Author: By Lynda Williams, Senior medwireNews Reporter
medwireNews: A study of US patients treated for metastatic clear cell renal cell carcinoma (RCC) outside of clinical trials adds support for the use of first-line immunotherapy (IO) with or without targeted therapy (TT) over TT alone.
The analysis of the National Cancer Database included 5872 patients treated between 2015 and 2017, and calculated overall survival (OS) based on date of diagnosis to death, or to data censoring, after a median of 9.6 months.
These included 4755 patients given only TT in the first line, 638 patients given only IO and 479 patients given both forms of treatment. A propensity-matched cohort was created including 479 patients for each of the treatment options.
Nicholas Chakiryan, from H Lee Moffitt Cancer Center and Research Institute in Tampa, Florida, USA, and co-investigators found that patients given IO alone or with TT were significantly younger than those given only TT (median 61 and 62 vs 64 years, respectively) and more likely to be treated in an academic centre (49 and 45 vs 41%).
Combination and IO-only treatment patients also had significantly fewer comorbidities than those given only TT, with 74% and 75%, respectively, having a Charlson-Deyo score of 0 versus 69% of TT-only patients.
Moreover, patients in the matched cohort given first-line IO alone or in combination with TT both achieved significantly better OS than those given TT only, with hazard ratios for death of 0.60 and 0.74, respectively, whereas there was no significant difference in OS between the IO and IO–TT groups.
These findings were confirmed in a multivariable Cox proportional hazards regression analysis adjusting for patient and tumour confounding factors, with IO alone or with TT offering a significant – and comparable – improvement in OS versus TT alone (HRs=0.70 and 0.76, respectively).
The 12-month estimated OS rate was 73% for IO alone, 68% for combination treatment and 59% for TT alone, the researchers add in JAMA Network Open.
Nicholas Chakiryan et al admit that their analysis does not account for immortal time bias, that the median follow-up time was “short” and that there was no analysis of subsequent treatments given to the patients.
In addition, they note that their analysis was restricted by the lack of information on the specific agents received and factors such as kidney function, body mass index, performance status, treatment-related toxicity, response rates and progression- or recurrence-free survival.
Nevertheless, the researchers believe that their results “provide external validation for the OS benefit associated with [IO] and combination TT and [IO] regimens compared with TT alone as first-line therapy for metastatic clear cell RCC among a nationally representative cohort of patients treated in real-world clinical practice.”
They conclude: “Patients encountered in real-world clinical practice tend to be older and have more comorbidities than those enrolled in clinical trials, emphasizing the importance of studying more generalizable populations.”
Chakiryan NH, Jiang DD, Gillis KA, et al. Real-world survival outcomes associated with first-line immunotherapy, targeted therapy, and combination therapy for metastatic clear cell renal cell carcinoma. JAMA Netw Open;4:e2111329. Published online 25 May 2021. DOI:10.1001/jamanetworkopen.2021.11329
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