Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial / 中华医学杂志(英文版)

BACKGROUND@#LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.@*METHODS@#We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.@*RESULTS@#On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).@*CONCLUSION@#LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.@*TRIAL REGISTRATION@#ClinicalTrials.gov, NCT04563936.

BSD2000 deep hyperthermia combined with chemotherapy of PT regimen in patients with non-small cell lung cancer / 中国肺癌杂志

<p><b>BACKGROUND AND OBJECTIVE</b>The aim of this study is to determine the short-term efficacy, toxicity and the rate of life-quality improvement of BSD2000 deep hyperthermia combined with chemotherapy of PT regimen in patients with non-small cell lung cancer (NSCLC) by comparation with PT regimen alone.</p><p><b>METHODS</b>Sixty patients with NSCLC were randomly divided into the treatment group and control group, with 30 each. The treatment group was treated with chemotherapy (paclitaxel: 135 mg/m2 ivdirp 3 h qd d1+cisplatin: 20 mg/m2 ivdirp qd d1-5) in combination with BSD2000 deep hyperthermia, and hyperthermia was positioned precisely and maintained for 60 min (2 times a cycle: d1, 4 after the end of chemotherapy within two hours). The control group was treated with chemotherapy alone. Treatment response in both groups were evaluated as well as side-effects after 3 cycles. By observing the results, comparing response rate, toxic side effects and quality of life improvement rate in two groups.</p><p><b>RESULTS</b>The efficiency and the rate of life-quality improvement in the treatment group were 63.33%, 76.67% respectively, and 36.67%, 40.00% in the control group respectively. There were significant differences between two groups (P < 0.05). The main side-effects were myelosuppression and gastrointestinal reactions, no significant difference between two groups (P > 0.05).</p><p><b>CONCLUSION</b>BSD2000 deep hyperthermia combined with chemotherapy in patients with NSCLC can significantly increase the efficacy, response rate and quality of life improvement and without increasing side-effects compared to chemotherapy alone.</p>

Study on screening simulated epitopes of protective antigens of Schistosoma japonicum and their immuno-protective effect / 中国血吸虫病防治杂志

Objective To study the immuno-protective effect against Schistosoma japonicum challenge of the positive monoclonal phages which were screened from the 12 mers-phage random peptide library by the new model rabbit serum. Methods The new model was established by injecting the Schistosoma japonicum infection rabbits with inhibitor of phenol oxidose. Positive clones immunoscreened with the new model rabbit sera were absorbed by SEA immune rabbit sera, and 14 clones selected randomly from them were compared and their antigenic ability was identified by ELISA. The two best positive monoclonal phages (No.8, No.13) recognized by the new model rabbit sera were selected to immunize Kunming mice by subcutaneously injecting 1?10~15 pfu positive phages at 0, 2nd, 4th week respectively. After 4 weeks of the last immunity,each mouse was challenged with 40?1 S.japonicum cercariae. All mice were sacrificed after 42 days and the reduction rates of adult worms and the liver eggs were investigated. Results The positive phage clones after immune absorption were weakly recognized by the SEA immune rabbit sera. The 14 monoclonal phages were recognized by the rabbit sera of the new model and the normal model. Especially No.8, No.13 were strongly recognized by the rabbit sera of the new model,while weakly recognized by the SEA immune rabbit sera. The reduction rates of adult worms and liver eggs induced by the monoclonal phage No.13, the monoclonal phage No.8 and the original peptide library were 35.81% and 63.32%, 32.09% and 52.02%, 14.90% and 30.64%, respectively. Conclusion Most clones of simulated epitopes of SEA can be removed by absorbing positive clones with SEA immune rabbit serum .The 14 monoclonal phages from the new model contain the simulated S.japonicum epitope. The two monoclonal phages have higher reduction rates of adult worms and eggs than original 12 mers-phage random peptide library and the positive polyclonal phages.[