TABLE 1.
CLINICAL CHARACTERISTICS AND OUTCOMES
| ID | Age/Sex | Stage | Dose Level | Baseline Meso-thelin level (nM) | Day 64 Modified RECIST Response | Day 64 Size Change (MR) | Day 64 PET Response | Day 64 Meso-thelin Level | 6-mo Tumor Response | 6-mo Meso-thelin Level | Survival Time (mo post vector) | Reason for Death |
| 301 | 51/M | IV | 1 | 44 | SD | +19.8% | NA | NA | PD | NA | 7 | PD |
| 302 | 68/F | III/IV | 1* | 8 | SD | +14.7% | NA | 13 | PD | 14 | 14 | PD |
| 303 | 79/M | IV | 1 | 23 | NA | NA | NA | NA | NA | NA | 1 | PD |
| 304 | 56/M | I | 2 | 1.4 | SD | −15% | SD | 0.9 | PR (−46%) | NA | 22† | alive |
| 307 | 69/M | III | 2 | 11 | PR | −36% | SD | 26.4 | PD | 34.1 | 8 | PD |
| 308 | 52/M | IV | 2 | 21.9 | PD | +105% | PD | NA | NA | NA | 4 | PD |
| 309 | 71/M | III | 2 | 0.4 | SD | −10% | PR | 0.5 | SD (−20%) | 1.1 | 18† | alive |
| 312 | 80/M | III | 2 | 1.5 | NA | NA | NA | 4‡ | NA | NA | 1 | PD |
| 313 | 59/F | I | 2* | 1.0 | PR | −51 | PR | 1.0 | SD | NA | 11† | Alive |
Definition of abbreviations: Dose Level 1 = 1 × 1012 viral particles per dose, Dose Level 2 = 3 × 1011 viral particles per dose, F = Female, M = male, MR = modified RECIST measurement, NA = not available, PD = progressive disease, PR = partial response, SD = stable disease.
Table summarizes demographic data (subject identification number, age, sex, tumor stage, and dose level) and clinical response data as measured by serum mesothelin levels (in ng/ml), CT scan radiographic responses (using Modified RECIST), 18FDG PET Scan responses (based on SUVmax), survival time, and reason for death.
*
One dose only.
†
As of May 2011.
‡
Level measured 30 d after gene transfer.