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*For medical professionals to read only for reference, high-risk/high-tumor-burden mHSPC patients receive apatamide treatment, the PSA level decreases rapidly, deeply, and lastingly, with significant curative effect and good safety.
Case introduction ▎Basic situation The patient is male, 62 years old.
The patient came to the outpatient clinic of the hospital in August 2016 due to "difficult urination".
▎Physical examination results of digital rectal examination: the prostate is hard.
▎Laboratory examination of prostate specific antigen (PSA): 110.
4 ng/ml.
▎Imaging examination CT pelvic cavity + chest + whole abdomen scan + enhancement (2016-09-13): There were no enlarged lymph nodes in the pelvic cavity, and no clear abnormal enhancement lesions.
However, there are multiple osteogenic foci in the spine, ribs and iliac bones on both sides, and the possibility of metastasis needs to be considered.
Whole body bone imaging (2016-09-14) (Figure 1): The 5th posterior rib on the right, the 7th and 11th posterior ribs on the left, the 8th and 10th thoracic vertebrae, and the 4th lumbar vertebra.
The local radioactivity of the left ilium is abnormally concentrated.
Gather, consider the possibility of transfer.
Figure 1 Results of whole-body bone imaging (2016-09-14) ▎Prostate cancer tissues were found at the 10 points in the pathological examination of prostate puncture specimens at "14" points, and the Gleason score was 4+4=8 points.
▎The diagnosis result is high-risk/high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC), T4N0M1b.
After treatment On September 22, 2016, the patient started taking apatamide 240mg QD treatment.
On October 11, 2016, the patient started to inject goserelin acetate.
After the patient received apatamide+ADT (androgen deprivation therapy) for 2 months, the re-examination showed that PSA decreased rapidly from 110.
4 ng/ml to 35.
37 ng/ml, and decreased to 0.
02 ng/ml after 4 months and continued to maintain ( figure 2).PSA showed rapid and deep reduction.
Testosterone has been maintained at 0.
57 nmol/l; and as of December 22, 2017, whole-body bone imaging showed reduced foci of concentration (Figure 3).
Figure 2 Changes in PSA during the treatment of apatamide + ADT Figure 3 Changes in the results of the patient's whole body bone imaging (2016.
09-2019.
07) In October 2019, the patient had PSA progression after 37 months of treatment with apatamide (no imaging) Progression, asymptomatic progression), the patient continues to maintain apatamide treatment.
In September 2020, after 48 months of treatment with apatamide, the patient began to receive follow-up treatments such as abiraterone due to the progress of imaging.
Case provided by doctor Shen Zhiyuan, Attending Physician, Department of Urology, East China Hospital, Fudan University, Attending Physician, Graduated from Fudan University, Shanghai Medical College, Member and Secretary of the Urinary and Male Reproductive Tumor Precision Medicine Group, Chinese Anti-Cancer Association, Good at minimally invasive treatment of urinary tumors and prostate hyperplasia Laser-like enucleation, minimally invasive treatment of urinary stones.
The main focus is the targeted precision puncture of prostate MRI/ultrasound fusion, focal HIFU treatment of prostate cancer, robotic radical prostatectomy and comprehensive treatment.
As SUB-I, it is responsible for multiple international and domestic multi-centers, and participating countries in phase II/III drug clinical trials.
The Youth Nature Fund project published 18 papers in professional journals at home and abroad, including 4 SCI papers, and participated in 1 monograph.
Case analysis.
mHSPC patients treated with ADT alone progressed to metastatic castration-resistant prostate cancer (mCRPC) within one to two years , The median overall survival time is less than 4 years [1].
In addition, the combined androgen blockade based on traditional AR inhibitors (traditional CAB) has limited benefits [2], and it is difficult to meet the increasing treatment expectations of patients.
With the support of evidence-based research and clinical practice, new AR inhibitors, represented by apatamide, combined with ADT therapy have become a new trend in mHSPC treatment-the 2020 European Association of Urology (EAU) guidelines strongly recommend apatamide Combined ADT is used for patients with M1 disease for the first time and suitable for this regimen [3].
The 2020 National Comprehensive Cancer Network (NCCN) guidelines and the American Urological Association (AUA) guidelines also recommend apatamide as one of the treatment options for mHSPC[4,5].
In addition, the final analysis of the TITAN study was announced at the 2021 American Society of Clinical Oncology Symposium on Urogenital Cancer (ASCO-GU).
After 4 years of follow-up, the results show that the 4-year survival rate of mHSPC patients receiving apatamide + ADT treatment can reach About 65%, the overall risk of death was reduced by 35%; subgroup analysis further revealed that apatamide can benefit all types of mHSPC patients [6].
This patient belongs to a high-risk/high tumor burden mHSPC with high Gleason score and multiple bone metastases.
Due to the active treatment willingness of the patient, he was enrolled in the clinical phase III study of a new generation of antiandrogenic inhibitor apatamide immediately after diagnosis.
After treatment, the patient The PSA level achieved rapid, deep, and lasting reduction, and the PSA level was maintained at 0.
02ng/ml for a long time.
After 4 years of apatamide+ADT treatment, the patient's imaging did not progress, and the metastasis was reduced, showing a significant effect.
Expert comment 1 When the patient in this case was diagnosed with high-risk/high tumor burden mHSPC, he was 62 years old.
Among patients with advanced prostate cancer, he was considered a "young age".
The patient's willingness to survive and treatment is strong, and we should work hard to delay the disease for the patient.
Progress and fight for survival time.
Traditional CAB treatment has limited benefits, and enrolling in the apatamide clinical trial is a better treatment option for the patients at that time.
Subsequent clinical efficacy confirmed this point.
37 months after the patient received apatamide+ADT treatment, PSA did not progress, and the patient’s imaging did not progress for 4 years, which showed that apatamide brought the patient.
Significant curative effect.
In addition, PFS2 can reflect the influence of the study drug on subsequent treatment, and fully reflect the benefit of the study drug for the patient's treatment.
Although the patient was treated with apatamide for 48 months, the subsequent treatment was switched to abiraterone and other drugs due to advances in imaging, but the results of the PFS2 risk stratification analysis of the TITAN study showed that regardless of high-risk/high tumor burden or For patients with low-risk/low tumor burden, first-line use of apatamide combined with ADT can reduce the risk of PFS2 [7].
Expert profile Professor Sun Zhongquan Chief physician, professor, and postgraduate tutor, Deputy Director of Urology, East China Hospital, Fudan University, "National Clinical Research Institute for Drugs-Head of Urology Specialty Group, Chinese Anti-Cancer Association Urology and Male Genital Tumor Precision Medicine Group Team Leader Chinese Society of Clinical Oncology (CSCO) Prostate Cancer Expert Committee Member Chinese Urology Society: Director of China Prostate Cancer Alliance Director of Shanghai Anti-Cancer Association, Good at early diagnosis and comprehensive treatment of urinary and male reproductive system tumors, leading domestic experts comment 2 Ah Pa flutamide inhibitor as a new AR, the ability to inhibit binding of androgens -AR, ability to prevent activation of AR enter the nucleus, and prevents AR binding capacity in the nuclear DNA of AR inhibitors are stronger than conventional bicalutamide.
in The key clinical phase III study TITAN included the "All Comer" type mHSPC population, including patients with localized prostate cancer recurrence and metastasis, mHSPC patients who had previously received systemic/local treatment, and the CHAARTED study population (high tumor burden/low tumor The results show that apatamide has a significant survival benefit, and shows a rapid and long-lasting deep response to PSA, and the results show that apatamide has a rapid and long-lasting deep response to PSA, and it is suitable for including high-risk/high-risk mHSPC patients.
All types of patients, including those with tumor burden, have significant benefits[8], which brings an efficient and safe treatment plan for mHSPC patients.
In
this case, the patient was lucky to be included in the group after being diagnosed as a high-risk/high tumor-burden mHSPC patient In the clinical trial of apalamide, the PSA level dropped rapidly after 2 months of treatment and remained at a low level of 0.
02ng/ml for a long time.
There was no progress in imaging during the 4 years of treatment.
This is consistent with previous studies confirming that apatamide has better and better results.
The faster PSA response rate is consistent with better survival benefits.
The final results of the TITAN study have established the first-line recommendation status of apatamide in mHSPC guidelines.
We look forward to its early standardized clinical application and strive for long-term clinical application for patients.
The survival benefit. Expert Profile: Associate Professor Sha Jianjun, Associate Chief Physician, PhD, Associate Professor, Department of Urology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Associate Professor, Vice Chairman of the Youth Committee of the Urinary Health Promotion Branch of China Association for International Exchange and Promotion of Health Care, Renji Hospital, Shanghai Jiaotong University School of Medicine Prostate Director of Cancer Center (Puxi) is good at laparoscopic and open surgery of various urinary system tumors, especially laparoscopic radical prostatectomy, nerve-sparing radical prostatectomy, and laparoscopic minimally invasive radical treatment of high-risk locally advanced prostate cancer The main focus of difficult surgery such as surgery and expanded lymph node dissection is the early diagnosis of prostate tumors, minimally invasive surgical treatment, and the individualized and precise standardized treatment of advanced prostate cancer.
More than 10 papers have been published in international English SCI journals as the first author and corresponding author.
Articles, 14 papers published in domestic core journals, participated in the editor-in-chief of urology monographs, 1 reference: [1] James ND, et al.
Survival with Newly Diagnosed Metastatic Prostate Cancer in the "Docetaxel Era": Data from 917 Patients in the Control Arm of the STAMPEDE Trial (MRC PR08, CRUK/06/019)[J].
Eur Urol.
2015 Jun;67(6):1028-1038.
[2] Usami M, et al.
Bicalutamide 80 mg combined with a luteinizing hormone -releasing hormone agonist (LHRH-A) versus LHRH-A monotherapy in advanced prostate cancer: findings from a phase III randomized, double-blind, multicenter trial in Japanese patients.
Prostate Cancer and Prostatic Diseases 2007; 10: 194-201.
[ 3] Mottet N,et al.
EAU/ESTRO/ESUR/SIOG Guidelines on Prostate Cancer 2020.
[4] James LM, et al.
NCCN Clinical Practice Guideline in Prostate Cancer 2020 v1.
[5] Lowrance W, et al.
AUA Guideline.
American Urological Association 2020.
[6] Apalutamide (APA) for metastatic castration-sensitive prostate cancer (mCSPC) in TITAN:Outcomes in patients (pts) with low- and high-risk disease.
Mustafa O, et al.
, 2020 ASCO GU.
Abstract 87 .
[7] Chi KN, Chowdhury S, Bjartell A et al.
Final analysis results from TITAN: A phase III study of apalutamide (APA) versus placebo (PBO) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT).
Journal of Clinical Oncology 39, 2021 (Suppl 6; abstr 11).
[8] Chi KN, Agarwal N, Bjartell A, et al.
Apalutamide for metastatic, castration-sensitive prostate cancer.
New England Journal of Medicine 2019; 381:13-24.
Case introduction ▎Basic situation The patient is male, 62 years old.
The patient came to the outpatient clinic of the hospital in August 2016 due to "difficult urination".
▎Physical examination results of digital rectal examination: the prostate is hard.
▎Laboratory examination of prostate specific antigen (PSA): 110.
4 ng/ml.
▎Imaging examination CT pelvic cavity + chest + whole abdomen scan + enhancement (2016-09-13): There were no enlarged lymph nodes in the pelvic cavity, and no clear abnormal enhancement lesions.
However, there are multiple osteogenic foci in the spine, ribs and iliac bones on both sides, and the possibility of metastasis needs to be considered.
Whole body bone imaging (2016-09-14) (Figure 1): The 5th posterior rib on the right, the 7th and 11th posterior ribs on the left, the 8th and 10th thoracic vertebrae, and the 4th lumbar vertebra.
The local radioactivity of the left ilium is abnormally concentrated.
Gather, consider the possibility of transfer.
Figure 1 Results of whole-body bone imaging (2016-09-14) ▎Prostate cancer tissues were found at the 10 points in the pathological examination of prostate puncture specimens at "14" points, and the Gleason score was 4+4=8 points.
▎The diagnosis result is high-risk/high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC), T4N0M1b.
After treatment On September 22, 2016, the patient started taking apatamide 240mg QD treatment.
On October 11, 2016, the patient started to inject goserelin acetate.
After the patient received apatamide+ADT (androgen deprivation therapy) for 2 months, the re-examination showed that PSA decreased rapidly from 110.
4 ng/ml to 35.
37 ng/ml, and decreased to 0.
02 ng/ml after 4 months and continued to maintain ( figure 2).PSA showed rapid and deep reduction.
Testosterone has been maintained at 0.
57 nmol/l; and as of December 22, 2017, whole-body bone imaging showed reduced foci of concentration (Figure 3).
Figure 2 Changes in PSA during the treatment of apatamide + ADT Figure 3 Changes in the results of the patient's whole body bone imaging (2016.
09-2019.
07) In October 2019, the patient had PSA progression after 37 months of treatment with apatamide (no imaging) Progression, asymptomatic progression), the patient continues to maintain apatamide treatment.
In September 2020, after 48 months of treatment with apatamide, the patient began to receive follow-up treatments such as abiraterone due to the progress of imaging.
Case provided by doctor Shen Zhiyuan, Attending Physician, Department of Urology, East China Hospital, Fudan University, Attending Physician, Graduated from Fudan University, Shanghai Medical College, Member and Secretary of the Urinary and Male Reproductive Tumor Precision Medicine Group, Chinese Anti-Cancer Association, Good at minimally invasive treatment of urinary tumors and prostate hyperplasia Laser-like enucleation, minimally invasive treatment of urinary stones.
The main focus is the targeted precision puncture of prostate MRI/ultrasound fusion, focal HIFU treatment of prostate cancer, robotic radical prostatectomy and comprehensive treatment.
As SUB-I, it is responsible for multiple international and domestic multi-centers, and participating countries in phase II/III drug clinical trials.
The Youth Nature Fund project published 18 papers in professional journals at home and abroad, including 4 SCI papers, and participated in 1 monograph.
Case analysis.
mHSPC patients treated with ADT alone progressed to metastatic castration-resistant prostate cancer (mCRPC) within one to two years , The median overall survival time is less than 4 years [1].
In addition, the combined androgen blockade based on traditional AR inhibitors (traditional CAB) has limited benefits [2], and it is difficult to meet the increasing treatment expectations of patients.
With the support of evidence-based research and clinical practice, new AR inhibitors, represented by apatamide, combined with ADT therapy have become a new trend in mHSPC treatment-the 2020 European Association of Urology (EAU) guidelines strongly recommend apatamide Combined ADT is used for patients with M1 disease for the first time and suitable for this regimen [3].
The 2020 National Comprehensive Cancer Network (NCCN) guidelines and the American Urological Association (AUA) guidelines also recommend apatamide as one of the treatment options for mHSPC[4,5].
In addition, the final analysis of the TITAN study was announced at the 2021 American Society of Clinical Oncology Symposium on Urogenital Cancer (ASCO-GU).
After 4 years of follow-up, the results show that the 4-year survival rate of mHSPC patients receiving apatamide + ADT treatment can reach About 65%, the overall risk of death was reduced by 35%; subgroup analysis further revealed that apatamide can benefit all types of mHSPC patients [6].
This patient belongs to a high-risk/high tumor burden mHSPC with high Gleason score and multiple bone metastases.
Due to the active treatment willingness of the patient, he was enrolled in the clinical phase III study of a new generation of antiandrogenic inhibitor apatamide immediately after diagnosis.
After treatment, the patient The PSA level achieved rapid, deep, and lasting reduction, and the PSA level was maintained at 0.
02ng/ml for a long time.
After 4 years of apatamide+ADT treatment, the patient's imaging did not progress, and the metastasis was reduced, showing a significant effect.
Expert comment 1 When the patient in this case was diagnosed with high-risk/high tumor burden mHSPC, he was 62 years old.
Among patients with advanced prostate cancer, he was considered a "young age".
The patient's willingness to survive and treatment is strong, and we should work hard to delay the disease for the patient.
Progress and fight for survival time.
Traditional CAB treatment has limited benefits, and enrolling in the apatamide clinical trial is a better treatment option for the patients at that time.
Subsequent clinical efficacy confirmed this point.
37 months after the patient received apatamide+ADT treatment, PSA did not progress, and the patient’s imaging did not progress for 4 years, which showed that apatamide brought the patient.
Significant curative effect.
In addition, PFS2 can reflect the influence of the study drug on subsequent treatment, and fully reflect the benefit of the study drug for the patient's treatment.
Although the patient was treated with apatamide for 48 months, the subsequent treatment was switched to abiraterone and other drugs due to advances in imaging, but the results of the PFS2 risk stratification analysis of the TITAN study showed that regardless of high-risk/high tumor burden or For patients with low-risk/low tumor burden, first-line use of apatamide combined with ADT can reduce the risk of PFS2 [7].
Expert profile Professor Sun Zhongquan Chief physician, professor, and postgraduate tutor, Deputy Director of Urology, East China Hospital, Fudan University, "National Clinical Research Institute for Drugs-Head of Urology Specialty Group, Chinese Anti-Cancer Association Urology and Male Genital Tumor Precision Medicine Group Team Leader Chinese Society of Clinical Oncology (CSCO) Prostate Cancer Expert Committee Member Chinese Urology Society: Director of China Prostate Cancer Alliance Director of Shanghai Anti-Cancer Association, Good at early diagnosis and comprehensive treatment of urinary and male reproductive system tumors, leading domestic experts comment 2 Ah Pa flutamide inhibitor as a new AR, the ability to inhibit binding of androgens -AR, ability to prevent activation of AR enter the nucleus, and prevents AR binding capacity in the nuclear DNA of AR inhibitors are stronger than conventional bicalutamide.
in The key clinical phase III study TITAN included the "All Comer" type mHSPC population, including patients with localized prostate cancer recurrence and metastasis, mHSPC patients who had previously received systemic/local treatment, and the CHAARTED study population (high tumor burden/low tumor The results show that apatamide has a significant survival benefit, and shows a rapid and long-lasting deep response to PSA, and the results show that apatamide has a rapid and long-lasting deep response to PSA, and it is suitable for including high-risk/high-risk mHSPC patients.
All types of patients, including those with tumor burden, have significant benefits[8], which brings an efficient and safe treatment plan for mHSPC patients.
In
this case, the patient was lucky to be included in the group after being diagnosed as a high-risk/high tumor-burden mHSPC patient In the clinical trial of apalamide, the PSA level dropped rapidly after 2 months of treatment and remained at a low level of 0.
02ng/ml for a long time.
There was no progress in imaging during the 4 years of treatment.
This is consistent with previous studies confirming that apatamide has better and better results.
The faster PSA response rate is consistent with better survival benefits.
The final results of the TITAN study have established the first-line recommendation status of apatamide in mHSPC guidelines.
We look forward to its early standardized clinical application and strive for long-term clinical application for patients.
The survival benefit. Expert Profile: Associate Professor Sha Jianjun, Associate Chief Physician, PhD, Associate Professor, Department of Urology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Associate Professor, Vice Chairman of the Youth Committee of the Urinary Health Promotion Branch of China Association for International Exchange and Promotion of Health Care, Renji Hospital, Shanghai Jiaotong University School of Medicine Prostate Director of Cancer Center (Puxi) is good at laparoscopic and open surgery of various urinary system tumors, especially laparoscopic radical prostatectomy, nerve-sparing radical prostatectomy, and laparoscopic minimally invasive radical treatment of high-risk locally advanced prostate cancer The main focus of difficult surgery such as surgery and expanded lymph node dissection is the early diagnosis of prostate tumors, minimally invasive surgical treatment, and the individualized and precise standardized treatment of advanced prostate cancer.
More than 10 papers have been published in international English SCI journals as the first author and corresponding author.
Articles, 14 papers published in domestic core journals, participated in the editor-in-chief of urology monographs, 1 reference: [1] James ND, et al.
Survival with Newly Diagnosed Metastatic Prostate Cancer in the "Docetaxel Era": Data from 917 Patients in the Control Arm of the STAMPEDE Trial (MRC PR08, CRUK/06/019)[J].
Eur Urol.
2015 Jun;67(6):1028-1038.
[2] Usami M, et al.
Bicalutamide 80 mg combined with a luteinizing hormone -releasing hormone agonist (LHRH-A) versus LHRH-A monotherapy in advanced prostate cancer: findings from a phase III randomized, double-blind, multicenter trial in Japanese patients.
Prostate Cancer and Prostatic Diseases 2007; 10: 194-201.
[ 3] Mottet N,et al.
EAU/ESTRO/ESUR/SIOG Guidelines on Prostate Cancer 2020.
[4] James LM, et al.
NCCN Clinical Practice Guideline in Prostate Cancer 2020 v1.
[5] Lowrance W, et al.
AUA Guideline.
American Urological Association 2020.
[6] Apalutamide (APA) for metastatic castration-sensitive prostate cancer (mCSPC) in TITAN:Outcomes in patients (pts) with low- and high-risk disease.
Mustafa O, et al.
, 2020 ASCO GU.
Abstract 87 .
[7] Chi KN, Chowdhury S, Bjartell A et al.
Final analysis results from TITAN: A phase III study of apalutamide (APA) versus placebo (PBO) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT).
Journal of Clinical Oncology 39, 2021 (Suppl 6; abstr 11).
[8] Chi KN, Agarwal N, Bjartell A, et al.
Apalutamide for metastatic, castration-sensitive prostate cancer.
New England Journal of Medicine 2019; 381:13-24.
