Antibodies, Monoclonal, Murine-Derived ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Humans ; Lymphoma, Follicular ; drug therapy ; Rituximab

OBJECTIVEA prospective, multicenter and non-interventional prospective study was conducted to evaluate the clinical features of rituximab combined with chemotherapy (R-Chemo) as first-line treatment on newly diagnosed Chinese patients with diffuse large B-cell lymphoma (DLBCL).

METHODSThis was a single arm, prospective, observational multicenter and phase IV clinical trial for 279 patients, who were newly diagnosed as CD20-positive DLBCL from 24 medical centers in China 2011 and 2012, no special exclusion criteria were used. All patients received rituximab based R-Chemo regimes, such as R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisolone) and other regimes as the first-line treatment. The treatment strategies were determined by physicians and patients without detailed description for treatment course, dose, interval time and examination. Clinical response and safety of all patients were investigated in 120 days after completion of last dose of rituximab.

RESULTSOf 279 patients, 258 with stage I-IV who received at least 1 cycle of rituximab treatment and completed at least one time of tumor assessment were enrolled into intention-to-treat analysis, including 148 male and 110 female. The median age of all patients was 57.2(12.8-88.4) years. ECOG performance statuses of 0 or 1 were observed in 91.1% of patients, international prognostic index levels in the low-risk and low-middle-risk groups in 76.4% of patients, the tumor diameters smaller than 7.5 cm in 69.0% of patients. All patients received 6 median cycles of R-Chemo treatment every 24.4 days. R-CHOP treatment was shown to improve the clinical response with overall response rates of 94.2%. Common adverse events included anemia, marrow failure, leukopenia, thrombocytopenia, digestive diseases, infection and liver toxicity. All adverse events are manageable.

CONCLUSIONNon-interventional clinical trial of R-Chemo remains the standard first-line treatment for newly diagnosed patients with DLBCL in real clinical practice, which is consistent with international treatment recommendations for DLBCL patients. R-Chemo can provide the clinical evidence and benefit as the first-line standard treatment for Chinese patients with DLBCL.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Murine-Derived ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Child ; Female ; Humans ; Lymphoma, Large B-Cell, Diffuse ; drug therapy ; Male ; Middle Aged ; Prospective Studies ; Rituximab ; Treatment Outcome

Objective To investigate the clinicopathologic features and prognostic significance of BRCA1 and Ki-67 expression in breast cancer.Methods The expression levels of BRCA1 and Ki-67 were assayed by immunohistochemistry in 194 cases of breast cancer tissues.The correlations of BRCA1 and Ki-67 expression with patients' clinicopathologic features were also analysed.Results Low expression of BRCA1 was detected in the lymph node metastasis group,ER/PR negative group,and HER-2 positive group in 194 patients with breast cancer (P ＜ 0.05),as well as in the triple negative breast cancer (TNBC) group compared to non-TNBC group (P ＜0.05).High expression of Ki-67 was detected in patients with higher histological grade,negative ER/PR,and positive HER-2 (P ＜ 0.05).Furthermore,negative correlation was found between the expression of BRCA1 and Ki-67 (P ＜ 0.05).The combination of low expression of BRCAl and high expression of Ki-67 was mostly found in the patients with postmenopausal,lower histological grade,lymph node metastasis,negative ER/PR and positive HER-2 (P ＜ 0.05).However,there was no significant difference between TNBC and non-TNBC.Conclusion Joint detection of BRCA1 and Ki-67 might play an important role in predicting clinical outcomes of breast cancer,especially BRCA1 may be one of prognostic factors in TNBC.

Objective:To investigate the expression of XIAP and Smac in human non-small-cell lung carcinoma (NSCLC) and the relationship with clinical significance and prognosis. Methods:Immunohistochemical staining was performed to determine the ex-pression of X-linked inhibitor of apoptosis protein (XIAP) and second mitochondria-derived activator of caspase (Smac) in 70 cases of NSCLC and 70 cases of non-cancerous adjacent lung tissues. Results:XIAP is mostly present (59/70) in tumor tissues with 16 high ex-pressions, whereas only five high expressions in non-cancerous adjacent lung tissues are observed (52/70). The statistical difference of these two sets of data is significant (Z=-5.484, P<0.001). Comparatively, Smac is present (63/70) in tumor tissues, which is significant-ly (Z=-5.484, P<0.001) higher than in the non-cancerous adjacent lung tissues (53/70). The expression levels of XIAP and Smac in NSCLC tissues are closely related to the lymph node metastasis at the TNM stages (P<0.05) and not associated to gender, age, size of tumor, and differentiation grades (P>0.05). The Kaplan-Meier analysis results show that survival by XIAP and Smac protein in NSCLC has no significant effect (P>0.05). Conclusion:XIAP and Smac are expressed in NSCLC and noncancerous adjacent lung tissues, and the differences in their expression levels is significant. The deterioration of NSCLC results in apoptosis/anti-apoptotic synchronized with tumor cell proliferation. The expression levels of XIAP and Smac in NSCLC are not related with the prognosis.

Objective:To evaluate the efficacy and safety of palonosetron in preventing chemotherapy-induced vomiting. Meth-ods:A multi-center, randomized, double-blind, and self-cross-over positively controlled clinical trial design was used. All patients were randomized into two groups, as follows:Regiment A (61 cases) and Regiment B (64 cases). Regimen A with palonosetron hydrochlo-ride injection (test agent) was used in the treatment cycle A, whereas granisetron hydrochloride injection (control drug) was used in the cycle B. Treatments were randomly administered on the patients of the two groups. Regimen B was on the contrary, the control drug was used in the cycle A, and the test agent was used in the treatment cycle B. All patients treated with the test agent were classified as the test group, whereas those treated with the control drug were classified as the control group. Complete control rate and adverse reac-tion of acute and delayed vomiting in the two groups during the two cycles of chemotherapy regimen were compared. Results: In Group One, the complete control rate of delayed vomiting was significantly higher in the palonosetron administration cycles than in the granisetron cycles (76.92%vs. 55.38%, P=0.0110). In the same group, the frequency of vomiting was significantly less in palonosetron cycles than in the granisetron cycles during day 1 to day 5 (1.32±3.42 vs. 1.94±3.03, P=0.0096). The incidences of adverse effects were low in both groups. No grades 3 and 4 adverse effects were observed. Conclusion: Palonosetron showed efficacy in preventing the acute and delayed chemotherapy-induced vomiting. The drug is superior to granisetron, specifically in delaying vomiting in Group One. Palonosetron hydrochloride showed slight adverse effects. Hence, this drug can be used in clinic.

Chemotherapy completion rate can reflect the tolerance and compliance of patients to chemotherapy. Poor tolerance may result in delay or suspension of the comprehensive treatment plan, thus affect the efficacy of cancer treatment. Evaluating methods to improve the completion rate of chemotherapy and reduce the occurrence of delayed chemotherapy has gained increasing attention and is the significant area of study in the field of cancer treatment. Studies have shown that Chinese medicine combined with chemotherapy could improve the quality of life in patients with stage IIIB/IV non-small-cell lung cancer (NSCLC).

Recently the maintenance therapy of non-small-cell lung cancer (NSCLC) patients who completed required treatment cycles has caused widespread interests in the medical field. Traditional Chinese medicine may be a useful complement in maintenance treatment of mid-to-late stage NSCLC.

BACKGROUNDRecently chemoradiotherapy becomes a standard treatment for un- resectable advanced non-small cell lung cancer (NSCLC) instead of radiotherapy alone. Superior sulcus tumor of the lung (Pancoast tumor) is a clinical subtype of NSCLC. The aim of this study is to compare the clinical effects and toxicities of preoperative concurrent chemoradiotherapy with radiotherapy alone in patients with superior sulcus tumors.

METHODSFifty-six patients with superior sulcus tumors were divided randomly into two groups: twenty-six patients received concurrent chemoradiotherapy (chemoradiotherapy group), the other thirty patients received only radiotherapy (radiotherapy group). For both groups, the same radiation technic was given with the convention fraction. The total dose was 45Gy/25 fraction/5 weeks. For the chemoradiotherapy group, the patients were also given with concurrent chemotherapy (navelbine 15-18mg/m² on the 1st and 8th day, cisplatin 60mg/m² on the 1st day).

RESULTSThe rate of complete resection in the chemoradiotherapy group was significantly higher than that in the radiotherapy group (92.3% vs 80.0%, P < 0.05); The complete pathological response rate and 2-year survival rate in the chemoradiotherapy group were significantly higher than those in the radiotherapy group (P < 0.01, P < 0.01). The incidences of grade III-IV radiation esophagitis and leukopenia in the chemoradiotherapy group were significantly higher than those in the radiotherapy group (23.1% and 23.1% vs 6.7% and 0, P < 0.01, P < 0.01).

CONCLUSIONSPreoperative concurrent chemoradiotherapy has the potential of improving the survival rate of superior sulcus tumors. It can also increase the acute toxic effect, but all patients can tolerate this treatment regimen, so it might be a new "standard treatment" for superior sulcus tumor of the lung.

BACKGROUNDLung carcinoma is one of the most common malignant tumors in China.The increasing incidence of lung cancer has been alerted and multimodality treatments including surgery,radiotherapy,chemotherapy etc.have been highly aware.However,the outcome of treatment in lung cancer remains poor,because there is still no definite molecular targeting drug affecting its biological behavior significantly.To find an useful clinical tool,the aims of this study are to explore the effects of a novel monoclonal antibody targeting at the α-strain of insulin-like growth factor 1 receptor(IGF1-αR) on lung adenocarcinoma cell lines.

METHODSThe novel monoclonal antibody targeting at IGF1-αR was exacted by hybrid cell processes and purified by Protein G column.The effects of growth were investigated on SPCA-1 and A549 cell lines by MTT curve lines and the expression of Ki67.

RESULTSThe combination of IGF1 with IGF1-αR could be competitively inhibited by the novel monoclonal antibody significantly.Intervented by the novel monoclonal antibody,SPCA-1 and A549 cell lines proliferated more slowly than that of the respective control,with significant statistic value(P < 0.05).Besides,the expression of Ki67 showed significant downregulation under the invention of the monoclonal antibody.

CONCLUSIONSThe special monoclonal antibody extracted in our laboratory shows good affinity with IGF1-αR,and can inhibit the growth of SPCA-1 and A549 cell lines.

BACKGROUNDLentinus edodes polysaccharide (Lentinan) has attracted great attention from both pharmacologists and clinicians as a biological response modifier, and is widely used as an anti-tumor agent in both China and Japan. The aim of this study is to observe the efficacy of Lentinan combined with chemotherapy in stage III-IV non-small cell lung cancer (NSCLC).

METHODSEighty-one patients with stage III-IV NSCLC were randomly divided into two groups: (1)Lentinan + chemotherapy group (group A, 42 cases); (2)Simple chemotherapy group (group B, 39 cases). The peripheral blood T lymphocyte subsets (CD3, CD4, CD4/CD8) and natural killer (NK) cell activity of patients in both groups were measured before and after treatment, while compared with healthy control (30 cases). The immune functions, the effect of treatment, quality of life, and adverse reactions were observed.

RESULTSAfter treatment the objective response rate (CR+PR) was 50% in group A, compared to 33% in group B (P < 0.05). The blood T cell levels(CD3, CD4, CD4/CD8) and NK cell activity in group A increased (P < 0.01), CD8 reduced (P < 0.05), but in group B the value had no obvious change (P > 0.05). Quality of life in group A was higher than that in group B (P < 0.01). The incidence of grade II-IV leukopenia, nausea and vomiting in group B was much higher than those in group A (P < 0.05).

CONCLUSIONSThe therapeutic effect of Lentinan combined with chemotherapy is better than that of chemotherapy alone.