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On January 8, the "2022 Beijing Urological Cancer Youth Forum" was successfully held by the Youth Committee of the Urology and Male Genital Oncology Committee of the Beijing Anti-Cancer Association and the Beijing Medical Award Foundation
.
During the meeting, Professor Guo Gang from the General Hospital of the Chinese People's Liberation Army shared the clinical value and timing of cytoreductive nephrectomy (CN) for metastatic renal cancer (mRCC)
.
Expert Profile Prof.
Guo Gang Chief Physician of Urology Department, Chinese People's Liberation Army General Hospital, MD Director of Urology Department of the Third Medical Center of Chinese People's Liberation Army General Hospital, member of Standing Committee of Urology Professional Committee of Beijing Association of Integrative Medicine, Member of Beijing Medical Association Rare Disease Branch Member, Cancer Society TSC-AML Collaborative Group Member, CSCO Urothelial Carcinoma Expert Committee Member, CSCO Rare Tumor Expert Committee Member Efficacy and safety of cytoreductive nephrectomy (CN) + sunitinib for metastatic renal cancer
.
The study included 450 patients
.
The final results showed that the median overall survival (OS) of CN+ sunitinib group (group A) and sunitinib group (group B) in the total population were both 15.
6 months (HR=0.
97), and in IMDC In the intermediate-risk group, the median OS of the two groups was 19 months and 27.
9 months, respectively (HR=0.
94); in the high-risk group of IMDC, the median OS of the two groups was 9.
5 months and 11.
8 months, respectively (HR=0.
94).
1.
01)
.
Subgroup analysis showed that among intermediate-risk patients with IMDC, patients with one risk factor had significantly better median OS with cytoreductive resection, whereas patients with two risk factors had no difference in OS
.
Similarly, patients with only 1 metastases had better median OS with the combination therapy, while there was no difference in median OS in the subgroup of patients with more than 1 metastases
.
Follow-up CN in the sunitinib treatment group: More than 80% of patients required CN due to metastatic CR or near CR or patients with certain symptoms
.
31.
1% of patients who received follow-up CN were re-used sunitinib postoperatively
.
After sunitinib treatment, the median OS for CN patients was 48.
5 months, compared with 15.
7 months for sunitinib-only patients (HR=0.
34)
.
Long-term follow-up results suggest that the 61.
5-month follow-up results show that sunitinib monotherapy is non-inferior to CN + sunitinib for both intermediate and high-risk patients with MDKCC or IMDC; this study confirms that CN should no longer be used as a standard treatment regimen ; Screening patients: patients with only 1 IMDC risk factor may benefit from CN, especially those with only 1 metastases; number of metastases cannot be used to guide selection of patients who would benefit from surgery; initial Patients with better remission after treatment may accept delayed CN
.
The EAU Kidney Cancer Guidelines Recommendations on CN For high-risk MSKCC patients, CN is no longer recommended; for asymptomatic MSKCC intermediate-risk renal cancer patients requiring systemic therapy with vascular endothelial growth factor receptor inhibitors, immediate CN is not recommended
.
Limitations of the CARMENA study 22.
5% of patients in the CN + sunitinib arm did not receive targeted therapy and only received surgery, compared with 17% of sunitinib alone patients who received CN
.
These data may have an impact on the results of the study, and further analysis of these factors is required to draw more accurate conclusions
.
The CARMENA study included patients with moderate and poor prognosis in MSKCC, so the results were not applicable to patients with good prognosis; in terms of tumor burden, only those with large primary tumors and small metastatic lesions were included, ignoring those with small primary tumors and large metastatic burden.
crowd
.
The CARMENA study re-understands that the treatment of renal cancer was in the era of targeted therapy when the CARMENA study was carried out.
In the new era of combined immune targeting as first-line mRCC therapy, the value of CN needs to be re-evaluated
.
According to the stratification of the disease and the guidance of molecular markers, individualized treatment is carried out
.
The treatment idea for metastatic renal cell carcinoma in the new era is systemic therapy-maximum tumor debulking-adjuvant therapy
.
A recently published article summarizes the current treatment model: for patients with single or few metastases (in the case of surgical intervention), the investigators recommend maximal tumor debulking; for patients temporarily unable to surgically intervene, it is recommended to perform systematic first.
After treatment, cytoreduction should be performed to the maximum extent, and adjuvant therapy is recommended after surgery (based on the KEYNOTE-564 study).
For high-risk groups, immediate systemic therapy is recommended for symptomatic lesions
.
CN treatment timing SURTIME study: In the era of targeted therapy, CN timing has no significant effect on the benefit of mRCC.
The phase III SURTIME study aims to evaluate the impact of CN timing on the outcomes of mRCC patients in the era of targeted therapy
.
Ninety-nine patients were included in the study, with 50 and 49 in the immediate CN group (CN first followed by targeted therapy) and the delayed CN group (targeted therapy followed by CN), respectively
.
The primary endpoint was progression-free survival (PFR)
.
The results showed that the 28-week PFR in the immediate CN group and the delayed CN group were 42% and 42.
9%, respectively
.
Necessity and advantages of accepting CN in mRCC first CN, then targeting (honeycomb theory): the primary tumor is the main source of metastatic lesions and pro-angiogenic substances, CN can suppress the host immune response, after primary tumor resection, targeted drugs Not only can it inhibit metastatic lesions more effectively, but also facilitate adjustment of drug dosage and treatment cycle
.
Target first, then CN: Similar to preoperative neoadjuvant chemotherapy for other malignant tumors, preoperative targeted therapy can shrink the primary and metastatic lesions, thereby facilitating the implementation of CN
.
Application and role of CN in the era of targeted combination therapy Checkmate9ER study: subgroup analysis results stratified by prior nephrectomy Checkmate9ER study aims to evaluate nivolumab + cabozantinib vs sunitinib in advanced stage Efficacy in kidney cancer
.
In the subgroup of patients with prior nephrectomy, the OS benefit was greater with nivolumab plus cabozantinib than with sunitinib
.
Similarly, among patients who underwent nephrectomy within the first 3 months of trial enrollment, the OS benefit of nivolumab plus cabozantinib was greater than that of sunitinib
.
Post hoc analysis of the JAVELIN Renal 101 study This study evaluated the role of prior nephrectomy in the first-line treatment of mRCC with avelumab + axitinib vs sunitinib
.
In the avelumab + axitinib group, progression-free survival (PFS) and OS were numerically longer in patients who had undergone prior nephrectomy compared with patients who had not undergone nephrectomy; There was no difference in the tinib group
.
The confirmed objective response rate (ORR) was numerically superior in patients who had previously undergone nephrectomy compared with patients who had not undergone nephrectomy, but there was no difference in the sunitinib group
.
The research suggests that in the era of combined immune targeting, the status and role of cytoreductive surgery are different from those in the era of targeted therapy, and further research and verification are needed
.
A retrospective analysis recently published in EAU showed that in patients with intermediate-risk metastatic clear cell renal cell carcinoma, targeting the CN first is more advantageous
.
Another real-world study showed that pre-CN had a survival advantage over systemic therapy alone
.
Most of the studies currently being carried out have chosen the "drug-CN-drug" sequential model
.
Conclusion In the era of targeted + immunotherapy, CN is still an independent predictor of reducing the risk of death in mRCC patients
.
And CN timing had no significant effect on patient outcomes
.
Patients with MSKCC low/intermediate risk and good physical status benefit from CN+ targeted drugs than targeted therapy alone
.
So far, there are few studies on targeting + immunotherapy vs combined CN in the treatment of mRCC, and the existing studies have limitations
.
CN improves symptoms of mRCC patients and improves patients' quality of life and confidence
.
A new mode of maximal CN+ drug therapy is expected to achieve greater clinical benefit
.
.
During the meeting, Professor Guo Gang from the General Hospital of the Chinese People's Liberation Army shared the clinical value and timing of cytoreductive nephrectomy (CN) for metastatic renal cancer (mRCC)
.
Expert Profile Prof.
Guo Gang Chief Physician of Urology Department, Chinese People's Liberation Army General Hospital, MD Director of Urology Department of the Third Medical Center of Chinese People's Liberation Army General Hospital, member of Standing Committee of Urology Professional Committee of Beijing Association of Integrative Medicine, Member of Beijing Medical Association Rare Disease Branch Member, Cancer Society TSC-AML Collaborative Group Member, CSCO Urothelial Carcinoma Expert Committee Member, CSCO Rare Tumor Expert Committee Member Efficacy and safety of cytoreductive nephrectomy (CN) + sunitinib for metastatic renal cancer
.
The study included 450 patients
.
The final results showed that the median overall survival (OS) of CN+ sunitinib group (group A) and sunitinib group (group B) in the total population were both 15.
6 months (HR=0.
97), and in IMDC In the intermediate-risk group, the median OS of the two groups was 19 months and 27.
9 months, respectively (HR=0.
94); in the high-risk group of IMDC, the median OS of the two groups was 9.
5 months and 11.
8 months, respectively (HR=0.
94).
1.
01)
.
Subgroup analysis showed that among intermediate-risk patients with IMDC, patients with one risk factor had significantly better median OS with cytoreductive resection, whereas patients with two risk factors had no difference in OS
.
Similarly, patients with only 1 metastases had better median OS with the combination therapy, while there was no difference in median OS in the subgroup of patients with more than 1 metastases
.
Follow-up CN in the sunitinib treatment group: More than 80% of patients required CN due to metastatic CR or near CR or patients with certain symptoms
.
31.
1% of patients who received follow-up CN were re-used sunitinib postoperatively
.
After sunitinib treatment, the median OS for CN patients was 48.
5 months, compared with 15.
7 months for sunitinib-only patients (HR=0.
34)
.
Long-term follow-up results suggest that the 61.
5-month follow-up results show that sunitinib monotherapy is non-inferior to CN + sunitinib for both intermediate and high-risk patients with MDKCC or IMDC; this study confirms that CN should no longer be used as a standard treatment regimen ; Screening patients: patients with only 1 IMDC risk factor may benefit from CN, especially those with only 1 metastases; number of metastases cannot be used to guide selection of patients who would benefit from surgery; initial Patients with better remission after treatment may accept delayed CN
.
The EAU Kidney Cancer Guidelines Recommendations on CN For high-risk MSKCC patients, CN is no longer recommended; for asymptomatic MSKCC intermediate-risk renal cancer patients requiring systemic therapy with vascular endothelial growth factor receptor inhibitors, immediate CN is not recommended
.
Limitations of the CARMENA study 22.
5% of patients in the CN + sunitinib arm did not receive targeted therapy and only received surgery, compared with 17% of sunitinib alone patients who received CN
.
These data may have an impact on the results of the study, and further analysis of these factors is required to draw more accurate conclusions
.
The CARMENA study included patients with moderate and poor prognosis in MSKCC, so the results were not applicable to patients with good prognosis; in terms of tumor burden, only those with large primary tumors and small metastatic lesions were included, ignoring those with small primary tumors and large metastatic burden.
crowd
.
The CARMENA study re-understands that the treatment of renal cancer was in the era of targeted therapy when the CARMENA study was carried out.
In the new era of combined immune targeting as first-line mRCC therapy, the value of CN needs to be re-evaluated
.
According to the stratification of the disease and the guidance of molecular markers, individualized treatment is carried out
.
The treatment idea for metastatic renal cell carcinoma in the new era is systemic therapy-maximum tumor debulking-adjuvant therapy
.
A recently published article summarizes the current treatment model: for patients with single or few metastases (in the case of surgical intervention), the investigators recommend maximal tumor debulking; for patients temporarily unable to surgically intervene, it is recommended to perform systematic first.
After treatment, cytoreduction should be performed to the maximum extent, and adjuvant therapy is recommended after surgery (based on the KEYNOTE-564 study).
For high-risk groups, immediate systemic therapy is recommended for symptomatic lesions
.
CN treatment timing SURTIME study: In the era of targeted therapy, CN timing has no significant effect on the benefit of mRCC.
The phase III SURTIME study aims to evaluate the impact of CN timing on the outcomes of mRCC patients in the era of targeted therapy
.
Ninety-nine patients were included in the study, with 50 and 49 in the immediate CN group (CN first followed by targeted therapy) and the delayed CN group (targeted therapy followed by CN), respectively
.
The primary endpoint was progression-free survival (PFR)
.
The results showed that the 28-week PFR in the immediate CN group and the delayed CN group were 42% and 42.
9%, respectively
.
Necessity and advantages of accepting CN in mRCC first CN, then targeting (honeycomb theory): the primary tumor is the main source of metastatic lesions and pro-angiogenic substances, CN can suppress the host immune response, after primary tumor resection, targeted drugs Not only can it inhibit metastatic lesions more effectively, but also facilitate adjustment of drug dosage and treatment cycle
.
Target first, then CN: Similar to preoperative neoadjuvant chemotherapy for other malignant tumors, preoperative targeted therapy can shrink the primary and metastatic lesions, thereby facilitating the implementation of CN
.
Application and role of CN in the era of targeted combination therapy Checkmate9ER study: subgroup analysis results stratified by prior nephrectomy Checkmate9ER study aims to evaluate nivolumab + cabozantinib vs sunitinib in advanced stage Efficacy in kidney cancer
.
In the subgroup of patients with prior nephrectomy, the OS benefit was greater with nivolumab plus cabozantinib than with sunitinib
.
Similarly, among patients who underwent nephrectomy within the first 3 months of trial enrollment, the OS benefit of nivolumab plus cabozantinib was greater than that of sunitinib
.
Post hoc analysis of the JAVELIN Renal 101 study This study evaluated the role of prior nephrectomy in the first-line treatment of mRCC with avelumab + axitinib vs sunitinib
.
In the avelumab + axitinib group, progression-free survival (PFS) and OS were numerically longer in patients who had undergone prior nephrectomy compared with patients who had not undergone nephrectomy; There was no difference in the tinib group
.
The confirmed objective response rate (ORR) was numerically superior in patients who had previously undergone nephrectomy compared with patients who had not undergone nephrectomy, but there was no difference in the sunitinib group
.
The research suggests that in the era of combined immune targeting, the status and role of cytoreductive surgery are different from those in the era of targeted therapy, and further research and verification are needed
.
A retrospective analysis recently published in EAU showed that in patients with intermediate-risk metastatic clear cell renal cell carcinoma, targeting the CN first is more advantageous
.
Another real-world study showed that pre-CN had a survival advantage over systemic therapy alone
.
Most of the studies currently being carried out have chosen the "drug-CN-drug" sequential model
.
Conclusion In the era of targeted + immunotherapy, CN is still an independent predictor of reducing the risk of death in mRCC patients
.
And CN timing had no significant effect on patient outcomes
.
Patients with MSKCC low/intermediate risk and good physical status benefit from CN+ targeted drugs than targeted therapy alone
.
So far, there are few studies on targeting + immunotherapy vs combined CN in the treatment of mRCC, and the existing studies have limitations
.
CN improves symptoms of mRCC patients and improves patients' quality of life and confidence
.
A new mode of maximal CN+ drug therapy is expected to achieve greater clinical benefit
.
