Heavy release!

*Only for medical professionals to read and refer to the annual China Urology Conference, where all the national urology elites actively participate offline and online
.

The 28th National Urology Annual Conference was successfully held in Nanjing on October 22-24.
This is the annual China Urology Conference.
All the national urology elites actively participated offline and online
.

In the oral presentation session of the eye-catching male reproductive oncology session, the finale was the research report "China Olapali Real World Research Data" from the team of Professor Ye Dingwei from the Cancer Hospital of Fudan University
.

This is a major domestic disclosure of real-world data on Olapali prostate cancer
.
Let us take a look at it .

Metastatic castration-resistant prostate cancer (mCRPC) is the terminal stage of the development of prostate cancer.
It is a lethal malignant tumor with a poor prognosis
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A number of clinical studies have shown that the benefits of sequential treatment of new endocrine therapy in the mCRPC stage are limited, and patients with advanced prostate cancer need more precise treatment in order to achieve longer survival
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The tumor heterogeneity of advanced prostate cancer is high, and there are many genetic changes.
Among them, homologous recombination repair (HRR) gene mutations are a common type, accounting for about 20%-30%.
Among them, germline mutations and somatic mutations are about each Accounted for half [1]
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The Cancer Hospital of Fudan University is dedicated to the study of molecular typing of prostate cancer patients in the Chinese population.
Past studies have found that the proportion of HRR mutations in the mesoderm of advanced prostate cancer in China is generally close to foreign data [2]
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With the publication of the PROfound data of the Phase III registered clinical study, olaparib has been approved in the United States and China for mCRPC patients with HRR or BRCA gene mutations who have failed a new endocrine therapy, which has changed the treatment of advanced prostate cancer patients.
Pattern
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However, because the PROfound study did not enroll the Chinese population, there is a lack of data reports on the efficacy and safety of olaparib in Chinese mCRPC patients
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# Based on the above background, the Department of Urology, Affiliated Tumor Hospital of Fudan University School of Medicine, retrospectively analyzed the efficacy data of mCRPC patients spontaneously using olaparib in the real world in order to fill the gap in this research
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The results confirmed that olaparib is beneficial in patients with mCRPC
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For people with HRR mutations in China, olaparib can achieve a better curative effect similar to that shown in the PROfound Institute, and its safety can be guaranteed, which is consistent with the results of the Phase III study
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Dr.
Pan Jian from the Cancer Hospital of Fudan University reported the results of the retrospective study
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# This study retrospectively analyzed 43 mCRPC patients who received olaparib monotherapy or olaparib combined with abiraterone from December 2018 to February 2021
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All patients have received prostate cancer primary tumors containing 15 HRR genes (BRCA1, BRCA2, ATM, BRIP1, BARD1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, or RAD54L) Tissue gene sequencing, and recording germline or systemic gene mutation status of 43 patients, 41 patients received olaparib 300mgBID monotherapy, 2 patients received olaparib combined with abiraterone therapy
.

# The overall PSA partial remission rate was 76.
7% (33/43), the PSA remission rate was 48.
8% (21/43), and 14% (6/43) had a PSA decrease of more than 90%
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A stratified analysis of the HRR gene mutation status found that the 26 patients with positive HRR mutations had a higher PSA partial remission rate, reaching 88.
5% (23/26), and the PSA remission rate was 57.
7% (15/26), with 15.
4% (4/26) The PSA of the patients dropped by more than 90%
.

In the PROfound study, the PSA remission rate of the HRR mutation population reached 43%, while the PSA remission rate of the Chinese population was similar or even slightly better than the PROfound study data (58% vs 43%), suggesting that olaparib may be more effective for the Chinese population.
Good anti-tumor activity; in patients with negative HRR gene mutations, treatment effectiveness was also observed: PSA partial remission rate was 58.
8% (10/17), PSA remission rate was 35.
3% (6/17), with 11.
8% The PSA of (2/17) patients decreased by more than 90%, and the PROfound study did not include such patients.
This is also the first disclosure of the efficacy of olaparib in HRR-negative mCRPC patients
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Among the 17 negative patients, a total of 10 patients who did not carry HRR gene mutations benefited after receiving olaparib treatment.
Among them, 2 cases were treated with abiraterone and 2 cases carried TP53 system mutations.
These may be benefits Potential factors
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The genotype analysis of patients with positive HRR mutations showed that BRCA2 is the most common mutation in the HRR pathway, which is consistent with the PROfound study.
In addition, in the Chinese population, the mutation of CDK12 is much higher than that of the PROfound study, which suggests that prostate cancer patients The difference between the east and west of the gene spectrum may result in different response effects of targeted drugs
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In terms of safety, 95% of patients reported adverse events during treatment.
The top three adverse events were fatigue (70%), anemia (65%), loss of appetite (55%), grade 3 and The incidence of the above adverse events was 30%
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The overall types of adverse events in the Fudan real-world study are basically the same as the registered clinical study PROfound, and the incidence of grade 3 and above adverse events is lower (51% in the PROfound study); this may be due to Fudan University Affiliated Cancer Hospital’s acceptance of the Austrian Patients treated with lapali will adopt a follow-up strategy of regular monitoring of clinical indicators and questionnaires
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Finally, the key information of the study is summarized as follows: "Fudan Cancer Hospital has observed in the real world that olaparib can achieve similar or even better treatment effects in mCRPC patients with HRR gene mutations than in phase III clinical trials.
Chinese prostate cancer The difference between the patient’s genetic profile and Western ethnicity further proves the necessity of olaparib Chinese population data; at the same time, it has been observed that some mCRPC patients with non-HRR mutations can also benefit from olaparib treatment, indicating The prospect of olaparib combined therapy and the possibility that olaparib has an anti-tumor effect on other non-HRR gene pathway mutations are the future for targeted drugs represented by olaparib in the wider prostate cancer population beyond mutation application tips direction
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in addition, after treatment safety follow-up strategies to effectively manage adverse events in patients after treatment, the treatment can be controlled overall security management, to provide a reliable theoretical basis for standardization precise treatment
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"Professor Ye Dingwei, Deputy Dean of Fudan University Cancer Hospital, Chief Expert of Urinary Oncology MDT Director of Shanghai Urological Oncology Institute Director of Prostate Cancer Institute of Fudan University, Chinese Anti-Cancer Association Urinary and Male Reproductive Tumor Committee (CACA- GU) Chairman Chinese Society of Clinical Oncology (CSCO) Prostate Cancer Expert Committee Chairman, Chinese Medical Association Urology Branch (CUA) Oncology Group Vice Chairman, Chinese Society of Clinical Oncology (CSCO) Urothelial Cancer Expert Committee Vice Chairman China Vice Chairman of the Renal Cancer Expert Committee of the Society of Clinical Oncology (CSCO) Vice Chairman of the Immunotherapy Expert Committee of the Chinese Society of Clinical Oncology (CSCO) Chairman of the Urinary Oncology Group (UCOG) of the Chinese Cancer Hospital Executive Director of the Chinese Anti-Cancer Association, Chinese Society of Clinical Oncology Executive Director, Chinese Anti-Cancer Association Urology and Male Genital Tumor Committee (CACA-GU) Prostate Cancer Group Leader NCCN Kidney Cancer Diagnosis and Treatment Guide China Edition Deputy Group Leader NCCN Prostate Cancer, Kidney Cancer, Bladder Cancer Asia Consensus Expert on Diagnosis and Treatment Committee Member, Advanced Prostate Cancer Asia-Pacific Consensus Expert Committee Member, Shanghai Medical Doctor Association, Vice President of Urology Branch, Former Chairman of Shanghai Anti-Cancer Association, National Science Gold Second Review Expert, Asia-Pacific Prostate Society (APPS), Vice President, Asia-Pacific Society of Cryosurgery Professor Zhu Yao, Executive Deputy Director of the Department of Urology, Fudan University Cancer Hospital, Secretary-General of the Prostate Cancer Expert Committee of the Chinese Society of Clinical Oncology, Deputy Chairman of the Youth Council of the Shanghai Anti-Cancer Association, has long been engaged in the clinical diagnosis and treatment of urinary male reproductive system tumors.
He focuses on radical prostatectomy and comprehensive treatment
.

Winner of the May 4th Youth Medal of Fudan University in 2019 and the Young May 4th Medal of Shanghai Municipal Health Commission
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Selected as an outstanding young medical talent in Shanghai "New Star of Medical Garden" in 2018, and selected as the 7th Fudan University The top ten medical young people of the university, was selected as the third batch of Fudan University Zhuoxue Talent Program, and was selected as the 2015 Shanghai Youth Science and Technology Star Program
.

Served as an editorial board member of Prostate Cancer and Prostatic Disease, and published 8 articles in European Urology and Journal of Urology as the corresponding author.
The thesis, won the first prize of Shanghai Science and Technology Progress Award as the second completer
.

References: [1].
Van Dessel LF, van Riet J, Smits M, et al.
The genomic landscape of metastatic castration-resistant prostate cancers reveals multiple distinct genotypes with potential clinical impact.
Nat Commun.
2019;10(1): 5251.
doi:10.
1038/s41467-019-13084-7[2].
Wei Y, Wu J, Gu W, et al.
Germline DNA Repair Gene Mutation Landscape in Chinese Prostate Cancer Patients.
Eur Urol.
2019;76(3) :280-283.
doi:10.
1016/j.
eururo.
2019.
06.
004[3].
De Bono J, Mateo J, Fizazi K, et al.
Olaparib for Metastatic Castration-Resistant Prostate Cancer.
N Engl J Med.
2020;382 (22):2091-2102.
doi:10.
1056/NEJMoa1911440*This article is only used to provide scientific information to medical professionals and does not represent the views of this platform