Bayer Korea’s liver cancer therapy Stivarga (regorafenib) is expected to strengthen its position in the field. The drug is the only second-line treatment for hepatocellular carcinoma patients who progressed after first-line treatment with Nexavar (sorafenib).
Stivarga is proved to achieve an overall survival improvement in patients according to the Phase 3 RESORCE clinical trial results of the Real World Data analysis conducted on 40 hepatocellular carcinoma patients.
|Professor Yoo Chang-hoon explains the results of his research regarding the real world data for Stivarga prescription among Asians at the 2018 Asia Pacific Liver Cancer Expert Conference (2018 APPLE).
This study, which analyzed patients at five hospitals including Asa Medical Center, Samsung Medical Center, National Cancer Center, Seoul National University Hospital and Severance Hospital, was presented at the 2018 Asia Pacific Liver Cancer Expert Conference (2018 APPLE). Among Real World Data researches on Stivarga, this study has the largest number of participating patients from Asia.
Professor Yoo Changhoon of Asan Medical Center who recently published the manifold collection data at APPLE 2018 was interviewed to discuss this study.
Question: What triggered the Real World Data research on Stivarga targeting Korean patients?
Answer: Although liver cancer has a high mortality rate, related medicine has been rather underdeveloped. While techniques such as surgery and embolization have greatly improved so far, the development of systemic anticancer drugs is relatively slow. Anticancer drug development has, in fact, been stalled for nearly a decade since Nexavar. As a doctor I was frustrated and my patients also seemed to feel that there is no hope.
That is when Stivarga appeared with proof of overall survival improvement. The only doubt was how effective it would be on Korean patients as only few Koreans were included in the global clinical trial. So we analyzed the treatment results of the patients prescribed with Stivarga as SPU (Single Patient Use) in the five hospitals.
Q: How was the Real World Data analysis results?
A: It was encouraging. It was similar to the Phase 3 RESORCE clinical trial results (median overall survival or 2.8 months). (Real World Data of Korean patients: overall survival rate was 52.2 percent, median of progression-free survival period was 8 months) The adverse events were also similar to those of the Phase 3 clinical outcomes; grade 3 to 4 adverse events included hand-foot syndrome (8 percent), hypertension (5 percent), AST increase (5 percent) and thrombocytopenia (3 percent).
Q: What is the significance of the Real World Data analysis results?
A: This research analyzed the largest number of Asian patients. Japan also conducted a Real World Data analysis on Stivarga but it has less significance since it was on 9 patients from a single institution.
The results do require careful consideration as the number of patients are 40. Regarding that liver cancer patients in the general practice room are often in poorer condition than those who participated in the clinical trial, however, the results are significant.
Patients who participate in clinical trials are mostly young, in good condition and have strong commitment to treatments. Other patients that we generally face often suffer from poorer liver functions are physically worn-out. It is meaningful that the treatment results were good even in such situations. I personally have more confidence in prescribing Stivarga. It is also good news for the patients.
If we take a look at the Asian sub-analaysis of the Phase 3 clinical trial of Stivarga, most of the targeted Asians are Japanese, Chinese and Taiwanese. There were only 19 Korean patients. Therapeutic results (for Asian patients) were worse than in the case of overall global patients. In Korea’s data analysis, however, the results were similar (as with that of the global patients).
Q: What is the difference between the global Phase 3 data results and the Real World Data results?
A: Both the effects and the adverse events were similar. Among adverse events, however, the hand-foot syndrome marked over 60 percent. The number of patients with grade 3 or higher hand-foot syndrome was similar to that of global patients, there were more with the syndrome of grade 1 or 2. Generally, for grade 3 or higher hand-foot syndrome, the prescription dose is lowered or discontinued. In case of grade 1 or 2, medical prescription is not much of an issue.
Q: How are the patients prescribed to Stivarga adapting to the drug as the second-line treatment?
A: Better than expected. There were concerns on how the tolerable the patients will be when the Phase 3 trial results were out. As Stivargar is supposed to be taken after Nexavar, the adverse events are similar. The profile of the adverse events of Stivarga are similar to Nexavar. Specialists, therefore, are well aware of the adverse events expected on a patient before moving onto Stivarga. Patients also seem to adapt better to Stivarga than to Nexavar for the same reason. Some of the patients now have been taking the medicine for over 10 to 15 months.
Q: Are you conducting other studies on liver cancer?
A: I need to have more than this result. I plan to research on the possibility of merging recently developed medicines including Stivarga or on the order or priority on prescribing different medicines. In case of liver cancer studies, I am currently conducting collaborative researches with several pharmaceutical companies. Results on immunological cancer drugs will come out this October.
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