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Focus on the key points of the CSCO Kidney Cancer Guidelines 2024 first-line treatment update.
The 2024 Chinese Society of Clinical Oncology (CSCO) guidelines will be held in Jinan from April 26th to 27th.
Current status of kidney cancer treatment
Kidney cancer is one of the three major tumors of the urinary system, and renal cell carcinoma (RCC) accounts for 80%~90% of all kidney cancers [1]. According to statistics, there were about 77,000 new cases and 46,000 deaths of kidney cancer in China in 2022 [2]. The prognosis for advanced metastatic renal cancer is poor, with an overall five-year survival rate of less than 20 percent [3]. In recent years, with the research progress of targeted and immunological therapeutic drugs, great progress has been made in the treatment of advanced kidney cancer. A number of large-scale phase III studies of target-immune combination therapy have been successful, marking that the first-line treatment of advanced kidney cancer has now fully entered the era of target-free combination therapy.
Update and interpretation of first-line treatment progress for advanced kidney cancer
At the CSCO Guidelines for Kidney Cancer, the CSCO Guidelines for the Diagnosis and Treatment of Kidney Cancer 2024 upgraded the recommendation level of "axitinib + toripalimab" in the first-line treatment of metastatic or unresectable clear cell renal cell carcinoma to Level I (Category 1A evidence).
The RENOTORCH study [3] is the first randomized, controlled, multicenter phase III clinical study of targeted combination PD-1 monoclonal antibody in intermediate- and high-risk kidney cancer, aiming to evaluate the efficacy and safety of toripalimab in combination with axitinib versus sunitinib in patients with advanced RCC. A total of 421 patients with advanced RCC were randomized 1:1 to toripalimab plus axitinib or sunitinib. The primary endpoint was progression-free survival (PFS) as assessed by an independent review committee (IRC), and the secondary endpoints included investigator-assessed PFS, IRC or investigator-assessed objective response rate (ORR), duration of response (DoR), disease control rate (DCR), overall survival (OS), and safety.
The results showed that toripalimab plus axitinib achieved a median PFS of 18.0 months in the combination with axitinib (9.8 months in the sunitinib alone arm), reducing the risk of disease progression or death by 35%. Compared with targeted therapy alone, the efficacy data of target-immune combination therapy has nearly doubled.
In subgroup analysis, toripalimab plus axitinib was superior to sunitinib.
Based on blinded independent central assessment (BICR), the ORR of toripalimab plus axitinib was 56.7%, which was significantly higher than that of the sunitinib group (30.8%), and the results were consistent based on investigator's assessment (INV) (ORR of 58.1% versus 30.8% of sunitinib). At present, the median duration of response has not been reached in the target-immune combination group.
For the first-line treatment selection of low-risk advanced kidney cancer, it is necessary to conduct specific analysis based on the biological characteristics, metastasis site, growth rate, tumor burden and marker expression of patients, and conduct propensity screening.
brief summary
One of the major updates in the first-line treatment of advanced kidney cancer is to upgrade the recommendation level of "axitinib + toripalimab" in the first-line treatment of metastatic or unresectable clear cell renal cell carcinoma to level I (category 1A evidence) based on the results of the RENOTORCH study. With the approval of relevant indications, it marks that the treatment of advanced kidney cancer in mainland China has officially entered a new era of target-free combination therapy. In addition, the CSCO Kidney Cancer Committee will officially release the 2024 CSCO Guidelines for the Diagnosis and Treatment of Kidney Cancer in September this year, looking forward to bringing better clinical benefits to patients with advanced kidney cancer under the standardized guidance of the guidelines, so as to improve the survival rate of kidney cancer patients as a whole.
Bibliography:
[1] Guidelines for the diagnosis and treatment of renal cell carcinoma (2022 edition), National Health Commission of the People's Republic of China.
[2] Xia C, Dong X, Li H, et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl) 2022;135:584-90.
[3] Yan XQ, Ye MJ, Zou Q, et al. Toripalimab plus axitinib versus sunitinib as first-line treatment for advanced renal cell carcinoma: RENOTORCH, a randomized, open-label, phase III study. Ann Oncol. 2024 Feb; 35(2):190-199.
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