Published online Jul 28, 2018. doi: 10.3748/wjg.v24.i28.3155
Peer-review started: March 17, 2018
First decision: April 18, 2018
Revised: May 9, 2018
Accepted: June 22, 2018
Article in press: June 22, 2018
Published online: July 28, 2018
A surrogate marker that reflects a better prognosis after the introduction of sorafenib has not yet been established.
The incidence of adverse events after sorafenib introduction is high, reducing drug adherence.
The authors performed intervention by pharmacists using the double-check system to improve drug adherence. In addition, they evaluated a surrogate marker reflecting a better prognosis after sorafenib introduction under increased adherence.
This retrospective study was conducted on advanced hepatocellular carcinoma patients who had been treated with sorafenib between May 2009 and March 2017. Establishing the overall survival (OS) as a primary endpoint, the authors evaluated a surrogate marker using multivariate analysis. Furthermore, the effects of intervention by pharmacists on drug adherence were assessed using the time to treatment failure (TTF), median cumulative dose, and medication possession ratio (MPR).
The subjects were 40 patients who had undergone sorafenib therapy. In the presence of grade 1 or higher multikinase inhibitor (MKI)-associated hand-foot skin reaction (HFSR), OS was significantly prolonged. The results of multivariate analysis showed that the presence of MKI-associated HFSR (hazard ratio = 0.241, 95%CI: 0.102-0.567; P = 0.001) was one of the significant predictive factors for the prolongation of OS. There were significant differences in the TTF, median cumulative dose, and MPR between the intervention and non-intervention groups.
Intervention by pharmacists increased the drug adherence. The MKI-associated HFSR was an advantageous surrogate marker under increased adherence. Intervention by healthcare providers needs to be performed for adequate sorafenib treatment.
It remains to be clarified whether intervention by healthcare providers improves the prognosis of hepatocellular carcinoma patients after sorafenib introduction. Therefore, the double-check system should be further improved, and a larger number of patients should be evaluated. Furthermore, a prospective study should be conducted.