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On April 23-24, 2021, the Chinese Society of Clinical Oncology (CSCO) Guidelines Conference was successfully held in Beijing, the capital.
As one of the most influential academic festivals in the field of oncology in China, big coffees from all over the country gathered together to witness the update of multiple guidelines.
In the urinary system tumor special session on the afternoon of the 23rd, Professor Cui Chuanliang from Peking University Cancer Hospital and Professor Ye Dingwei from Fudan University Cancer Hospital respectively interpreted the updated points of the 2021 CSCO Urothelial Cancer Diagnosis and Treatment Guidelines and the Update Points of the Prostate Cancer Diagnosis and Treatment Guidelines.
2021 CSCO Urothelial Carcinoma Diagnosis and Treatment Guidelines Update Points 01 Adjuvant treatment of muscular invasive bladder cancer after surgery.
Adjuvant treatment of superficial muscular invasive bladder cancer.
For patients with muscular invasive bladder cancer, transurethral bladder tumor resection combined with postoperative surgery The comprehensive treatment plan of radiotherapy and chemotherapy can achieve a 10-year overall survival rate and progression-free survival rate similar to standard radical bladder cancer surgery; it can be used as a treatment option for patients who are not suitable or who refuse to undergo cystectomy.
For patients with poor surgical margins and late local lesions, and only undergoing palliative surgery, postoperative radiotherapy can improve the local control rate.
For patients with pT3/4 and/or lymph node positive and no distant metastasis (M0), adjuvant chemotherapy after radical cystectomy is still controversial.
Based on the CheckMate-274 study reaching the primary research endpoint, in 2021 CSCO urothelial cancer plans to increase the postoperative adjuvant treatment of PD-1 monoclonal antibody as a grade III recommendation.
02 First-line treatment of metastatic urothelial cancer Table first-line treatment Currently, chemotherapy is still the basis for the treatment of urothelial cancer.
Based on the IMvigor210 study and the KEYNOTE-052 study, atezolizumab and pembrolizumab were approved by the FDA for the first-line treatment of platinum-intolerant metastatic urothelial cancer.
In the KEYNOTE-052 study, PD-L1 positive patients benefited more significantly.
At present, atelizumab and pembrolizumab have not yet obtained indications for the treatment of metastatic urothelial carcinoma in China, and are only suitable for patients with PD-L1 expression or who cannot tolerate platinum-based chemotherapy.
In the first-line treatment of the new CSCO guidelines for urothelial cancer, for patients with locally advanced or metastatic urothelial cancer that are not suitable for cisplatin, the level III recommendation still retains atezizumab (class 2A evidence) and pembrolizumab Monoclonal antibody (Class 2A evidence).
03Maintenance treatment after first-line treatment of metastatic urothelial cancer.
With the development of immunotherapy, the indications of maintenance treatment after first-line treatment continue to move forward.
Based on the results of the JAVELIN Bladder 100 study and the HCRN GU14-182 study, for patients with stable or objectively effective disease after 4 to 6 cycles of first-line chemotherapy, avirumumab is recommended for level II (Class 1A evidence); level III is recommended for Pascal Bolivizumab (Class 2A evidence).
Aviruzumab has not yet been marketed in China, and pembrolizumab has not yet obtained indications for advanced urothelial cancer in China.
04 Second-line treatment of advanced urothelial cancer table Second-line treatment of urothelial cancer is given priority to immunotherapy; Erdatinib has not been approved for marketing in China, and is only suitable for advanced urothelial cancer with FGFR2/3 gene mutation; Riprolizumab, pembrolizumab, and aviruzumab have not yet obtained indications for advanced urothelial cancer in China.
Because the US FDA withdrew the indications of atilizumab and duvalizumab for the second-line treatment of urothelial cancer.
This year's CSCO guidelines also removed Level III recommendations.
Based on the results of BGB-A317-204 and POLARIS-03, the new CSCO guidelines continue to recommend tislelizumab (class 2A evidence) (only applicable to locally advanced or metastatic urothelial cancer with high PD-L1 expression), Teriplizumab (Class 2A evidence) is used for the second-line treatment of advanced urothelial cancer (Class II recommendation).
In addition, these two drugs are relatively well accessible, and both have been approved for urothelial cancer indications in China, and tislelizumab has entered medical insurance.
05 Third-line treatment for advanced urothelial cancer Table third-line treatment For patients who have failed previous platinum-based chemotherapy and immunotherapy, based on the data of the BLC2001 study, the guidelines continue to use Erdafitinib as a level III recommendation (class 2A evidence).
Patients with FGFR2/3 gene mutations; Based on the EV-301 study data, the guideline adds a new level III recommendation for the new antibody conjugate drug Enfortumab vedotin (Class 2A evidence).
Based on the results of the domestic phase II study of widisituzumab (RC48-ADC), the new version of the guidelines intends to add widisituzumab for posterior treatment (level III recommendation).
Similar to the second-line treatment, the new version of the guidelines also deletes the atilizumab and pembrolizumab regimens in the third-line treatment grade III recommendation.
2021 CSCO prostate cancer diagnosis and treatment guidelines update key points The guidelines update principles are: evidence-based evidence, advance with the times; precision medicine, diagnosis first; drug accessibility, therapeutic value; local data, leading guidelines.
After the guide kick-off meeting and internal seminars, the new guide will be officially released on July 10.
01 The MDT Diagnosis and Treatment Model of Prostate Cancer The 2021 CSCO Prostate Cancer Guidelines "MDT Diagnosis and Treatment Model" emphasizes the importance of participating in clinical trials: clinical trials may bring better treatment opportunities for patients, and prostate cancer patients should be strongly encouraged after evaluation Participate in clinical trials.
In addition, the 2021 version of the CSCO prostate cancer guidelines also emphasizes the importance of network MDT: network-based telemedicine can help patients obtain rapid, timely and undifferentiated treatment opinions.
02 A study published in 2020 of complications related to prostate puncture infection found that compared with transperineal biopsy, the complications of infection after rectal biopsy were significantly higher (Class 1A evidence).
Another meta-analysis showed that the use of povidone-iodine preparations before biopsy, in addition to preventive antibacterial, can significantly reduce the incidence of infection complications (type 1A evidence).
A meta-analysis of 11 studies showed that after the use of prophylactic antibiotics, infections after transrectal prostate biopsy were significantly reduced (5.
6% vs.
11.
6%) (type 1A evidence). Based on the above evidence, the 2021 version of the CSCO prostate cancer guidelines emphasizes complications related to puncture infection and coping strategies.
03 Genetic testing and liquid biopsy: update the detection of patient types, update the detection of patient types, update the 2021 V2 version of the NCCN guidelines recommended genetic testing population: patients with metastatic prostate cancer recommend tumor homologous recombination repair (HRR) mutation testing; limited-stage patients can also consider tumors HRR mutation detection.
Test content: Level III recommendation to add TP53 is based on the latest study of Shandong University Qilu Hospital found that the incidence of TP53 mutations in Chinese hormone-sensitive prostate cancer patients is 22.
3%, which is a high incidence.
TP53 is often associated with mutations in other genes and can be used as a core mutation in patients with prostate cancer.
Patients with TP53 mutations have a poor prognosis and are not sensitive to new endocrine therapies such as abiraterone or enzalutamide.
Types of test samples: tissue samples + plasma ctDNA samples TRITON2, TRITON3 studies have shown that in metastatic prostate cancer, plasma samples have a high success rate (94% ctDNA samples are successfully tested).
The study also found that the detection of BRCA1/2 mutant tissue samples and plasma samples were highly consistent.
Similarly, the Profound study showed that the test results of tissue samples and plasma samples were highly consistent: the positive agreement rate was 81%, and the negative agreement rate was 92%).
Based on the above evidence, the 2021 version of the CSCO prostate cancer guidelines for patients with metastatic prostate cancer for the purpose of making treatment decisions, the genetic testing type III recommended a new TP53, and a new tumor tissue + plasma ctDNA sample for the test sample type (I Grade/II recommendation).
Table prostate cancer gene detection and liquid biopsy 04 Treatment of localized prostate cancer (very low-risk, low-risk, intermediate-risk) Based on a study discovered in 2020, for localized extremely low-risk, low-risk and some selected intermediate-risk For prostate cancer patients, the 2021 version of the CSCO guidelines update: If there is no recent history of transurethral resection of the prostate and patients with a good IPSS score, low-dose brachytherapy can be recommended.
05 Treatment of Metastatic Hormone Sensitive Prostate Cancer (mHSPC) A study published in 2020 showed that for mHSPC patients, combination therapy based on androgen deprivation therapy (ADT) is more effective than ADT alone, but it has not been confirmed yet.
A combination method is more effective.
At the same time, the 2021 version of the EAU guidelines also emphasizes: For patients who are first diagnosed with mHSPC, if there is no contraindication to the combination therapy, if they have sufficient life expectancy to benefit from the combination therapy, and are willing to accept the increased risk of side effects, they should be based on ADT.
Combine other treatments.
Based on this, the 2021 CSCO prostate cancer guidelines no longer recommend ADT alone for mHSPC patients.
06Diagnosis and treatment of metastatic castration-resistant prostate cancer (mCRPC) The 2021 version of the CSCO prostate cancer guidelines adopts whether or not to have received new endocrine therapy/chemotherapy in the past to replace the traditional first-line and second-line classification methods to guide the treatment of patients at different stages more clearly and intuitively .
Diagnosis and treatment of metastatic castration-resistant prostate cancer 07 Prevention and treatment of bone-related events Desulumab is a fully human monoclonal antibody directed against the nuclear factor receptor activator KB ligand.
A phase III study found that disulumab versus zoledronic acid can significantly delay or prevent the occurrence of bone-related events.
The 2021 V1 edition of the NCCN Guidelines recommends that Disulumab can be used as a class I preference for anti-bone resorption in patients with bone metastases.
In 2020, the National Medical Products Administration (NMPA) of China approved disulumab for the prevention of bone metastases from solid tumors and bone-related events caused by multiple bone marrow.
The 2021 version of the CSCO prostate cancer guidelines recommends: Disumab can prevent bone-related events in patients with mCRPC bone metastasis, and the recommendation is updated from category Ⅱ to category Ⅰ recommendation.
08 The local data update is based on a review published by the Fudan University Cancer Hospital in Nature Reviews Urology.
The new version of the CSCO guidelines has improved the epidemiological data of the Chinese population in the chapter "Prostate Cancer Screening": Countries that implement prostate cancer screening strategies, Japan’s five-year survival rate has increased rapidly, with an average annual increase of about 11.
7%, and a 5-year survival rate of 93%, while China’s annual increase is only 3.
7%, and the 5-year survival rate is 69.
2%.
At the same time, the "genetic counseling" data in "gene testing and liquid biopsy" was added: the incidence of DDR gene germline mutations in the Chinese population with metastatic, localized, and limited high-risk prostate cancer is 12%, 10%, and 8.
1%.
In addition, single nucleotide polymorphisms are associated with the risk of prostate cancer.
Genome-wide studies have shown that there are large differences between East Asian and Asian populations.
As one of the most influential academic festivals in the field of oncology in China, big coffees from all over the country gathered together to witness the update of multiple guidelines.
In the urinary system tumor special session on the afternoon of the 23rd, Professor Cui Chuanliang from Peking University Cancer Hospital and Professor Ye Dingwei from Fudan University Cancer Hospital respectively interpreted the updated points of the 2021 CSCO Urothelial Cancer Diagnosis and Treatment Guidelines and the Update Points of the Prostate Cancer Diagnosis and Treatment Guidelines.
2021 CSCO Urothelial Carcinoma Diagnosis and Treatment Guidelines Update Points 01 Adjuvant treatment of muscular invasive bladder cancer after surgery.
Adjuvant treatment of superficial muscular invasive bladder cancer.
For patients with muscular invasive bladder cancer, transurethral bladder tumor resection combined with postoperative surgery The comprehensive treatment plan of radiotherapy and chemotherapy can achieve a 10-year overall survival rate and progression-free survival rate similar to standard radical bladder cancer surgery; it can be used as a treatment option for patients who are not suitable or who refuse to undergo cystectomy.
For patients with poor surgical margins and late local lesions, and only undergoing palliative surgery, postoperative radiotherapy can improve the local control rate.
For patients with pT3/4 and/or lymph node positive and no distant metastasis (M0), adjuvant chemotherapy after radical cystectomy is still controversial.
Based on the CheckMate-274 study reaching the primary research endpoint, in 2021 CSCO urothelial cancer plans to increase the postoperative adjuvant treatment of PD-1 monoclonal antibody as a grade III recommendation.
02 First-line treatment of metastatic urothelial cancer Table first-line treatment Currently, chemotherapy is still the basis for the treatment of urothelial cancer.
Based on the IMvigor210 study and the KEYNOTE-052 study, atezolizumab and pembrolizumab were approved by the FDA for the first-line treatment of platinum-intolerant metastatic urothelial cancer.
In the KEYNOTE-052 study, PD-L1 positive patients benefited more significantly.
At present, atelizumab and pembrolizumab have not yet obtained indications for the treatment of metastatic urothelial carcinoma in China, and are only suitable for patients with PD-L1 expression or who cannot tolerate platinum-based chemotherapy.
In the first-line treatment of the new CSCO guidelines for urothelial cancer, for patients with locally advanced or metastatic urothelial cancer that are not suitable for cisplatin, the level III recommendation still retains atezizumab (class 2A evidence) and pembrolizumab Monoclonal antibody (Class 2A evidence).
03Maintenance treatment after first-line treatment of metastatic urothelial cancer.
With the development of immunotherapy, the indications of maintenance treatment after first-line treatment continue to move forward.
Based on the results of the JAVELIN Bladder 100 study and the HCRN GU14-182 study, for patients with stable or objectively effective disease after 4 to 6 cycles of first-line chemotherapy, avirumumab is recommended for level II (Class 1A evidence); level III is recommended for Pascal Bolivizumab (Class 2A evidence).
Aviruzumab has not yet been marketed in China, and pembrolizumab has not yet obtained indications for advanced urothelial cancer in China.
04 Second-line treatment of advanced urothelial cancer table Second-line treatment of urothelial cancer is given priority to immunotherapy; Erdatinib has not been approved for marketing in China, and is only suitable for advanced urothelial cancer with FGFR2/3 gene mutation; Riprolizumab, pembrolizumab, and aviruzumab have not yet obtained indications for advanced urothelial cancer in China.
Because the US FDA withdrew the indications of atilizumab and duvalizumab for the second-line treatment of urothelial cancer.
This year's CSCO guidelines also removed Level III recommendations.
Based on the results of BGB-A317-204 and POLARIS-03, the new CSCO guidelines continue to recommend tislelizumab (class 2A evidence) (only applicable to locally advanced or metastatic urothelial cancer with high PD-L1 expression), Teriplizumab (Class 2A evidence) is used for the second-line treatment of advanced urothelial cancer (Class II recommendation).
In addition, these two drugs are relatively well accessible, and both have been approved for urothelial cancer indications in China, and tislelizumab has entered medical insurance.
05 Third-line treatment for advanced urothelial cancer Table third-line treatment For patients who have failed previous platinum-based chemotherapy and immunotherapy, based on the data of the BLC2001 study, the guidelines continue to use Erdafitinib as a level III recommendation (class 2A evidence).
Patients with FGFR2/3 gene mutations; Based on the EV-301 study data, the guideline adds a new level III recommendation for the new antibody conjugate drug Enfortumab vedotin (Class 2A evidence).
Based on the results of the domestic phase II study of widisituzumab (RC48-ADC), the new version of the guidelines intends to add widisituzumab for posterior treatment (level III recommendation).
Similar to the second-line treatment, the new version of the guidelines also deletes the atilizumab and pembrolizumab regimens in the third-line treatment grade III recommendation.
2021 CSCO prostate cancer diagnosis and treatment guidelines update key points The guidelines update principles are: evidence-based evidence, advance with the times; precision medicine, diagnosis first; drug accessibility, therapeutic value; local data, leading guidelines.
After the guide kick-off meeting and internal seminars, the new guide will be officially released on July 10.
01 The MDT Diagnosis and Treatment Model of Prostate Cancer The 2021 CSCO Prostate Cancer Guidelines "MDT Diagnosis and Treatment Model" emphasizes the importance of participating in clinical trials: clinical trials may bring better treatment opportunities for patients, and prostate cancer patients should be strongly encouraged after evaluation Participate in clinical trials.
In addition, the 2021 version of the CSCO prostate cancer guidelines also emphasizes the importance of network MDT: network-based telemedicine can help patients obtain rapid, timely and undifferentiated treatment opinions.
02 A study published in 2020 of complications related to prostate puncture infection found that compared with transperineal biopsy, the complications of infection after rectal biopsy were significantly higher (Class 1A evidence).
Another meta-analysis showed that the use of povidone-iodine preparations before biopsy, in addition to preventive antibacterial, can significantly reduce the incidence of infection complications (type 1A evidence).
A meta-analysis of 11 studies showed that after the use of prophylactic antibiotics, infections after transrectal prostate biopsy were significantly reduced (5.
6% vs.
11.
6%) (type 1A evidence). Based on the above evidence, the 2021 version of the CSCO prostate cancer guidelines emphasizes complications related to puncture infection and coping strategies.
03 Genetic testing and liquid biopsy: update the detection of patient types, update the detection of patient types, update the 2021 V2 version of the NCCN guidelines recommended genetic testing population: patients with metastatic prostate cancer recommend tumor homologous recombination repair (HRR) mutation testing; limited-stage patients can also consider tumors HRR mutation detection.
Test content: Level III recommendation to add TP53 is based on the latest study of Shandong University Qilu Hospital found that the incidence of TP53 mutations in Chinese hormone-sensitive prostate cancer patients is 22.
3%, which is a high incidence.
TP53 is often associated with mutations in other genes and can be used as a core mutation in patients with prostate cancer.
Patients with TP53 mutations have a poor prognosis and are not sensitive to new endocrine therapies such as abiraterone or enzalutamide.
Types of test samples: tissue samples + plasma ctDNA samples TRITON2, TRITON3 studies have shown that in metastatic prostate cancer, plasma samples have a high success rate (94% ctDNA samples are successfully tested).
The study also found that the detection of BRCA1/2 mutant tissue samples and plasma samples were highly consistent.
Similarly, the Profound study showed that the test results of tissue samples and plasma samples were highly consistent: the positive agreement rate was 81%, and the negative agreement rate was 92%).
Based on the above evidence, the 2021 version of the CSCO prostate cancer guidelines for patients with metastatic prostate cancer for the purpose of making treatment decisions, the genetic testing type III recommended a new TP53, and a new tumor tissue + plasma ctDNA sample for the test sample type (I Grade/II recommendation).
Table prostate cancer gene detection and liquid biopsy 04 Treatment of localized prostate cancer (very low-risk, low-risk, intermediate-risk) Based on a study discovered in 2020, for localized extremely low-risk, low-risk and some selected intermediate-risk For prostate cancer patients, the 2021 version of the CSCO guidelines update: If there is no recent history of transurethral resection of the prostate and patients with a good IPSS score, low-dose brachytherapy can be recommended.
05 Treatment of Metastatic Hormone Sensitive Prostate Cancer (mHSPC) A study published in 2020 showed that for mHSPC patients, combination therapy based on androgen deprivation therapy (ADT) is more effective than ADT alone, but it has not been confirmed yet.
A combination method is more effective.
At the same time, the 2021 version of the EAU guidelines also emphasizes: For patients who are first diagnosed with mHSPC, if there is no contraindication to the combination therapy, if they have sufficient life expectancy to benefit from the combination therapy, and are willing to accept the increased risk of side effects, they should be based on ADT.
Combine other treatments.
Based on this, the 2021 CSCO prostate cancer guidelines no longer recommend ADT alone for mHSPC patients.
06Diagnosis and treatment of metastatic castration-resistant prostate cancer (mCRPC) The 2021 version of the CSCO prostate cancer guidelines adopts whether or not to have received new endocrine therapy/chemotherapy in the past to replace the traditional first-line and second-line classification methods to guide the treatment of patients at different stages more clearly and intuitively .
Diagnosis and treatment of metastatic castration-resistant prostate cancer 07 Prevention and treatment of bone-related events Desulumab is a fully human monoclonal antibody directed against the nuclear factor receptor activator KB ligand.
A phase III study found that disulumab versus zoledronic acid can significantly delay or prevent the occurrence of bone-related events.
The 2021 V1 edition of the NCCN Guidelines recommends that Disulumab can be used as a class I preference for anti-bone resorption in patients with bone metastases.
In 2020, the National Medical Products Administration (NMPA) of China approved disulumab for the prevention of bone metastases from solid tumors and bone-related events caused by multiple bone marrow.
The 2021 version of the CSCO prostate cancer guidelines recommends: Disumab can prevent bone-related events in patients with mCRPC bone metastasis, and the recommendation is updated from category Ⅱ to category Ⅰ recommendation.
08 The local data update is based on a review published by the Fudan University Cancer Hospital in Nature Reviews Urology.
The new version of the CSCO guidelines has improved the epidemiological data of the Chinese population in the chapter "Prostate Cancer Screening": Countries that implement prostate cancer screening strategies, Japan’s five-year survival rate has increased rapidly, with an average annual increase of about 11.
7%, and a 5-year survival rate of 93%, while China’s annual increase is only 3.
7%, and the 5-year survival rate is 69.
2%.
At the same time, the "genetic counseling" data in "gene testing and liquid biopsy" was added: the incidence of DDR gene germline mutations in the Chinese population with metastatic, localized, and limited high-risk prostate cancer is 12%, 10%, and 8.
1%.
In addition, single nucleotide polymorphisms are associated with the risk of prostate cancer.
Genome-wide studies have shown that there are large differences between East Asian and Asian populations.
