For patients with hepatocellular carcinoma, adjuvant immunotherapy with autologous cytokine-induced killer cells significantly expands the 5-year disease-free and overall survival, according to the study extension study.
"It's amazing, but the gain in survival was even after the abolition of immunotherapy with a finite length", - said Chong-Hoon Lee, MD, Ph.D., from the College of Medicine at the University of Seoul in South Korea.
In immunotherapy using T cells derived from patient peripheral blood. They are expressed cytokines and cytotoxic T cells, and then re-administered to the patient at fixed intervals.
Lee announced the following results of a study of immunotherapy in patients with hepatocellular carcinoma who underwent surgical resection, radiofrequency ablation, or percutaneous ethanol injection in the university hospitals in Korea at the International Congress of the liver in 2018.
Initial research has shown that the primary endpoint of median relapse-free survival was better therapy with immunotherapy than without adjuvant therapy (44 vs 30 months, hazard ratio [HR], 0,63, P = 0,01), and secondary endpoints (HR 0.21, 95% confidence interval [CI], 0,06-0,75, P = 0,008) and death associated with hepatocellular carcinoma (HR, 0,19, 95% CI, 0,04-0,87 , P = 0,02) (Gastroenterology, 2015, 148: 1383-1391.e6).
Adverse events were significantly more prevalent in the immunotherapy group than in the control group (62% vs 41%, P = 0,002), but the difference in serious side effects between the groups was small (7.8% against 3,5%, P =. 15).
Under immunotherapy cytokine-induced cells - killer 200 mL were administered intravenously during 60 minutes. 16 treatments were carried out once a week for the first 4 weeks, then four treatments every 2 weeks, four treatments every 4 weeks, and then four treatments every 8 weeks.
In a study to increase the participants - 89 from a group of immunotherapy and 73 - the control group - median to give 68.5 months.
After 5 years, the median survival without recurrence was still better in the immunotherapy group than in the control group (44.8% vs 33,1%, HR, 0,67, P = 0,009), as well as overall survival (HR 0 33; P = 006) and specific survival (HR, 0.33, P = .02)..
Most of the benefit was in patients with tumors of at least 2 cm (HR, 0,66, P = 0,035). Despite the fact that patients with lesions smaller than 2 cm was some relapse prevention, the difference was not statistically significant, possibly due to the relatively small sample size.
It is possible that long-term anti-tumor activity of the cells induced by cytokines, promotes long-term storage of T cells and natural killer cells of memory, Lee said. In fact, the cells themselves are a form of terminally differentiated memory T-cells, he added.
Cost is an obstacle to the widespread use of this approach, he said, noting that in Korea, the procedure is not currently reimbursed.
Despite the cost, any effective and safe adjuvant therapy would be welcomed in the treatment of patients with hepatocellular carcinoma , said Ronald Sokol, MD, from the University of Colorado School of Medicine in Aurora.
"In cancer research, if you prolong survival without recurrence at 14, 16, 18 months, it is often considered to be very important interval, especially when the drug combination ultimately used and prolong survival without cancer."