Real-world Outcome of Patients with Advanced Renal Cell Carcinoma and Intermediate- or Poor-risk International Metastatic Renal Cell Carcinoma Database Consortium Criteria Treated by Immune-oncology Combinations: Differential Effectiveness by Risk Group?

被引:22
作者
Santoni, Matteo [1 ]
Buti, Sebastiano [2 ]
Myint, Zin W. [3 ]
Maruzzo, Marco [4 ]
Iacovelli, Roberto [5 ]
Pichler, Martin [6 ]
Kopecky, Jindrich [7 ]
Kucharz, Jakub [8 ]
Rizzo, Mimma [9 ]
Galli, Luca [10 ]
Buettner, Thomas [11 ,28 ,29 ]
De Giorgi, Ugo [12 ]
Kanesvaran, Ravindran [13 ]
Fiala, Ondrej [14 ,15 ]
Grande, Enrique [16 ]
Zucali, Paolo Andrea [17 ,18 ]
Kopp, Ray Manneh [19 ]
Fornarini, Giuseppe [20 ]
Bourlon, Maria T. [21 ]
Scagliarini, Sarah [22 ]
Molina-Cerrillo, Javier [23 ]
Aurilio, Gaetano [24 ]
Matrana, Marc R. [25 ]
Pichler, Renate [26 ]
Cattrini, Carlo [27 ]
Buechler, Tomas
Massari, Francesco [30 ]
Seront, Emmanuel [31 ]
Calabro, Fabio [32 ]
Pinto, Alvaro [33 ]
Berardi, Rossana [34 ]
Zgura, Anca [35 ]
Mammone, Giulia [36 ]
Ansari, Jawaher [37 ]
Atzori, Francesco [38 ]
Chiari, Rita [39 ]
Bamias, Aristotelis [40 ]
Caffo, Orazio [41 ]
Procopio, Giuseppe [42 ,43 ]
Sunela, Kaisa [44 ]
Bassanelli, Maria [45 ]
Ortega, Cinzia [46 ]
Grillone, Francesco [47 ]
Landmesser, Johannes [48 ]
Milella, Michele [49 ,50 ]
Messina, Carlo [51 ]
Kueronya, Zsofia [52 ]
Mosca, Alessandra [53 ]
Bhuva, Dipen [54 ]
Santini, Daniele [55 ]
机构
[1] Macerata Hosp, Oncol Unit, Macerata, Italy
[2] Univ Parma, Univ Hosp Parma, Dept Med & Surg, Med Oncol Unit, Parma, Italy
[3] Univ Kentucky, Markey Canc Ctr, Lexington, KY USA
[4] Ist Oncol Veneto IOV IRCCS, Dept Oncol, Oncol Unit 3, Padua, Italy
[5] Fdn Policlin Univ Agostino Gemelli IRCCS, Oncol Med, Rome, Italy
[6] Med Univ Graz, Dept Internal Med, Div Oncol, Graz, Austria
[7] Univ Hosp Hradec Kralove, Dept Clin Oncol & Radiotherapy, Hradec Kralove, Czech Republic
[8] Mar Sklodowska Curie Natl Res Inst Oncol, Dept Urooncol, Warsaw, Poland
[9] AOU Consorziale Policlin Bari, Div Med Oncol, Bari, Italy
[10] Univ Hosp Pisa, Oncol Unit 2, Pisa, Italy
[11] Univ Hosp Bonn UKB, Dept Urol, Bonn, Germany
[12] IRCCS Ist Romagnolo deiTumori IRST Dino Amadori, Dept Med Oncol, Meldola, Italy
[13] Natl Canc Ctr Singapore, Div Med Oncol, Singapore, Singapore
[14] Charles Univ Prague, Fac Med, Dept Oncol & Radiotherapeut, Plzen, Czech Republic
[15] Charles Univ Prague, Univ Hosp Pilsen, Plzen, Czech Republic
[16] MD Anderson Canc Ctr Madrid, Dept Med Oncol, Madrid, Spain
[17] Humanitas Univ, Dept Biomed Sci, Milan, Italy
[18] IRCCS Humanitas Res Hosp, Dept Oncol, Milan, Italy
[19] Soc Oncol & Hematol Cesar, Clin Oncol, Valledupar, Colombia
[20] IRCCS Osped Policlin San Martino, Genoa, Italy
[21] Inst Nacl Ciencias Med Nutr Salvador Zubiran, Hematol & Oncol Dept, Mexico City, Mexico
[22] Azienda Osped Rilievo Nazl Cardarelli Napoli, UOC Oncol, Naples, Italy
[23] Hosp Ramon & Cajal, Dept Med Oncol, Madrid, Spain
[24] IRCCS, European Inst Oncol, Med Oncol Div Urogenital & Head & Neck Tumours, IEO, Milan, Italy
[25] Ochsner Med Ctr, Dept Internal Med, Hematol Oncol, New Orleans, LA USA
[26] Med Univ Innsbruck, Dept Urol, Innsbruck, Austria
[27] Maggiore della Carita Univ Hosp, Dept Med Oncol, Novara, Italy
[28] Charles Univ Prague, Fac Med 1, Dept Oncol, Prague, Czech Republic
[29] Thomayer Univ Hosp, Prague, Czech Republic
[30] IRCCS Azienda Osped Univ Bologna, Med Oncol, Bologna, Italy
[31] Ctr Hosp Jolimont, Dept Med Oncol, Haine St Paul, Belgium
[32] San Camillo Forlanini Hosp, Dept Oncol, Rome, Italy
[33] La Paz Univ Hosp, Med Oncol Dept, Madrid, Spain
[34] Univ Politecn Marche, Dept Med Oncol, AOU Osped Riunitidelle Marche, Ancona, Italy
[35] Carol Davila Univ Med & Pharm, Prof Dr Alexandru Trestioreanu Inst Oncol, Dept Oncol Radiotherapy, Bucharest, Romania
[36] Sapienza Univ Rome, Dept Radiol Oncol & Anatomopathol Sci, Rome, Italy
[37] Tawam Hosp, Med Oncol, Al Ain, U Arab Emirates
[38] Azienda Osped Univ Cagliari, Unita Oncol Med, Cagliari, Italy
[39] Azienda Osped Osped Riuniti Marche Nord, UOC Oncol, Pesaro, Italy
[40] Natl & Kapodistrian Univ Athens, ATTIKON Univ Hosp, Sch Med, Propaedeut Dept Internal Med 2, Athens, Greece
[41] Santa Chiara Hosp, Med Oncol Unit, Trento, Italy
[42] Fdn IRCCS Ist Nazl Tumori, Dipartimento Oncol Med, Milan, Italy
[43] Osped Maggiore Cremona, Oncol Med, Cremona, Italy
[44] Tampere Univ Hosp, Tays Canc Ctr, Dept Oncol, Tampere, Finland
[45] IRCCS Regina Elena Natl Canc Inst, Med Oncol 1, Rome, Italy
[46] Inst Canc Res & Treatment, Div Oncol, Alba Bra, Italy
[47] Azienda Osped Univ Mater Domini, Policlin Catanzaro, Catanzaro, Italy
[48] Klin Urol, Lubeck, Germany
[49] Univ Verona, Sch Med, Dept Med, Sect Oncol, Verona, Italy
[50] Verona Univ Hosp Trust, Verona, Italy
来源
EUROPEAN UROLOGY ONCOLOGY | 2024年 / 7卷 / 01期
关键词
ARON-1; study; Intermediate-risk International; Metastatic Renal Cell Carcinoma; Database Consortium criteria; Immunotherapy; Immune-oncology combinations; NCT05287464; Renal cell carcinoma; Poor-risk International; Survival;
D O I
10.1016/j.euo.2023.07.003
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background: Renal c carcinoma (RCC) is one of the most common urinary cancers worldwide, with a predicted increase in incidence in the coming years. Immunotherapy, as a single agent, in doublets, or in combination with anti-vascular endothelial growth factor receptor tyrosine kinase inhibitors (TKIs), has rapidly become a cornerstone of the RCC therapeutic scenario, but no head -to -head comparisons have been made. In this setting, real -world evidence emerges as a cornerstone to guide clinical decisions. Objective: The objective of this retrospective study was to assess the outcome of patients treated with first -line immune combinations or immune oncology (IO)-TKIs for advanced RCC. Design, setting, and participants: Data from 930 patients, 654 intermediate risk and 276 poor risk, were collected retrospectively from 58 centers in 20 countries. Special data such as sarcomatoid differentiation, body mass index, prior nephrectomy, and metastatic localization, in addition to biochemical data such as hemoglobin, platelets, calcium, lactate dehydrogenase, neutrophils, and radiological response by investigator's criteria, were collected. Outcome measurements and statistical analysis: Overall survival (OS) and progressionfree survival (PFS) were estimated using the Kaplan -Meier method. The median follow-up was calculated by the inverse Kaplan -Meier method. Results and limitations: The median follow-up time was 18.7 mo. In the 654 intermediate -risk patients, the median OS and PFS were significantly longer in patients with the intermediate than in those with the poor International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria (38.9 vs 17.3 mo, 95% confidence interval [CI] p < 0.001, and 17.3 vs 11.6 mo, 95% CI p < 0.001, respectively). In the intermediate -risk subgroup, the OS was 55.7 mo (95% CI 31.4-55.7) and 40.2 mo (95% CI 29.6-51.6) in patients treated with IO + TKI and IO + IO combinations, respectively (p = 0.047). PFS was 30.7 mo (95% CI 16.5-55.7) and 13.2 mo (95% CI 29.6-51.6) in intermediate -risk patients treated with IO + TKI and IO + IO combinations, respectively (p < 0.001). In the poor -risk subgroup, the median OS and PFS did not show a statistically significant difference between IO + IO and IO + TKI. Our study presents several limitations, mainly due to its retrospective nature. Conclusions: Our results showed differences between the IO + TKI and IO + IO combinations in intermediate -risk patients. A clear association with longer PFS and OS in favor of patients who received the IO + TKI combinations compared with the IO-IO combination was observed. Instead, in the poor -risk group, we observed no significant difference in PFS or OS between patients who received different combinations. Patient summary: Renal cancer is one of the most frequent genitourinary tumors. Treatment is currently based on immunotherapy combinations or immunotherapy with tyrosine kinase inhibitors, but there are no comparisons between these.In this study, we have analyzed the clinical course of 930 patients from 58 centers in 20 countries around the world. We aimed to analyze the differences between the two main treatment strategies, combination of two immunotherapies versus immunotherapy + antiangiogenic therapy, and found in real-life data that intermediate-risk patients (approximately 60% of patients with metastatic renal cancer) seem to benefit more from the combination of immunotherapy + antiangiogenic therapy than from double immunotherapy. No such differences were found in poor-risk patients. This may have important implications in daily practice decision-making for these patients. (c) 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.
引用
收藏
页码:102 / 111
页数:10
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