ABSTRACT
OBJECTIVE@#To investigate resistance and safety of HHPG-19K in treating non-small cell lung cancer patients.@*METHODS@#A total of 30 cases were selected and randomly divided into 5 groups: three HHPG-19K groups of different dosage (60 μg/kg/day, 100 μg/kg/day, 200 μg/kg/day), positive control group (Filgrastim, namely G-CSF5 μg/kg/day) and negative control group. Safety indexes of 5 groups were observed and compared.@*RESULTS@#All patients had adverse event (100%) in three HHPG-19K groups, and increased ALP, ALT and AST were main events. The degree was mild to moderate. There was no significant difference in the incidence of adverse event between dosage groups and positive control group no difference. But the incidence of negative control group was 13%, which was significantly lower than dosage groups and positive control group.@*CONCLUSIONS@#non-small cell lung cancer patients have satisfactory tolerance to HHPG-19K, and have no resistance. Besides, dosage at 100 μ g/kg is the most safe.
Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Antineoplastic Combined Chemotherapy Protocols , Carcinoma, Non-Small-Cell Lung , Drug Therapy , Mortality , Pathology , Cisplatin , Docetaxel , Drug Administration Schedule , Filgrastim , Granulocyte Colony-Stimulating Factor , Therapeutic Uses , Lung Neoplasms , Drug Therapy , Mortality , Pathology , Neoplasm Staging , Polyethylene Glycols , Therapeutic Uses , Protective Agents , Therapeutic Uses , Recombinant Proteins , Therapeutic Uses , Taxoids , Treatment OutcomeABSTRACT
<p><b>OBJECTIVE</b>To analyze the efficacy and quality of life and safety for paclitaxel and carboplatin (TC) and TC combined with endostar in the treatment of advanced non-small cell lung cancer (NSCLC).</p><p><b>METHODS</b>This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical study. A total of 126 cases of untreated advanced NSCLC were enrolled in this study. There were 63 patients in the TC control arm and TC combined endostar arm, respectively. All enrolled patients were continuously followed-up for disease progression and death.</p><p><b>RESULTS</b>The objective response rate (ORR) of TC combined with endostar arm was 39.3%, and that of TC control arm was 23.0%, P = 0.078. The progression-free survival rates for TC combined with endostar arm and TC control arm were 78.3% and 58.8%, respectively, in 24 weeks (P = 0.017). The hazard ratio for the risk of disease progression was 0.35 (95%CI 0.13 to 0.90, P = 0.030). The median time to progression (TTP) of the TC combined with endostar arm was 7.1 months and TC arm 6.3 months (P > 0.05). The follow-up results showed that the median survival time (mOS) of the TC + Endostar arm was 17.6 months; (95%CI 13.4 to 21.7 months), and the TC + placebo arm 15.8 months (95%CI 9.4 to 22.9 months) (P > 0.05). The quality of life scores (LCSS patient scale) after treatment of the TC combined with endostar arm was improved, and that of the TC group was improved after completion of two cycles and three cycles of treatment. The quality of life scores compared with baseline after the completion of one cycle treatment was significantly improved for both the TC combined with endostar arm (P = 0.028 and), and TC arm (P = 0.036). It Indicated that TC combined with endostar treatment improved the patient's quality of life in the early treatment. The difference of adverse and serious adverse event rates between the two groups was not significant (P > 0.05).</p><p><b>CONCLUSIONS</b>Compared with TC alone treatmrnt, TC combined with endostar treatment can reduce the risk of disease progression at early time (24 weeks), increase the ORR, and can be used as first-line treatment for advanced NSCLC. The TC combined with endostar treatment has good safety and tolerability, improves the quality of life, and not increases serious adverse effects and toxicity for patients with advanced NSCLC.</p>
Subject(s)
Humans , Antineoplastic Agents , Therapeutic Uses , Antineoplastic Combined Chemotherapy Protocols , Therapeutic Uses , Carboplatin , Carcinoma, Non-Small-Cell Lung , Drug Therapy , Pathology , Disease Progression , Disease-Free Survival , Double-Blind Method , Endostatins , Therapeutic Uses , Follow-Up Studies , Leukopenia , Lung Neoplasms , Drug Therapy , Pathology , Nausea , Neoplasm Staging , Paclitaxel , Prospective Studies , Quality of Life , Remission InductionABSTRACT
<p><b>OBJECTIVE</b>To investigate neuroendocrine differentiation and its mechanism in ovarian epithelial tumors.</p><p><b>METHODS</b>Neuroendocrine (NE) cells were identified by immunohistochemical staining for chromogranin A and synaptophysin in 79 cases of ovarian epithelial tumor and 22 cases of normal ovary. Double-labeling technique was used for simultaneous detection of CgA and epithelial membrane antigean (EMA), and the staining intensity was quantitatively evaluated using an image analysis system.</p><p><b>RESULTS</b>The positive staining rate for CgA and SYN in ovarian epithelial tumors was 59.4% and 65.36%, respectively, which was higher than that in normal ovary (P=0.000), in which numerous NE cells were found. Both the number and staining intensity of NE cells in ovarian epithelial tumor were increased as compared with normal ovary. Cells co-expressing CgA and EMA were detected in the ovarian epithelial tumors.</p><p><b>CONCLUSION</b>The presence of NE cells in ovarian epithelial tumor suggests heterogeneity of the tumors, and the occurrence of "multidirectional differentiation cells" within the these tumors indicates that NE cells might derive from malignant cells with multidirectional differentiation capacity.</p>