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Vaccination of castration-resistant prostate cancer patients with TroVax (MVA-5T4) in combination with docetaxel: a randomized phase II trial.
Vaccination of castration-resistant prostate cancer patients with TroVax (MVA-5T4) in combination with docetaxel: a randomized phase II trial.
- Source :
-
Cancer immunology, immunotherapy : CII [Cancer Immunol Immunother] 2013 Sep; Vol. 62 (9), pp. 1511-20. Date of Electronic Publication: 2013 Jul 23. - Publication Year :
- 2013
-
Abstract
- The attenuated vaccinia virus, modified vaccinia Ankara, has been engineered to deliver the tumor antigen 5T4 (TroVax®). Here, we report results from a randomized open-label phase II trial in castration-resistant prostate cancer patients in which TroVax was administered in combination with docetaxel and compared against docetaxel alone. The aim was to recruit 80 patients (40 per arm), but the study was terminated early due to recruitment challenges. Therefore, this paper reports the comparative safety and immunological and clinical efficacy in 25 patients, 12 of whom were treated with TroVax plus docetaxel and 13 with docetaxel alone. 5T4-specific immune responses were monitored throughout the study. Clinical responses were assessed by measuring changes in tumor burden by CT and bone scan and by quantifying PSA concentrations. TroVax was well tolerated in all patients. Of 10 immunologically evaluable patients, 6 mounted 5T4-specific antibody responses. Patients treated with TroVax plus docetaxel showed a greater median progression-free survival of 9.67 months compared with 5.10 months for patients on the docetaxel alone arm (P = 0.097; HR = 0.31; 95% CI 0.08-1.24). Importantly, a pre-treatment biomarker previously demonstrated to predict 5T4 immune response and treatment benefit showed a strong association with 5T4 antibody response and a statistically significant association with progression-free survival in patients treated with TroVax plus docetaxel, but not docetaxel alone.
- Subjects :
- Aged
Aged, 80 and over
Combined Modality Therapy
Disease-Free Survival
Docetaxel
Humans
Male
Middle Aged
Prostatic Neoplasms, Castration-Resistant drug therapy
Prostatic Neoplasms, Castration-Resistant immunology
Prostatic Neoplasms, Castration-Resistant pathology
Vaccines, DNA
Antineoplastic Agents therapeutic use
Cancer Vaccines therapeutic use
Prostatic Neoplasms, Castration-Resistant therapy
Taxoids therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1432-0851
- Volume :
- 62
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Cancer immunology, immunotherapy : CII
- Publication Type :
- Academic Journal
- Accession number :
- 23877659
- Full Text :
- https://doi.org/10.1007/s00262-013-1457-z