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. Author manuscript; available in PMC: 2019 Jul 30.
Published in final edited form as: Clin Cancer Res. 2010 Nov 24;17(4):907–917. doi: 10.1158/1078-0432.CCR-10-1762

Table 1.

Clinical Characteristics

Study Thal K + A T + D ATTP TRIC
Start date 2/27/96 3/23/99 12/20/99 3/13/05 5/22/03
Number of patients assessed 54 62 50 54 47
Median age (range) 68 (50–83) 72 (51–85) 71 (52–83) 66 (44–79) 66 (47–81)
Median Gleason score (range) 8 (5–10) 8 (4–9) 8 (6–9) 8 (5–10) 8 (5–10)
ECOG PS (%)           0 28 19 22 13 30
1 66 70 78 80 64
2 6 11 - 7 6
One or more prior chemotherapies (%) 26 N/A 10 19 13
Secondary hormonal treatment (%) N/A 58% 61% 95% 100%
Soft tissue lesions (%) 84% 22% 41%1 62% 46%
Lactate dehydrogenase, U/L N/A 196 (137–525) 190 (143–777) 198.5 (122–397) 181 (115–916)
Alkaline phosphatase, U/L N/A 134.5 (71–4000) 126 (73–591) 107 (45–720) 77 (26–1752)
Hemoglobin N/A 13.05 (9–15.4) 13.2 (7.2–15.1) 12.7 (8.3–14.3) 12.6 (7.5–16.4)
Overall survival (K-M)    All patients2 457 635 730 8462 8012
Enrollment PSA ≤ median3,4 520ns 762ns 882* 907ns 1140**
Enrollment PSA > median3,5 333ns 592ns 466* 779ns 520**
Parameters describing treatment response
Log median growth or regression rates (days−1) and median doubling or half-times (days)
Log of pre-enrollment growth rate −1.82 N/A N/A −1.89 −1.96
Pre-enrollment doubling time 47 N/A N/A 53 66
Log of growth rate on therapy6 −2.08 −2.66 −2.57 −3.25 −2.07
Doubling time on therapy7 83 320 260 1244 124
Correlation of log growth rate with OS −0.386 −0.723 −0.748 −0.492 −0.413
Log of regression rate on therapy8 −1.52 −1.66 −1.74 −1.52 −1.57
Tumor half life on therapy9 23 32 38 23 26
Median times on study or to nadir (days)
Time on therapy10 70 240 203 424 147
Time to nadir11 14 59 75 168 0
Correlation of time to nadir with OS 0.24ns 0.624 0.435 0.476 0.27ns
Time from nadir to off therapy 56 181 128 256 147
Median PSA levels and medians of ratios
Enrollment PSA12 121.9 75.2 60.5 101.6 93
Nadir PSA13 70.2 22.2 19.2 9.45 67.6
Ratio nadir PSA/enrollment PSA 0.69 0.38 0.52 0.082 1
Correlation of nadir ratio with OS −0.16ns −0.508 −0.512 −0.383 −0.22ns
Off therapy PSA14 133.4 48.8 41.5 65.5 203
Ratio off therapy PSA/nadir PSA 1.9 2.19 2.16 6.93 3.0
1

Measurable

2

Thal vs. TRIC, p = 0.002; Thal vs. ATTP, p = 0.007. All other pair-wise comparisons, p > 0.05, ns

3

Pair-wise comparisons of OS on study PSA ≤ median vs. on study PSA > median: ns = p > 0.05, [*] = p < 0.05, [**] = p < 0.001

4

Within group of “enrollment PSA ≤ median”: TRIC vs. ATTP, p = 0.025; vs. T+D, p = 0.040; vs. K+ A, p = 0.006; vs. Thal, p = 0.002. All other pair-wise comparisons, p > 0.05, ns

5

Within group of “enrollment PSA > median”, all pair-wise comparisons, p > 0.05, ns

6,7

Thal vs. TRIC, n.s.; K + A vs. T + D, ns; Thal or TRIC vs. T + D or K + A, p < 0.001; ATTP vs. all others, p < 0.001. Doubling time = 0.0693/10 −log growth rate

8,9

T + D vs. Thal, p < 0.005, T + D vs. ATTP, p = 0.012; all others ns (For TRIC, n = 5).

Tumor half life = 0.0693/10 −log regression rate

10

Thal vs. all others, p < 0.001, TRIC vs. K + A or T + D, p < 0.05; K + A vs. T + D, ns; ATTP vs. all others p < 0.001

11

TRIC vs. Thal, p = 0.011, TRIC vs. all others, p < 0.001; Thal vs. all others, p < 0.001; K + A vs. T + D, ns; ATTP vs. all others, p < 0.001

12

All pair-wise comparisons, p > 0.05, ns

13

TRIC vs. Thal, ns; K + A vs. T + D, ns; Thal or TRIC vs. K + A or T + D or ATTP, p = 0.008 or less; K+A vs. ATTP, p = 0.042; T + D vs. ATTP, ns

14

Thal vs. TRIC, n.s; K + A vs. T + D or ATTP, ns; Thal or TRIC vs. K + A or T + D or ATTP, p < 0.001

Abbreviations: Thal: Thalidomide; K + A: Ketoconazole + alendronate; T + D: Thalidomide + docetaxel; TRICOM: PSA vaccine study; ATTP: Avastin, thalidomide, taxotere, prednisone; N/A: not available; ns: not significant.