PMID- 33531869
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220420
IS  - 1428-2526 (Print)
IS  - 1897-4309 (Electronic)
IS  - 1428-2526 (Linking)
VI  - 24
IP  - 4
DP  - 2020
TI  - 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.
PG  - 221-228
LID - 10.5114/wo.2020.102802 [doi]
AB  - 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.
CI  - Copyright (c) 2020 Termedia.
FAU - Abdelaziz, Lobna A
AU  - Abdelaziz LA
AD  - Clinical Oncology and Nuclear Medicine Department, Faculty of Medicine, Zagazig 
      University, Zagazig, Egypt.
FAU - Taha, Heba F
AU  - Taha HF
AD  - Medical Oncology Department, Faculty of Medicine, Zagazig University, Zagazig, 
      Egypt.
FAU - Ali, Magid M
AU  - Ali MM
AD  - Urology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
FAU - Abdelgawad, Marwa I
AU  - Abdelgawad MI
AD  - Clinical Oncology Department, Faculty of Medicine, Assiut University, Assiut, 
      Egypt.
FAU - Elwan, Amira
AU  - Elwan A
AD  - Clinical Oncology and Nuclear Medicine Department, Faculty of Medicine, Zagazig 
      University, Zagazig, Egypt.
LA  - eng
PT  - Journal Article
DEP - 20210104
PL  - Poland
TA  - Contemp Oncol (Pozn)
JT  - Contemporary oncology (Poznan, Poland)
JID - 101233223
PMC - PMC7836283
OTO - NOTNLM
OT  - 2/1 schedule
OT  - 4/2 schedule
OT  - adverse events
OT  - metastatic renal cell carcinoma
OT  - outcome
OT  - sunitinib
COIS- The authors declare no conflict of interest.
EDAT- 2021/02/04 06:00
MHDA- 2021/02/04 06:01
PMCR- 2020/01/01
CRDT- 2021/02/03 05:58
PHST- 2020/08/29 00:00 [received]
PHST- 2020/11/02 00:00 [accepted]
PHST- 2021/02/03 05:58 [entrez]
PHST- 2021/02/04 06:00 [pubmed]
PHST- 2021/02/04 06:01 [medline]
PHST- 2020/01/01 00:00 [pmc-release]
AID - 43068 [pii]
AID - 10.5114/wo.2020.102802 [doi]
PST - ppublish
SO  - Contemp Oncol (Pozn). 2020;24(4):221-228. doi: 10.5114/wo.2020.102802. Epub 2021 
      Jan 4.