Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma: The ARON-1 Study

被引:21
|
作者
Santoni, Matteo [1 ]
Massari, Francesco [2 ]
Myint, Zin W. [3 ]
Iacovelli, Roberto [4 ]
Pichler, Martin [5 ]
Basso, Umberto [6 ]
Kopecky, Jindrich [7 ]
Kucharz, Jakub [8 ]
Buti, Sebastiano [9 ]
Rizzo, Mimma [10 ]
Galli, Luca [11 ]
Buettner, Thomas [12 ]
De Giorgi, Ugo [13 ]
Kanesvaran, Ravindran [14 ]
Fiala, Ondrej [15 ]
Grande, Enrique [16 ]
Zucali, Paolo Andrea [17 ,18 ]
Fornarini, Giuseppe [19 ]
Bourlon, Maria T. [20 ]
Scagliarini, Sarah [21 ]
Molina-Cerrillo, Javier [22 ]
Aurilio, Gaetano [23 ]
Matrana, Marc R. [24 ]
Pichler, Renate [25 ]
Cattrini, Carlo [26 ]
Buechler, Tomas [27 ]
Seront, Emmanuel [28 ]
Calabro, Fabio [29 ]
Pinto, Alvaro [30 ]
Berardi, Rossana [31 ]
Zgura, Anca [32 ]
Mammone, Giulia [33 ]
Ansari, Jawaher [34 ]
Atzori, Francesco [35 ]
Chiari, Rita [36 ]
Bamias, Aristotelis [37 ]
Caffo, Orazio [38 ]
Procopio, Giuseppe [39 ,40 ]
Bassanelli, Maria [41 ]
Merler, Sara [42 ]
Messina, Carlo [43 ]
Kueronya, Zsofia [44 ]
Mosca, Alessandra [45 ]
Bhuva, Dipen [46 ]
Vau, Nuno [47 ]
Incorvaia, Lorena [48 ]
Rebuzzi, Sara Elena [49 ,50 ]
Roviello, Giandomenico [51 ]
Zabalza, Ignacio Ortego [16 ]
Rizzo, Alessandro [52 ]
机构
[1] Macerata Hosp, Oncol Unit, Via Santa Lucia 2, I-62100 Macerata, Italy
[2] IRCCS Azienda Osped Univ Bologna, Med Oncol, Via Albertoni 15, Bologna, Italy
[3] Univ Kentucky, Markey Canc Ctr, Lexington, KY 40536 USA
[4] Fdn Policlin Univ Agostino Gemelli IRCCS, Oncol Med, Rome, Italy
[5] Med Univ Graz, Dept Internal Med, Div Oncol, Augenbruggerplatz 15, A-8010 Graz, Austria
[6] Ist Oncol Veneto IOV IRCCS, Dept Oncol, Oncol Unit 3, Padua, Italy
[7] Univ Hosp Hradec Kralove, Dept Clin Oncol & Radiotherapy, Hradec Kralove, Czech Republic
[8] Maria Sklodowska Curie Natl Res Inst Oncol, Dept Uro Oncol, Warsaw, Poland
[9] Univ Parma, Univ Hosp Parma, Dept Med & Surg, Med Oncol Unit, Parma, Italy
[10] AOU Consorziale Policlin Bari, Div Med Oncol, Piazza G Cesare 11, I-70124 Bari, Italy
[11] Univ Hosp Pisa, Oncol Unit 2, I-56126 Pisa, Italy
[12] Univ Hosp Bonn UKB, Dept Urol, D-53127 Bonn, Germany
[13] IRCCS Ist Romagnolo Studio Tumori IRST Dino Amador, Dept Med Oncol, Meldola, Italy
[14] Natl Canc Ctr Singapore, Div Med Oncol, Singapore, Singapore
[15] Charles Univ Prague, Univ Hosp Pilsen, Fac Med, Dept Oncol & Radiotherapeut, Plzen, Czech Republic
[16] MD Anderson Canc Ctr Madrid, Dept Med Oncol, Madrid, Spain
[17] Humanitas Univ, Dept Biomed Sci, Pieve Emanuele, Milan, Italy
[18] IRCCS Humanitas Res Hosp, Dept Oncol, Milan, Italy
[19] IRCCS Osped Policlin San Martino, Genoa, Italy
[20] Inst Nacl Ciencias Med & Nutr Salvador Zubiran, Hematol & Oncol Dept, Mexico City, Mexico
[21] Azienda Osped Rilievo Nazl Cardarelli Napoli, UOC Oncol, Naples, Italy
[22] Hosp Ramon & Cajal, Dept Med Oncol, Madrid, Spain
[23] European Inst Oncol IRCCS, Med Oncol Div Urogenital & Head & Neck Tumours, IEO, Milan, Italy
[24] Ochsner Med Ctr, Dept Internal Med, Hematol Oncol, New Orleans, LA USA
[25] Med Univ Innsbruck, Dept Urol, Anichstr 35, A-6020 Innsbruck, Austria
[26] Maggiore Car Univ Hosp, Dept Med Oncol, I-28100 Novara, Italy
[27] Charles Univ Prague, Thomayer Univ Hosp, Fac Med 1, Dept Oncol, Prague 14059, Czech Republic
[28] Ctr Hospitalier Jolimont, Dept Med Oncol, Haine St Paul, Haine Saint Paul, Belgium
[29] San Camillo Forlanini Hosp, Dept Oncol, Rome, Italy
[30] La Paz Univ Hosp, Med Oncol Dept, Madrid, Spain
[31] Univ Politecn Marche, Dept Med Oncol, AOU Ospedali Riuniti Marche, Ancona, Italy
[32] Carol Davila Univ Med & Pharm, Prof Dr Alexandru Trestioreanu Inst Oncol, Dept Oncol Radiotherapy, Bucharest, Romania
[33] Sapienza Univ Rome, Dept Radiol Oncol & Anatomo Pathol Sci, Viale Regina Elena 324, I-00185 Rome, Italy
[34] Tawam Hosp, Med Oncol, Al Ain, U Arab Emirates
[35] Azienda Osped Univ Cagliari, Unita Oncol Med, Cagliari, Italy
[36] Azienda Osped Ospedali Riuniti Marche Nord, UOC Oncol, Tuscany, Italy
[37] Natl & Kapodistrian Univ Athens, ATTIKON Univ Hosp, Sch Med, Propaedeut Dept Internal Med 2, Athens, Greece
[38] Santa Chiara Hosp, Med Oncol Unit, Trento, Italy
[39] Fdn IRCCS Ist Nazl Tumori, Dipartimento Oncol Med, Milan, Italy
[40] Osped Maggiore Cremona, Oncol Med, Cremona, Italy
[41] IRCCS Regina Elena Natl Canc Inst, Med Oncol 1, Rome, Italy
[42] Univ Verona, Verona Univ Hosp Trust, Dept Med, Sect Oncol,Sch Med, Verona, Italy
[43] ARNAS Civ, Oncol Unit, Palermo, Italy
[44] Natl Inst Oncol, Dept Genitourinary Med Oncol & Clin Pharmacol, Budapest, Hungary
[45] IRCCS FPO, Candiolo Canc Inst, Oncol, I-10060 Turin, Italy
[46] Army Hosp Res & Referral, Dept Med Oncol, New Delhi, India
[47] Champalimaud Clin Ctr, Urol Oncol, P-1400038 Lisbon, Portugal
[48] Univ Palermo, Dept Surg Oncol & Oral Sci, Sect Med Oncol, Palermo, Italy
[49] Osped San Paolo, Med Oncol, I-17100 Savona, Italy
[50] Univ Genoa, Dept Internal Med & Med Specialties DiMI, Genoa, Italy
关键词
CYTOREDUCTIVE NEPHRECTOMY; SUNITINIB; CANCER;
D O I
10.1007/s11523-023-00978-2
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
BackgroundImmuno-oncology combinations have achieved survival benefits in patients with metastatic renal cell carcinoma (mRCC).ObjectiveThe ARON-1 study (NCT05287464) was designed to globally collect real-world data on the use of immuno-combinations as first-line therapy for mRCC patients.Patients and MethodsPatients aged & GE; 18 years with a cytologically and/or histologically confirmed diagnosis of mRCC treated with first-line immuno-combination therapies were retrospectively included from 47 International Institutions from 16 countries. Patients were assessed for overall survival (OS), progression-free survival (PFS), and overall clinical benefit (OCB).ResultsA total of 729 patients were included; tumor histology was clear-cell RCC in 86% of cases; 313 patients received dual immuno-oncology (IO + IO) therapy while 416 were treated with IO-tyrosine kinase inhibitor (IO + TKI) combinations. In the overall study population, the median OS and PFS were 36.5 and 15.0 months, respectively. The median OS was longer with IO+TKI compared with IO+IO therapy in the 616 patients with intermediate/poor International mRCC Database Consortium (IMDC) risk criteria (55.7 vs 29.7 months; p = 0.045). OCB was 84% for IO+TKI and 72% for IO + IO combination (p < 0.001).ConclusionsOur study may suggest that immuno-oncology combinations are effective as first-line therapy in the mRCC real-world context, showing outcome differences between IO + IO and IO + TKI combinations in mRCC subpopulations.
引用
收藏
页码:559 / 570
页数:12
相关论文
共 50 条
  • [41] Real-world short-term outcomes and treatment regimen comparisons in patients with metastatic renal cell carcinoma treated with first-line immune combinations
    Kikuta, Masato
    Naito, Sei
    Osawa, Takahiro
    Numakura, Kazuyuki
    Narisawa, Takafumi
    Takai, Yuki
    Yagi, Mayu
    Sekine, Yuya
    Tokairin, Ojiro
    Shinohara, Nobuo
    Habuchi, Tomonori
    Tsuchiya, Norihiko
    BMC CANCER, 2025, 25 (01)
  • [42] Efficacy and safety of pembrolizumab and axitinib as first-line treatment for patients with advanced renal cell carcinoma: Real-world experience in Japan
    Harada, Ken-ichi
    Sato, Ryo
    Bando, Yukari
    Sano, Asuka
    Matsushita, Yuto
    Tamura, Keita
    Terakawa, Tomoaki
    Furukawa, Junya
    Fujimoto, Naohiro
    Fujisawa, Masato
    Miyake, Hideaki
    INTERNATIONAL JOURNAL OF UROLOGY, 2023, 30 (09) : 772 - 777
  • [43] Real-world experience of the feasibility and tolerability of the 2/1 dosing schedule with sunitinib in the treatment of patients with advanced renal cell carcinoma in Australia
    Crumbaker, Megan
    Guminski, Alexander
    Gurney, Howard
    Sabanathan, Dhanusha
    Wong, Shirley
    Pavlakis, Nick
    ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, 2018, 14 (02) : E45 - E49
  • [44] Real-world treatment trends for patients with advanced prostate cancer and renal cell carcinoma and their cost-a survey in Japan
    Osawa, Takahiro
    Sasaki, Keita
    Machida, Ryunosuke
    Matsumoto, Takashi
    Matsui, Yoshiyuki
    Kitamura, Hiroshi
    Nishiyama, Hiroyuki
    JAPANESE JOURNAL OF CLINICAL ONCOLOGY, 2024, 54 (10) : 1062 - 1070
  • [45] Nivolumab VERSUS Cabozantinib as Second-Line Therapy in Patients With Advanced Renal Cell Carcinoma: A Real-World Comparison
    Santoni, Matteo
    Aurilio, Gaetano
    Massari, Francesco
    Grande, Enrique
    Matrana, Marc R.
    Rizzo, Mimma
    De Giorgi, Ugo
    Incorvaia, Lorena
    Martignetti, Angelo
    Molina-Cerrillo, Javier
    Zabalza, Ignacio Ortego
    Mollica, Veronica
    Rizzo, Alessandro
    Battelli, Nicola
    Porta, Camillo
    CLINICAL GENITOURINARY CANCER, 2022, 20 (03) : 285 - 295
  • [46] Real-world Data of Nivolumab for Patients With Advanced Renal Cell Carcinoma in the Netherlands: An Analysis of Toxicity, Efficacy, and Predictive Markers
    Verhaart, Saskia Lisa
    Abu-Ghanem, Yasmin
    Mulder, Sasja F.
    Oosting, Sjoukje
    Van Der Veldt, Astrid
    Osanto, Susanne
    Aarts, Maureen J. B.
    Houtsma, Danny
    Peters, Frank P. J.
    Groenewegen, Gerard
    Van Herpen, Carla M. L.
    Pronk, Loes M.
    Tascilar, Metin
    Hamberg, Paul
    Los, Maartje
    Vreugdenhil, Gerard
    Polee, Marco
    Ten Tije, Albert J.
    Haanen, John B. A. G.
    Bex, Axel
    van den Eertwegh, Alfonsus J.
    CLINICAL GENITOURINARY CANCER, 2021, 19 (03) : 274.e1 - 274.e16
  • [47] Role of dose exposure and inflammatory status in a single center, real-world analysis of sunitinib in patients with metastatic renal cell carcinoma
    Maruzzo, Marco
    Basso, Umberto
    Diminutto, Alberto
    Roma, Anna
    Zustovich, Fable
    Brunello, Antonella
    Fiduccia, Pasquale
    Banzato, Alberto
    Zattoni, Filiberto
    Zagonel, Vittorina
    FUTURE ONCOLOGY, 2016, 12 (07) : 909 - 919
  • [48] Comparison of patients with renal cell carcinoma in adjuvant therapy trials to a real-world population
    Millan, Braden
    Breau, Rodney H.
    Mallick, Ranjeeta
    Wood, Lori
    Rendon, Ricardo
    Finelli, Antonio
    So, Alan I.
    Lavallee, Luke T.
    Pouliot, Frederic
    Bhindi, Bimal
    Heng, Daniel
    Drachenberg, Darrel
    Tanguay, Simon
    Dean, Lucas
    Basappa, Naveen S.
    Lattouf, Jean-Baptiste
    Bjarnason, George
    Lalani, Aly-Khan
    Kapoor, Anil
    UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS, 2023, 41 (07) : 328.e15 - 328.e23
  • [49] Real-world outcomes in patients with metastatic renal cell carcinoma according to risk factors: the STAR-TOR registry
    Strauss, Arne
    Schmid, Marianne
    Rink, Michael
    Moran, Michael
    Bernhardt, Stephan
    Hubbe, Marcus
    Bergmann, Lothar
    Schlack, Katrin
    Boegemann, Martin
    FUTURE ONCOLOGY, 2021, 17 (18) : 2325 - 2338
  • [50] Real-world comparison of the efficacy of first-line therapies and the influence of risk factors in advanced renal cell carcinoma
    Haack, Maximilian
    Neuberger, Stephanie
    Boerner, Jan Hendrik
    Ziewers, Stefanie
    Duwe, Gregor
    Dotzauer, Robert
    Haferkamp, Axel
    Mager, Rene
    DISCOVER ONCOLOGY, 2025, 16 (01)