2022 ESMO ｜ Professor Wang Yongsheng: The effectiveness and convenience of the long -acting dosage formation of Goghelin in the new crown epidemic during the new crown epidemic

*For medical professionals for reading reference

The March long -acting dosage type of Gosherin 10.8mg brought both curative and convenient treatment for breast cancer management during the epidemic.

The annual European Cancer Internal Science Society (ESMO) conference has just come to an end. As one of the most authoritative international conferences in the tumor field, the research progress announced during the period has attracted much attention from the fields. Among them, during the discussion of the new coronary pneumonia epidemic, patients with menopause pre -breast cancer received 10.8 mg of gosherelin in Goshelin (Nole De) long -acting dosage effectiveness and convenient clinical study every 3 months ( Summary number: 209p) [1], the results show that Gosherein's March long -acting dosage format is equivalent to the 3.6mg dosage format in January, but it is more convenient and economic benefits. New evidence has been added to the clinical application of Gobosorin's March long -acting dosage form. It is worth mentioning that as early as 2021 "Guidelines for Breast Cancer Reasonable Diagnosis and Treatment During the New Coronary Virus pneumonia epidemic" [2] During the epidemic, it is necessary to convert ovarian function inhibitors (OFS) into March dosage forms. In 2022, the Consensus of the Diagnostic and Treatment of Chinese Young Breast Cancer (YBCC) [3] also promoted the March dosage formation of gonadotropin to release hormone agonists (GNRHA). Combining the results of this research undoubtedly confirmed the rationality of Gosherelin's March long -acting dosage type. The "Medical Tumor Channel" specially invited Professor Wang Yongsheng of Shandong Cancer Hospital to express his views on relevant content.

Study interpretation

Research Background

Breast cancer is the largest malignant tumor that threatens women's health, and the incidence is increasing year by year. HR+/HER2-breast cancer accounts for more than 70%of the overall breast cancer, and the standard treatment of patients with endocrine therapy [4]. Among them, patients with menopausal patients often use OFS drug GNRHA [5], which have the advantages of non -invasiveness, low adverse reactions, and reversible after stopping drugs. Treatment of patients with advanced breast cancer.

Gosherin belongs to GNRHA drugs. It is a synthetic analog of naturally promoting gonadotropin to release hormones. It has long used this product to inhibit the secretion of pituitary gonad hormones, which causes a decline in female serum estradiol. Although previous studies have confirmed the safety and efficacy of Goshery's 3.6 MG once a month, the effective data of the long -acting 3 -month preparation is still insufficient.

Research purpose and method

Evaluate serum estradiol (E2) and follicle stimulatory (FSH) levels every 3 months (0, 12, 24, and 36 weeks). Compare 3.6 mg compared to the 10.8 MG Gosherelin group's menstruation, tolerance and adverse events, non -transfer of patients' disease -free survival (DFS), and no progressive survival (PFS) for transferring patients. Queen A: Patients accept 10.8 mg Gosherin, once every 12 weeks (n = 41). Questing B: A retrospective review of patient files receiving 3.6 mg Gosherin (n = 42).

Research result

Base line features: In almost all sub -groups, the baseline features of queue A and queue B are significantly different.

Figure 1. Base line feature

The results of the efficacy: The follow-up time of the two groups was 18 months (12-2 April). All of the patients in the two groups were amenorrhea at the 12th week and maintained during the follow -up period. Both DFS and PFS of the two groups have no statistical differences. Prompt that the two groups have similar treatment effects.

Figure 2. The results of the effect

Results of safety: There is no statistical difference in the two groups in terms of hot, headache, sweating, and bone arthrocontinal pain, indicating that safety is similar.

Figure 3. Safety results

Analysis conclusion

Every March 10.8 MG Gosherin and 3.6 MG Gosherylin each month are equivalent, which is manifested in similar DFS, PFS, and toxicity spectrum; No need to go to the hospital frequently to reduce the risk of infection and spread.

Director comment

In China, Gosherin 3.6mg was approved for prostate cancer for hormone treatment in 1996; the pre -menopausal period of menopause and women's breast cancer that can be treated with hormones; and endometriosis [8]. It has benefited about 300,000 male patients and more than 700,000 female patients. As of March 2021, the 10.8mg breast cancer indications in Gosherin have been approved in 37 countries around the world. It can be seen from these data that, as a classic OFS drug, whether it is 3.6mg conventional dosage form or 10.8mg long -acting dosage form, Gosherin has become an important choice for tumor patients who need hormone therapy.

Looking back at previous research data, Phase II research in Japan D8664C00004 [9] is a comparison of the open, random, parallel group, parallel group, parallel group, parallel group, parallel group, parallel group, parallel group, parallel group, parallel group, parallel group, parallel group, parallel group, parallel group, parallel group, parallel group, parallel group. Multi -center research. A total of 170 cases of ER receptor positive before menopause, early breast cancer patients with root treatment surgery are the E2 serum concentration AUC during the treatment period of the first 24 weeks. Shearin 3.6mg.

Another multi -centered, open, random, parallel, and intervention phase III clinical study D8666C00001 [10] in the Asian region. Ruilin 10.8mg and Goshelin 3.6mg combined with him for treatment, and the main ending of the PFS of 24 weeks. The final research results also showed that Gosherelin 10.8mg compared to Gosherin 3.6mg to achieve non -inferiority. The results of this study announced by the ESMO conference also fully showed that compared with the 3.6mg dosage type once a month, it is more convenient to use Gosherelin for 10.8mg every March. , Save medical and health resources. For patients with HR+/HER2-breast cancer before menopause, it is a very worthwhile treatment option.

The application of the 10.8mg long -acting dosage type of Gosherin has also received more and more attention in China. In the article "Thinking of Ten Hot Issues of Breast Cancer Diagnosis and Treatment of Breast Cancer in the New Coronatte Virus Pneumonia", it is recommended that high -risk patients who need to do OFS, can Adopt a long -term preparation every 3 months [11]. In 2021, "Guidelines for Breast Cancer Reasonable Chemical Chemical Diagnosis and Treatment During the New Coronatte Pneumonic Pneumonia Epideosis" [2] pointed out: During the epidemic, it is preferentially considered oral endocrine drugs. The number of times to the hospital. In 2022, the "Consensus on the Diagnosis and Treatment of YBCC) Diagnosis and Treatment of Chinese Young Breast Cancer [3] also pointed out: GnRHA has a dosage formation in March or January. The physiology and clinical ending of the two have been confirmed by multiple studies. However, the March dosage GNRHA can reduce the number and cost of patients to and from the hospital, which may increase the treatment compliance of patients. Therefore, March GNRHA is also a common clinical choice that can meet the personalized needs of patients. Among similar long -term preparations, Gosherin's 10.8mg long -acting dose has a stronger ovarian function inhibitory effect (E2 suppression rate ≥98.8%[9]). As a clinical urgent need of medication, since the epidemic of new coronary pneumonia, it has become increasingly increasing The more clinical application.

Summarize

In the end of the 20th century, Gosherin was applied to the treatment of patients with breast cancer patients in the early stage of menopause. So far, it has accumulated rich evidence -based evidence. As a typical representative of OFS drugs, the advantages of low hormone escape rate, fast and stable reduction of E2 level Essence Its March long -effect format of 10.8mg can provide greater convenience for breast cancer patients during the epidemic, and the effect and safety are not affected. It has become an important recommendation of domestic guidelines and consensus.

Expert Introduction

Professor Wang Yongsheng

Second -level professor doctoral supervisor instructor

Director of Breast Disease Center of Shandong Cancer Hospital

Deputy Chairman of the Breast Cancer Professional Committee of China Anti -Cancer Association

Deputy Chairman of the International Medical Exchange Branch of the China Anti -Cancer Association

Standing Committee of the Breast Cancer Expert Committee of the China Clinical Oncology Society

Deputy Leader of the Tumor Branch of the Chinese Physician Association

Member of the Breast Cancer Team of the Chinese Medical Association oncology Branch

Members of the National Health and Health Commission's breast cancer diagnosis and treatment specifications

GBCC International Guidance Expert Committee member

The Chairman of the Objective Treatment Branch of the Shandong Provincial Anti -Cancer Association

references:

[1] .zawawy sf, kHedr g, et al. Effical and featured event every allths goserlin for premenopausal patients during panemic2022 eSmo. 209P. 209P. 209P. 209P. 209P. 209P. 209P.

[2]. 2021 "Guidelines for Breast Cancer Reasonable Chemical Chemical Diagnosis and Treatment During the New Coronatte Pneumonic Pneumonia Epidemic"

[3]. In 2022, "Consensus Experts and Treatment Experts of Young Breast Cancer (YBCC)"

[4]. Li Yanjun, Xu Binghe. The research progress of breast cancer aromatic enzyme inhibitors [J]. China Cancer Magazine, 2021, 31 (2): 9.

[5].McDonald Wade S 3rd, Hackney MH, Khatcheressian J, et al. Ovarian suppression in the management of premenopausal breast cancer: methods and efficacy in adjuvant and metastatic settings. Oncology. 2008;75(3-4):192- 202.

[6]. NCCN Breast Cancer Guidelines 2022 v1.

[7] .csco breast cancer diagnosis and treatment guide (2022).

[8]. Data source: instruction manual.

. Breast Cancer. 2016 SEP; 23 (5): 771-9.

[11]. Jiang Zefei, Li Jianbin. Chinese Medical Magazine, 2020,100 (10): 721-723.

*This article is only used to provide scientific information to medical people, and does not represent the viewpoint of this platform

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