eISSN: 1897-4309
ISSN: 1428-2526
Contemporary Oncology/Współczesna Onkologia
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4/2020
vol. 24
 
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abstract:
Original paper

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

Lobna A. Abdelaziz
1
,
Heba F. Taha
2
,
Magid M. Ali
3
,
Marwa I. Abdelgawad
4
,
Amira Elwan
1

  1. Clinical Oncology and Nuclear Medicine Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt
  2. Medical Oncology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt
  3. Urology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt
  4. Clinical Oncology Department, Faculty of Medicine, Assiut University, Assiut, Egypt
Contemp Oncol (Pozn) 2020; 24 (4): 221–228
DOI: https://doi.org/10.5114/wo.2020.102802
Online publish date: 2021/01/04
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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.

Material 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.

keywords:

metastatic renal cell carcinoma, sunitinib, 4/2 schedule, 2/1 schedule, adverse events, outcome
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