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Poster display

3575 - Tolerability associated with sunitinib (SU) 2-week on and 1-week off schedule (2/1 schedule) compared with its standard schedule in metastatic RCC (mRCC): Meta-analysis


09 Oct 2016


Poster display


Hee Jung Kang


Annals of Oncology (2016) 27 (6): 266-295. 10.1093/annonc/mdw373


H.J. Kang1, S. Lee2

Author affiliations

  • 1 Medical Affairs Korea, Pfizer Oncology, 100771 - Seoul/KR
  • 2 Medical Affairs Korea, Pfizer Oncology, Seoul/KR


Abstract 3575


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.

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