Table. Distribution and Comparison of Clinical Characteristics and Treatment Stratified by Whether the Candidate Surrogate Was Observed or Not.
| Characteristics | Candidate Surrogate, No. (%) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PSA Failure | P Value | PSA Nadir (>0.5 ng/mL) | P Value | PSA DT (<9 mo) | P Value | Int to PSA Failure (<30 mo) | P Value | |||||
| Yes (n = 85) |
No (n = 72) |
Yes (n = 58) |
No (n = 99) |
Yes (n = 35) |
No (n = 122) |
Yes (n = 29) |
No (n = 128) |
|||||
| Age, median (range), y | 72.12 (67.43-75.01) | 73.09 (69.96-76.29) | .25 | 72.04 (66.81-75.01) | 72.81 (69.97-75.61) | .26 | 71.97 (66.74-76.45) | 72.48 (68.86-75.04) | .86 | 72.57 (68.94-75.71) | 72.40 (68.64-75.46) | .70 |
| PSA, median (range), ng/mL | 12.20 (8.40-17.79) | 9.95 (5.97-13.45) | .004 | 11.92 (9.00-17.93) | 11.00 (6.86-14.84) | .04 | 16.15 (9.10-26.90) | 10.95 (7.21-40.12) | .002 | 16.50 (10.96-21.90) | 10.85 (7.26-14.52) | .001 |
| 1992 AJCC T stage | ||||||||||||
| T2 (n = 76) | 51 (67.11) | 25 (32.89) | .002 | 32 (42.11) | 44 (57.89) | .20 | 25 (12.35) | 71 (87.65) | .002 | 22 (28.95) | 54 (71.05) | .001 |
| T1 (n = 81) | 34 (41.98) | 47 (58.02) | 26 (32.10) | 55 (67.90) | 10 (32.89) | 51 (67.11) | 7 (8.64) | 74 (91.36) | ||||
| Highest Gleason Score | ||||||||||||
| 8-10 (n = 18) | 12 (66.67) | 6 (33.33) | .02 | 8 (44.44) | 10 (55.56) | .41 | 8 (44.44) | 10 (55.56) | .001 | 7 (38.89) | 11 (61.11) | .002 |
| 7 (n = 91) | 54 (59.34) | 37 (40.66) | 34 (37.36) | 57 (62.64) | 23 (25.27) | 68 (74.73) | 19 (20.88) | 72 (79.12) | ||||
| ≤6 (n = 48) | 19 (39.58) | 29 (60.42) | 16 (33.33) | 32 (66.67) | 4 (8.33) | 44 (91.67) | 3 (6.25) | 45 (93.75) | ||||
| Randomized treatment | ||||||||||||
| RT+ADT (n = 78) | 25 (32.05) | 53 (67.95) | <.001 | 5 (6.41) | 73 (93.59) | <.001 | 11 (14.10) | 67 (85.90) | .01 | 6 (7.69) | 72 (92.31) | <.001 |
| RT (n = 79) | 60 (75.95) | 19 (24.05) | 53 (67.09) | 26 (32.91) | 24 (30.38) | 55 (69.62) | 23 (29.11) | 56 (70.89) | ||||
| Odds ratio (95% CI)a | 6.70 (3.32-13.50) | <.001 | 29.76 (10.73-82.55) | <.001 | 2.66 (1.20-5.90) | .02 | 4.93 (1.88-12.92) | .001 | ||||
Abbreviations: ADT, androgen deprivation therapy; AJCC, American Joint Commission on Cancer; DT, doubling time; Int, interval; PSA, prostate-specific antigen; RT, radiation therapy.
a
Unadjusted odds ratio represents the likelihood that the candidate surrogate was observed in men randomized to receive RT compared with RT and ADT. Mantel-Haenszel χ2 is used to compare the distributions of categorical variables. Wilcoxon 2-sample test is used to compare the distributions of continuous variable.