AIM:To establish the quality standard for Xuesaitong Granule(total saponins of Radix et Rhizoma Notoginseng). METHODS:The contents of notoginsenoside R1,ginsenoside Rg1 and Rb1 were determined on the Shim-Pack C 18 (250 mm?4.6 mm,5 ?m) column,with CH3CN—H2O gradual elution and monitored at 203 nm. RESULTS:The average recovery of notoginsenoside R1 was 100.0% (RSD=1.00%,n=6),the minimum detection quantity cannot be lower than 5% labelled weight. The average recovery of ginsenoside Rg1 was 99.8 % (RSD=0.47%,n=6),the minimum detection quantity cannot be lower than 20% labelled weight. The average recovery of ginsenoside Rb1 was 99.8% (RSD=0.79%,n=6),the minimum detection quantity cannot be lower than 30% labelled weight. CONCLUSION:The method is simple,reliable,accurate and can be applied to the quality control of Xuesaitong Granules.

Objective To evaluate the efficacy and safety of sorafenib in the treatment of Chi-nese patients with metastatic renal cell carcinoma. Methods This muhicenter phase Ⅱ clinical trial was performed from May 2006 to December 2006. Sixty-two patients with metastatic renal cell carci-noma not suitable for curative treatment were enrolled. All patients received oral sorafenib as single a-gent at the dose of 400 mg twice a day until disease progression or intolerable toxicities occurred. Re-salts Partial responses were recorded as best response in 11 patients, while complete remission was found in 1 patient and stable diseases were found in another 35 patients. According to the intents-to-treatment population, the overall response rate was 19.4% (12/62), and the disease control rate was 77.4%(48/62). The median progression free survival time was 9.6 months with 1-year progression-free survival rate of 41.9%. However, the median survival time had not reached due to the short fol-low-up. The most frequent adverse events included alopecia (66.1%), diarrhea (62.9%), hand-foot syndrome (58.1%), anorexia (40.3%), rash(37.1%), fatigue (37.1%), hypertension (35.5%), hoarseness(32.3%), joint pain (25.8%), hypophosphatemia (21.0%), fever (19.4%), nausea (19.4%), abnormal transeaminase( 11.3% ), elevated total bilirubicin( 16.1% ), leucopenia( 12.9% ), bleeding under nail(16.1%), and gum bleeding(11.3%). Grade 3 adverse events included hand-foot syndrome (16.1%), hypertension (12.9%), diarrhea(6.5%), hypophosphatemia (4.8%), joint pain (3.2%), and leucopenia(3.2%). Conclusions Sorafenib has prominent anti-tumor activity in Chi-nese metastatic renal cell cancer patients with most adverse events being grade 1 or 2. More attention should be paid to hypertension and cardio-cerebral vascular events during the application of sorafenib.

Objective:To compare the efficacy of a single injection of pegylated filgrastim with daily doses of filgrastim as pro-phylaxis for chemotherapy-induced neutropenia in Chinese cancer patients. Methods:Single-institution data from a phase 2 study and a phase 3 trial on pegylated filgrastim were combined to analyze the efficacy and safety parameters. In the two randomized crossover tri-als, patients with previously untreated cancers received two cycles of chemotherapy with identical regimen. In the study cycle, the pa-tients received a single subcutaneous injection of pegylated filgrastim (100 μg/kg), whereas those in the control cycle received daily subcutaneous injections of filgrastim (5μg/kg). Results:Among the 56 patients enrolled, 53 were evaluable for efficacy. These patients received one cycle with pegylated filgrastim prophylaxis and one cycle with filgrastim support each. Results indicated that 94.3%(50/53) of the cycles with pegylated filgrastim or filgrastim support did not develop grade 4 neutropenia. Moreover, febrile neutropenia did not occur in the cycles. The incidence rates of antibiotic administration were 7.5%(4/53) and 3.8%(2/53) in the pegylated filgrastim and filgrastim cycles, respectively (P=0.678). The median duration of filgrastim administration was 10 days (3-14 days). Generally, the safety profile of pegylated filgrastim is similar to that of filgrastim, including skeletal pain, pain at the injection site, palpitation, fever, and fatigue. Conclusion:A single dose of pegylated filgrastim demonstrated comparable efficacy with 10 consecutive doses of filgras-tim as prophylaxis for chemotherapy-induced neutropenia.

Objective:Primary gastric diffuse large B-cell lymphoma (PGLBCL) is a highly common subtype of extranodal non-Hodgkin lymphoma. We analyzed the disease's clinical features and prognosis to guide better treatment. Methods:We retrospectively collect-ed data from PGLBCL cases seen from January 1999 to March 2012 in one cancer center. We then analyzed the demographic character-istics, clinical stage, histological diagnosis, complications, treatment, and prognostic characteristics of such patients. Results:A total of 126 patients with median age of 49 years old (range:16-81 years) were included in the study. The male-to-female ratio was 68:58. A to-tal of 96 patients were pathologically diagnosed with pure diffuse large B-cell lymphoma (DLBCL), 27 with mucosa-assouated lymphoid (MALT) component, and 3 with plasmacytoid differentiation. Meanwhile, 90%of the patients were in the early stage of the disease. For the early-stage patients, treatment strategy included surgery+chemotherapy ± radiotherapy for 38 cases, chemoradiotherapy for 39 cases, chemotherapy alone for 37 cases, and surgery alone for 1 case. Under a median follow up of 48 months, the 4-year progres-sion free survival (PFS) and overall ourvival (OS) rate of the whole group were 75.6%and 82.7%, respectively. PFS rates for early and advanced stage patients were 77%and 41.7%(P=0.005), respectively. For the early-stage patients treated with chemotherapy alone, chemoradiotherapy, and surgery with therapy, the PFS rates were 67.3%, 77.8%, and 77.8%(P=0.588), respectively. The patients with international prognostic index (IPI) score of 0, 1, and>1 achieved PFS of 85.4%, 74.4%, and 55.6%(P=0.011), respectively. The PFS rates were 81.2%and 66.1%(P=0.018) for stagesⅠandⅡ, respectively, and 86.6%and 63.3%(P=0.006) for the normal and elevated LDH levels, respectively. The pathological type of pure DLBCL or a MALT component, GCB or non-GCB origin, and age more than 60 years old were not associated with prognosis. Conclusion:The majority of the PGLBCL patients were in the early stage of disease, but the outcome of early-stage disease was favorable. Surgery did not improve outcomes. Univariate analysis demonstrated that IPI score>1, stageⅡdisease, and elevated LDH levels were associated with poor prognosis in the early-stage patient.

OBJECTIVETo detect the contaminating minimal residual disease (MRD) in autologous peripheral blood stem cells (APBSC) and evaluate its impact on the prognosis of non-Hodgkin's lymphoma NHL patients.

METHODSMinimal residual disease was detected in 72 APBSC samples from 33 NHL patients through PCR or PCR combined with DNA single-strand conformation polymorphism analysis (SSCP) with the BCL-2/IgH, clonal rearrangement of IgH and TCR gamma gene as markers. Minimal residual disease was also monitored in bone marrow samples collected pre-, post-induction chemotherapy and post-transplantation.

RESULTSMRD was positive in 17/72 (23.6%) APBSC samples. The incidence of positive MRD in bone marrow pre-, post-induction chemotherapy and post-transplantation was 44.0% (11/25), 28.1% (9/32) and 11.5% (3/26) respectively. Six (66.6%) of 9 patients with positive MRD in pre-mobilization bone marrow, compared with 2 (8.7%) of 23 patients with negative MRD in bone marrow, were positive in contamination (P < 0.01). The estimated overall 3-year post-transplantation survival rate for patients with positive and negative MRD in their APBSC would be 71.4% and 71.2% respectively, and the estimated 3-year disease free survival rates of 25.0% and 61.5% respectively (P = 0.53).

CONCLUSIONAPBSC collected from NHL patients after mobilization by chemotherapy combined with colony stimulating factor may be contaminated by lymphoma cells. The presence of minimal residual disease in bone marrow at mobilization may increase the incidence of APBSC contamination.

Adolescent ; Adult ; Child ; Female ; Hematopoietic Stem Cell Transplantation ; Humans ; Lymphoma, Non-Hodgkin ; pathology ; therapy ; Male ; Middle Aged ; Neoplasm, Residual ; therapy ; Polymerase Chain Reaction ; Prognosis

OBJECTIVETo analyze the clinical features, therapeutic outcome and prognostic factors of mantle cell lymphoma (MCL).

METHODSClinical data of a total of 68 patients with MCL admitted from August 2003 to June 2013 in our department were retrospectively analyzed.

RESULTSOf all the patients, the median age was 58.5 years, with marked male predominance (2.8:1), 59 patients (86.8%) were in Ann Arbor stage III/IV. 56 cases (82.4%) primarily showed lymph node involvement, 49 cased showed extranodal involvement and 19 cases (38.8%) had bone marrow involvement. Patients were followed up for 4 to 122 months with a median follow up time of 35 months. The 3- and 5-year overall survival (OS) rates were 78.5% and 64.1%, respectively. The 2- and 3-year progression-free survival (PFS) rates were 41.3% and 23.7%, respectively, and the median time to progression was 20.0 months. The overall response rate (ORR) of CHOP regimen was superior to that of intense regimens (P = 0.036). Univariate analysis showed that stage III/IV,IPI score of 3-5, expression of Ki-67 higher than 30%, elevated LDH, elevated β2-MG, blastic variant, more than 5 lymph nodes involved, and failure to chemotherapy were the negative factors. Multivariate analysis showed that Ki-67 index, LDH and the response to chemotherapy were independent factors affecting survival.

CONCLUSIONSMost patients with MCL were elderly males with advanced stage and usually had bone marrow involvement. Although ORR of CHOP regimen is superior to intense regimens, the prognosis of MCL remains poor.

Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; Cyclophosphamide ; Disease Progression ; Disease-Free Survival ; Doxorubicin ; Female ; Humans ; Lymphoma, Mantle-Cell ; diagnosis ; Male ; Middle Aged ; Multivariate Analysis ; Prednisolone ; Prognosis ; Retrospective Studies ; Survival Rate ; Vincristine

OBJECTIVETo analyze the duration of preventive filgrastim administration as support for chemotherapy and its affecting factors.

METHODSSingle institutional data from a phase Ⅱ clinical trial and a phase Ⅲ clinical trial of pegylated filgrastim were combined. In the two randomized cross-over trials, patients with previously untreated cancer received two cycles of chemotherapy of the same regimen. In the study group, the patients received a single subcutaneous injection of 100 μg/kg pegylated filgrastim, and in the control group, they received daily subcutaneous injections of 5 μg/kg filgrastim.

RESULTSIn 53 chemotherapy cycles, the median duration of filgrastim administration was (9.57±2.10)d. 83.0% (44/53) of them received filgrastim for 7-11 days. Patients with baseline absolute neutrophil count of <4×10(9)/L or body mass index less than 22 received a longer filgrastim prophylaxis(P<0.05). RESULTS of multivariate analysis showed that the baseline absolute neutrophil count is associated with the time of filgrastim administration(P=0.019). The most common adverse event of rhG-CSF was skeletal pain, generally mild and no treatment-related death occurred.

CONCLUSIONSThe median duration of filgrastim support for chemotherapy was 10 days. Patients with lower baseline neutrophil count require a longer filgrastim prophylaxis.

TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01285219.

Antineoplastic Agents ; adverse effects ; Cross-Over Studies ; Filgrastim ; adverse effects ; therapeutic use ; Hematologic Agents ; adverse effects ; therapeutic use ; Humans ; Induction Chemotherapy ; Injections, Subcutaneous ; Multivariate Analysis ; Neoplasms ; drug therapy ; Neutropenia ; chemically induced ; prevention & control ; Time Factors

Objective:To investigate the clinical features, survival and prognostic factors of elder patients with diffuse large B-cell lymphoma (DLBCL).Methods:The clinical data of elder patients with diffuse large B-cell lymphoma enrolled in the Cancer Hospital of Chinese Academy of Medical Sciences from April 2006 to December 2012 were retrospectively collected. All the patients were divided into R-CHOP-like group and CHOP-like group according to the dosage regimen. And the differences in demographic characteristics, clinical features, survival time and prognostic factors were compared between these two groups.Results:A total of 158 patients were enrolled, of which 78 patients in the R-CHOP-like group and 80 patients in the CHOP-like group were eligible. There were no significant differences between two groups on age, gender, pathological staging, B symptoms, bulky mass, ECOG score, IPI score, pathological type, LDH level, β 2-MG level, lymphocyte/monocyte ratio(LMR), neutrophils/lymphocyte ratio(NLR), platelet/lymphocyte ratio(PLR), Ki-67 index and bone marrow invasion. In the R-CHOP like group, the median progression-free survival (PFS) time was 10 months, and the median overall survival (OS) time was 30 months. The 1-year and 2-year PFS rates were 46.2% and 19.2%, respectively. The 1-, 2-, and 5-year OS rates were 79.5%, 59.0%, and 19.2%, respectively. In the CHOP-like group, the median PFS was 7 months, and the median OS was 15 months. The 1-year and 2-year PFS rates were 27.5% and 12.5% respectively. The 1-year, 2-year, and 5-year OS rates were 65.0%, 32.5% and 13.8%, respectively. The median PFS time and OS time in the R-CHOP group were significantly better than those in the CHOP group ( P<0.05 for both). A stratified analysis showed that the PFS time and OS time were superior in the R-CHOP-like group compared to the CHOP-like group among patients older than 70 years ( P<0.05 for both). In patients with stage Ⅲ-Ⅳ, the PFS time and OS time in the R-CHOP-like group were also superior to CHOP-like group ( P<0.05 for both). Univariate Cox regression analysis showed that IPI score, LDH value, β 2-MG value, ECOG score, LMR, and PLR had an significant effect on prognosis ( P<0.05 for all). Multivariate Cox regression analysis showed that lymphocyte/monocyte ratio and platelet/lymphocyte ratio were independent prognostic factors for diffuse large B-cell lymphoma ( P<0.05 for both). Conclusions:The R-CHOP-like chemotherapy regimen is superior to the CHOP-like regimen in the first-line treatment of patients with diffuse large B-cell lymphoma. ECOG score, LMR and PLR may be independent prognostic factors for diffuse large B-cell lymphoma. ECOG score, LMR and PLR are independent prognostic factors.

Objective:To investigate the clinical features, survival and prognostic factors of elder patients with diffuse large B-cell lymphoma (DLBCL).Methods:The clinical data of elder patients with diffuse large B-cell lymphoma enrolled in the Cancer Hospital of Chinese Academy of Medical Sciences from April 2006 to December 2012 were retrospectively collected. All the patients were divided into R-CHOP-like group and CHOP-like group according to the dosage regimen. And the differences in demographic characteristics, clinical features, survival time and prognostic factors were compared between these two groups.Results:A total of 158 patients were enrolled, of which 78 patients in the R-CHOP-like group and 80 patients in the CHOP-like group were eligible. There were no significant differences between two groups on age, gender, pathological staging, B symptoms, bulky mass, ECOG score, IPI score, pathological type, LDH level, β 2-MG level, lymphocyte/monocyte ratio(LMR), neutrophils/lymphocyte ratio(NLR), platelet/lymphocyte ratio(PLR), Ki-67 index and bone marrow invasion. In the R-CHOP like group, the median progression-free survival (PFS) time was 10 months, and the median overall survival (OS) time was 30 months. The 1-year and 2-year PFS rates were 46.2% and 19.2%, respectively. The 1-, 2-, and 5-year OS rates were 79.5%, 59.0%, and 19.2%, respectively. In the CHOP-like group, the median PFS was 7 months, and the median OS was 15 months. The 1-year and 2-year PFS rates were 27.5% and 12.5% respectively. The 1-year, 2-year, and 5-year OS rates were 65.0%, 32.5% and 13.8%, respectively. The median PFS time and OS time in the R-CHOP group were significantly better than those in the CHOP group ( P<0.05 for both). A stratified analysis showed that the PFS time and OS time were superior in the R-CHOP-like group compared to the CHOP-like group among patients older than 70 years ( P<0.05 for both). In patients with stage Ⅲ-Ⅳ, the PFS time and OS time in the R-CHOP-like group were also superior to CHOP-like group ( P<0.05 for both). Univariate Cox regression analysis showed that IPI score, LDH value, β 2-MG value, ECOG score, LMR, and PLR had an significant effect on prognosis ( P<0.05 for all). Multivariate Cox regression analysis showed that lymphocyte/monocyte ratio and platelet/lymphocyte ratio were independent prognostic factors for diffuse large B-cell lymphoma ( P<0.05 for both). Conclusions:The R-CHOP-like chemotherapy regimen is superior to the CHOP-like regimen in the first-line treatment of patients with diffuse large B-cell lymphoma. ECOG score, LMR and PLR may be independent prognostic factors for diffuse large B-cell lymphoma. ECOG score, LMR and PLR are independent prognostic factors.

Objective:To investigate the relationship between plasma levels of complements before treatment and the clinicopathological feathers and prognoses of diffuse large B-cell lymphoma (DLBCL) patients treated with Rituximab (R)-CHOP or R-CHOP-like therapy.Methods:The clinicopathological data of 105 DLBCL patients treated in cancer Hospital of Chinese Academy of Medical Sciences from 2010 to 2016 were collected. The plasma samples from 105 DLBCL patients treated with R-CHOP or R-CHOP-like therapy and 80 healthy controls were used to detect 34 complement levels before treatment by utilizing antibody microarray. The relationship between plasma levels of complements and the clinicopathological feathers and prognosis of DLBCL patients were analyzed.Results:The signal values of C1QA and CR1L in patients with international prognostic index (IPI) scores of 3-5 were 1 261.43±138.9 and 2 214.69±98.58, respectively, higher than 950.79±80.19 and 984.67±121.79 in patients with IPI scores of 0~2 (both P<0.05). The levels of C1QA and CR1L in the non-complete response (CR) group were 1 165.43±98.56 and 2 263.13±145.63, respectively, higher than 914.70±100.77 and 1 821.34±84.68 in the CR group (both P<0.05). Cox regression analysis showed that elevated C1QA signal value was associated with poor progression-free survival (PFS) and poor overall survival (OS) (PFS: HR=2.063, 95% CI: 1.220-3.489, P=0.007; OS: HR=2.23, 95% CI: 1.036~4.798, P=0.040). After IPI correction by Cox multivariate model, the elevated C1QA signal value was still correlated with poor PFS ( HR=1.765, 95% CI 1.034~3.013, P=0.037). Conclusions:The baseline plasma levels of C1QA and CR1L are correlated with IPI scores and therapeutic effects of DLBCL patients treated with R-CHOP. The baseline plasma level of C1QA has a certain predictive value for the prognostic evaluation of DLBCL.