Sunitinib dosing schedule 2/1 improves tolerability, efficacy, and health-related quality of life in Chinese patients with metastatic renal cell carcinoma

Pan, Xiuwu; Huang, Hai; Huang, Yi; Liu, Bing; Cui, Xingang; Gan, Sishun; Ye, Jianqing; Xu, Danfeng; Chen, Lu; Zhou, Qiongqiong; Li, Lin; Yang, Hong

doi:10.1016/j.urolonc.2015.03.008

Cited by 32 publications

(41 citation statements)

References 28 publications

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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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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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“…In a retrospective analysis of patients with mRCC in China, data were reviewed from 108 patients treated with first-line sunitinib in one of three regimens -a four/two schedule (n=50), a transitional schedule starting with a four/ two schedule and switching to a two/one schedule due to toxicity (n=26), and an initial two/one schedule (n=32). 8 AEs, including hand-foot syndrome, fatigue, diarrhea, and bone marrow suppression, were significantly less common in both the transitional four/two to two/one schedule and the initial two/one schedule than in the four/two schedule (p<0.05). HRQOL, measured by Functional Assessment of Cancer Therapy-Kidney Symptom Index-19 (FKSI-19) scores, did not differ significantly among the three groups during the first two treatment cycles; however, HRQOL declined significantly less during Cycles 3-9 in the group treated initially with a two/one schedule, than among those treated with either a four/two schedule or the transitional schedule.…”

Section: Henry Jacob Conter MD Mscmentioning

confidence: 93%

Practical first-line management of renal cell carcinoma in a community practice

Conter

2016

CUAJ

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Sunitinib is an oral receptor tyrosine kinase inhibitor (TKI) that targets signalling by vascular endothelial growth factor receptors (VEGFRs). The standard sunitinib dosing schedule for metastatic renal cell carcinoma (mRCC) is 50 mg for four weeks (28 days) of treatment, followed by a two-week (14-day) break from treatment (four/two schedule). However, this schedule is associated with toxicities that can limit the patient's health-related quality of life (HRQOL) and impede treatment compliance. Given the generally incurable nature of mRCC and the toxicity associated with therapy, treatment strategies should focus on achieving long-term response, preserving HRQOL, and minimizing treatment-related toxicity. The William Osler Cancer Clinic in Brampton, ON, has instituted an alternative schedule of sunitinib treatment as our standard dosing strategy, involving two weeks of treatment, followed by a oneweek break (two/one schedule), to minimize toxicity and improve HRQOL among their patients with mRCC.

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“…Several studies, however, including the RAINBOW, RESTORE (randomized phase II trial of sunitinib four weeks on and two weeks off vs. two weeks on and one week off in metastatic clear-cell type renal cell carcinoma), and single-center studies, have investigated sunitinib on schedule 2/1 or other alternative schedules (in both Western and Asian patients with advanced RCC). The results from these studies suggest that schedule 2/1 might have an improved safety profile compared with schedule 4/2 but with similar efficacy [50][51][52][53][54][55][56][57]. Patients experiencing AEs with schedule 4/2 might tolerate treatment better when switched to schedule 2/1.…”

Section: Dose and Schedulementioning

confidence: 95%

Sunitinib: Ten Years of Successful Clinical Use and Study in Advanced Renal Cell Carcinoma

Motzer

Escudier

Gannon³

et al. 2017

The Oncologist

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The oral multikinase inhibitor sunitinib malate was approved by the U.S. Food and Drug Administration in January 2006 for use in patients with advanced renal cell carcinoma (RCC). Since then, it has been approved globally for this indication and for patients with imatinib-resistant or -intolerant gastrointestinal stromal tumors and advanced pancreatic neuroendocrine tumors. As we mark the 10-year anniversary of the beginning of the era of targeted therapy, and specifically the approval of sunitinib, it is worthwhile to highlight the progress that has been made in advanced RCC as it relates to the study of sunitinib. We present the key trials and data for sunitinib that established it as a reference standard of care for first-line advanced RCC therapy and, along with other targeted agents, significantly altered the treatment landscape in RCC. Moreover, we discuss the research with sunitinib that has sought to refine its role via patient selection and prognostic markers, improve dosing and adverse event management, and identify predictive efficacy biomarkers, plus the extent to which this research has contributed to the overall understanding and management of RCC. We also explore the key learnings regarding study design and data interpretation from the sunitinib studies and how these findings and the sunitinib development program, in general, can be a model for successful development of other agents. Finally, ongoing research into the continued and future role of sunitinib in RCC management is discussed. The Oncologist 2017;22:41-52 Implications for Practice: Approved globally, sunitinib is established as a standard of care for first-line advanced renal cell carcinoma (RCC) therapy and, along with other targeted agents, has significantly altered the treatment landscape in RCC. Research with sunitinib that has sought to refine its role via patient selection and prognostic markers, improve dosing and adverse event management, and identify predictive efficacy biomarkers has contributed to the overall understanding and management of RCC. Key learnings regarding study design and data interpretation from the sunitinib studies and the sunitinib development program, in general, can be a model for the successful development of other agents.

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Sunitinib dosing schedule 2/1 improves tolerability, efficacy, and health-related quality of life in Chinese patients with metastatic renal cell carcinoma

Cited by 32 publications

References 28 publications

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

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

Practical first-line management of renal cell carcinoma in a community practice

Sunitinib: Ten Years of Successful Clinical Use and Study in Advanced Renal Cell Carcinoma

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