion, and posterior correction osteotomy. However, there is still a lack of a unified understanding on how to choose appropriate treatment method for SCOVF. In order to reflect the new treatment concept and the evidence-based medicine progress of SCOVF in a timely manner and standardize its treatment, the clinical guideline for surgical treatment of SCOVF is formulated in compliance with the principle of scientificity, practicability and advancement and based on the level of evidence-based medicine.
9.Clinical guideline for diagnosis and treatment of adult ankylosing spondylitis combined with thoracolumbar fracture (version 2023)
Jianan ZHANG ; Bohua CHEN ; Tongwei CHU ; Yirui CHEN ; Jian DONG ; Haoyu FENG ; Shunwu FAN ; Shiqing FENG ; Yanzheng GAO ; Zhong GUAN ; Yong HAI ; Lijun HE ; Yuan HE ; Dianming JIANG ; Jianyuan JIANG ; Bin LIN ; Bin LIU ; Baoge LIU ; Dechun LI ; Fang LI ; Feng LI ; Guohua LYU ; Li LI ; Qi LIAO ; Weishi LI ; Xiaoguang LIU ; Yong LIU ; Zhongjun LIU ; Shibao LU ; Wei MEI ; Yong QIU ; Limin RONG ; Yong SHEN ; Huiyong SHEN ; Jun SHU ; Yueming SONG ; Honghui SUN ; Tiansheng SUN ; Yan WANG ; Zhe WANG ; Zheng WANG ; Yongming XI ; Hong XIA ; Jinglong YAN ; Liang YAN ; Wen YUAN ; Gang ZHAO ; Jie ZHAO ; Jianguo ZHANG ; Xiaozhong ZHOU ; Yue ZHU ; Yingze ZHANG ; Dingjun HAO ; Baorong HE
Chinese Journal of Trauma 2023;39(3):204-213
Ankylosing spondylitis (AS) combined with spinal fractures with thoracic and lumbar fracture as the most common type shows characteristics of unstable fracture, high incidence of nerve injury, high mortality and high disability rate. The diagnosis may be missed because it is mostly caused by low-energy injury, when spinal rigidity and osteoporosis have a great impact on the accuracy of imaging examination. At the same time, the treatment choices are controversial, with no relevant specifications. Non-operative treatments can easily lead to bone nonunion, pseudoarthrosis and delayed nerve injury, while surgeries may be failed due to internal fixation failure. At present, there are no evidence-based guidelines for the diagnosis and treatment of AS combined with thoracic and lumbar fracture. In this context, the Spinal Trauma Academic Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate the Clinical guideline for the diagnosis and treatment of adult ankylosing spondylitis combined with thoracolumbar fracture ( version 2023) by following the principles of evidence-based medicine and systematically review related literatures. Ten recommendations on the diagnosis, imaging evaluation, classification and treatment of AS combined with thoracic and lumbar fracture were put forward, aiming to standardize the clinical diagnosis and treatment of such disorder.
10.Evidence-based guideline for clinical diagnosis and treatment of acute combination fractures of the atlas and axis in adults (version 2023)
Yukun DU ; Dageng HUANG ; Wei TIAN ; Dingjun HAO ; Yongming XI ; Baorong HE ; Bohua CHEN ; Tongwei CHU ; Jian DONG ; Jun DONG ; Haoyu FENG ; Shunwu FAN ; Shiqing FENG ; Yanzheng GAO ; Zhong GUAN ; Yong HAI ; Lijun HE ; Yuan HE ; Dianming JIANG ; Jianyuan JIANG ; Weiqing KONG ; Bin LIN ; Bin LIU ; Baoge LIU ; Chunde LI ; Fang LI ; Feng LI ; Guohua LYU ; Li LI ; Qi LIAO ; Weishi LI ; Xiaoguang LIU ; Yong LIU ; Zhongjun LIU ; Shibao LU ; Fei LUO ; Jianyi LI ; Yong QIU ; Limin RONG ; Yong SHEN ; Huiyong SHEN ; Jun SHU ; Yueming SONG ; Tiansheng SUN ; Jiang SHAO ; Jiwei TIAN ; Yan WANG ; Zhe WANG ; Zheng WANG ; Xiangyang WANG ; Hong XIA ; Jinglong YAN ; Liang YAN ; Wen YUAN ; Jie ZHAO ; Jianguo ZHANG ; Yue ZHU ; Xuhui ZHOU ; Mingwei ZHAO
Chinese Journal of Trauma 2023;39(4):299-308
The acute combination fractures of the atlas and axis in adults have a higher rate of neurological injury and early death compared with atlas or axial fractures alone. Currently, the diagnosis and treatment choices of acute combination fractures of the atlas and axis in adults are controversial because of the lack of standards for implementation. Non-operative treatments have a high incidence of bone nonunion and complications, while surgeries may easily lead to the injury of the vertebral artery, spinal cord and nerve root. At present, there are no evidence-based Chinese guidelines for the diagnosis and treatment of acute combination fractures of the atlas and axis in adults. To provide orthopedic surgeons with the most up-to-date and effective information in treating acute combination fractures of the atlas and axis in adults, the Spinal Trauma Group of Orthopedic Branch of Chinese Medical Doctor Association organized experts in the field of spinal trauma to develop the Evidence-based guideline for clinical diagnosis and treatment of acute combination fractures of the atlas and axis in adults ( version 2023) by referring to the "Management of acute combination fractures of the atlas and axis in adults" published by American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) in 2013 and the relevant Chinese and English literatures. Ten recommendations were made concerning the radiological diagnosis, stability judgment, treatment rules, treatment options and complications based on medical evidence, aiming to provide a reference for the diagnosis and treatment of acute combination fractures of the atlas and axis in adults.