Abstract 1002P
Background
Sorafenib is a first-line oral drug for advanced hepatocellular carcinoma (HCC). Hand-foot skin reaction (HFSR) is a common adverse effect of sorafenib in HCC patients, is difficult to manage, and has a negative impact on quality of life. However, HFSR may also be a prognostic marker in these patients. Adherence to sorafenib needs to be increased by interventions to address adverse effects and discontinuation. Thus, our aim was to assess the impact of different interventions for HFSR on patient prognosis.
Methods
In total, 137 patients treated with sorafenib between 2009 and 2019 were enrolled in this multi-institutional study. Group A (n = 41) did not receive HFSR or pharmacist interventions, while Group B (n = 30) and Group C (n = 66) received both. In Groups B and C, pharmacists provided care and advice for adverse events, tablet counts, and telephone consultations. In Group C, information obtained in interviews with pharmacists was shared with oncologists in reports and medical charts (cooperative double check system). In Group B, this information was not provided to oncologists (uncooperative double check system).
Results
Median overall survival (mOS) was 7.2 months for Group A, 8.5 months for Group B, and 18.2 months for Group C. On comparison among the three groups, a significant difference was observed between Groups A and C (p = 0.04). In the multivariate analysis, HFSR was the only significant prognostic marker (hazard ratio 0.51, 95% CI 0.30-0.86, p = 0.01). Time-to-treatment failure (TTF) was 2.3 months for Group A, 0.5 months for Group B, and 4.1 months for Group C. TTF significantly decreased in Group B only (p <0.01). mOS correlated with TTF in Group C with a Spearman’s rank correlation coefficient of 0.41 (p <0.01), but not in Group B.
Conclusions
The emergence of HFSR significantly improved patient prognosis under appropriate adherence. The cooperative double check system increased adherence, and a correlation was observed between mOS and TTF. The cooperative double check system needs to be implemented for sorafenib.
Clinical trial identification
UMIN ID: 000038701, 11/27/2019.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.