Safety and Efficacy of Sunitinib in Patients from Italy with Metastatic Renal Cell Carcinoma: Final Results from an Expanded-Access Trial

被引：23

作者：

Sternberg, Cora N. ^{[1
]}

Calabro, Fabio ^{[1
]}

Bracarda, Sergio ^{[4
]}

Carteni, Giacomo ^{[5
]}

Lo Re, Giovanni ^{[6
]}

Ruggeri, Enzo M. ^{[7
]}

Basso, Umberto ^{[8
]}

Gasparini, Giampietro ^{[2
]}

Ciuffreda, Libero ^{[9
]}

Ferrari, Vittorio ^{[10
]}

Bonetti, Andrea ^{[11
]}

Fea, Elena ^{[12
]}

Gasparro, Donatello ^{[13
]}

Tassinari, Davide ^{[14
]}

Labianca, Roberto ^{[15
]}

Masini, Cristina ^{[16
]}

Fly, Kolette ^{[18
]}

Zhang, Ke ^{[19
]}

Hariharan, Subramanian ^{[20
]}

Capaccetti, Barbara ^{[3
]}

Porta, Camillo ^{[17
]}

机构：

[1] San Camillo Forlanini Hosp, Rome, Italy

[2] San Filippo Neri Hosp, Rome, Italy

[3] Pfizer Oncol, Rome, Italy

[4] San Donato Hosp, Ist Toscano Tumori, Arezzo, Italy

[5] AORN A Cardarelli, Div Oncol, Naples, Italy

[6] Santa Maria Angeli Hosp, Pordenone, Italy

[7] Osped Belcolle AUSL Viterbo, Div Oncol, Viterbo, Italy

[8] IRCCS, IOV, Med Oncol Unit 1, Padua, Italy

[9] Univ & ASO San Giovanni Battista, Turin, Italy

[10] Beretta Fdn, Azienda Spedali Civili, Brescia, Italy

[11] Osped Mater Salutis, Legnago, Italy

[12] Croce Gen Hosp, Cuneo, Italy

[13] Univ Hosp Parma, Parma, Italy

[14] City Hosp, Rimini, Italy

[15] Riuniti Hosp, Bergamo, Italy

[16] IRCCS Arcispedale Santa Maria Nuova, SC Oncol, Reggio Emilia, Italy

[17] San Matteo Univ Hosp Fdn, IRCCS, Pavia, Italy

[18] Pfizer Oncol, Groton, CT USA

[19] Pfizer Oncol, La Jolla, CA USA

[20] Pfizer Oncol, New York, NY USA

来源：

ONCOLOGY | 2015年 / 88卷 / 05期

关键词：

Sunitinib malate; Renal cell carcinoma; Expanded-access program; Receptor tyrosine kinase inhibitor; Safety; Survival; TYROSINE KINASE INHIBITOR; ENDOTHELIAL GROWTH-FACTOR; INTERFERON-ALPHA; ELDERLY-PATIENTS; CLINICAL-TRIALS; BREAST-CANCER; IN-VIVO; SU11248; MULTICENTER; GUIDELINES;

D O I：

10.1159/000369256

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Objectives: Patients with metastatic renal cell carcinoma (mRCC) received sunitinib in a global expanded-access program (EAP). Here, we report the efficacy and safety results for the EAP subpopulation in Italy. Methods: Patients >= 18 years old with previously treated or treatment-naive mRCC received oral sunitinib 50 mg/day on a 4-weeks-on/2-weeks-off schedule. Tumor measurements were scheduled per local practice (using Response Evaluation Criteria in Solid Tumors). Safety was regularly assessed. Results: A total of 521 patients participated, including 40% aged >= 65 years, 11% with an Eastern Cooperative Oncology Group performance status >= 2, 14% with non-clear cell RCC, and 11% with brain metastases. The median treatment duration and posttreatment follow-up were 7.4 and 12.3 months, respectively. The objective response rate was 12%, and the median progression-free and overall survival was 9.1 and 27.2 months, respectively. 514 patients (99%) discontinued treatment; reasons included death (17%), nonresponse (46%), or adverse events (AEs; 13%). The most common any-grade treatment-related AEs were asthenia (44%, plus 15% reporting fatigue), thrombocytopenia and stomatitis (both 37%), diarrhea (36%), mucosal inflammation (29%), hypertension (26%), and dysgeusia (25%). The most common grade 3/4 treatment-related AEs were thrombocytopenia (10%), asthenia (9%, plus 3% reporting fatigue), neutropenia, stomatitis (both 6%), and hypertension (5%). Conclusion: In a large population of Italian mRCC patients, sunitinib had a manageable safety profile and encouraging efficacy. (C) 2015 S. Karger AG, Basel

引用

页码：273 / 280

页数：8

共 30 条

[11] An orally administered multitarget tyrosine kinase inhibitor, SU11248, is a novel potent inhibitor of thyroid oncogenic RET/papillary thyroid cancer kinases [J].