Table 1.
Patient Characteristics
| Characteristic | Patients With Quantifiable Change by RECIST (n = 468) |
Patients With Best Response of New Lesion (ie, unquantifiable; n = 102) |
||
|---|---|---|---|---|
| No. of Patients | % | No. of Patients | % | |
| Age, years | ||||
| Median | 57 | 56 | ||
| Range | 2-88 | 33-82 | ||
| Sex | ||||
| Male | 265 | 56.6 | 54 | 52.9 |
| Female | 203 | 43.4 | 48 | 47.1 |
| Race | ||||
| White | 367 | 78.4 | 79 | 77.5 |
| Black | 40 | 8.5 | 8 | 7.8 |
| Hispanic | 38 | 8.1 | 13 | 12.7 |
| Asian | 21 | 4.5 | 2 | 2.0 |
| Other | 2 | 0.5 | 0 | 0.0 |
| Performance status | ||||
| 0 | 155 | 33.1 | 33 | 32.5 |
| 1 | 295 | 63.0 | 61 | 59.8 |
| ≥ 2 | 18 | 3.8 | 8 | 7.8 |
| Tumor type | ||||
| Breast, n = 47 | 32 | 6.8 | 15 | 14.7 |
| GI, n = 177 | 137 | 29.3 | 40 | 39.2 |
| Genitourinary, n = 51 | 43 | 9.2 | 8 | 7.8 |
| Gynecologic, n = 17 | 13 | 2.8 | 4 | 3.9 |
| Head and neck, n = 41 | 35 | 7.5 | 6 | 5.9 |
| Lymphoma/myeloma, n = 19 | 8 | 1.7 | 1 | 1.0 |
| Melanoma, n = 52 | 40 | 8.5 | 12 | 11.7 |
| Sarcoma, n = 37 | 36 | 7.7 | 1 | 1.0 |
| Thoracic, n = 45 | 38 | 8.1 | 7 | 6.7 |
| All other, n = 157 | 86 | 18.4 | 8 | 7.8 |
| Total No. of prior treatments | ||||
| Mean | 5.8 | 6.2 | ||
| SD | 2.7 | 3.1 | ||
| Systemic treatments | ||||
| Mean | 3.6 | 4.1 | ||
| SD | 2.3 | 2.6 | ||
| Radiation treatments | ||||
| Mean | 0.6 | 0.7 | ||
| SD | 0.8 | 1.0 | ||
| Surgical treatments | ||||
| Mean | 1.4 | 1.2 | ||
| SD | 1.3 | 0.9 | ||
| Other treatments* | ||||
| Mean | 0.2 | 0.2 | ||
| SD | 0.6 | 0.8 | ||
| Time from cancer diagnosis to C1D1 of study treatment, years† | ||||
| Median | 3.7 | 2.8 | ||
| Range | 0.1-36.7 | 0.1-26.8 | ||
| Time from end of last treatment to C1D1 of trial, months‡ | ||||
| Median | 2.0 | 1.7 | ||
| Range | 0.0-269.9 | 0.0-20.2 | ||
| Time from C1D1 of study treatment to best RECIST response, days | ||||
| Median | 59 | 57 | ||
| Range | 25-854 | 25-79 | ||
Abbreviation: SD, standard deviation.
*
Concurrent chemotherapy with radiation therapy is categorized as other treatments.
†
C1D1 is cycle 1, day 1 of phase I treatment.
‡
Two patients (one in each group) had no therapy before phase I treatment.