Academic Journal
Telomerase-based GX301 cancer vaccine in patients with metastatic castration-resistant prostate cancer: a randomized phase II trial
| العنوان: | Telomerase-based GX301 cancer vaccine in patients with metastatic castration-resistant prostate cancer: a randomized phase II trial |
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| المؤلفون: | Filaci, Gilberto, Fenoglio, Daniela, Nolè, Franco, Zanardi, Elisa, Tomasello, Laura, Aglietta, Massimo, Del Conte, Gianluca, Carles, Joan, Morales-Barrera, Rafael, Guglielmini, Pamela, Scagliotti, Giorgio, Signori, Alessio, Parodi, Alessia, Kalli, Francesca, Astone, Giuseppina, Ferrera, Francesca, Altosole, Tiziana, Lamperti, Giuseppina, Criscuolo, Domenico, Gianese, Francesco, Boccardo, Francesco |
| المساهمون: | Mediolanum Farmaceutici Spa, Università degli Studi di Genova |
| المصدر: | Cancer Immunology, Immunotherapy ; volume 70, issue 12, page 3679-3692 ; ISSN 0340-7004 1432-0851 |
| بيانات النشر: | Springer Science and Business Media LLC |
| سنة النشر: | 2021 |
| الوصف: | Debate is around the optimal immunization regimen for cancer vaccines since too intense vaccination schedules may exhaust reactive lymphocytes. GX301 is a telomerase-based cancer vaccine whose safety and immunological effects were tested in a phase I trial applying an eight administrations schedule. Main objective of this study was to comparatively analyse safety and immunological response to three GX301 regimens in metastatic castration-resistant prostate cancer patients with response/disease stability after docetaxel chemotherapy. This was a multicentre, randomized, parallel-group, open-label trial registered with EudraCT (2014-000095-26) and ClinicalTrials.gov (NCT02293707, 2014). Ninety-eight patients were randomized to receive either eight (regimen 1), four (regimen 2) or two (regimen 3) vaccine administrations. Sixty-three patients were assessable for the primary immunological end-point. Vaccine-specific immune responses were evaluated by intracellular staining for IFN, elispot and cytotoxic assay at 90 and 180 days from baseline. No major side effects were recorded. A 54% overall immune responder rate was observed with 95% of patients showing at least one vaccine-specific immune response. Rate of immunological responders and number of immunizations were proportionally related, suggesting superiority of regimens 1 and 2 over regimen 3. Overall survival did not differ among regimens in both immunological responders and non-responders and was inversely associated ( P = 0.002) with increase in the number of circulating CD8 + T regulatory cells at 180 days. These data indicate that GX301 cancer vaccine is safe and immunogenic in metastatic castration-resistant prostate cancer patients. Schedules with high number of administrations should be preferred in future studies due to their better immunological outcome. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1007/s00262-021-03024-0 |
| DOI: | 10.1007/s00262-021-03024-0.pdf |
| DOI: | 10.1007/s00262-021-03024-0/fulltext.html |
| الاتاحة: | http://dx.doi.org/10.1007/s00262-021-03024-0 https://link.springer.com/content/pdf/10.1007/s00262-021-03024-0.pdf https://link.springer.com/article/10.1007/s00262-021-03024-0/fulltext.html |
| Rights: | https://creativecommons.org/licenses/by/4.0 ; https://creativecommons.org/licenses/by/4.0 |
| رقم الانضمام: | edsbas.6EDA7BD3 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1007/s00262-021-03024-0 |
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