Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

Objective To analyze the clinical features,therapeutic effect and prognosis in patients with bone pain induced by malignant bone me?tastasis as well as the rationality of analgesic application,so as to improve the level of diagnosis and treatment for metastatic bone pain. Methods Totally 123 patients with pain due to malignant bone metastasis received antitumor therapy and analgesic therapy based on standardized three?step guidelines. Their clinical characteristics were retrospectively analyzed. Results The total pain relief rate was 85.4%and the pain was significantly relieved(P<0.05). The DUI value of each narcotic agent was close to 1 and the application of narcotic agents tended to be rational. The Kaplan?Meier survival analysis showed that patients with moderate pain had longer survival time than those with severe pain(P=0.015). The survival rate of patients with significant pain relief after treatment was higher than those unrelieved(P=0.021). The survival rate of patients without visceral me?tastasis was higher than those with visceral metastasis(P=0.000). The COX multivariate analysis indicated that the pain intensity and visceral me?tastasis were independent risk factors influencing patient prognosis. Conclusion Standard treatment can improve symptoms in most patients with bone metastasis and prolong survival time. Opioids have satisfactory analgesic effect for moderate to severe pain and the adverse reactions can be tol?erated.

BACKGROUNDTo study the diagnostic value of detection of carcinoembryonic antigen (CEA), cancer antigen 125 (CA125), cancer antigen 153 (CA153) and cancer antigen 199 (CA199) in pleural fluid samples for lung cancer.

METHODSImmunoprotein quantity of CEA, CA125, CA153 and CA199 was analyzed in pleural fluid and serum from patients with lung cancer (52 cases) and in pleural fluid from non cancerous patients (50 cases) by chemiluminescence.

RESULTSThe levels of CEA, CA125, CA153 and CA199 in pleural fluid of patients with lung cancer were significantly higher than those of non cancerous patients ( P < 0.01 or P < 0.05). In lung cancer patients, the levels of CEA, CA125, CA153 and CA199 in pleural fluid were obviously higher than those in serum ( P < 0.01 or P < 0.05). The sensitivity and the specificity of CEA+CA199 were 96.2% and 96.0%, respectively.

CONCLUSIONSDetection of CEA, CA125, CA153 and CA199 in pleural fluid might be helpful for diagnosing lung cancer, and the optimal combination for assay is CEA+CA199.