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Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.
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Objective:To investigate the association of plasma EBV-DNA copy number, serum cytokines and B symptoms in patients with extranodal natural killer/T-cell lymphoma, nasal type (ENKTL), unravel the mechanism and assess the prognostic value of clinical indicators.Methods:Clinical data of 173 newly-diagnosed ENKTL patients (116 male, 57 female; median age: 43, 4 to 71 years)were retrospectively analyzed. According to Ann Arbor stage, 126 cases were classified as stage I-II and 47 cases of stage Ⅲ-IV. The primary sites of tumors included nasal cavity (n=100), extranasal upper aerodigestive tract (extranasal UADT, n=34), and extra-upper aerodigestive tract (extra-UADT, n=39). Prior to treatment, 91 patients had B symptoms and 82 cases of without B symptoms. According to plasma EBV-DNA copy levels, all patients were divided into the negative group (n=36), low load group (<10 4 copies/ml, n=73) and high load group (≥10 4 copies/ml, n=64). Serum cytokines including IFN-γ, IL-2, IL-4, IL-6, IL-10 and TNF-α were detected. Correlation analysis was performed by Cochran-Armitage trend test and Spearman correlation analysis. Survival analysis was conducted using univariate and multivariate Cox regression hazard analysis and survival curves were derived from Kaplan-Meier survival analysis. Results:The incidence of B symptoms and fever showed a significant upward trend with the increasing plasma EBV-DNA copy levels. In addition, serum levels of IFN-γ, IL-6 and IL-10 cytokines were higher in patients with B symptoms than those without B symptoms (all P<0.05). Serum IFN-γ, IL-6, and IL-10 levels were also positively correlated with plasma EBV-DNA copy number. The occurrence of B symptoms was associated with high-risk clinical features including advanced stage, primary tumor invasion, regional lymph node involvement, and elevated pre-treatment LDH. Survival analysis showed that stage, B symptoms, plasma EBV-DNA, and the above serum cytokines affected the prognosis of overall survival (OS) and progression-free survival (PFS) (all P<0.05). However, multivariate analysis showed that the occurrence of B symptoms was not an independent prognostic factor of ENKTL patients. Conclusion:This exploratory study suggests that the incidence of B symptoms is associated with increasing levels of EBV-DNA copies and cytokines, and these indicators are also important factors influencing the prognosis of ENKTL patients.
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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.
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Objective To investigate the expression of interleukin 6 (IL-6) in tumor microenvironment of natural killer/T cell lymphoma (NKTCL) and its relationship with clinical characteristics and prognosis. Methods From January 2005 to December 2012, 93 patients with NKTCL and available paraffin-embedded tissue in Sun Yat-sen University Cancer Center were included. The expression or IL-6 in tumor microenvironment was investigated by immunohistochemistry. The positive IL-6 expression was identified as≥10 cells/HP. The enumeration data and measurement data were compared by t test andχ2 test, respectively. Overall survival (OS) and progression free survival (PFS) were estimated with the Kaplan-Meier method. Survival rates were compared by the Log-rank test. Statistical significance was determined at a level of P<0.05. Results The median count of IL-6 positive cell number was 21 cells/HPF (range, 0-150 cells/HP), and 61.29%(57/93) patients were positive. Positive IL-6 expression was mostly associated with fever and high Korean prognostic index (KPI) score (both P< 0.05). The serum c-reactive protein (CRP) level was (29.28 ± 2.62) mg/L in IL-6 positive patients and (11.14±2.77) mg/L in IL-6 negative patients (t= -2.276, P= 0.025). Patients with negative IL-6 expression had better survival, with 52.7 % of 5-year PFS rate,and 60.0 % of 5-year OS rate; the 5-year PFS and OS rates in those with IL-6 positive were 23.6 % and 27.1 %, respectively (both P= 0.001). Conclusion The high expression of IL-6 in patients with NKTCL might be associated with adverse clinical feature and poor survival.
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Objective To explore the clinical effect of dorsal digital artery reverse island flap in the repair of distal finger skin defect.Methods From January,2011 to January,2015,60 fingers of 60 cases with dorsal branch of the digital artery were used to repair the defect of the distal finger skin.The 30 refers to the index finger,middle finger 15 fingers,10 ring fingers and 5 little fingers.Harvested area of 1.2 cm ×1.7 cm to 3.2 cm × 3.6 cm,the wrist or distal medial arm full thickness skin graft donor site.Evaluation of sensory recovery by the British Medical Research Association.Results All flaps survived.Twelve finger flap tension blisters,and the flaps survived after the stitches.Follow-up of 60 cases of 60 to hand function according to the Chinese medicine will hand surgery society of upper extremity function evaluation standard trial Tam method to evaluate the:50 excellent,10 fingers good,the excellent and good rate was 100％;48 fingers flap sensation recovery to S4 class,and 12 refers to the recovery to S3.The two-point discrimination perception of 5 to 8 mm,average 6.5 mm;patients far,nearly interphalangeal joint average activity recovery was good.Skin flap skin ruddy,soft texture,no fat,no pigmentation,fearless cold performance.No scar hypertrophy and contracture,skin pain no allergy and reoperation.Conclusion The flap for repair of distal finger skin defect is a simple,no damage to the main artery and nerve and good sensory recovery,less postoperative complications,and excellent method of flap survival.It is worth promotion in primary hospitals.
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Objective:To evaluate the efficacy and toxicity of single-agent bendamustine in patients with indolent B-cell non-Hodgkin's lymphoma (NHL) refractory to rituximab. Methods:Between April 2010 and April 2013, 100 patients with rituximab-refrac-tory indolent B-cell NHL from 8 institutions were enrolled. Bendamustine was administered at 120 mg/m2 on days 1 and 2 every 21 days for 6-8 cycles. The primary endpoint was the overall response rate (ORR). The secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results:One hundred patients with a median age of 56 (rang-ing from 28 to 74) years were recruited in this clinical study. The total number of chemotherapy was 447 cycles, and the median number was 4 cycles. Ninety-three patients could be evaluated for efficacy. Fifteen patients (16.1%) had complete remission (CR), 52 (55.9%) had partial remission (PR), 22 (23.7%) had stable disease (SD), and 4 (4.3%) had progression disease (PD). The ORR and DCR were 72%and 95.7%, respectively. After a median follow-up of 26.6 months (ranging from 2 to 48.4 months), 59 patients (63.4%) had PD.The median PFS was 8.53 (95%CI:6.518-10.542) months, and PFS rate for 1 year was (40.6±5.3)%. Forty-eight patients (48%) had 3/4 grade adverse events, including leucopenia (26%), neutropenia (24%), and anemia (11%). Conclusion:Single-agent bendamustine produced a high rate of objective responses in patients with rituximab-refractory indolent B-cell NHL and could be one of the new op-tions for second-line treatment of these patients. The most common adverse event is hematologic toxicity.
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The treatment status and progress in T cell lymphoma including epigenetic involved mutations that control DNA and histone methylation were reported and intensively discussed in 2014 international T cell lymphoma forum.According to the theory,treatment with HDAC inhibitor belinostat and romidepsin for peripheral T cell lymphoma (PTCL) can achieve 29 ％-38 ％ overall response rate (ORR) and 13.6 months median relief time.NK/T cell lymphoma in southeast asia is a common malignant lymphoma,15 ％-28 ％ of the NHL accounted in China and Japan for,which is significantly higher than that in the European and American countries,mainly related to EB virus widespread infection.L-asparaginase enzymes,such as SMILE and AspMetDex,can make the early cases with more than 70 ％ long-term survival rate,advanced cases with 40 ％ response rate.Some new drugs,such as pralatrexate,combined with romidepsin can be used in PTCL cases to improve the complete remission rate.
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Objective To determine the relationship between the serum level of β2-microglobin (β2-MG)and international prognostic index (IPI) and investigate the role of IPI in predicting the prognosis and making individualized therapy for peripheral T-cell lymphoma (PTCL).Methods Eighty-one patients with PTCL were treated by standard CHOP regimen.The clinical characteristics,response,long-term surival rates and the relationship between serum level of β2-MG and IPI scores were analyzed retrospectively.Results Eighty-one patients were eligible.All of them were treated by CHOP regimen.The overall response rate (RR) was 82.7 ％ with 53.1％ complete remission (CR) rate.The RR of IPI low risk,low-intermediate risk,high-intermediate risk,and high risk were 95.7 ％,87.5 ％,53.8 ％ and 20.0 ％,with CR rate 74.5 ％,37.5 ％,15.4 ％ and 0,respectively (P ＜0.05).The median survival times (MST) were 31.2 months at a median follow-up of 30 months (2-98 months).The acturial 1-,3-,and 5-year overall survival (OS) rates were 83.5 ％,41.8 ％ and 34.7 ％,respectively.The 5-year OS rates of low risk,low-intermediate risk,high-intermediate risk,high risk were 57.3 ％,55.9 ％,0 and 0,respectively (P ＜0.05).The OS rates of low risk group (IPI 0-2 scores) and high risk group (IPI 3-5 scores) were 54.8 ％ and 0,respectively (P ＜0.05).Serum levels of β2-MG were significantly elevated in the high risk group than those in the low risk group.The proportion of abnormal serum level of [β2-MG were also significantly elevated in the high risk group than those in the low risk group.The results of multivariante analysis showed that serum level of β2-MG and IPI scores were independent prognostic factors for PTCL (P＜0.05).Conclusion The serum level of β2-MG with IPI scores system can be uscd for evaluating the prognosis of PTCL patients.
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[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.
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[Objective]To evaluate the clinical efficacy and side effects of DHAOx±R regimen in the patients with relapsed and refractory non-Hodgkin's lymphoma(NHL).[Methods]Twenty patients with relapsed or refractory NHL were enrolled into this study in Cancer Center of Sun Yat-sen University.These patients were treated with DHAOx±R regimen(Dexamethasone 20 mg/day intravenous(Ⅳ)on day 1 to day 4,cytarabine 2 000 mg/m~2 3 h Ⅳ,every 12 hours on day 2;oxaliplatin 130 mg/m~2 2 h Ⅳ on day 1;with or without rituximab 375 ms/m~2 on day 0).Six patients were followed by high dose chemotherapy with autologous peripheral blood stem cell transplantation.Response to treatment wag assessed according to The International Working Group Criteria,including CR,PR,SD and PD.Side effects were graded according to WHO criteria,including 0-Ⅳ grades.[Results]Twenty patients received 47 cycles chemotherapy,13 patients(65%)received DHAOx chemotherapy and 7(35%)received DHAOx+R.The response rate(RR)for the whole group was 55%(11/20)with comeplete response(CR)rate 35%(7/20).The response can also be obtained in the patients who were already treated by platinum-based regimen before.The major toxicity Wag myelosuppression.The incidence of grade Ⅲ～Ⅳ neutropenia Wag 35%(16/47),and febrile neutropenia was 17%(8/47).The incidence of grade Ⅲ～Ⅳ thrombocytopenia was 20%(9/47).Eight cycles(17%)occurred mild neumtoxicity.With median follow-up of 12 months,1 and 2-year overall survival rate were 70.6%.[Conclusion]DHAOx was an effective regimen for recurrent and relapsed NHL patients with mild side effects and further investigation is needed.
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<p><b>OBJECTIVE</b>To investigate the flavonoids in Rhododendron mariae.</p><p><b>METHOD</b>The constituents in R. mariae were determined by UPLC/Q-TOF-MS. The chromatographic separation was performed on a C18 column (2.1 mm x 50 mm, 1.7 microm) with a gradient elufion of methanol-water containing 0.1% formic acid. The mass specfrometer eqaipped with elecfrospay ionizafion source was usedas defecfor and operated in data was collected under the positive and negative ion modes.</p><p><b>RESULT</b>Seven constituents were identified as myricetin-3-O-beta-D-gluconside (1), myricetin-3'-O-beta-D-xylopyraoside (2), hyperoside (3), isoquercitrin (4), avicularin (5), quercitroside (6) and quercetin (7).</p><p><b>CONCLUSION</b>In this study, the main flavonoids in R. mariae were separated by UPLC, and identified through the information of positive ion and negative ion and relative molecular mass which were determined by Q-TOF-MS. It is an accurate and effective method which can be applied for the constituent identification of R. mariae.</p>
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Chromatographie en phase liquide à haute performance , Flavonoïdes , Chimie , Spectrométrie de masse , Rhododendron , ChimieRÉSUMÉ
Objective To evaluate the efficacy and toxicity of SMILE regimen for NK/T-cell lymphoma. Methods From November 2006 to February 2008, 5 patients with relapsed and 5 with first treatment NK/T-cell lymphoma were involved in this study. These patients were treated with SMILE regimen including methotrexate, isofosfamide, L-asparaginase and etoposide.1 patient were treated with autolognus hematopoietic stem cell transplantation (AHSCT), and 2 patients received local regional radiation following SMILE. Results Among 10 patients, 8 were eligible to response evaluation. The overall response rate for whole group was 50 %(4/8) without complete remission. The overall response rate for both previously untreated and relapsed patients were 50 %(2/4). Major toxicity were bone marrow supression and transient transaminase elevation, the incidence of grade Ⅲ -Ⅳ neutroponia was 65 %, and febrile neutropenia was 25 %, Grade Ⅲ transaminase elevation was 10 %. Other toxicities were mild, no treatment-related mortality occurred. 26.1% cycles discontinued due to severe side effect. Conclusion SMILE may be an effective regimen for relapsed or refractory NK/T-cell lymphoma while significant toxicities were observed. Further investigation is requried before SMILE become a standard combination for relapsed or refractory NK/T-cell lymphoma.
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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.
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<p><b>BACKGROUND</b>To study the expressions and its clinical significances of fas and P53 protein in human non-small cell lung cancer (NSCLC) after complete surgical resection.</p><p><b>METHODS</b>Immunohistochemical stain of fas and P53 was performed on paraffin-embedded sections from 269 NSCLC patients who underwent surgery and were followed up for 1.1 to 122.2 (median, 48.4) months postoperatively. Differences in survival rates and clinical characteristics were evaluated by SPSS10.0 statistical software packet.</p><p><b>RESULTS</b>The rate of fas and P53 expression in NSCLC cancer tissue was 43.1% and 49.4% respectively. Fas expressions were seen more frequently in female patients (59.3% vs 39.1%, P < 0.01). Univariate analysis showed that fas expression was a good factor for predicting prognosis. The 5-year survival rate of the patients whose tumors had positive fas expression was significantly better than those individuals whose tumors had negative fas expression (51.4% vs 42.4%, P=0.02), especially in patients in stage I and IIIA . The expression of P53 had no significant influence on the prognosis of these 269 NSCLC patients. Combined analysis of fas and P53 expression in NSCLC cancer tissues showed significant prognostic influence (P=0.01). The 5-year survival were 40.1% (fas+ and P53-), 45.4% (both positive or both negative) and 57.2% (fas- and P53+), respectively. COX multivariate analysis showed that reduced fas expression in 269 NSCLC is an independent risk factor, especially in stage IIIA NSCLC.</p><p><b>CONCLUSIONS</b>Fas and P53 protein are indicators of NSCLC biological behavior. Reduced fas expression in NSCLC is an independent risk factor for early stage patients. Analysis of apoptosis related proteins expression in tumors might be helpful to predict the prognosis of patients with NSCLC.</p>
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Purpose:To study the expressions and its clinical significances of bcl-2 and integrin?3 in human Non-small cell lung cancer(NSCLC)after radical surgical resection. Methods:Immunohistochemical (IHC) staining of bcl-2 and integrin?3 was performed on paraffin-embedded sections from 269 NSCLC patients who underwent surgery and were followed up for 1.1 to 122.2(median, 48.4) months postoperatively. Differences in survival rates and clinical characteristics were evaluated by SPSS10.0 statistical software packet. Results:The prevalence of bcl-2, integrin?3 and both these proteins expression in NSCLCs was 56.9%, 47.2% and 34.9%, respectively. Bcl-2 expression was seen more frequently in female NSCLCs and smaller tumors. Integrin?3 was seen more frequently in squamous carcinomas. Cox multivariate analysis showed that bcl-2 expression in stage Ⅱ NSCLC was an independent risk factor (5 years survival rate: 39.3% vs 52.1% P=0.04), and both bcl-2 and integrin ?3 positive in stage Ⅲa NSCLC are independent good factors(5 years survival rate: 34.5% vs 23.8% P=0.04). Conclusions:Bcl-2 and integrin ?3 are indicators of NSCLC biological behavior. Combined analysis of expression of these proteins in tumors may indicate the prognosis of NSCLC.