Health-related quality-of-life outcomes in patients with advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab or everolimus versus sunitinib (CLEAR): a randomised, phase 3 study

Motzer, Robert J.; Porta, Camillo; Alekseev, B. Ya.; Rha, Sun Young; Choueiri, Toni K.; Mendez-Vidal, María José; Hong, Sung‐Hoo; Kapoor, Anil; Goh, Jeffrey C.; Eto, Masatoshi; Bennett, Lee; Wang, Jinyi; Pan, Jie Janice; Saretsky, T.; Perini, Rodolfo F.; He, Cixin; Mody, Kalgi; Cella, David

doi:10.1016/s1470-2045(22)00212-1

Cited by 45 publications

(26 citation statements)

References 23 publications

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“…Sunitinib as a first-line treatment has since been replaced. In several trials, Sunitinib served as the comparator against combination therapy, and was found to be inferior [ 8 , 9 , 10 , 11 ]. For example, in the CheckMate 9ER [ 8 ] trial, a combination of Cabozantinib and Nivolumab demonstrated superior overall survival (OS), as well as PFS, and a more likely response than Sunitinib monotherapy.…”

Section: Resultsmentioning

confidence: 99%

“…The safety profiles of both drugs did not differ significantly, with an overall incidence rate of grade 3 or 4 AE in 67% of those receiving cabozantinib and 68% receiving sunitinib [ 26 ]. Additionally, the open-label, randomised phase 3 trial (METEOR) compared cabozantinib with everolimus to treat clear-cell mRCC and showed better OS (median 21.4 months vs. 16.5) and ORR (17% [ 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ] vs. 3% [ 2 , 27 , 28 , 29 , 30 ]) with cabozantinib 60mg/daily compared to Everolimus 10mg/daily. Included in this trial were patients who had already undergone treatment with one or more VEGFR TKI [ 31 ].…”

Section: Resultsmentioning

confidence: 99%

“…Beyond that, the lenvatinib/pembrolizumab combination’s toxicity stands out with AE ≥ grade 3 of 82.4% (compared to 75.8% for pembrolizumab/axitinib or 75.3% for nivolumab/cabozantinib), leading to the highest proportion of treatment discontinuation due to AEs at 37.2% (compared to pembrolizumab/axitinib’s 30.5% and nivolumab/cabozantinib’s 19.7%). Nonetheless, health-related quality of life was not worse than with sunitinib [ 10 ].…”

Section: Resultsmentioning

confidence: 99%

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Tyrosine Kinase Inhibitors in the Treatment of Metastasised Renal Cell Carcinoma—Future or the Past?

Michaelis

Grabbert

Sigle

et al. 2022

Cancers

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Background: To review and discuss the literature on applying tyrosine kinase inhibitors (TKIs) in the treatment of metastasised renal cell carcinoma (mRCC). Materials and Methods: Medline, PubMed, the Cochrane database, and Embase were screened for randomised controlled trials, clinical trials, and reviews on treating renal cell carcinoma, and the role of TKI. Each substance’s results were summarised descriptively. Results: While TKI monotherapy is not currently recommended as a first-line treatment for metastasized renal cell carcinoma, TKIs are regularly applied to treat treatment-naïve patients in combination with immunotherapy. TKIs depict the first-choice alternative therapy if immunotherapy is not tolerated or inapplicable. Currently, seven different TKIs are available to treat mRCC. Conclusions: The importance of TKIs in a monotherapeutic approach has declined in the past few years. The current trend toward combination therapy for mRCC, however, includes TKIs as one significant component of treatment regimens. We found that to remain applicable to ongoing studies, both when including new substances and when testing novel combinations of established drugs. TKIs are of major importance for the treatment of renal cancer now, as well as for the foreseeable future.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Tyrosine Kinase Inhibitors in the Treatment of Metastasised Renal Cell Carcinoma—Future or the Past?

Michaelis

Grabbert

Sigle

et al. 2022

Cancers

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show abstract

“…Recently published phase-III trial randomized 1,069 patients into three arms: lenvatinib + pembrolizumab, lenvatinib + everolimus, and sunitinib. 10 Primary end point was PFS assessed by independent review committee. Secondary end points were ORR, OS, safety, and PFS assessed by investigators.…”

Section: Lenvatinib–pembrolizumab Versus Sunitinibmentioning

confidence: 99%

“…Programmed cell death ligand-1 (PDL1) testing has been done in various studies, but none of the studies have shown correlation of PDL1 status with survival. 5 6 9 10…”

Section: Introductionmentioning

confidence: 99%