Authors' objectives: The hTERT subunit of the telomerase enzyme has become the target of new lines of research in active immunotherapy to slow the progression of cancer, such as the peptide GV1001 and autologous dendritic cells pulsed with different compounds. A systematic review was made to evaluate the immunogenicity, survival and safety of active immunotherapy against telomerase in patients with solid-organ cancer. Four phase I / II clinical trials and a synthesis report were recovered. Two of the clinical trials evaluated the peptide GV1001 in pancreatic cancer and NSCLC and the others studied autologous dendritic cells (prostate cancer and metastatic renal cancer). All the clinical trials evaluated were of poor quality. In general, studies were nonrandomized, unblinded, with a large number of losses (many of them without justification), presenting most of the results by per-protocol analysis. 68.4% of patients in the pancreatic cancer study, with at least 6 injections received, and 46% in the lung cancer study had a positive immune response GV1001 (appearance of T lymphocytes and/or a delayed hypersensitivity test). Regarding dendritic cells, only the prostate cancer study provided evidence on the increase of T lymphocytes. 75% and 91.6% of patients who received 3 doses presented an increase in CD4 and CD8 lymphocytes, respectively. 28% of patients with lung cancer treated with GV1001 had stable disease at the end of the follow-up period. As for the dendritic cells preparation, this percentage was higher (57% in renal cancer). In the prostate cancer, there was a slowdown in disease progression (PSA doubling time of 2.9 months pre-intervention vs. 100 months postintervention). The survival time among patients with pancreatic cancer who responded to the vaccine (7.2 months on average) was higher than those who did not (2.9 months, p = 0.0001).

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/efectividad-y-seguridad-de-la-inmunoterapia-activa-frente-a-la-telomerasa-en-el-cancer-de-organo-solido/

Year Published: 2011

URL for published report: https://www.aetsa.org/download/publicaciones/antiguas/AETSA_2009-2-3_Vacuna_Telomerasa.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: Andalusian Agency for Health Technology Assessment (AETSA)