Table 1.
Cumulative Clinical Trial Data.
| # | Sex | Age | Smoking History |
PVL | Previous Biopsies† |
Lesional
Size (mm2) |
Histopathology |
LOH |
Cumulative Responsiveness (Score) |
3-Month Recurr- ance |
||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PkYrs (*) | PreTx | PostTx | Pretreatment | Posttreatment | PreTx | PostTx | ||||||||
| Active | A1 | F | 55 | 0 | N | Y (5) | 32.07 | 19.68 | DYS (Mild to moderate) | DYS (Mild) | 3 | 0 | High (5) | Y |
| A2 | F | 62 | 0 | Y | Y (2) | 59.84 | 54.06 | ATY | ATY | 3 | 0 | Intermediate (3) | N | |
| A3 | F | 74 | 26 (1991) | Y | Y (3) | 21.54 | 23.27 | ATY | ATY | 1 | 1 | Non (0) | Y | |
| A4 | M | 69 | 0 | Y | Y (4) | NE | NE | DYS (Focally mild) | DYS (Mild) | 2 | 0 | Low (2) | N | |
| A5 | F | 65 | 0 | N | Y (6) | 8.87 | 6.80 | DYS (Moderate to severe) | DYS (Moderate to severe) | 2 | 1 | Low (1) | N | |
| A6 | M | 56 | 5 (1980) | N | N | 58.18 | 0.00 | DYS (Mild) | Normal | 3 | 0 | High (8) | LC | |
| A7 | F | 55 | 0 | N | Y (4) | 6.78 | 0.00 | DYS (Severe) | DYS (Mild to moderate) | 0 | 0 | High (6) | Y | |
| A8 | F | 69 | 35 (1996) | Y | Y (3) | 30.60 | 33.93 | DYS (Mild) | DYS (Mild) | 1 | 0 | Low (1) | Y | |
| A9 | M | 60 | 20 (1975) | Y | Y (1) | 74.80 | 42.28 | ATY | ATY | 0 | 0 | Low (1) | N | |
| A10 | M | 66 | 5 (1968) | N | Y (1) | 39.64 | 43.07 | DYS (Mild) | DYS (Mild) | 0 | 0 | Non (0) | N | |
| A11 | M | 47 | 0 | Y | N | 170.87 | 72.56 | ATY | ATY | 0 | 0 | Low (2) | N | |
| A12 | F | 59 | 25 (2010) | Y | Y (1) | 24.07 | 10.88 | ATY | ATY | 0 | 0 | Low (2) | N | |
| A13 | F | 70 | 0 | Y | Y (1) | 53.98 | 49.71 | DYS (Mild) | ATY | 0 | 0 | Low (1) | N | |
| A14 | F | 61 | 0 | Y | Y (1) | 63.33 | 106.45 | DYS (Mild) | DYS (Moderate) | 3 | 3 | Low (−4) | N | |
| A15 | F | 73 | 20 (1989) | Y | N | 279.24 | 231.40 | DYS (Mild) | ATY | 1 | 1 | Low (1) | N | |
| A16 | F | 56 | 1.05 (1997) | N | N | 12.15 | 8.82 | DYS (Mild) | ATY, | 0 | 0 | Low (2) | N | |
| A17 | M | 70 | 20 (1996) | N | N | 227.70 | 137.69 | ATY | ATY | 0 | 0 | Low (1) | Y | |
| A18 | F | 56 | 0 | Y | N | 23.85 | 16.99 | DYS (Mild to focally moderate) | DYS (Mild) | 1 | 0 | Intermediate (3) | N | |
| A19 | F | 77 | 0 | Y | Y (1) | 53.28 | 49.44 | ATY | ATY | 3 | 0 | Intermediate (3) | Y | |
| A20 | M | 59 | 5 (2006) | N | Y (3) | 110.71 | 54.60 | ATY | ORT | 1 | 0 | High (4) | N | |
| A21 | F | 44 | 0 | N | Y (1) | 63.37 | 30.05 | DYS (Moderate to focally severe) | DYS (Moderate) | 2 | 2 | Intermediate (3) | N | |
| A22 | F | 65 | 0 | N | Y (1) | 75.06 | 77.99 | DYS (Ulcerated severe) | DYS (Severe) | 4 | 1 | Intermediate (3) | N | |
| Placebo | P1 | M | 78 | 5 (1992) | Y | Y (4) | 25.55 | 46.44 | DYS (Mild to moderate) | DYS (Mild to moderate) | 2 | 3 | Non (−4) | Y |
| P2 | M | 63 | 0 | N | Y (3) | 8.76 | 5.94 | DYS (Moderate to severe) | DYS (Moderate to severe) | 1 | 1 | Low (1) | Y | |
| P3 | M | 60 | 0 | N | Y (1) | 50.49 | 51.38 | DYS (Mild to focally moderate) | DYS (Mild) | 0 | 0 | Low (1) | Y | |
| P4 | F | 59 | 0 | N | Y (1) | 38.47 | 52.79 | ATY | ATY | 3 | 0 | Low (2) | N | |
| P5 | M | 41 | 0 | N | N | 43.98 | 47.11 | DYS (Mild) | DYS (Moderate) | 1 | 0 | Non (−1) | Y | |
| P6 | F | 67 | 0 | N | Y (2) | 95.75 | 123.65 | DYS (Mild to moderate) | DYS (Focally mild) | 1 | 2 | Non (−1) | Y | |
| P7 | M | 58 | 5.71 (1999) | N | N | 9.81 | 10.96 | DYS (Mild) | DYS (Mild) | 0 | 0 | Non (0) | LC | |
| P8 | F | 32 | 7.5 (2011) | Y | Y (8) | 64.43 | 78.80 | DYS (Mild) | DYS (Mild) | 2 | 0 | Low (2) | Y | |
| P9 | F | 65 | 0 | N | Y (4) | 256.69 | 308.77 | DYS (Mild to moderate) | DYS (Mild) | 1 | 2 | Non (0) | N | |
| P10 | M | 46 | 0 | N | N | 68.85 | 41.72 | ATY | ATY | 1 | 0 | Low (2) | N | |
| P11 | M | 66 | 0.75 (1960) | N | Y (1) | NE | NE | ATY | DYS (Moderate) | 2 | 2 | Non (−3) | N | |
| P12 | M | 62 | 20 (1987) | N | Y (1) | 28.78 | 29.83 | DYS (Moderate to severe) | DYS (Mild to moderate) | 0 | 0 | Low (2) | N | |
| P13 | F | 61 | 0 | N | Y (1) | 10.62 | 8.75 | DYS (Mild to moderate) | DYS (Mild to moderate) | 1 | 0 | Low (1) | N | |
| P14 | F | 68 | 0 | N | N | 77.87 | 74.58 | DYS (Mild to focally moderate) | DYS (Mild) | 1 | 0 | Low (2) | N | |
| P15 | F | 50 | 0 | N | Y (2) | 17.39 | 35.18 | DYS (Severe) | DYS (Moderate to severe) | 0 | 0 | Non (−2) | Y | |
| P16 | F | 52 | 0 | N | Y (1) | 47.54 | 47.21 | DYS (Moderate) | DYS (Moderate) | 3 | 2 | Low (1) | N | |
| P17 | F | 39 | 0 | N | Y (1) | 95.45 | 123.13 | DYS (Mild) | ATY | 0 | 0 | Non (0) | N | |
| P18 | M | 71 | 15 (1994) | Y | Y (1) | 107.23 | 167.23 | DYS (Mild) | DYS (Mild) | 0 | 0 | Non (−2) | N | |
Abbreviations: ATY=atypia DYS=dysplasia LC=lost contact NE=not evaluable ORT=orthokeratosis Pk Yrs=pack years PVL=proliferative verrucous leukoplakia
*
(year) patient quit smoking
†
Previous biopsies for OIN at lesional treatment site (number of biopsies performed prior to the trial)