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This article from the NEJM meta-Journal (NEJM Journal Watch) Cabozantinib plus Nivolumab Improves Overall Survival in Advanced Kidney Cancer Cabozantinib joint Carolina Wu Li You monoclonal antibody in patients with advanced kidney cancer prolongs overall survival comment author: Robert Dreicer, MD, MS , MACP, FASCO in patients receiving combination therapy, progression-free survival and overall survival are longer than those receiving TKI sunitinib treatment.
In the initial treatment of metastatic clear cell renal cell carcinoma, monotherapy with tyrosine kinase inhibitor (TKI) cabozantinib and immune checkpoint inhibitor nivolumab both prolonged the overall survival of patients.
The researchers conducted an international randomized phase 3 trial.
This trial compared cabozantinib (40 mg/d) combined with nivolumab (240 mg intravenously every 2 weeks) with the previous standard treatment TKI sunil Efficacy of tinib (50 mg/d; 4 weeks of medication, 2 weeks of withdrawal).
The primary endpoint is progression-free survival (PFS).
Among the 651 untreated patients with metastatic renal cell carcinoma, about 80% of the IMDC (International Metastatic Renal-Cell Carcinoma Database) score was low-risk or intermediate-risk, and 11% of the patients It has sarcoma-like characteristics.
At an 18-month follow-up of intermediate risk, the median PFS of the combined treatment group was 16.
6 months, while that of the sunitinib group was 8.
3 months (hazard ratio, 0.
51; P<0.
001).At 12 months, the progression-free survival rate of the combined treatment group was 57.
6%, while that of the sunitinib group was 36.
9%.
The overall survival rate of the two groups was 85.
7% vs.
75.
6% (hazard ratio, 0.
60; P=0.
001) .
The objective remission rates of the two groups were 55.
7% vs.
27.
1% (P<0.
001), and the complete remission rates were 8.
0% vs.
4.
6%.
In the combination therapy group and sunitinib group, the incidence of grade 3 or higher adverse events was 75.
3% and 70.
6%, respectively; the incidence of adverse events leading to study drug discontinuation was 19.
7% and 16.
9%, respectively.
Comments Cabozantinib combined with nivolumab has high anti-cancer activity in patients with untreated clear cell renal cell carcinoma, and has recently been approved by the US FDA.
Recently, there was also a phase 3 trial that released the results of lenvatinib combined with pembrolizumab (NEJM JW Oncol Hematol Feb 25 2021; [e-pub] and N Engl J Med 2021 Feb 13; [e-pub]).
We may have as many as 4 initial treatment options to choose from.
In the absence of comparative data, it is best for clinicians to choose a plan to accumulate professional skills while waiting for further research results that help predict which plan is more suitable for a particular patient.
Commented articles Choueiri TK et al.
Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma.
N Engl J Med 2021 Mar 4; 384:829.
(https://doi.
org/10.
1056/NEJMoa2026982) Related reading NEJM journals NEJM Journal Watch is published by NEJM Group.
Internationally renowned doctors are invited to comment on important papers in the medical field to help doctors understand and use the latest developments. "NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers in Medicine" jointly created by Jiahui Medical Research and Education Group (JMRE) and "New England Journal of Medicine" (NEJM).
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities.
In the initial treatment of metastatic clear cell renal cell carcinoma, monotherapy with tyrosine kinase inhibitor (TKI) cabozantinib and immune checkpoint inhibitor nivolumab both prolonged the overall survival of patients.
The researchers conducted an international randomized phase 3 trial.
This trial compared cabozantinib (40 mg/d) combined with nivolumab (240 mg intravenously every 2 weeks) with the previous standard treatment TKI sunil Efficacy of tinib (50 mg/d; 4 weeks of medication, 2 weeks of withdrawal).
The primary endpoint is progression-free survival (PFS).
Among the 651 untreated patients with metastatic renal cell carcinoma, about 80% of the IMDC (International Metastatic Renal-Cell Carcinoma Database) score was low-risk or intermediate-risk, and 11% of the patients It has sarcoma-like characteristics.
At an 18-month follow-up of intermediate risk, the median PFS of the combined treatment group was 16.
6 months, while that of the sunitinib group was 8.
3 months (hazard ratio, 0.
51; P<0.
001).At 12 months, the progression-free survival rate of the combined treatment group was 57.
6%, while that of the sunitinib group was 36.
9%.
The overall survival rate of the two groups was 85.
7% vs.
75.
6% (hazard ratio, 0.
60; P=0.
001) .
The objective remission rates of the two groups were 55.
7% vs.
27.
1% (P<0.
001), and the complete remission rates were 8.
0% vs.
4.
6%.
In the combination therapy group and sunitinib group, the incidence of grade 3 or higher adverse events was 75.
3% and 70.
6%, respectively; the incidence of adverse events leading to study drug discontinuation was 19.
7% and 16.
9%, respectively.
Comments Cabozantinib combined with nivolumab has high anti-cancer activity in patients with untreated clear cell renal cell carcinoma, and has recently been approved by the US FDA.
Recently, there was also a phase 3 trial that released the results of lenvatinib combined with pembrolizumab (NEJM JW Oncol Hematol Feb 25 2021; [e-pub] and N Engl J Med 2021 Feb 13; [e-pub]).
We may have as many as 4 initial treatment options to choose from.
In the absence of comparative data, it is best for clinicians to choose a plan to accumulate professional skills while waiting for further research results that help predict which plan is more suitable for a particular patient.
Commented articles Choueiri TK et al.
Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma.
N Engl J Med 2021 Mar 4; 384:829.
(https://doi.
org/10.
1056/NEJMoa2026982) Related reading NEJM journals NEJM Journal Watch is published by NEJM Group.
Internationally renowned doctors are invited to comment on important papers in the medical field to help doctors understand and use the latest developments. "NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers in Medicine" jointly created by Jiahui Medical Research and Education Group (JMRE) and "New England Journal of Medicine" (NEJM).
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities.