DEERFIELD, Ill.--(BUSINESS WIRE)--TerSera Therapeutics LLC announced today the presentation of new real-world analyses on the treatment patterns of goserelin in women with breast cancer. The data were presented in a poster session at the 2024 American Society of Clinical Oncology (ASCO) Quality Care Symposium, held September 27th and 28th in San Francisco, CA.1 A copy of the poster is available here..

伊利诺伊州迪尔菲尔德。-（商业新闻短讯）--TerSera Therapeutics LLC今天宣布，将对乳腺癌女性戈舍瑞林治疗模式进行新的现实分析。这些数据在9月27日和28日于加利福尼亚州旧金山举行的2024年美国临床肿瘤学会（ASCO）质量护理研讨会上的海报会议上发布。1海报副本可在此处获得。。

The goal of this study was to demonstrate the characteristics of US patients with a diagnosis of breast cancer treated with either goserelin 3.6 mg or 10.8 mg and analyze goserelin treatment patterns using real-world evidence (RWE). This retrospective study used US electronic health record data through TriNetX, a global healthcare research network.

这项研究的目的是证明用戈舍瑞林3.6 mg或10.8 mg治疗的诊断为乳腺癌的美国患者的特征，并使用现实世界证据（RWE）分析戈舍瑞林的治疗模式。这项回顾性研究通过全球医疗保健研究网络TriNetX使用了美国电子健康记录数据。

The study included adult women with a history of breast cancer and with ≥2 prescriptions of goserelin between January 2017 – December 2022. Follow-up occurred until March 15, 2024..

该研究包括2017年1月至2022年12月期间有乳腺癌病史且服用戈舍瑞林≥2次处方的成年女性。随访至2024年3月15日。。

Overall, 3,620 patients were identified: 2,870 treated with goserelin 3.6 mg, 410 with goserelin 10.8 mg, and 340 who switched from goserelin 3.6 mg to 10.8 mg. Patient demographics, treatment adherence, and healthcare resource utilization (HCRU) were examined and summarized using descriptive analytics..

总体而言，共鉴定出3620名患者：2870名接受戈舍瑞林3.6 mg治疗，410名接受戈舍瑞林10.8 mg治疗，340名患者从戈舍瑞林3.6 mg改为10.8 mg治疗。使用描述性分析对患者人口统计学，治疗依从性和医疗资源利用率（HCRU）进行了检查和总结。。

“For young women with hormone-sensitive breast cancer at high-risk of relapse, suppression of ovarian function is an essential component of their long-term treatment plan,' said Lonnie Brent, Pharm.D., Senior Vice President, Medical and Scientific Affairs for TerSera. “This real-world evidence presented at the ASCO Quality Care Symposium increases our understanding of the current treatment patterns for young women with breast cancer receiving goserelin.'.

TerSera医学和科学事务高级副总裁Lonnie Brent博士说：“对于激素敏感型乳腺癌复发风险高的年轻女性来说，抑制卵巢功能是其长期治疗计划的重要组成部分。在ASCO质量护理研讨会上提出的这一实际证据增加了我们对接受戈舍瑞林治疗的乳腺癌年轻女性当前治疗模式的理解。”。

U.S. INDICATIONS

U、 美国适应症

ZOLADEX 3.6 mg and ZOLADEX 10.8 mg are indicated for:

ZOLADEX 3.6 mg和ZOLADEX 10.8 mg适用于：

Management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate in combination with flutamide. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.

联合氟他胺治疗局部局限性T2b-T4期（B2-C期）前列腺癌。ZOLADEX和氟他胺治疗应在开始放射治疗前8周开始，并在放射治疗期间继续进行。

Palliative treatment of advanced carcinoma of the prostate.

晚期前列腺癌的姑息治疗。

ZOLADEX 3.6 mg is also indicated for:

ZOLADEX 3.6 mg也适用于：

Management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. Experience with ZOLADEX for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months.

管理子宫内膜异位症，包括缓解疼痛和减少治疗期间的子宫内膜异位病变。。

Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding.

在子宫内膜消融治疗功能失调性子宫出血之前用作子宫内膜变薄剂。

Palliative treatment of advanced breast cancer in pre- and perimenopausal women.

绝经前和围绝经期妇女晚期乳腺癌的姑息治疗。

IMPORTANT SAFETY INFORMATION

重要安全信息

Anaphylactic reactions to ZOLADEX have been reported in the medical literature. ZOLADEX is contraindicated in patients with a known hypersensitivity to GnRH, GnRH agonist analogues, or any of the components in ZOLADEX.

医学文献报道了对ZOLADEX的过敏反应。ZOLADEX禁用于对GnRH，GnRH激动剂类似物或ZOLADEX中任何成分具有已知超敏反应的患者。

ZOLADEX is contraindicated during pregnancy unless used for palliative treatment of advanced breast cancer. ZOLADEX can cause fetal harm when administered to a pregnant woman. If used during pregnancy, the patient should be apprised of the potential hazard to the fetus. There is an increased risk for pregnancy loss due to expected hormonal changes that occur with ZOLADEX treatment.

除非用于晚期乳腺癌的姑息治疗，否则ZOLADEX在怀孕期间是禁忌的。ZOLADEX给孕妇服用时会对胎儿造成伤害。如果在怀孕期间使用，应告知患者对胎儿的潜在危害。由于ZOLADEX治疗发生的预期激素变化，导致流产的风险增加。

ZOLADEX should not be given to women with undiagnosed abnormal vaginal bleeding..

未确诊阴道异常出血的女性不应服用ZOLADEX。。

Pregnancy must be excluded for use in benign gynecological conditions. Women should be advised against becoming pregnant while taking ZOLADEX. Effective nonhormonal contraception must be used by all premenopausal women during ZOLADEX therapy and for 12 weeks following discontinuation of therapy.

怀孕必须排除在良性妇科疾病中使用。应建议女性在服用ZOLADEX时不要怀孕。在ZOLADEX治疗期间以及停止治疗后12周内，所有绝经前妇女都必须使用有效的非激素避孕药。

Transient worsening of tumor symptoms, or the occurrence of additional signs and symptoms of breast cancer, may occasionally develop during the first few weeks of treatment. Some patients may experience a temporary increase in bone pain. Monitor patients at risk for complications of tumor flare.

在治疗的最初几周内，偶尔会出现肿瘤症状的短暂恶化，或乳腺癌的其他体征和症状的发生。一些患者可能会暂时增加骨痛。监测有肿瘤复发并发症风险的患者。

Hyperglycemia and an increased risk of developing diabetes or worsening of glycemic control in patients with diabetes have been reported in men receiving GnRH agonists like ZOLADEX. Monitor blood glucose levels and glycosylated hemoglobin (HbA1c) periodically and manage according to current clinical practice..

据报道，接受GnRH激动剂（如ZOLADEX）的男性患有高血糖症，糖尿病患者患糖尿病或血糖控制恶化的风险增加。定期监测血糖水平和糖化血红蛋白（HbA1c），并根据当前的临床实践进行管理。。

Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists like ZOLADEX in men. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice..

据报道，在男性中使用GnRH激动剂如ZOLADEX会增加发生心肌梗塞，心源性猝死和中风的风险。应监测接受GnRH激动剂的患者是否有提示心血管疾病发展的症状和体征，并根据当前的临床实践进行管理。。

Hypercalcemia has been reported in some breast cancer patients with bone metastases after starting treatment with ZOLADEX. If hypercalcemia does occur, appropriate treatment measures should be initiated.

据报道，一些乳腺癌骨转移患者在开始使用ZOLADEX治疗后出现高钙血症。如果确实发生高钙血症，应采取适当的治疗措施。

Hypersensitivity, antibody formation and acute anaphylactic reactions have been reported with GnRH agonist analogues.

已经报道了GnRH激动剂类似物的超敏反应，抗体形成和急性过敏反应。

ZOLADEX may cause an increase in cervical resistance. Therefore, caution is recommended when dilating the cervix for endometrial ablation.

ZOLADEX可能导致宫颈阻力增加。因此，建议在扩张子宫颈进行子宫内膜消融时要谨慎。

GnRH agonists may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval.

GnRH激动剂可以延长QT/QTc间隔。提供者应考虑雄激素剥夺治疗的益处是否超过先天性长QT综合征，充血性心力衰竭，频繁电解质异常以及服用已知延长QT间期药物的患者的潜在风险。

Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes..

应纠正电解质异常。考虑定期监测心电图和电解质。。

Injection site injury and vascular injury including pain, hematoma, hemorrhage and hemorrhagic shock, requiring blood transfusions and surgical intervention, have been reported with ZOLADEX. Extra care should be taken when administering ZOLADEX to patients with low BMI and/or to patients receiving full dose anticoagulation..

ZOLADEX报道了注射部位损伤和血管损伤，包括疼痛，血肿，出血和失血性休克，需要输血和手术干预。当给低BMI患者和/或接受全剂量抗凝治疗的患者服用ZOLADEX时，应格外小心。。

Depression may occur or worsen in women receiving GnRH agonists.

在接受GnRH激动剂的女性中，抑郁症可能会发生或恶化。

Treatment with ZOLADEX may be associated with a reduction in bone mineral density over the course of treatment. Data suggest a possibility of partial reversibility. In women, current available data suggest that recovery of bone loss occurs on cessation of therapy in the majority of patients.

ZOLADEX治疗可能与治疗过程中骨密度的降低有关。数据表明部分可逆性的可能性。在女性中，目前可用的数据表明，大多数患者在停止治疗后会恢复骨质流失。

In women, the most frequently reported adverse reactions were related to hypoestrogenism. The adverse reaction profile was similar for women treated for breast cancer, dysfunctional uterine bleeding, and endometriosis.

在女性中，最常报告的不良反应与低雌激素有关。乳腺癌，功能失调性子宫出血和子宫内膜异位症患者的不良反应相似。

The most commonly reported adverse reactions with ZOLADEX in clinical trials for endometriosis were: hot flashes (96%), vaginitis (75%), headache (75%), decreased libido (61%), emotional lability (60%), depression (54%), sweating (45%), acne (42%), breast atrophy (33%), seborrhea (26%), and peripheral edema (21%)..

在子宫内膜异位症的临床试验中，最常报告的ZOLADEX不良反应是：潮热（96%），阴道炎（75%），头痛（75%），性欲下降（61%），情绪不稳定（60%），抑郁症（54%），出汗（45%），痤疮（42%），乳房萎缩（33%），皮脂溢（26%）和外周水肿（21%）。。

The most commonly reported adverse reactions with ZOLADEX in clinical trials for endometrial thinning were: vasodilation/hot flashes (57%), headache (32%), sweating (16%), and abdominal pain (11%).

在子宫内膜变薄的临床试验中，ZOLADEX最常见的不良反应是：血管舒张/潮热（57%），头痛（32%），出汗（16%）和腹痛（11%）。

The most commonly reported adverse reactions with ZOLADEX in breast cancer clinical trials were hot flashes (70%), decreased libido (47.7%), tumor flare (23%), nausea (11%), edema (5%), and malaise/fatigue/lethargy (5%). Injection site reactions were reported in less than 1% of patients.

在乳腺癌临床试验中，ZOLADEX最常见的不良反应是潮热（70%），性欲下降（47.7%），肿瘤发作（23%），恶心（11%），水肿（5%）和不适/疲劳/嗜睡（5%）。不到1%的患者报告了注射部位反应。

For ZOLADEX 3.6 mg: Hot flashes (62%), sexual dysfunction (21%), decreased erections (18%), lower urinary tract symptoms (13%), lethargy (8%), pain (worsened in the first 30 days) (8%), edema (7%), upper respiratory infection (7%), rash (6%), and sweating (6%).

对于ZOLADEX 3.6 mg：潮热（62%），性功能障碍（21%），勃起减少（18%），下尿路症状（13%），嗜睡（8%），疼痛（前30天恶化）（8%），水肿（7%），上呼吸道感染（7%），皮疹（6%）和出汗（6%）。

For ZOLADEX 10.8 mg: Hot flashes (64%), pain (general) (14%), gynecomastia (8%), pelvic pain (6%), and bone pain (6%).

对于ZOLADEX 10.8 mg：潮热（64%），疼痛（一般）（14%），男性乳房发育（8%），骨盆疼痛（6%）和骨痛（6%）。

In the locally advanced carcinoma of the prostate clinical trial, additional adverse event data were collected for the combination therapy with radiation group during both the hormonal treatment and hormonal treatment plus radiation phases of this study. Adverse experiences (incidence >5%) in both phases of this study were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%).

在局部晚期前列腺癌临床试验中，在本研究的激素治疗和激素治疗加放疗阶段，收集了与放疗组联合治疗的其他不良事件数据。本研究两个阶段的不良经历（发生率>5%）为潮热（46%），腹泻（40%），恶心（9%）和皮疹（8%）。

Treatment with ZOLADEX and flutamide did not add substantially to the toxicity of radiation treatment alone..

用ZOLADEX和氟他胺治疗并没有显着增加单独放射治疗的毒性。。

Please see Full Prescribing Information for ZOLADEX 3.6 mg and ZOLADEX 10.8 mg.

。

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/safety/medwatch or call 1-800-FDA-1088. You can also contact TerSera Therapeutics at 1-844-334-4035 or medicalInformation@tersera.com.

鼓励您向FDA报告处方药的负面副作用。访问fda.gov/safety/medwatch或致电1-800-fda-1088。您也可以致电1-844-334-4035或联系TerSera TherapeuticsmedicalInformation@tersera.com.

About HR-positive breast cancer

关于HR阳性乳腺癌

Breast cancer is the second most commonly diagnosed cancer and one of the leading causes of cancer-related deaths worldwide. 2 In the United States, over 310,000 women will be diagnosed with breast cancer this year; 40,000 will be under the age of 50. 3 Approximately 75% of diagnosed cases in women under age 50 are considered to be hormone positive (HR+) breast cancer.

。2在美国，今年将有超过31万名女性被诊断出患有乳腺癌；40000名年龄在50岁以下。3大约75%的50岁以下女性确诊病例被认为是激素阳性（HR+）乳腺癌。

Compared to older women, young women generally face more aggressive cancers and lower survival rates.4,5 Recent studies have shown that breast cancer before age 40 differs biologically from the cancer faced by older women.6.

与老年女性相比，年轻女性通常面临更具侵袭性的癌症和更低的生存率[4,5]。最近的研究表明，40岁之前的乳腺癌在生物学上与老年女性面临的癌症不同。

About ZOLADEX® (goserelin implant)

关于ZOLADEX®（戈舍瑞林植入物）

ZOLADEX is an injectable luteinizing hormone-releasing hormone agonist (LHRHa) used to treat prostate cancer, breast cancer, and certain benign gynecological disorders. First approved in the U.S. in 1989, ZOLADEX is available as a 3.6 mg implant dosed every 28 days or as a 10.8 mg implant dosed every 12 weeks.

ZOLADEX是一种可注射的黄体生成素释放激素激动剂（LHRHa），用于治疗前列腺癌，乳腺癌和某些良性妇科疾病。ZOLADEX于1989年在美国首次获得批准，每28天服用3.6毫克植入物，或每12周服用10.8毫克植入物。

Worldwide, ZOLADEX 3.6 mg is approved for use in breast cancer in 125 countries. ZOLADEX 10.8 mg is approved for use in breast cancer in over 60 countries..

在世界范围内，ZOLADEX 3.6 mg被批准用于125个国家的乳腺癌。ZOLADEX 10.8毫克被批准用于60多个国家的乳腺癌治疗。。

About TerSera Therapeutics

关于TerSera Therapeutics

TerSera Therapeutics is a biopharmaceutical company with a focus in oncology and non-opioid pain management. Founded in 2016, TerSera is building new cornerstones of care through its portfolio of unique therapeutics, amplifying their ability to deliver meaningful outcomes for patients. TerSera has been recognized as a 2024 Healthcare Top Workplace.

TerSera Therapeutics是一家生物制药公司，专注于肿瘤学和非阿片类药物疼痛管理。TerSera成立于2016年，通过其独特的治疗组合，建立了新的护理基石，增强了他们为患者提供有意义结果的能力。TerSera已被公认为2024年医疗保健顶级工作场所。

For additional information, please visit tersera.com and follow us on LinkedIn..

有关更多信息，请访问tersera.com并在LinkedIn上关注我们。。

References

参考文献

1.

1.

Treatment patterns of goserelin 3.6 mg once monthly and 10.8 mg every three months in women with breast cancer: a real-world analysis. McCann KE, Kaklamani V, Osman N, et al. Poster presented at the American Society of Clinical Oncology (ASCO) Quality Care Symposium, September 27-28, 2021. Abstract #391; Poster Session B Poster F19..

乳腺癌患者戈舍瑞林的治疗模式为每月3.6毫克，每三个月10.8毫克：一项现实分析。McCann KE，Kaklamani V，Osman N等人于2021年9月27-28日在美国临床肿瘤学会（ASCO）质量护理研讨会上发布的海报。摘要#391；海报课程B海报F19。。

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Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 Apr 4. doi: 10.3322/caac.21834.

Bray F等人，《2022年全球癌症统计：GLOBOCAN对185个国家36种癌症的全球发病率和死亡率的估计》。CA癌症J临床。2024年4月4日。doi:10.3322/caac.21834。

3.

3.

National Cancer Institute. Surveillance, Epidemiology and End Results Program. Accessed September 2024.

国家癌症研究所。监测、流行病学和最终结果计划。2024年9月访问。

4.

4.

Carey K. Anders et al., 'Breast Carcinomas Arising at a Young Age: Unique Biology or a Surrogate for Aggressive Intrinsic Subtypes?' Journal of Clinical Oncology 29, no. 1 (2011): e18-e20.

Carey K.Anders等人，“年轻时产生的乳腺癌：独特的生物学还是侵袭性内在亚型的替代品？”临床肿瘤学杂志29，第1期（2011）：e18-e20。

5.

5.

Carey K. Anders et al., 'Young Age at Diagnosis Correlates with Worse Prognosis and Defines a Subset of Breast Cancers with Shared Patterns of Gene Expression,' Journal of Clinical Oncology 26, no. 10 (2008): 3324-3330.

Carey K.Anders等人，“诊断时的年轻年龄与较差的预后相关，并定义了具有共同基因表达模式的乳腺癌子集”，Journal of Clinical Oncology 26，no.10（2008）：3324-3330。

6.

6.

Ann H. Partridge et al., “Breast Cancer in Younger Women,” Diseases of the Breast (4th ed.), In J. Harris (Ed.) (2010): 1073-1083.

Ann H.Partridge等人，《年轻女性乳腺癌》，乳腺疾病（第四版），J.Harris（编辑）（2010）：1073-1083。

ZOLADEX® is a registered trademark of AstraZeneca or its affiliates and is used herein under license.

ZOLADEX®是阿斯利康（AstraZeneca）或其附属公司的注册商标，在许可的情况下在此使用。

©2024 TerSera Therapeutics LLC. All rights reserved.

©2024 TerSera Therapeutics LLC.保留所有权利。