Sunitinib administered on 2/1 schedule in patients with metastatic renal cell carcinoma: the RAINBOW analysis

Bracarda, Sergio; Iacovelli, Roberto; Boni, Luca; Rizzo, Mimma; Derosa, Lisa; Rossi, Marta; Galli, Luca; Procopio, Giuseppe; Sisani, Michele; Longo, Flavia; Santoni, Matteo; Morelli, Franco; Lorenzo, Giuseppe Di; Altavilla, Amelia; Porta, Camillo; Camerini, Andrea; Escudier, Bernard; Martignetti, Angelo; Ricotta, Riccardo; Gasparro, Donatello; Sabbatini, Roberto; Ceresoli, Giovanni Luca; Mosca, Alessandra; Santini, Daniele; Caserta, Claudia; Cavanna, Luigi; Massari, Francesco; Sava, Teodoro; Boni, C.; Verzoni, Elena; Cartenì, Giacomo; Hamzaj, Alketa

doi:10.1093/annonc/mdv315

Cited by 97 publications

(73 citation statements)

References 21 publications

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“…To balance the clinical benefit with the toxicity of these agents, alternative ways to deliver these drugs have also been evaluated. A retrospective analysis (RAINBOW) reported by Bracarda et al evaluated 208 consecutive patients with previously untreated mRCC who started sunitinib on a 4/2 schedule, switched to a 2‐weeks‐on/1‐week‐off (2/1) schedule for toxicity, and used a second group of 211 patients who were treated on the 4/2 schedule for external control. In the group that changed from the 4/2 to the 2/1 schedule, grade 3 and 4 AEs were significantly reduced from 45.7% to 8.2% ( P < .001) after switching to the 2/1, including fatigue, hypertension, hand‐foot syndrome, and thrombocytopenia.…”

Section: Systemic Therapy For Metastatic Diseasementioning

confidence: 99%

Treatment of renal cell carcinoma: Current status and future directions

Barata

Rini

2017

CA A Cancer J Clinicians

684

528

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Answer questions and earn CME/CNE Over the past 12 years, medical treatment for renal cell carcinoma (RCC) has transitioned from a nonspecific immune approach (in the cytokine era), to targeted therapy against vascular endothelial growth factor (VEGF), and now to novel immunotherapy agents. Multiple agents-including molecules against vascular endothelial growth factor, platelet-derived growth factor, and related receptors; inhibitors of other targets, such as the mammalian target of rapamycin and the MET and AXL tyrosine-protein kinase receptors; and an immune-checkpoint inhibitor-have been approved based on significant activity in patients with advanced RCC. Despite these advances, important questions remain regarding biomarkers of efficacy, patient selection, and the optimal combination and sequencing of agents. The purpose of this review is to summarize present management and future directions in the treatment of metastatic RCC. CA Cancer J Clin 2017;67:507-524. © 2017 American Cancer Society.

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Section: Systemic Therapy For Metastatic Diseasementioning

confidence: 99%

Treatment of renal cell carcinoma: Current status and future directions

Barata

Rini

2017

CA A Cancer J Clinicians

684

528

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“…[20][21][22][23][24] Three ongoing prospective studies (NCT02060370, NCT02689167, and NCT02398552) will further evaluate the value of the two/ one schedule. It is important to note that based on the dose/schedule distribution (Table 1) in our individualization study, the two/ one schedule was optimal in only 39 (37%) patients.…”

Section: Changing the Schedule From Four/two To Two/one May Not Optimmentioning

confidence: 99%

Can individualized sunitinib dose and schedule changes optimize outcomes for kidney cancer patients?

Bjarnason

2016

CUAJ

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“…The results of this trial demonstrated better toxicity profile and better compliance with the 2/1 schedule 36. A retrospective analysis with 249 patients concluded with similar results 37. Even though this scheme has not been evaluated in GIST patients, it could be considered in some patients with poor tolerance to the conventional schedule 38…”

Section: Development Of Sunitinib In Gist: From Bench To Bedsidementioning

confidence: 55%

Sunitinib in the treatment of gastrointestinal stromal tumor: patient selection and perspectives

Mulet-Margalef¹,

García‐del‐Muro²

2016

OTT

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Gastrointestinal stromal tumor (GIST) is the most common mesenchymal tumor of the gastrointestinal tract. In advanced setting and after progression to imatinib, the multi-targeted receptor tyrosine kinase inhibitor sunitinib has clearly demonstrated a clinical benefit in terms of response rate and progression-free survival with an acceptable toxicity profile. The recommended schedule for sunitinib administration is 50 mg per day 4 weeks ON and 2 weeks OFF; however, potential alternative schedules are also reviewed in the present article. Several biomarkers have been explored to better select candidates for sunitinib therapy, such as the value of early changes in standardized uptake value assessed by positron emission tomography with 18F-fluorodeoxyglucose, circulating biomarkers, clinical biomarkers such as the appearance of arterial hypertension during treatment that correlates with better outcomes, and the GIST genotype. GISTs with KIT mutations at exon 9 and the so-called wild-type GISTs seem to better respond to sunitinib. Nonetheless, further investigation is required to confirm these findings as well as to understand the mechanisms of sunitinib resistance such as the development of new KIT mutations or conformational changes in KIT receptor.

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Sunitinib administered on 2/1 schedule in patients with metastatic renal cell carcinoma: the RAINBOW analysis

Abstract: mRCC patients who moved to a modified 2/1 schedule of sunitinib experience an improved safety profile compared with that observed during the initial 4/2 schedule.

Cited by 97 publications

References 21 publications

Treatment of renal cell carcinoma: Current status and future directions

Treatment of renal cell carcinoma: Current status and future directions

Can individualized sunitinib dose and schedule changes optimize outcomes for kidney cancer patients?

Sunitinib in the treatment of gastrointestinal stromal tumor: patient selection and perspectives

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