BACKGROUND: In the interim analysis of MONARCH plus, adding abemaciclib to endocrine therapy (ET) improved progression-free survival (PFS) and objective response rate (ORR) in predominantly Chinese postmenopausal women with HR+/HER2- advanced breast cancer (ABC). This study presents the final pre-planned PFS analysis. METHODS: In the phase III MONARCH plus study, postmenopausal women in China, India, Brazil, and South Africa with HR+/HER2- ABC without prior systemic therapy in an advanced setting (cohort A) or progression on prior ET (cohort B) were randomized (2:1) to abemaciclib (150 mg twice daily [BID]) or placebo plus: anastrozole (1.0 mg/day) or letrozole (2.5 mg/day) (cohort A) or fulvestrant (500 mg on days 1 and 15 of cycle 1 and then on day 1 of each subsequent cycle) (cohort B). The primary endpoint was PFS of cohort A. Secondary endpoints included cohort B PFS (key secondary endpoint), ORR, overall survival (OS), safety, and health-related quality of life (HRQoL). RESULTS: In cohort A (abemaciclib: n  = 207; placebo: n  = 99), abemaciclib plus a non-steroidal aromatase inhibitor improved median PFS vs . placebo (28.27 months vs . 14.73 months, hazard ratio [HR]: 0.476; 95% confidence interval [95% CI]: 0.348-0.649). In cohort B (abemaciclib: n  = 104; placebo: n  = 53), abemaciclib plus fulvestrant improved median PFS vs . placebo (11.41 months vs . 5.59 months, HR: 0.480; 95% CI: 0.322-0.715). Abemaciclib numerically improved ORR. Although immature, a trend toward OS benefit with abemaciclib was observed (cohort A: HR: 0.893, 95% CI: 0.553-1.443; cohort B: HR: 0.512, 95% CI: 0.281-0.931). The most frequent grade ≥3 adverse events in the abemaciclib arms were neutropenia, leukopenia, anemia (both cohorts), and lymphocytopenia (cohort B). Abemaciclib did not cause clinically meaningful changes in patient-reported global health, functioning, or most symptoms vs . placebo. CONCLUSIONS: Abemaciclib plus ET led to improvements in PFS and ORR, a manageable safety profile, and sustained HRQoL, providing clinical benefit without a high toxicity burden or reduced quality of life. TRIAL REGISTRATION ClinicalTrials.gov (NCT02763566).
Humans ; Female ; Fulvestrant/therapeutic use* ; Breast Neoplasms/metabolism* ; Aminopyridines/therapeutic use* ; Benzimidazoles/therapeutic use* ; Middle Aged ; Aromatase Inhibitors/therapeutic use* ; Aged ; Receptor, ErbB-2/metabolism* ; Adult ; Letrozole/therapeutic use* ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Anastrozole/therapeutic use*

With advancements in molecular biology research and precision medicine,treatment options for advanced breast cancer have become increasingly diverse.In 2024,significant research progress has been achieved across different molecular subtypes of advanced breast cancer.Endocrine therapy combined with cyclin-dependent kinase 4/6(CDK4/6)inhibitors has become the standard first-line treatment for hormone receptor-positive advanced breast cancer.Fulvestrant combined with abemaciclib serves as a treatment option after failure in CDK4/6 inhibitors.For patients with mutations in the AKT pathway,fulvestrant combined with the AKT inhibitor capivasertib provides significant long-term survival benefits.Trastuzumab deruxtecan(T-DXd)has emerged as a novel treatment option for patients with HER2 ultra-low expression.For HER2-positive advanced breast cancer,taxanes combined with trastuzumab and pertuzumab or pyrotinib remain the standard first-line treatments for trastuzumab-sensitive patients.The DESTINY-Breast07 trial evaluated the feasibility of using T-DXd as a first-line treatment,showing that whether used as monotherapy or in combination with pertuzumab,progression-free survival(PFS)was non-inferior to standard regimens reported in previous studies.For HER2-positive patients with brain metastases,updated results from the PERMEATE trial indicated that the combination of pyrotinib and capecitabine could provide overall survival benefits.The DESTINY-Breast12 trial demonstrated that T-DXd had similar antitumor activity against systemic and intracranial lesions,making it an effective treatment option for HER2-positive patients with brain metastases.Treatment strategies for advanced triple-negative breast cancer(TNBC)are shifting from conventional chemotherapy to regimens centered on chemotherapy combined with immunotherapy and antibody-drug conjugates(ADCs).The TORCHLIGHT trial showed that chemotherapy combined with the immune checkpoint inhibitor toripalimab improved the prognosis of patients with advanced TNBC.The NCC2167 trial found that when chemotherapy was combined with immunotherapy,metronomic chemotherapy offered superior efficacy and lower toxicity compared to conventional approaches.This article reviewed the significant research progress in advanced breast cancer in 2024.By summarizing related research data,it provides insights into the clinical experience of managing and making treatment decisions for patients with advanced breast cancer,serving as a reference for peers.Looking ahead,future clinical research should focus on individual differences among patients,tumor heterogeneity,and treatment resistance,aiming to improve treatment outcomes and the quality of life for patients with advanced breast cancer.

With the advancement of precision medicine, the treatment of early-stage breast cancer is gradually moving toward standardized individualization. While ensuring therapeutic efficacy, increasing attention is being given to patients′ quality of life. In recent years, as clinical research data on targeted therapies for HER2-positive breast cancer, CDK4/6 inhibitors for hormone receptor-positive breast cancer, and immune checkpoint inhibitors for triple-negative breast cancer have accumulated, the treatment of early-stage breast cancer has become more precise and personalized. Furthermore, the growing body of clinical research on breast-conserving surgery, axillary preservation, and even the omission of primary tumor resection has significantly improved patients′ quality of life. These more effective drugs and advanced technologies provide the foundation for de-escalation treatment strategies in early-stage breast cancer, driving the development of a more refined, patient-centered treatment approach.

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.

Peripheral nerve injury refers to the impairment that occurs when the sens-ory nerves and motor nerves are damaged.Professor Zhang Hong has unique insights into the treatment of neurologically diseases in children.Based on the different manifestations of the disease,it is categorized under the traditional Chinese medicine concepts of"atro-phy syndrome","muscle injury"and"Bi syndrome".Professor Zhang believes that the disease is fundamentally rooted in the liver and kidneys,and that treatment should notonly address the acquired symptoms but also nurture the innate foundation.This article a-nalyze and summarize professor Zhang's clinical experience in using acupuncture,electroa-cupuncture,moving cupping,and moxibustion in the comprehensive treatment of peripheral nerve injury,providing a reference for clinical treatment of peripheral neuropathy in chil-dren.

With advancements in molecular biology research and precision medicine,treatment options for advanced breast cancer have become increasingly diverse.In 2024,significant research progress has been achieved across different molecular subtypes of advanced breast cancer.Endocrine therapy combined with cyclin-dependent kinase 4/6(CDK4/6)inhibitors has become the standard first-line treatment for hormone receptor-positive advanced breast cancer.Fulvestrant combined with abemaciclib serves as a treatment option after failure in CDK4/6 inhibitors.For patients with mutations in the AKT pathway,fulvestrant combined with the AKT inhibitor capivasertib provides significant long-term survival benefits.Trastuzumab deruxtecan(T-DXd)has emerged as a novel treatment option for patients with HER2 ultra-low expression.For HER2-positive advanced breast cancer,taxanes combined with trastuzumab and pertuzumab or pyrotinib remain the standard first-line treatments for trastuzumab-sensitive patients.The DESTINY-Breast07 trial evaluated the feasibility of using T-DXd as a first-line treatment,showing that whether used as monotherapy or in combination with pertuzumab,progression-free survival(PFS)was non-inferior to standard regimens reported in previous studies.For HER2-positive patients with brain metastases,updated results from the PERMEATE trial indicated that the combination of pyrotinib and capecitabine could provide overall survival benefits.The DESTINY-Breast12 trial demonstrated that T-DXd had similar antitumor activity against systemic and intracranial lesions,making it an effective treatment option for HER2-positive patients with brain metastases.Treatment strategies for advanced triple-negative breast cancer(TNBC)are shifting from conventional chemotherapy to regimens centered on chemotherapy combined with immunotherapy and antibody-drug conjugates(ADCs).The TORCHLIGHT trial showed that chemotherapy combined with the immune checkpoint inhibitor toripalimab improved the prognosis of patients with advanced TNBC.The NCC2167 trial found that when chemotherapy was combined with immunotherapy,metronomic chemotherapy offered superior efficacy and lower toxicity compared to conventional approaches.This article reviewed the significant research progress in advanced breast cancer in 2024.By summarizing related research data,it provides insights into the clinical experience of managing and making treatment decisions for patients with advanced breast cancer,serving as a reference for peers.Looking ahead,future clinical research should focus on individual differences among patients,tumor heterogeneity,and treatment resistance,aiming to improve treatment outcomes and the quality of life for patients with advanced breast cancer.

Peripheral nerve injury refers to the impairment that occurs when the sens-ory nerves and motor nerves are damaged.Professor Zhang Hong has unique insights into the treatment of neurologically diseases in children.Based on the different manifestations of the disease,it is categorized under the traditional Chinese medicine concepts of"atro-phy syndrome","muscle injury"and"Bi syndrome".Professor Zhang believes that the disease is fundamentally rooted in the liver and kidneys,and that treatment should notonly address the acquired symptoms but also nurture the innate foundation.This article a-nalyze and summarize professor Zhang's clinical experience in using acupuncture,electroa-cupuncture,moving cupping,and moxibustion in the comprehensive treatment of peripheral nerve injury,providing a reference for clinical treatment of peripheral neuropathy in chil-dren.

With the advancement of precision medicine, the treatment of early-stage breast cancer is gradually moving toward standardized individualization. While ensuring therapeutic efficacy, increasing attention is being given to patients′ quality of life. In recent years, as clinical research data on targeted therapies for HER2-positive breast cancer, CDK4/6 inhibitors for hormone receptor-positive breast cancer, and immune checkpoint inhibitors for triple-negative breast cancer have accumulated, the treatment of early-stage breast cancer has become more precise and personalized. Furthermore, the growing body of clinical research on breast-conserving surgery, axillary preservation, and even the omission of primary tumor resection has significantly improved patients′ quality of life. These more effective drugs and advanced technologies provide the foundation for de-escalation treatment strategies in early-stage breast cancer, driving the development of a more refined, patient-centered treatment approach.

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.

The 2024 CSCO Breast Cancer Diagnosis and Treatment Guidelines have synthesized key international and domestic research ad-vancements in 2023,considering drug accessibility and medical insurance and incorporating a measure of Chinese experts consensus to up-date diagnosis and treatment recommendations.These guidelines recommend best practices for treatment of different types of breast can-cer,including hormone receptor-positive(HR+),HER2-positive and triple-negative breast cancer.Moreover,the guidelines include diagnosis and treatment recommendations for HER2-low advanced breast cancer and provision of standardized and precise treatment options to pa-tients with different cancer types and stratification.This study aimed to interpret the key updated points for advanced breast cancer treat-ment.