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 explore the occurrence of immune-related adverse events (irAEs) and the relationship to efficacy of camrelizumab in treatment for patients with non-small cell lung cancer (NSCLC).Methods:Clinical data of patients with NSCLC who received camrelizumab in at the Affiliated Hospital of Inner Mongolia Medical University from December 2020 to December 2022 were collected, and the efficacy of camrelizumab and the occurrence of irAEs were retrospectively analyzed. Patients were divided into irAEs group and non-irAEs group according to whether they developed irAEs. The objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS) of the 2 groups were compared.Results:A total of 48 patients were entered in the analysis, including 41 males (85.4%) and 7 females (14.6%), with an age of (65.9±7.4) years; the median treatment cycle was 9 (6, 14); the overall ORR was 52.1% (25/48), the DCR was 83.3% (40/48), and the median PFS was 11 months. Among the 48 patients, 34 patients (70.8%) had 59 times of irAEs, of which 8 patients (16.7%) had at least one irAE of grade ≥3. The median time of irAEs occurrence was 5 (3, 7) treatment cycles. The irAEs with an incidence of >10% included reactive cutaneous capillary endothelial proliferation (RCCEP), thyroid injury, skin injury, lung injury, liver injury, and blood toxicity, with the incidences of 37.5% (18/48), 18.8 (9/48), 16.7% (8/48), 12.5% (6/48), 10.4% (5/48), and 10.4% (5/48), respectively. Compared with non-irAEs group, patients in the irAEs group had higher ORR and DCR [64.7% (22/34) vs. 3/14, 91.2% (31/34) vs. 9/14] and longer median PFS (12.0 months vs. 7.0 months, hazard ratio=0.418, 95% confidence interval: 0.193-0.905), and the differences were statistically significant (all P<0.05). Conclusions:The common irAEs of camrelizumab in treatment for patients with NSCLC was RCCEP, and fewer serious irAEs occurs. To a certain extent, patients who experience irAEs during camrelizumab treatment may predict a more pronounced therapeutic response.

Objective:To explore the occurrence of immune-related adverse events (irAEs) and the relationship to efficacy of camrelizumab in treatment for patients with non-small cell lung cancer (NSCLC).Methods:Clinical data of patients with NSCLC who received camrelizumab in at the Affiliated Hospital of Inner Mongolia Medical University from December 2020 to December 2022 were collected, and the efficacy of camrelizumab and the occurrence of irAEs were retrospectively analyzed. Patients were divided into irAEs group and non-irAEs group according to whether they developed irAEs. The objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS) of the 2 groups were compared.Results:A total of 48 patients were entered in the analysis, including 41 males (85.4%) and 7 females (14.6%), with an age of (65.9±7.4) years; the median treatment cycle was 9 (6, 14); the overall ORR was 52.1% (25/48), the DCR was 83.3% (40/48), and the median PFS was 11 months. Among the 48 patients, 34 patients (70.8%) had 59 times of irAEs, of which 8 patients (16.7%) had at least one irAE of grade ≥3. The median time of irAEs occurrence was 5 (3, 7) treatment cycles. The irAEs with an incidence of >10% included reactive cutaneous capillary endothelial proliferation (RCCEP), thyroid injury, skin injury, lung injury, liver injury, and blood toxicity, with the incidences of 37.5% (18/48), 18.8 (9/48), 16.7% (8/48), 12.5% (6/48), 10.4% (5/48), and 10.4% (5/48), respectively. Compared with non-irAEs group, patients in the irAEs group had higher ORR and DCR [64.7% (22/34) vs. 3/14, 91.2% (31/34) vs. 9/14] and longer median PFS (12.0 months vs. 7.0 months, hazard ratio=0.418, 95% confidence interval: 0.193-0.905), and the differences were statistically significant (all P<0.05). Conclusions:The common irAEs of camrelizumab in treatment for patients with NSCLC was RCCEP, and fewer serious irAEs occurs. To a certain extent, patients who experience irAEs during camrelizumab treatment may predict a more pronounced therapeutic response.

Objective Currently , the targeted therapy is the first-choice treatment of advanced non-small cell lung cancer (NSCLC) in with epidermal growth factor receptor (EGFR) mutations, but few studies have been reported on the relationship between immunohistochemical markers and the EGFR mutation.The aim of this study is to analyze the relationship of the EGFR mutation with the ex-pressions of thymidylate synthetase (TS), excision repair cross-com-plementation group 1 ( ERCC1 ) , β-tubulin-III, and ribonucleofide reductase large subunit-l ( RRM1) in NSCLC. Methods We retro-spectively analyzed 336 cases of NSCLC treated in the Department of Medical Oncology , the Affiliated Hospital of Inner Mongolia Medical University, from June 2014 to December 2015 and examined 29 EGFR mutations.We divided the patients into a mutation and a non-mutation group, performed immunohistochemical staining of the TS, ERCC1,β-tubulin-III and RRM1 proteins and compared their expressions in the NSCLC tissue between the two groups . Results EGFR mutations were found in 138 ( 41.07%) of the 336 NSCLC patients but not in the other 198 ( 58.93%) .The expression of TS was significantly lower in the mutation than in the non-mutation group (9.42%vs 39.39%, P<0.05), and so was that of β-tubulin-III (44.2%vs 60.1%, P<0.05).EGFR mutations were correlated with decreased expressions of TS (r=-0.332, P<0.05) andβ-tubulin-III (r=-0.157, P<0.05).Multivariate regression analysis showed that the risk of EGFR mutations was 2.109 times higher in the fe-male patients than in the males (OR=2.109, 95%CI:1.268-3.509), 24.265 times higher in the adenocarcinoma than in the adeno-squamous carcinoma patients (OR=24.265, 95%CI:3.508-167.845), 15.2 times higher in the squamous carcinoma than in the ade-nocarcinoma patients (OR=15.200, 95%CI:4.480-51.569), 2.364 times higher in the lung biopsy specimens than in the surgically treated patients (OR=2.364, 95%CI:1.266-4.413), and 6.171 times higher in the patients with lowly expressed than in those with highly expressed TS (OR=6.171, 95%CI: 3.145-12.109). Conclusion The decreased expressions of TS and β-tubulin-Ⅲ in NSCLC indicate the mutation of the EGFR gene.