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  • American Society of Hematology  (17)
  • 1
    In: Blood, American Society of Hematology, Vol. 124, No. 21 ( 2014-12-06), p. 4444-4444
    Abstract: Purpose: Extranodal NK/T-cell lymphoma, nasal type (ENKTL), is a rare and highly aggressive disease. The Ann Arbor staging system had been unsuitable to proper staging of ENKTL. This study was conducted to establish a new staging system specified for ENKTL, which can identify poor prognostic patients. Patients and Methods: Patients with untreated, centrally reviewed diagnosis of ENKTL were included in our study. The new staging system was established based on the study of single center consecutive patients treated with CHOP-like regimens with or without involved field radiotherapy (IFRT), then we initinated a multicenter confirmation study and conducted a multicenter prospective study to validate the new staging system. Results: From Jan 1997 to June 2006, 134 consecutive patients treated in the cancer center of Sun Yat-sen University were analyzed. The following was a summary of the classification system developed: stage I: lesions confined within nasal cavity or nasopharynx without local invasiveness (paranasal sinuses or bony or skin invasion); stage II: localized disease with local invasiveness; stage III: localized disease with regional lymph node involvement (cervical lymph nodes); and stage IV: disseminated disease (lymph nodes on both sides of diaphragm, multiple extranodal site). The distribution of stage I to IV using the new system and Ann Arbor system were 39.6%, 23.9%, 23.1%, 13.4% and 63.4%, 23.1%, 5.2%, 8.2%, respectively. The 5-year OS rate of stage I to IV using the new system were 29.5%, 23.4%, 21.3% and 0.07% compared with 23.8%, 21.3%, 0.0% and 0.0% using the Ann Arbor system. In the multicenter confirmation study conducted in 18 centers in China, 722 patients were analyzed. The results showed that the distribution of the new system compared with Ann Arbor system from stage I to IV were 24.1%, 34.9%, 18.3%, 22.7% vs 59.1%, 19.0%, 6.9%, 15.0%, respectively, and the 5-year OS rate of stage I to IV were 56.0%, 48.3%, 33.8%, 26.1% vs 50.7%, 39.1%, 10.8%, 28.0%, respectively. For the multicenter prospective study, 233 newly diagnosed ENKTL patients treated with non-CHOP-like regimens were enrolled and showed a balanced distribution of 17.2%, 39.9%, 19.3%, 23.6% vs 53.6%, 25.3%, 6.9%, 14.2% from stage I to IV and superior 5-year OS rate: 82%, 73%, 67%, 54% vs 75.2%, 65.6%, 46.9%, 73.8% from stage I to IV using the new system in compared with the Ann Arbor system. Conclusions: The new staging system with a more balanced distribution and a superior prognostic discrimination as compared with Ann Arbor staging system no matter for CHOP-like or non-CHOP-like regimens, is more suitable for ENKTL and can be recommended used in the future. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2014
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  • 2
    In: Blood, American Society of Hematology, Vol. 124, No. 21 ( 2014-12-06), p. 5363-5363
    Abstract: Predictive value of therapeutic monitoring with plasma Epstein-Barr virus DNA in Extranodal NK/T cell lymphoma, nasal type Background: Predictive tumor markers are essential for extranodal NK/T cell lymphoma, nasal type (ENKTL), which pursues an aggressive clinical course with poorer prognosis. This prospective study was conducted to evaluate the dynamic monitoring value of circulating EBV DNA concentration for the prediction of ENKL during treatment. Method: Patients with untreated, centrally reviewed diagnosis of ENKTL were included in our study. Plasma Epstein-Barr virus (EBV) DNA levels were collected before and/or every 2 cycles of chemotherapies for circulating EBV DNA measurement by a real-time PCR assay. Result: From Jan 2002 to Aug 2012, 113 newly diagnostic ENKTL patients enrolled. The positive rate of circulating EBV DNA is 61.9% (70/113) with a median concentration of 1.21×103copies/ml. Patients who had initial positive circulating EBV-DNA had more lymph nodes invasion, higher IPI and KPI score. The more advance of the stage, the higher rate of the circulating EBV-DNA positive. When divided the positive group as low and high-dose ones by the cut-off value as 2×104copies/ml, the CR rate of the high-dose group is much lower and the 5-year OS is significantly better than the low-dose group and the negative group. After two cycles of chemotherapy, 45 patients were tested circulating EBV-DNA and 53.33% (24/45) patients became negative EBV-DNA candidates. There were 87.5% (21/24) patients obtained complete remission at the end of the treatment, comparing as 42.86% (9/21) in the still positive EBV-DNA groups(P= 0.002). There is a tendency that the patients whose circulating EBV-DNA become negative after two cycles will have better prognosis (5-year OS: 75% vs 46%, P=0.074). The similar situation of CR rate and OS happened in the EBV-DNA detection of completion of total chemotherapy. 7 of 13 relapsed pts of >1×103copies/ml EBV-DNA at the time of recurrent, and the survival outcome was dismal for them compared to the other 6 pts of ≤1×103copies/ml(5- year OS: 0% vs 80%, P=0.001) Conclusion: Circulating EBV-DNA level can predict the efficacy of treatment as a dynamic marker of ENKL. Patients with early positive detection of EBV-DNA after 2 cycles of chemotherapy maybe received more aggressive treatments. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2014
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  • 3
    In: Blood, American Society of Hematology, Vol. 126, No. 23 ( 2015-12-03), p. 3956-3956
    Abstract: Background and objectives: Methotrexate (MTX) is a folic acid reductase inhibitor widely used. Peripheral infusion of high dose MTX (HD-MTX) could prevent the central nervous system recurrence of leukemia and NHL. Due to the blood brain barrier, only 1-3% of MTX in the peripheral blood can enter the cerebrospinal fluid. Improving the peripheral MTX drug dosage helps to improve MTX concentration in the cerebrospinal fluid. However, high concentration of MTX has serious side effects to normal organs. Leucovorin (CF) rescue is given to reduce the toxic effect of methotrexate on normal cells. During high dose MTX therapy, monitoring of serum concentration of MTX and timely CF rescue therapy are mandatory so as to maximum the efficacy of MTX and minimize the toxicities. Due to the lack of randomized clinical trials with large sample, the safe dose and most appropriate time of leucovorin rescue treatment are of no consensus. In order to study the effect of different time of leucovorin rescue treatment on the serum concentration of MTX, we carried out this study. Patients and methods: We included patients who had pathological diagnosis of non-Hodgkin's lymphoma and indications to receive HD-MTX as single agent or component in combined regimen consecutively from October 2011 to June 2014 at our hospital. Patients were randomized to receive CF rescue at the sixth hour after MTX infusion in the first course and twelfth hour in the second course or the twelfth hour in the first course and sixth hour in the second course. A dosage of 3.5 g/m2 of MTX was provided. Adequate hydration, alkalization and monitoring of laboratory tests were administered. Intrathecal injection of MTX plus cytarabine and dexamethasone were given after MTX infusion. 100mg of CF was given at the first time, then 30mg of CF were given every 6 hours for a total of 7 times until the plasma concentration of MTX were lower than 1×10-7 mol/L. Blood samples were collected at 2, 12, 18, 24, 28, 72 hours after the beginning of MTX infusion. High performance liquid chromatography was used to test the plasma concentration of MTX. Results: There were 23 male patients and 12 female patients with a mean age of 41 years. Most of patients were diagnosed as diffuse large B cell lymphoma (65.7%). Eleven cases (31.4%) had central nervous system invasion at the time of HD-MTX treatment. Twenty-one patients (51%) had more than one extra-nodal lesion. Sixteen patients were randomly to be rescued at the sixth hour in the first course then the twelfth hour in the second course. Nineteen patients were randomly to be rescued at the twelfth hour in the first course then the sixth hour in the second course. The plasma concentration of MTX of patients rescued at the sixth hour at the time of 2, 12, 18, 24, 48 hours were 5.21±0.36×10-5 mol/L, 8.01±0.635×10-5 mol/L, 4.57±1.67×10-6 mol/L, 1.43±0.83×10-6 mol/L, 0.1±0.1×10-6 mol/L, respectively; The plasma concentration MTX of patients rescued at the twelfth hour at the time of 2, 12, 18, 24, 48 hours were 5.46±0.34×10-5 mol/L, 8.65±0.663×10-5 mol/L, 5.4±0.93×10-6 mol/L, 1.12±0.21×10-6 mol/L, 0.1±0.24×10-6 mol/L, respectively. There was no significant difference of MTX concentration level between patients treated with different CF rescue timing, P 〉 0.05. Most of patients achieved maximal MTX concentration at the twelfth hour, and descended to be lower than the minimal effective concentration at the eighteenth hour. At the forty-eighth hour, majority of patients had MTX concentration being in a safe range. The rate of grade 3 to 4 adverse reactions including neutropenia, anemia, thrombocytopenia and grade 1 to 2 side effects including neutropenia, thrombocytopenia, mucositis, fatigue, and MTX discharge delay were higher when patients were rescued with CF at the twelfth hour, though P 〉 0.05. Conclusion: Most of patients treated with high dose MTX reached the maximum MTX concentration at the twelfth hour after MTX infusion, and descended to be under the minimal effective concentration at the eighteenth hour, then to be in the safe range at the forty eighth hour. No significant difference of MTX concentration was found between patients rescued with CF at the sixth hour or the twelfth hour. However, adverse reactions were lower when patients were treated with CF rescue at the sixth hour. It seems a better choice to give patients CF rescue at the sixth hour after MTX infusion. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2015
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  • 4
    In: Blood, American Society of Hematology, Vol. 138, No. Supplement 1 ( 2021-11-05), p. 3531-3531
    Abstract: Background: Stage III follicular lymphoma (FL) is currently still considered incurable after RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy and rituximab maintenance. Radiotherapy plays a vital role in early-stage FL, but the value remains unclear in stage III FL. Here, we reported the results of invasive field radiotherapy (IFRT) combined with rituximab maintenance versus rituximab maintenance alone in patients with stage III FL who achieved complete remission (CR) or partial response (PR) after induction chemotherapy. Methods: From January 2015 and January 2020, patients aged 18-70 years with CR or PR after induction chemotherapy in stage III FL, grade 1, 2 or 3a and CD20 positive in immunohistochemical feature were randomly assigned (1:1) to receive IFRT combined rituximab maintenance or rituximab maintenance alone after induction chemotherapy in multicenter. The primary endpoint was progression-free survival at 5 years. This study is registered with Chinese ClinicalTrials.gov, number ChiCTR2000032550. Results: 63 patients were randomly assigned to IFRT combined rituximab maintenance (IFRT+R arm) and 66 patients to rituximab maintenance alone (R arm) after induction chemotherapy. The dose of IFRT was 30Gy. After a medium follow-up of 48 months (range 7-72 months), the 5-year progression free survival (PFS) were significantly improved in patients with IFRT +R, with 87.8% versus 67.1% (HR, 0.32; 95% CI, 0.14-0.72, P=0.006). Patients with IFRT +R also have a better overall survival (OS), OS was 96.6% versus 80% (HR, 0.28; 95% CI, 0.09-0.92, P=0.036). Thirty-six (57%) patients in IFRT+R arm and twenty-four (36%) patients in R arm suffered toxic effects (P=0.02). Grade 3 and 4 adverse events were recorded in 17 patients (27%) in IFRT+R arm and 11 (16%) in R arm (P=0.200). Conclusion: On the basis of rituximab maintenance, IFRT demonstrated promising efficacy and manageable toxicity in stage III FL, with longer PFS and OS compared with rituximab alone. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2021
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  • 5
    In: Blood, American Society of Hematology, Vol. 126, No. 23 ( 2015-12-03), p. 2690-2690
    Abstract: Background: CD20-antibody (rituximab) plus CHOP chemotherapy (R-CHOP) have become the first-line regimen for CD20 positive DLBCL since the introduction of rituximab at the end of 1990s. Our group (Chinese south-west oncology group, CSWOG) planned to evaluate the efficacy and toxicity of biweekly schedule of RCHOP (RCHOP-14) compared to triweekly RCHOP (RCHOP-21) for DLBCL. Purpose: RCHOP-14 vs. RCHOP-21 for untreated diffuse large B-cell lymphoma (DLBCL), compare the 5-year disease-free survival (DFS), overall survival (OS), response rate and the side effects. Patients and methods: Patients older than 18 years, newly diagnosed of CD20-positive DLBCL with adequate organ function were recruited. All patients were randomized into two groups after provided written informed consent, and received RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy. The RCHOP-14 group was administered every 2 weeks, patients received prophylactic granulocyte colony-stimulating after each chemotherapy cycle. The control group RCHOP-21 was administered every 3 weeks. The planned cycles of chemotherapy was 6 to 8 cycles. Patients received imaging evaluation at the baseline and every 2 cycles of chemotherapy. Radiotherapy was recommended to treat local residue or bulky tumor. Vital signs, physical examination, and laboratory studies were documented at each follow-up visit. Results: From January 2008 to December 2014, a total of 702 patients with newly diagnosed DLBCL were recruited in 14 cancer centers of CSWOG. There were 407 males (58.0%) , 295 females (42.0%) , and median age of 52 years (range 18-80 years). 353 assigned to the RCHOP-21 group and 349 assigned to the RCHOP-14 group, patients in the two groups totally received 3989 cycles of chemotherapy, an average of 5.70 cycles per patient. There was no significant difference between the RCHOP-21 and RCHOP-14 groups in terms of sex, age, Ann Arbor stage, International Prognostic Index, B symptoms, extranodal involvement and seropositive status for hepatitis-B surface antigen. Overall, 496 (70.7%) achieved CR, 136 (19.4%) PR, 16 (2.3%) SD and 50 (7.1%) PD. For RCHOP-21 group, the incidence of CR, PR and PD was 72.8%, 18.4%, 6.5%, respectively, the response rate was 91.2%, and relapse rate was 22.6%. For RCHOP-14 group, the incidence of CR, PR and PD was 69.1%, 20.9%, 7.7%, respectively, the response rate was 90.0%, relapse rate was 16.8%, and the results were no significant difference. With the median follow-up of 35.95 months, the 5-year DFS, OS, and PFS of RCHOP-21 compared with RCHOP-14 was 72.2% vs.72.8%, p=0.306; 68.9% vs62.3%, p=0.856; and 53.8% vs. 54.4%, p=0.357,respectively. The most common side effect was bone marrow suppression including 83.6% granulopenia and 46.7% grade III/IV granulopenia, Febrile Neutropenia 24.9%; 69.1% anemia and 12.6% grade III/IV anemia; 50.6% thrombocytopenia and 11.5% grade III/IV thrombocytopenia. Other side effects included: 18.6% pneumonia, 6.8% interstitial pneumonia, 17.1% other site of infection, 17.5% ALT/AST increasing, 17.4% peripheral neuritis, 13.1% fatigue, 11.9% nausea, 13.1% vomiting, 4.6% oral ulcer. There were no significant difference between the two groups about the above side effects. There were 32 patients (9.1%) in RCHOP-21 and 40 patients (11.5%) in RCHOP-14 delayed the chemotherapy because of severe side effects. High score of IPI, insufficient chemotherapy cycles and relapse during chemotherapy were independent prognosis factors in multivariate analysis. Conclusion: RCHOP-14 did not showed superior effective than RCHOP-21. The side effects were similar with prophylactic GCSF in RCHOP-14 regimen. Therefore, RCHOP-21 is still the standard treatment for DLBCL. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2015
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  • 6
    In: Blood, American Society of Hematology, Vol. 126, No. 23 ( 2015-12-03), p. 1458-1458
    Abstract: 18 F-PET-CT is clinically recommended for monitoring therapeutic response in DLBCL patients. But the role of interim PET-CT remains controversial, and most of the previous researches were retrospective. We designed this study to prospectively evaluate whether interim PET-CT was a valid prognostic tool for patients with DLBCL treated with R-CHOP regimen and if yes, try to determine the more appropriate time and interpretation method for interim PET-CT. This study was a sub-study of the parental study "A prospective, multicenter randomized phase III clinical trial of intensified chemotherapy in improving the treatment efficacy of patient with diffuse large B-cell lymphoma" (NCT01793844). The sub-study included patients that have already been enrolled in the parent study at Sun Yat-Sen University Cancer Center prospectively. Patients were evaluated with PET-CT scans before treatment and after every 2 cycles of R-CHOP and after the completion of first-line treatment. Regular follow-up starts from the enrollment. Between Jan. 2008 and Aug. 2014, 221 patients in Sun Yat-Sen University Cancer Center were enrolled in this sub-study, among whom 203 patients were included in the analysis and the other 18 were excluded for lacking the necessary raw data of PET-CT scan. PET evaluation would be applying the visual criteria of International Harmonization Project(IHP) and the Deauville 5-point scale(5-PS). The results showed PET positive in 103 patients and negative in 100 patients after 2 cycles of R-CHOP chemotherapy with IHP criteria. Among the 103 patients with positive PET-2, 53 patients turned negative after 4 cycles of chemotherapy and still 50 patients remain positive. At the evaluation of end-of-first-line-treatment, 165 patients achieved CR, while 30 achieved PR and 8 PD . According to 5-PS criteria, 146 patients were PET negative with 57 were positive after 2 cycles of chemotherapy. And 173 patients were negative in PET-4 evaluation, while 30 patients remained positive. With a median follow-up of 25.46 months (range 3.60~77.33 months) and according to IHP criteria, patients with negative PET-2 had superior 3-year PFS (84.7% vs. 63.8%, p 〈 0.001) and OS (89.8% vs. 80.4%, p = 0.045) than those with positive results. Patients with negative PET-4 also had a better clinical outcome compared with the positive group with 3-year PFS (84.1% vs. 43.8%, p 〈 0.001) and OS (90.7% vs. 67.8%, p 〈 0.001). A further analysis showed that patients who achieved PET negative just after 2 cycles of chemotherapy (Early responder, ER) had a similar prognosis comparing with those who achieved PET negative after 4 cycles (Later responder, LR). There were no significant differences in the persistent CR rates (87.00% vs. 86.79%, p = 0.971), 3-year PFS (84.7% vs. 82.2%, p = 0.867) and 3-year OS (89.8% vs. 92.9%, p = 0.638) between the ER group and the LR group. Patients who remained PET positive after 4 cycles of chemotherapy (Interim non-responder, I-NR) had the worst prognosis. Their persistent CR rate (42.00% vs. 87.00%, p 〈 0.001; 42.00% vs. 86.79%, p 〈 0.001), 3-year PFS (43.8% vs. 84.7%, p 〈 0.001; 43.8% vs. 82.2%, p 〈 0.001) and 3-year OS (67.8% vs. 89.8%, p 〈 0.001; 67.8% vs. 92.9%, p = 0.002) were significantly lower, comparing with the ER and LR group. And according to 5-PS criteria, the results were similar. Patients with negative PET-2 had superior 3-year PFS (82.9% vs. 51.6%, p 〈 0.001) and OS (89.7% vs. 72.9%, p = 0.001) than those with positive results. Patients with negative PET-4 also had a better clinical outcome compared with the positive group with 3-year PFS (81.8% vs. 30.0%, p 〈 0.001) and OS (90.1% vs. 54.2%, p 〈 0.001). In the multivariate analysis, PET-4 with IHP criteria, PET-4 with 5-PS criteria and IPI score were independent predictive factors for PFS of patients with DLBCL. A further analysis of positive predictive value (NPV) and negative predictive value (PPV) showed PET-4 was superior than PET-2, especially interpretated with 5-PS. The PPV and NPV of PET-4 with 5-PS criteria were 70.00% and 83.82% respectively. These data indicates that Interim 18 F-FDG PET-CT scan could predict the prognosis of DLBCL patients treated with R-CHOP regimen. And it was recommended that interim 18 F-FDG PET-CT scan be done after 4 cycles of chemotherapy, and that 5-PS criteria be applied in the interpretation of interim PET-CT scan rather than IHP criteria. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2015
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  • 7
    In: Blood, American Society of Hematology, Vol. 124, No. 21 ( 2014-12-06), p. 3011-3011
    Abstract: Purpose 18F-FDG PET-CT has been widely used for pre-treatment staging and post-treatment response assessment in diffuse large B cell lymphoma (DLBCL), but the predictive value of interim PET-CT remained controversial and most of studies were retrospective. Patients and Methods Newly-diagnosed DLBCL patients treated with R-CHOP regimen were included in our prospective study to evaluate the predictive value of interim PET-CT. All patients were evaluated with PET-CT scans before treatment and after every 2 cycles of R-CHOP. PET-CT positivity or negativity was related to survival using Kaplan-Meier analysis. Results From Feb 2008 to Jan 2013, 149 patients were included. After 2 cycles of R-CHOP, the PET-CT evaluation showed CR in 82 patients. Among the remaining 67 non-CR patients, 31 achieved CR after 4 cycles. At the end of treatment, PET-CT evaluation showed CR in 121, PR in 21, SD in 3 and PD in 4 patients. With a median follow-up of 20.6 months (range 1.5-60.5 months), patients with negative PET-2 (PET-CT scan after 2 cycles) had a superior 2-year PFS than those with positive PET-2 (86.6% vs. 67.0%, p=0.019) and a tendency of superior 2-year OS without statistical differences (91.9% vs. 85.2%, p=0.330). The 2-year PFS and OS for negative PET-4 (PET-CT scan after 4 cycles) compared with positive PET-4 group were 84.8% vs. 51.9% (p=0.001) and 93.1% vs. 73.0% (p=0.027) respectively. PET-CT scans were interpreted using the International Harmonization Project (IHP) criteria above. The second analysis applying the Five-Point Scale (5PS) criteria showed that 2-year PFS for score 1-2 (uptake<mediastinum), score 3 (mediastinum<uptake≤liver) and score 4-5 (uptake>liver) group were 86.6%, 75.8% and 71.0% according to PET-2, and 84.9%, 50.0% and 52.7% according to PET-4. PFS of score 3 group was not significant different from the other two groups in PET-2 (both P>0.05), but significantly inferior to score 1-2 group (p=0.046) and similar to score 4-5 group (p=0.767) in PET-4. In the multivariate analysis, only PET-4 (95%CI, 1.07-5.44) and IPI score (95%CI, 1.53-10.06) remained independent predictive factors for PFS. Conclusion PET-CT after 4 cycles of R-CHOP in patients with DLBCL is highly predictive of PFS and should be considered in clinical practice. (Clinical Trail Registration Number: CTR-TRC-11001687) Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2014
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  • 8
    In: Blood, American Society of Hematology, Vol. 116, No. 21 ( 2010-11-19), p. 4148-4148
    Abstract: Abstract 4148 Background extranodal NK/T cell lymphoma, nasal type (ENKL) has worse efficacy and prognosis than B-NHL. Circulating EBV DNA concentration can reflect the efficacy and prognosis in some EBV related malignance (nasopharyngeal carcinoma). But there are few studies about the relation between EBV infection and ENKL. This prospective study is to confirm predictive value of circulating EBV DNA concentration and EBV serology in ENKL patients. Methods In the prospective study, serum samples from 125 previously untreated ENKL patients were collected from Jan 2002 to Dec 2006. We detect VCA-IgA and EA-IgA level by immunoenzyme methods and circulating EBV DNA concentration by real-time PCR assay. All patients were received long-term efficacy and survival assessment. Results The median follow-up time is 4.53 years. The positive rates of VCA ƒüIgA and EA ƒüIgA are 30.6% and 1.6% respectively, both of which could not predict the efficacy and survivals. The positive rate of circulating EBV DNA is 69.4%, with a median concentration of 13400 copies/ml. Patients with extranodal involvement, B syndrome, upper respiratory involvement, neutropenia or anemia or thrombocytopenia, liver dysfunction, and increasing of β2MG, have significantly higher EBV DNA positive rate(45.1% A54.4% A62.3% A53.5% A90.0% A59.3%, respectively). Patients in higher EBV DNA concentration group is easier to have bone and/or skin involvement (≤13400 copies/ml group: 45.8%vs. 〉 13400 copies: 16.0%, p=0.024). The positive circulating EBV DNA group has a lower complete remission (CR) rate (38.8%vs.59.2%, p=0.026), higher relapse rate (52.6%VS.26.7%, p=0.046) than negative one. The 5-year DFS and 5-year OS decreased with the dose of circulating EBV DNA group (DFS: negative group74.3% vs. ≤13400 copies/ml group 55.0% vs. 〉 13400 copies/ml group 28.6%, p=0.003; OS: negative group 55.8% vs. ≤13400 copies/ml group 48.4% vs. 〉 13400 copies/ml group 29.2%, p=0.004). Conclusions The positive rate of circulating EBV DNA is much higher in ENKL. Circulating EBV DNA concentration, as measured by real-time PCR, is a useful tumor marker for diagnosis and prognostication with ENKL patients. Patients with higher dose of circulating EBV DNA level ( 〉 13400 copies/ml) may undergo more aggressive biological behavior. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2010
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  • 9
    In: Blood, American Society of Hematology, Vol. 128, No. 22 ( 2016-12-02), p. 5394-5394
    Abstract: Background: Rituximab (Rtx) with Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) regimen could improve the survivalship in treatment of B cell lymphoma, however, also increases the possibilities of infectious disease including pulmonary pneumonia. Methods and materials: A prospective study was conducted in Sun Yat-sen University Cancer Center from Feb 2008 to Oct 2015 to analyze the addition of thyomosin (Th α1) and intravenous immunoglobulin (IVIG) supportive therapy impact in preventive role of pulmonary adverse effect (PAE) incidence rate related to Rtx based immuno-chemotherapy. Results: Out of 379 cases, 215 in Th α1 and IVIG (study) group and 164 in non Th α1 and IVIG (control) group compared; 80 (21.1%) of them developed PAE: 39 Rtx immuno-chemotherapy induced interstitial pulmonary disease (IPD) and 41 infectious pneumonia (IP) cases were developed after the 4rth median cycles (2.8 months) of R-CHOP regimen from the first exposure until prior to induced PAE and 11 cases of IP were isolated with etiology. In comparing the role of Th α1 and IVIG vs. control group; out of 41 R-CHOP induced pneumonia cases: 9 (2.4%) vs. 32 (8.4%) with p 〈 0.001, respectively found. In multivariate analysis, Th α1 and IVIG (p 〈 0.001) was the independent highly significant factors related to decrease infectious pneumonia prevalence rate. Furthermore chemotherapy disruption rate due to pneumonia was 4.2% vs. 38.5%, in study and control group (p = 0.005), respectively. Incidence of pneumonia was found significantly lower in study group than control group in account of high risk advanced stages (Fisher's Exact Test, p 〈 0.001) and age≥60 (Fisher's Exact Test, p = 0.002) group. 6 years of event free survival (EFS) was found higher in study group 73.2% in compare to control group 52.6% with p 〈 0.001. Conclusions: The B cell lymphoma patients with high risk factors along with the risk of developing infectious pneumonia may be substantially decreased by the regular implication of Th α1 and IVIG along the Rtx based chemotherapy that may result effective in improving EFS too. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2016
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 10
    In: Blood, American Society of Hematology, Vol. 136, No. Supplement 1 ( 2020-11-5), p. 1-1
    Abstract: Background: Ibrutinib, a first-in-class Bruton's tyrosine kinase (BTK) inhibitor, has been approved for the treatment of relapsed/refractory (R/R) Mantle cell lymphoma (MCL). Both single-agent ibrutinib and combination of ibrutinib with rituximab have achieved great efficacy with manageable toxicity (Wang,NEJM2013; Wang,Lancet Oncol2015; Dreyling,Lancet2015). This study, for the first time, analyzed the real-world effectiveness and tolerability of ibrutinib for MCL patients in China. Methods: This multi-center, retrospective cohort study enrolled adult patients (pts) with pathologically confirmed MCL who initiated ibrutinib-containing treatment between November 2017 (date of commercialization) and April 2020. Eligible patients were retrospectively divided into 3 subgroups to receive ibrutinib-containing treatments for different purposes: R/R MCL group, newly diagnosed MCL group and maintenance therapy group. This analysis reports the baseline characteristics, efficacy and safety profiles in R/R MCL patients. Results: A total of 67 R/R MCL pts receiving ibrutinib-containing treatment from 9 medical centers in China were included in this analysis. At ibrutinib initiation, the median age was 61.0 (range 39-81) years, 68.7% were male and 81.8% had Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Approximately three-quarters of pts (72.3%) had 1 previous line of therapy before ibrutinib. Baseline characteristics are summarized in Table 1. Of all patients enrolled, 53.7% (36/67) of pts received ibrutinib monotherapy and 46.3% (31/67) received ibrutinib-containing combination therapy. IR (ibrutinib and rituximab) (16/31, 51.6%) and IR2 (ibrutinib, rituximab and lenalidomide) (5/31, 16.1%) were the two most common combination regimens. Nine patients (29.0%) received ibrutinib plus R-chemotherapy. Although no statistically significant difference was found in listed baseline characteristics between these two groups, a larger percentage of pts with bone marrow involvement (58.1% vs 35.7%) and bulky mass (largest diameter) ≥5 cm (46.4% vs 27.3%) were observed in combination therapy group. Best overall response rate (ORR) was 65.7% (20.9% complete remission [CR]). Median time to response (TTR) was 4.1 months and median duration of response (DOR) was 18.4 months. With a median follow-up of 10.2 months, median progression-free survival (PFS) was 21.3 months (95% confidence interval [CI] , 15.2 - not available [NA]) (Figure 1A). PFS rates were 86.0%, 69.8% and 47.6% at 6 months, 1 year and 2 years. With a median follow-up of 11.2 months, median overall survival (OS) was not reached with OS rates of 98.5%, 87.9% and 76.3% at 6 months, 1 year and 2 years (Figure 1B). Compared with ibrutinib monotherapy, combination therapy showed higher ORR (50.0% vs 83.9%), CR rate (8.3% vs 35.5%) and shorter TTR (median TTR, 6.0 vs 2.2 months; Logrank,p=0.0012) (Figure 2A). Although the combination therapy had a trend for better PFS, no statistically significant benefit in PFS or OS was observed (Figure 2B, C). Safety analysis focused on 55 R/R MCL pts from 3 centers with adequate adverse events information. The most common treatment emergent adverse events (TEAEs) of interest were infection (8/55, 14.6%), rash (8/55, 14.6%), bleeding (5/55, 9.1%; 1/5 was major bleeding [subdural hemorrhage]) and atrial fibrillation (3/55, 5.5%). Four pts (7.3%) experienced grade 3-4 TEAE (neutropenia, n=2; neutropenia and lung infection, n=1; subdural hemorrhage, n=1). Six pts (10.9%) had ≥1 temporary ibrutinib discontinuation due to TEAE (infection, n=3; neutropenia, n=1; rash, n=1; vomiting, n=1). One patient discontinued ibrutinib permanently due to TEAE (subdural hemorrhage). Combination therapy group showed a higher incidence of hematological TEAE (60.9% vs 39.1%) and infection (20.7% vs 7.7%). No TEAE-related death or new safety signals was recorded. Conclusion: This real-world analysis demonstrates that ibrutinib is effective and tolerable for R/R MCL in China. Ibrutinib-containing combination therapy outperformed ibrutinib monotherapy in response rate and TTR, but showed no survival benefits. The response rate data of ibrutinib monotherapy obtained from our study was different to existing clinical trial data, which may be mainly due to the short follow-up time of our study. Further analysis with longer follow-up is needed to validate these findings. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2020
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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