RandomizEd phase II trial of Sunitinib four weeks on and two weeks off versus Two weeks on and One week off in metastatic clear-cell type REnal cell carcinoma: RESTORE trial

Annals of Oncology : Official Journal of the European Society for Medical Oncology
J L LeeHanjong Ahn

Abstract

The standard sunitinib schedule, 4 weeks on, followed by 2 weeks off (4/2 schedule), is associated with troublesome toxicities, and maintenance of adequate sunitinib dosing and drug levels, which are essential for achieving an optimal treatment outcome, is challenging. The objective of this study was to investigate the efficacy and safety of an alternative sunitinib dosing schedule of 2 weeks on and 1 week off (2/1 schedule) compared with the standard sunitinib schedule of 4 weeks on and 2 weeks off (4/2 schedule). In this multicenter, randomized, open-label, phase II trial, treatment-naïve patients with clear-cell type metastatic renal cell carcinoma (mRCC) were randomly assigned to 4/2 or 2/1 schedules after stratification by Memorial Sloan Kettering Cancer Center risk group and the presence or absence of measurable lesions. The primary end point was the 6-month failure-free survival (FFS) rate, determined by intention-to-treat analysis. From November 2007 to February 2014, 76 patients were accrued, and 74 were eligible. FFS rates at 6 months were 44% with the 4/2 schedule (N = 36) and 63% with the 2/1 schedule (N = 38). Neutropenia (all grades, 61% versus 37%; grade 3-4, 28% versus 11%) and fatigue (all grades, 83% versus 58...Continue Reading

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Citations

Aug 4, 2016·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Jose Manuel Ruiz-MoralesDaniel Y C Heng
Oct 14, 2016·Frontiers in Pharmacology·Carmine D'AnielloSabrina Rossetti
Jan 4, 2017·Expert Review of Anticancer Therapy·Sergio BracardaBernard Escudier
Dec 15, 2016·Expert Review of Anticancer Therapy·Elise NassifStéphane Oudard
Dec 3, 2016·Therapeutic Advances in Urology·Thomas A Schmid, Martin E Gore
Apr 12, 2018·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Eric JonaschBrian I Rini
Nov 23, 2017·The Journal of Experimental Medicine·Marie Blanchette, Richard Daneman
Mar 1, 2019·Clinical Pharmacokinetics·Maddalena CentanniJ G Coen van Hasselt
Mar 27, 2019·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·Winnie ChengMário de Lemos
Feb 27, 2020·The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi·Se Woong ChoiMyung Hwan Noh
Jul 2, 2017·Cancer Chemotherapy and Pharmacology·Dhanusha SabanathanHoward Gurney
Apr 18, 2018·Therapeutic Advances in Urology·Mimma Rizzo, Camillo Porta
Aug 11, 2018·International Journal of Clinical Oncology·Atsunari KawashimaNorio Nonomura
Apr 20, 2019·International Journal of Molecular Sciences·Teresa Alonso-GordoaJavier Molina-Cerrillo
Sep 26, 2020·Yonsei Medical Journal·Hee Jung Kang, Soohyeon Lee
Jul 12, 2018·BioMed Research International·Claudia ArenaLorenzo Lo Muzio
Feb 6, 2019·Japanese Journal of Clinical Oncology·Takahiro OsawaHiroyuki Nishiyama
Oct 22, 2017·Fundamental & Clinical Pharmacology·Luc CabelFrancois Goldwasser
Dec 20, 2016·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Brian I Rini, Nicholas J Vogelzang

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