Enfortumab Vedotin Following Platinum Chemotherapy and Avelumab Maintenance in Patients with Metastatic Urothelial Carcinoma: A Retrospective Data from the ARON-2EV Study

被引：1

作者：

Fiala, Ondrej ^{[1
,2
]}

Massari, Francesco ^{[3
,4
]}

Basso, Umberto ^{[5
]}

Giannatempo, Patrizia ^{[6
]}

Grande, Enrique ^{[7
]}

Buti, Sebastiano ^{[8
,9
]}

Myint, Zin W. ^{[10
]}

De Giorgi, Ugo ^{[11
]}

Pichler, Renate ^{[12
]}

Grillone, Francesco ^{[13
]}

Urun, Yuksel ^{[14
]}

Calabro, Fabio ^{[15
]}

Bourlon, Maria T. ^{[16
,17
]}

Galli, Luca ^{[18
]}

Kanesvaran, Ravindran ^{[19
]}

Roviello, Giandomenico ^{[20
]}

Kucharz, Jakub ^{[21
]}

Rizzo, Mimma ^{[22
]}

Park, Se Hoon ^{[23
]}

Cerbone, Linda ^{[24
]}

Seront, Emmanuel ^{[25
]}

Messina, Carlo ^{[26
]}

Molina-Cerrillo, Javier ^{[27
]}

Santini, Daniele ^{[28
]}

Yano, Akihiro ^{[29
]}

Incorvaia, Lorena ^{[30
]}

Catalano, Martina ^{[19
]}

Pinto, Alvaro ^{[31
]}

Formisano, Luigi ^{[32
]}

Soares, Andrey ^{[33
,34
]}

Facchini, Gaetano ^{[35
]}

Fornarini, Giuseppe ^{[36
]}

Poprach, Alexandr ^{[37
,38
]}

Rebuzzi, Sara Elena ^{[39
,40
]}

Nasso, Cecilia ^{[41
]}

Spinelli, Gian Paolo ^{[42
]}

Angel, Martin ^{[43
]}

Stellato, Marco ^{[6
]}

Tural, Deniz ^{[44
]}

Aurilio, Gaetano ^{[45
]}

Epstein, Ilana ^{[46
]}

Carrozza, Francesco ^{[47
]}

Monteiro, Fernando Sabino Marques ^{[48
,49
]}

Benedetti, Giovanni ^{[50
]}

Buchler, Tomas ^{[51
,52
]}

Ortega, Cinzia ^{[53
]}

Zakopoulou, Roubini ^{[54
]}

Battelli, Nicola ^{[55
]}

Porta, Camillo ^{[56
]}

Bellmunt, Joaquin ^{[46
,57
]}

机构：

[1] Charles Univ Prague, Univ Hosp Pilsen, Fac Med, Dept Oncol & Radiotherapeut, Alej Svobody 80, Plzen 30460, Czech Republic

[2] Charles Univ Prague, Fac Med Pilsen, Biomed Ctr, Plzen, Czech Republic

[3] IRCCS Azienda Ospedaliero Univ Bologna, Med Oncol, Bologna, Italy

[4] Univ Bologna, Dept Med & Surg Sci DIMEC, Bologna, Italy

[5] Ist Oncol Veneto IOV IRCCS, Dept Oncol, Med Oncol Unit 1, I-35128 Padua, Italy

[6] Fdn IRCCS Ist Nazl Tumori, Med Oncol Dept, Via Giacomo Venezian 1, Milan, Italy

[7] MD Anderson Canc Ctr Madrid, Dept Med Oncol, Madrid, Spain

[8] Univ Parma, Dept Med & Surg, Parma, Italy

[9] Univ Hosp Parma, Med Oncol Unit, Parma, Italy

[10] Univ Kentucky, Markey Canc Ctr, Dept Internal Med, Div Med Oncol, Lexington, KY 40506 USA

[11] IRCCS Ist Romagnolo Studio Tumori IRST Dino Amador, Dept Med Oncol, Meldola, Italy

[12] Med Univ Innsbruck, Dept Urol, Innsbruck, Austria

[13] Unita Operativa Oncol Presidio Pugliese Ciaccio Az, Catanzaro, Italy

[14] Ankara Univ, Fac Med, Dept Med Oncol, Ankara, Turkiye

[15] IRCCS Regina Elena Natl Canc Inst, Med Oncol 1, Rome, Italy

[16] Inst Nacl Ciencias Med & Nutr Salvador Zubiran, Dept Hemato Oncol, Mexico City, Mexico

[17] Univ Panamericana, Escuela Med, Mexico City, DF, Mexico

[18] Azienda Ospedaliero Univ Pisana, Med Oncol Unit 2, Pisa, Italy

[19] Natl Canc Ctr Singapore, Div Med Oncol, Singapore City, Singapore

[20] Univ Florence, Dept Hlth Sci, Sect Clin Pharmacol & Oncol, Viale Pieraccini 6, I-50139 Florence, Italy

[21] Maria Sklodowska Curie Natl Res Inst Oncol, Dept Uro oncol, Warsaw, Poland

[22] Univ Consorziale Policlin Bari, Azienda Ospedaliera, Med Oncol Unit, Bari, Italy

[23] Sungkyunkwan Univ, Sch Med, Samsung Med Ctr, Seoul, South Korea

[24] San Camillo Forlanini Hosp, Dept Med Oncol, Rome, Italy

[25] Clin Univ St Luc, Dept Med Oncol, Brussels, Belgium

[26] ARNAS Civ, Oncol Unit, Palermo, Italy

[27] Hosp Ramon & Cajal, Dept Med Oncol, Madrid, Spain

[28] Policlin Umberto 1, Oncol Dip Sci & Biotecnol Med Chirurg, Rome, Italy

[29] Saitama Med Univ, Saitama Med Ctr, Dept Urol, Saitama, Japan

[30] Univ Palermo, Dept Precis Med Med, Sect Med Oncol, Surg & Cit Care Me Pre C C, Palermo, Italy

[31] Hosp Univ La Paz, Serv Oncol, Madrid, Spain

[32] Univ Naples Federico II, Dept Med & Surg, Naples, Italy

[33] Hosp Israelita Albert Einstein, Sao Paulo, SP, Brazil

[34] Ctr Paulista Oncol Oncoclin, Sao Paulo, SP, Brazil

[35] S Maria Grazie Hosp, ASL NA2 NORD, Oncol Unit, Naples, Italy

[36] IRCCS Osped Policlin San Martino, Genoa, Italy

[37] Masaryk Mem Canc Inst, Brno, Czech Republic

[38] Masaryk Univ, Fac Med, Brno, Czech Republic

[39] Osped San Paolo, Med Oncol Unit, Savona, Italy

[40] Univ Genoa, Dept Internal Md & Med Specialties Di M I, Genoa, Italy

[41] Osped Santa Corona, Med Oncol, Pietra Ligure, Italy

[42] UOC Oncol Territoriale Ausl Latina, Aprilia, Italy

[43] Alexander Fleming Inst, Genitourinary Oncol Unit, Clin Oncol, Buenos Aires, Argentina

[44] Bakirkoy Dr SadiKonuk Training & Res Hosp, Dept Med Oncol, Istanbul, Turkiye

[45] IEO European Inst Oncol IRCCS, Div Canc Prevent & Genet, Milan, Italy

[46] Dana Farber Canc Inst, Lank Ctr Genitourinary Oncol, Boston, MA USA

[47] Santa Maria Croci Hosp, AUSL Romagna, Dept Oncol & Hematol, Oncol Unit, Ravenna, Italy

[48] Hosp Sirio Libanes, Brasilia, DF, Brazil

[49] Latin Amer Cooperat Oncol Grp LACOG, Porto Alegre, Brazil

[50] Osped Civitanova Marche, UO Oncol, Civitanova Marche, Italy

来源：

TARGETED ONCOLOGY | 2024年 / 19卷 / 06期

关键词：

MULTICENTER; PEMBROLIZUMAB; CISPLATIN; THERAPY; CANCER;

D O I：

10.1007/s11523-024-01099-0

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background Enfortumab vedotin (EV) has been approved for the treatment of patients with locally advanced/metastatic urothelial carcinoma (la/mUC) who previously received platinum-based chemotherapy followed by immune checkpoint inhibitors. However, the pivotal clinical trials did not include patients previously treated with avelumab maintenance therapy. Objective The aim of the present retrospective analysis was to assess the effectiveness of EV following avelumab in patients with mUC enrolled in the ARON-2EV study. Patients and Methods The study included 182 patients with mUC treated with EV following avelumab maintenance. The primary objective was to assess clinical outcomes, including progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and duration of response (DoR). Statistical analysis involved Fisher exact test, Kaplan-Meier method, log-rank test, and univariate/multivariate Cox proportional hazard regression models. Results Median OS and PFS were 12.7 (95% CI 10.2-14.1) and 7.9 (95% CI 6.4-9.9) months, respectively. Complete response (CR) was achieved in 5% and partial response (PR) in 34% of patients, with an ORR of 39%. The DoR in patients who achieved CR/PR was 10.9 months (95% CI 8.1-11.4). The incidence of grade >= 3 peripheral neuropathy and skin rash was 9%, followed by 8% of grade >= 3 diarrhea and 4% of grade >= 3 hyperglycemia. Conclusions The results of our large international retrospective study confirm the effectiveness of EV and endorse its use in the population of patients with mUC treated with EV following the frontline platinum-based chemotherapy and subsequent maintenance treatment with avelumab.

引用

页码：905 / 915

页数：11

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