TABLE II.
Evidence of vaccine-mediated enhanced survival in prostate cancer clinical trials
| Reference | Patient population | Study arm | Patients (n) | Result |
|---|---|---|---|---|
| Small et al., 200615 | Metastatic asymptomatic hrpc |
apc/pap/gm-csf Placebo |
82
45 |
Median OS:
25.9 mo. 21.4 mo. |
| Simons et al., 2006 16; Small et al., 2006 17; and Simons et al., 2005 18 | Metastatic asymptomatic hrpc | Whole tumour cell (Gvax):
high dose mid-/low dose |
22
25/33 |
35 mo.
20.0/23.1 mo. |
| Kantoff et al., 2006 19 | Metastatic hrpc |
psa/tricom Vector control |
84
41 |
24.4 mo.
16.3 mo. |
| Petrylak et al., 2006 20 | Metastatic hrpc | Vaccine (apc/pap/gm-csf), then docetaxel
Control, then docetaxel |
51
31 |
OS:
50% (approx.) at 36 mo. 25% (approx.) at 36 mo. |
| Arlen et al., 2005 21; and Madan et al., 2007 22 | Non-metastatic hrpc | Vaccine (rv-psa/B7.1, rf-psa), with or without nilutamide a
Nilutamide, with or without vaccine |
21
21 |
59% at 5 years
38% at 5 years |
a
Nilutamide is a second-line hormone receptor antagonist.
hrpc = hormone refractory prostate cancer; apc = antigen-presenting cell; pap = prostatic acid phosphatase; gm-csf = granulocyte–macrophage colony stimulating factor; os = overall survival; psa = prostate-specific antigen.