Comprehensive investigation of clinicopathological and immunological features to determine prognostic impact in metastatic renal cell carcinoma: The JEWEL study.
Cox proportional hazards model
multivariate analysis
prognostic factors
renal cell carcinoma
tyrosine kinase inhibitors
Journal
International journal of urology : official journal of the Japanese Urological Association
ISSN: 1442-2042
Titre abrégé: Int J Urol
Pays: Australia
ID NLM: 9440237
Informations de publication
Date de publication:
11 2023
11 2023
Historique:
received:
03
03
2023
accepted:
20
06
2023
medline:
2
11
2023
pubmed:
12
7
2023
entrez:
12
7
2023
Statut:
ppublish
Résumé
Current prognostic models for metastatic renal cell carcinoma (mRCC) are likely inaccurate due to recent treatment advances and improved survival outcomes. The JEWEL study used a data set from patients who received tyrosine kinase inhibitors (TKIs) to explore the prognostic impact of the tumor immune environment in the absence of immune checkpoint inhibitor intervention. The primary analysis population comprised 569 of the 770 Japanese patients enrolled in the ARCHERY study who received first-line TKIs. Multivariable Cox proportional hazard models were used to identify factors associated with the primary (overall survival [OS]) and secondary outcomes (treatment duration) using 34 candidate explanatory variables. Median OS was 34.1 months (95% CI, 30.4-37.6) in the primary analysis population. A considerable negative prognostic impact (descriptive p ≤ 0.0005) on OS was seen with lactate dehydrogenase (LDH) >1.5 × upper limit of normal (adjusted HR [aHR], 3.30; 95% CI, 2.19-4.98), Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2 (aHR, 2.14; 95% CI, 1.56-2.94), World Health Organization (WHO)/International Society of Urological Pathology (ISUP) Grade 4 (aHR, 1.89; 95% CI, 1.43-2.51), C-reactive protein (CRP) level ≥0.3 (aHR, 1.78; 95% CI, 1.40-2.26), and age ≥75 years (aHR, 1.65; 95% CI, 1.24-2.18) in the multivariable analysis. PD-L1 and immunophenotype affected OS in univariable analyses but were not selected in the multivariable model as explanatory variables. JEWEL identified sex, age, ECOG PS, liver and bone metastases, CRP levels, WHO/ISUP grade, LDH, and albumin levels as key prognostic factors for OS after first-line TKI therapy for mRCC.
Substances chimiques
Protein Kinase Inhibitors
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
977-984Subventions
Organisme : This study and third-party medical writing assistance were sponsored by Chugai Pharmaceutical Co, Ltd.
Informations de copyright
© 2023 The Authors. International Journal of Urology published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Urological Association.
Références
Heng DY, Xie W, Regan MM, Warren MA, Golshayan AR, Sahi C, et al. Prognostic factors for overall survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor-targeted agents: results from a large, multicenter study. J Clin Oncol. 2009;27:5794-5799.
Motzer RJ, Bacik J, Murphy BA, Russo P, Mazumdar M. Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol. 2002;20:289-296.
Tran J, Ornstein MC. Clinical review on the management of metastatic renal cell carcinoma. JCO Oncol Pract. 2022;18:187-196.
Motzer RJ, Tannir NM, McDermott DF, Arén Frontera O, Melichar B, Choueiri TK, et al. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. N Engl J Med. 2018;378:1277-1290.
Motzer RJ, Penkov K, Haanen J, Rini B, Albiges L, Campbell MT, et al. Avelumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2019;380:1103-1115.
Rini BI, Plimack ER, Stus V, Gafanov R, Hawkins R, Nosov D, et al. Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2019;380:1116-1127.
Motzer R, Alekseev B, Rha SY, Porta C, Eto M, Powles T, et al. Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma. N Engl J Med. 2021;384:1289-1300.
Choueiri TK, Powles T, Burotto M, Escudier B, Bourlon MT, Zurawski B, et al. Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2021;384:829-841.
Pharmaceuticals and Medical Devices Agency. Review Report (Opdivo and Yervoy) [Internet]. 2018 Apr [cited 2022 Mar 15]. Available from: https://www.pmda.go.jp/files/000232985.pdf
Pharmaceuticals and Medical Devices Agency. Review Report (Cabometyx and Nivolumab) [Internet]. 2021 [cited 2022 May 5]. Available from: https://www.pmda.go.jp/drugs/2021/P20210818001/400256000_30200AMX00433_A100_1.pdf
Pharmaceuticals and Medical Devices Agency. Review Report (Keytruda and Axitinib) [Internet]. 2019 [cited 2022 May 5]. Available from: https://www.pmda.go.jp/drugs/2020/P20200109002/170050000_22800AMX00696000_A100_1.pdf
Pharmaceuticals and Medical Devices Agency. Review Report (Lenvatinib and Pembrolizumab) [Internet]. 2022 [cited 2022 May 5]. Available from: https://www.pmda.go.jp/drugs/2022/P20220216001/170050000_22800AMX00696000_A100_1.pdf
Pharmaceuticals and Medical Devices Agency. Review Report (Bavencio and Axitinib). 2019 [cited 2022 May 5]. Available from: https://www.pmda.go.jp/drugs/2019/P20191217003/380079000_22900AMX00990_A100_1.pdf
Mar N, Kaakour D, Rezazadeh Kalebasty A. Renal cell carcinoma-lessons in diversity, breakthroughs, and challenges. JCO Oncol Pract. 2021;18:197-199.
Albiges L, Tannir NM, Burotto M, McDermott D, Plimack ER, Barthélémy P, et al. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial. ESMO Open. 2020;5:e001079.
Motzer RJ, Rini BI, McDermott DF, Arén Frontera O, Hammers HJ, Carducci MA, et al. Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomised, controlled, phase 3 trial. Lancet Oncol. 2019;20:1370-1385.
Collins GS, Reitsma JB, Altman DG, Moons KG. Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD statement. BMC Med. 2015;13:1.
Zamanipoor Najafabadi AH, Ramspek CL, Dekker FW, Heus P, Hooft L, Moons KGM, et al. TRIPOD statement: a preliminary pre-post analysis of reporting and methods of prediction models. BMJ Open. 2020;10:e041537.
Uemura M, Nakaigawa N, Sassa N, Tatsugami K, Harada K, Yamasaki T, et al. Prognostic value of programmed death-ligand 1 status in Japanese patients with renal cell carcinoma. Int J Clin Oncol. 2021;26:2073-2084.
Mariathasan S, Turley SJ, Nickles D, Castiglioni A, Yuen K, Wang Y, et al. TGFβ attenuates tumour response to PD-L1 blockade by contributing to exclusion of T cells. Nature. 2018;554:544-548.
Harada K, Nozawa M, Uemura M, Tatsugami K, Osawa T, Yamana K, et al. Treatment patterns and outcomes in patients with unresectable or metastatic renal cell carcinoma in Japan. Int J Urol. 2019;26:202-210.
Miyazaki A, Miyake H, Harada KI, Inoue TA, Fujisawa M. Prognostic outcome in patients treated with tyrosine kinase inhibitors as first-line molecular-targeted therapy for metastatic renal cell carcinoma: experience in real-world clinical practice in Japan. Mol Clin Oncol. 2015;3:601-606.
Klatte T, Rossi SH, Stewart GD. Prognostic factors and prognostic models for renal cell carcinoma: a literature review. World J Urol. 2018;36:1943-1952.
Saito K, Kihara K. C-reactive protein as a biomarker for urological cancers. Nat Rev Urol. 2011;8:659-666.
Shinohara N, Nonomura K, Abe T, Maruyama S, Kamai T, Takahashi M, et al. A new prognostic classification for overall survival in Asian patients with previously untreated metastatic renal cell carcinoma. Cancer Sci. 2012;103:1695-1700.
Ishihara H, Kondo T, Omae K, Takagi T, Iizuka J, Kobayashi H, et al. Sarcopenia and the modified Glasgow prognostic score are significant predictors of survival among patients with metastatic renal cell carcinoma who are receiving first-line sunitinib treatment. Target Oncol. 2016;11:605-617.
Delahunt B, Cheville JC, Martignoni G, Humphrey PA, Magi-Galluzzi C, McKenney J, et al. The International Society of Urological Pathology (ISUP) grading system for renal cell carcinoma and other prognostic parameters. Am J Surg Pathol. 2013;37:1490-1504.
Tannir NM, Signoretti S, Choueiri TK, McDermott DF, Motzer RJ, Flaifel A, et al. Efficacy and safety of nivolumab plus ipilimumab versus sunitinib in first-line treatment of patients with advanced sarcomatoid renal cell carcinoma. Clin Cancer Res. 2021;27:78-86.
Choueiri TK, Larkin J, Pal S, Motzer RJ, Rini BI, Venugopal B, et al. Efficacy and correlative analyses of avelumab plus axitinib versus sunitinib in sarcomatoid renal cell carcinoma: post hoc analysis of a randomized clinical trial. ESMO Open. 2021;6:100101.
Tanaka N, Mizuno R, Ito K, Shirotake S, Yasumizu Y, Masunaga A, et al. External validation of the MSKCC and IMDC risk models in patients treated with targeted therapy as a first-line and subsequent second-line treatment: a Japanese multi-institutional study. Eur Urol Focus. 2016;2:303-309.