Safety and Efficacy of Cabozantinib in Metastatic Renal-Cell Carcinoma: Real-World Data From an Italian Managed Access Program

被引:30
|
作者
Procopio, Giuseppe [1 ]
Prisciandaro, Michele [1 ]
Iacovelli, Roberto [2 ]
Cortesi, Enrico [3 ]
Fornarini, Giuseppe [4 ]
Facchini, Gaetano [5 ]
Carteni, Giacomo [6 ]
Sabbatini, Roberto [7 ]
Del Bene, Gabriella [8 ]
Galli, Luca [9 ]
Caserta, Claudia [10 ]
Multari, Andrea Giovanni [11 ]
Bregni, Marco [12 ]
Massari, Francesco [13 ]
Buti, Sebastiano [14 ]
De Giorgi, Ugo [15 ]
Zustovich, Fable [16 ]
Milella, Michele [17 ]
Calabro, Fabio [8 ]
Mancini, Maria Laura [3 ]
Tortora, Giampaolo [2 ]
Vernieri, Claudio [1 ]
Santini, Daniele [18 ]
Soraru, Mariella [19 ]
Ricotta, Riccardo [20 ]
Masini, Cristina [21 ]
Tucci, Marcello [22 ]
Fedeli, Stefano Luzi [23 ]
Ortega, Cinzia [24 ]
Mecozzi, Antonella [25 ]
Ratta, Raffaele [1 ]
Sternberg, Cora N. [8 ]
Verzoni, Elena [1 ]
机构
[1] Fdn IRCCS Ist Nazl Tumori, Genitourinary Canc Unit, Dept Med Oncol, Via Giacomo Venezia 1, I-20133 Milan, Italy
[2] Univ Verona, AOUI, Med Oncol Unit, Verona, Italy
[3] Sapienza Univ Rome, Dept Med Oncol B, Policlin Umberto 1, Rome, Italy
[4] Univ San Martino, Med Oncol Dept, IRCCS Azienda Osped, IST Ist Nazl Ric Cancro, Genoa, Italy
[5] Ist Nazl Tumori Fdn G Pascale IRCCS, Div Med Oncol, Dept Urogynaecol Oncol, Naples, Italy
[6] Antonio Cardarelli Hosp, Oncol Unit, Naples, Italy
[7] Univ Hosp, Dept Oncol & Hematol & Resp Dis, Modena, Italy
[8] San Camillo Forlanini Hosp, Dept Med Oncol, Rome, Italy
[9] Ist Toscano Tumori, Dept Med Oncol 2, Pisa, Italy
[10] Santa Maria Hosp, Oncol Dept, Terni, Italy
[11] Univ Siena, Med Oncol Unit, Siena, Italy
[12] Osped Circolo Busto Arsizio, Busto Arsizio, Italy
[13] St Orsola Marcello Malpighi Hosp, Div Oncol, Bologna, Italy
[14] Univ Hosp Parma, Med Oncol Unit, Parma, Italy
[15] IRCCS, Ist Sci Romagnolo Studio Cura Tumori IRST, Dept Med Oncol, Meldola, Italy
[16] San Martino Hosp, Med Oncol, Belluno, Italy
[17] Ist Nazl Tumori Regina Elena IFO, Med Oncol Unit, Rome, Italy
[18] Campus Biomed Univ Rome, Med Oncol Unit, Rome, Italy
[19] Med Oncol Unit, Camposampiero, Italy
[20] Grande Osped Metropolitan Niguarda, Niguarda Canc Ctr, Milan, Italy
[21] IRCCS, Oncol Unit, Dept Oncol & Adv Technol, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy
[22] Univ Turin, San Luigi Gonzaga Hosp, Dept Oncol, Div Med Oncol, Turin, Italy
[23] Univ Poltecn Marche, AOU Osped Riuniti, Dept Med Oncol, Presidio San Salvatore, Pesaro, Italy
[24] ASL CN2 Alba Bra, Div Oncol, Inst Canc Res & Treatment, Alba, Italy
[25] S Giovanni CalibitaFatebenefratelli Isola Tiberin, Oncol Dept, Rome, Italy
关键词
c-Met; Metastatic renal cell carcinoma; METEOR study; Targeted therapy; VEGF inhibitor; MET; THERAPY; XL184;
D O I
10.1016/j.clgc.2018.03.014
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
The aim of this analysis was to evaluate the safely and activity of cabozantinib in a large unselected population of patients with metastatic renal-cell carcinoma (mRCC) progressing after prior treatments. Our data showed that cabozantinib is effective in a large unselected population of mRCC patients treated in everyday clinical practice. Cabozantinib was also safe and its toxicity profile was feasible and manageable. Background: The randomized phase 3 METEOR study confirmed a survival benefit of cabozantinib over everolimus in patients with metastatic renal-cell carcinoma (mRCC) with disease that progressed after treatment with at least one previous antiangiogenic inhibitor. The aim of this analysis was to evaluate the safety and activity of cabozantinib in an unselected population. Methods: Data were collected across 24 Italian centers. Cabozantinib therapy was initiated at physician request between September and December 2016. Patients with mRCC with disease that progressed after one or more prior systemic treatment were evaluated. Cabozantinib 60 mg was administered orally once daily. Doses were reduced to 40 mg or 20 mg in patients experiencing grade 3 or intolerable grade 2 adverse events (AEs). Results: Data from 96 patients were evaluated. Cabozantinib was administered as second-line therapy in 28 patients (29%) and as third-line therapy in 18 patients (19%), while the remaining 50 patients (52%) received cabozantinib in further treatment lines. Sixty-six patients began therapy with the full dose of 60 mg. Because of poor performance status, 29 patients began therapy with a reduced dose of 40 mg and 1 patient with 20 mg. At the time of our analysis, grade 3/4 AEs were observed in 35 patients (36%). Only 5 patients discontinued treatment as a result of AEs. Partial response was observed in 35 patients (36%), whereas 33 (34%) had stable disease and 28 (30%) progressive disease. Median progression-free survival was 8.0 months. Conclusion: Cabozantinib showed acceptable tolerability and activity in a large unselected population treated according to everyday clinical practice.
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收藏
页码:E945 / E951
页数:7
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