Recent advances in the cancer immunotherapy provide an opportunity to develop the therapeutic autologous dendritic cell vaccine for metastatic forms of soft tissues sarcomas (STS). Previous studies showed the possibility of developing delayed effects from this treatment. The aim of this study is to compare efficacy of the 2nd line therapy of STS patients with or without CaTeVac therapy during the whole systemic treatment.
Seventy-four patients (pts.) were included since 2008 to 2017. All patients had stage III inoperable or stage IV STS and received 2nd line of systemic therapy. Group 1 received CaTeVac as adjuvant therapy or maintenance therapy after the 1st or 2nd line of systemic therapy or as monotherapy after at least 1 line of chemotherapy. Group 2 never received CaTeVac during treatment course. Patients in the groups were comparable by histologic types and previous treatment. Overall survival (OS) from the start of the 2nd line of therapy to death was assessed as efficacy measure.
Median OS of patients in group 1 was 24,4 mo (741 days, 95% CI, 509-973), versus 14.2 mo (431 days, 95% CI, 56-806) in group 2 (Log-Rank p = 0.019, Breslow p = 0.03). Relative risk of death (exp(B)) in group 1 was 0,358 (95% CI 0.171-0.751) in the Cox regression and was independent from and comparable to the treatment effect (exp(B) 0.254 (95% CI 0.133-0.484), p = 0.000011. Sex and age showed no impact on survival (p > 0.05).
CaTeVac shows impact on overall survival and should be assessed in randomized clinical trials with OS endpoints.
Clinical trial identification
Legal entity responsible for the study
N.N. Petrov Research Institute of Oncology.
Ministry of Health Russian Federation.
All authors have declared no conflicts of interest.