Real-World HRQOL Findings Support Nivolumab for Previously Treated mRCC


Results of retrospective analysis of previously treated patients with metastatic renal cell carcinoma who received nivolumab in the second- and third-line showed that health-related quality of life was maintained in the real-world setting

Results of retrospective analysis of previously treated patients with metastatic renal cell carcinoma (mRCC) who received nivolumab (Opdivo) in the second- and third-line showed that health-related quality of life (HRQOL) was maintained in the real-world setting. Results of the analysis were presented in a poster during the 2022 ESMO Congress.

“Across all evaluated FKSI-19 and EQ-5D-3L scores, changes from baseline did not extend beyond the respective thresholds for clinically meaningful changes at any timepoint,” study authors wrote in a poster of the data. “These real-world findings add to the evidence base from the randomized, controlled CheckMate 025 trial [NCT01668784], and further our understanding of the impact of nivolumab on HRQOL in patients with previously treated mRCC.”

Investigators performed a pooled data analysis, IO-Synthesise RCC, using findings from the prospective real-world studies WITNESS (NCT03455452) and NORA (NCT02940639). Patients enrolled in the French WITNESS (n = 105) and the German NORA (n = 201) studies were aged 18 years or older at the start of nivolumab monotherapy and received treatment for mRCC as second- or third-line therapy. Patients were excluded if they received prior anti–PD-1/PD-L1 or ant-CTLA4 therapy.

Measurements used to analyze HRQOL outcomes were FKSI-19, which assesses kidney cancer disease-related symptoms, and EQ-5D-3L, which measures health status in the groups of mobility, self-care, usual activities, pain along with discomfort, and anxiety/depression. Higher scores from both measurement instruments indicate a better state of health and EQ-5D-3L also looks at the patient’s self-rated health on a visual analog score (VAS). FKSI-19 scores were very similar in the categories of disease-related symptoms (DRS); DRS-emotional (DRS-E); DRS-physical (DRS-P); functional well-being (FWB); treatment side effects (TSE).

Completion rates were comparable between the 2 assessments over time. FKSI-19 completion rates at week 6 ranging between 76.7% and 77.4% and completion rates at month 18 between 47.5% to 48.5%. For EQ-5D-3L week 6 rates were between 71.4% and 74.9% and were 46.5% at month 18.

Score ranges in the FKSI-19 assessment were: total score (range, 0-76); DRS (range,0-36); DRS-P (range, 0-48); DRS-E (range, 0-4); TSE (range, 0-12); FWB (range, 0-12). The baseline FKSI-19 scores were similar between the 2 studies. The pooled analysis mean scores were as follows:

  1. Total score: 52.80 (SD, 11.41)
  2. DRS: 28.0 (SD, 5.73)
  3. DRS-P: 34.86 (SD, 7.41)
  4. DRS-E: 2.14 (SD, 1.37)
  5. TSE: 10.58 (SD, 1.84)
  6. FWB: 5.37 (SD, 3.22)

Outcomes from the EQ-5D-3L assessment showed variation between the 2 studies. In terms of utility index (range, 0-1), the baseline score in the WITNESS study was 0.66 (SD, 0.30) compared with 0.69 (SD, 0.30) in the NORA study. The baseline VAS scores (range, 0-100) were 63.62 (SD, 18.52) and 56.64 (SD, 26.59), respectively.

“From months 6 to 9 onward, there was a numerical trend toward improved FKSI-19 total

and DRS subscale scores and a numerical trend toward worsened VAS, although these

changes did not reach the threshold for clinical meaningfulness,” the investigators wrote.

Although a notable number of patients were missing components of baseline data that may have affected HRQOL analysis, investigators reported that of the patients with available baseline data, 206 of 273 (75.5%) had a Karnofsky performance score (KPS) of more than 70%. Additionally, 262 of 302 (86.8%) had clear cell histology, and 240 of 303 (79.2%) had undergone previous nephrectomy.

Patients in the combined studies has a median age of 70 years (range, 38-89), 74.5% were men, and 83.3% of patients received nivolumab as second-line therapy. Prior to nivolumab treatment, 82.7% of patients reported receiving prior tyrosine kinase inhibitors, most common were sunitinib (Sutent; 55.9%) and/or pazopanib (Votrient; 51.6%).

There was some inconsistent data in the 2 groups before it was pooled including KPS where 62.4% of patients in the WITNESS study had a score greater than 70% and 83.1% of NORA patients had a score more than 70%. Patients who had previous nephrectomy were 65.7% compared with 86.4%, respectively. The stage of disease at initial diagnosis also had notable differences before the data was combined: 13.5%, 32.4%, 10.8%, and 43.2% of patients in the WITNESS study had stage I, II, III, and IV disease, respectively. These rates were 11%, 23.1%, 31.3%, and 34.6%, respectively, in the NORA study.

Limitations included bias that may occur during the real-world routine care in each country, the EQ-5D-3L utility index scores that were derived using a UK-based value set not specific to either group, or varying practice patterns in each country. The difficulty of collecting HQROL outcomes in a real-world setting also affected the pooled data as the collection of it was not mandatory in the WITNESS study resulting in a smaller sample size.

“Because there are limited data, additional exploratory analyses will be conducted on this data set to further investigate the relationship between baseline clinical factors along with clinical outcomes and HRQOL outcomes,” the authors concluded.

In CheckMate 025 nivolumab demonstrated efficacy as well as HRQOL outcomes compared with the agent everolimus (Afinitor). Specifically, patients who received nivolumab had an increase through week 136 in mean changes from baseline in Functional Assessment of Cancer Therapy–Kidney Symptom Index–Disease Related Symptoms score compared with those who received everolimus arm, who experienced a decrease. Scores using the EQ-5D for utility index and VAS showed improved outcomes for patients receiving nivolumab from baseline to week 104 vs those who received everolimus arm who had a decline in scores.


Guillaume M, Bedke J, Albigès L, et al. IO- Synthesise RCC: analysis of real-world health-related quality of life outcomes with nivolumab for previously treated metastatic renal cell carcinoma using pooled data from France and Germany. Poster presented at: 2022 European Society for Medical Oncology; September 9-13, 2022; Paris, France.

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