Improved long-term clinical outcomes and safety profile of sunitinib dosing schedule with 4/2 switched to 2/1 in patients with metastatic renal cell carcinoma

Zhang, X.; Sun, Guangxi; Zhao, Jinge; Shu, Kunpeng; Zhao, Peng; Liu, J.; Yang, Yubo; Tang, Qiong‐Lan; Chen, J.; Shen, Pengfei; Zeng, Hao

doi:10.1093/annonc/mdx371.047

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“…Miyake et al [27], Bracarda et al [28] and Najjar et al [14] who stated that switching from schedule 4/2 to schedule 2/1 lead to decrease the incidence and severity of sunitinib-induced toxicity. In addition, a significant reduction in toxicities (grade 3-4) was found in some trials such as fatigue, hypertension, hand-foot syndrome and thrombocytopenia [14,28,29]. These studies confirmed the results of other monocentric experiences [14][15][16][17][18].…”

Section: Discussionsupporting

confidence: 77%

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Tolerability and outcome of sunitinib by giving 4/2 schedule versus 2/1 schedule in metastatic renal cell carcinoma patients: a prospective randomized multi-centric Egyptian study

Abdel‐Aziz

Taha

Ali

et al. 2020

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Introduction: Sunitinib is a standard of care first line treatment for patients with metastatic renal cell carcinoma (RCC). Sunitinib standard dose is 50 mg once daily for 4 consecutive weeks followed by 2 weeks' off (4/2 schedule). Long-term and high exposure to this medication lead to severe adverse events (AEs); therefore, this trial was done to find the best schedule which gives the best outcome with minimal toxicity. Materials and methods: Seventy patients were randomly assigned into 2 groups, then received 50 mg/day of sunitinib. Group 1 (40 patients) received sunitinib for 4 consecutive weeks followed by 2 weeks off (4/2 schedule) while 30 patients were admitted to group 2 with 2 weeks on and 1 week off (2/1 schedule). Results: All patients (100%) had significantly higher AEs on schedule 4/2 vs. 73.3% on schedule 2/1 (p = 0.001). Furthermore, the grade 3 AEs on schedule 2/1 were significantly lower than those on schedule 4/2 (26.7% vs. 82.5%) respectively (p = 0.001), such as fatigue, diarrhea, hypertension, hand foot syndrome (HFS) and mucositis. Progression-free survival (PFS) rate was significantly higher in 2/1 schedule (60.9% vs. 38.6%) than in 4/2 schedule (p < 0.008). Multivariate analysis suggested that: age > 60 years, poor International Metastatic RCC Database Consortium (IMDC) risk category, tumor size > 10 cm and treatment schedule (group 1) were poor prognostic factors of PFS. Conclusions: Our study supported the use of 2/1 schedule of sunitinib in patients with metastatic RCC because of lower toxicity profile and better efficacy with improved PFS in comparison to 4/2 schedule.

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Section: Discussionsupporting

confidence: 77%

“…Zhang X et al [29] study demonstrated that the median PFS was longer in 4/2-2/1 schedule when compared with both the 2/1 and 4/2 groups (25.0, 11.0,12.5 months, respectively; p = 0.003). Similarly, OS was longer in patients in the 4/2-2/1 group than patients in the other two groups (median OS: 53.0, 28.0, 21 months, respectively; p = 0.03).…”

Section: Discussionmentioning

confidence: 94%

Tolerability and outcome of sunitinib by giving 4/2 schedule versus 2/1 schedule in metastatic renal cell carcinoma patients: a prospective randomized multi-centric Egyptian study

Abdel‐Aziz

Taha

Ali

et al. 2020

View full text Add to dashboard Cite

show abstract

Improved long-term clinical outcomes and safety profile of sunitinib dosing schedule with 4/2 switched to 2/1 in patients with metastatic renal cell carcinoma

Cited by 1 publication

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Tolerability and outcome of sunitinib by giving 4/2 schedule versus 2/1 schedule in metastatic renal cell carcinoma patients: a prospective randomized multi-centric Egyptian study

Tolerability and outcome of sunitinib by giving 4/2 schedule versus 2/1 schedule in metastatic renal cell carcinoma patients: a prospective randomized multi-centric Egyptian study

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