821P - Tolerability associated with sunitinib (SU) 2-week on and 1-week off schedule (2/1 schedule) compared with its standard schedule in metastatic RCC...

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Renal Cell Cancer
Presenter Hee Jung Kang
Citation Annals of Oncology (2016) 27 (6): 266-295. 10.1093/annonc/mdw373
Authors H.J. Kang1, S. Lee2
  • 1Medical Affairs Korea, Pfizer Oncology, 100771 - Seoul/KR
  • 2Medical Affairs Korea, Pfizer Oncology, Seoul/KR



SU is the 1st line standard treatment for mRCC and it requires 4-week on treatment and 2-week off as a standard schedule for mRCC. The treatment is associated with several adverse events (AEs), such as fatigue, hand-foot syndrome (HFS), neutropenia, thrombocytopenia etc. Schedule modifications of SU including 2/1 schedule are studied and the results provided the total number of treatment-related adverse events decreased in 2/1 schedule without compromising efficacy. However, the effect of 2/1 schedule on individual AEs was not clearly understood.


This analysis included 1 randomized controlled trial (RCT): Lee et al. 2015 (RESTORE trial, NCT00570882) and 4 non-randomized controlled studies (non-RCT): Neri et al. 2013, Kondo et al. 2014, Bradarda et al. 2015 and Pan et al. 2015. The primary objective was to estimate risk of individual adverse events in SU 2/1 schedule versus standard one and secondary objectives were to evaluate efficacy outcomes. 7 AEs were evaluated with a standard data of RCT compared with the weighted meta-analysis data (non-RCT meta). Meta-analysis technique, including fixed effects modelling with Review Manager v5.3 was used to pool study-level data using the inverse-variance of each study as the weight. Data cut-off for this analysis: Apr 2015


The selected studies included a total of 484 patients with mRCC, which comprised 74 and 410 from RCT and non-RCTs, respectively. The risk ratio of fatigue and neutropenia for 2/1 schedule vs. standard significantly decreased in both RCT and non-RCT meta (risk ratio (RR) of fatigue: 0.69 [95% confidence intervals (CI) 0.51, 0.95] vs. 0.75 [0.63, 0.89]; RR of neutropenia 0.60 [0.37, 0.99] vs. 0.58 [0.41, 0.83]). Other AEs also tended to decrease in both sets except diarrhea and anorexia. Efficacy outcomes were comparable between 2/1 and standard schedule.


This meta-analysis suggests that 2/1 schedule of SU compared to its standard one decreases risk of fatigue and neutropenia and also favoured to control other AEs without compromising efficacy even with limited sources of data. A patient-level meta-analysis to confirm these findings is warranted.

Clinical trial identification


Legal entity responsible for the study

Pfizer Pharmaceutical Korea Ltd.


Pfizer Pharmaceutical Korea Ltd.


H.J. Kang, S. Lee: Employee of Pfizer Pharmaceutical Korea Ltd.