Table 5.
Subgroup analysis of objective response rate, full analysis set
| Subgroup | n/Na | ORR (95% CI), % |
|---|---|---|
| All evaluable patients in phases 1 + 2 | 11/45 | 24 (13–40) |
| Sex | ||
| Men | 8/30 | 27 (12–46) |
| Women | 3/15 | 20 (4–48) |
| Age group | ||
| < 65 years | 6/16 | 38 (15–65) |
| ≥ 65 years | 5/29 | 17 (6–36) |
| No. of previous anti-tumor regimens | ||
| 1 | 5/19 | 26 (9–51) |
| 2 | 3/9 | 33 (8–70) |
| 3 | 3/10 | 30 (7–65) |
| ≥ 4 | 0/7 | 0 (0–41) |
| Histological classification | ||
| Peripheral T cell lymphoma, NOS | 5/22 | 23 (8–45) |
| Angioimmunoblastic T cell lymphoma | 6/18 | 33 (13–59) |
| Ann Arbor stageb | ||
| Stage I | 0/1 | 0 (0–98) |
| Stage II | 2/11 | 18 (2–52) |
| Stage III | 7/19 | 37 (16–62) |
| Stage IV | 2/13 | 15 (2–45) |
| ECOG performance status | ||
| 0 | 7/27 | 26 (11–46) |
| 1 | 4/18 | 22 (6–48) |
| Target lesion SPD | ||
| < 14 cm2 | 8/26 | 31 (14–52) |
| ≥ 14 cm2 | 3/19 | 16 (3–40) |
| LDH | ||
| Low/normal | 9/25 | 36 (18–58) |
| High | 2/20 | 10 (1–32) |
CI confidence interval, ECOG Eastern Cooperative Oncology Group, LDH lactate dehydrogenase, NOS not otherwise specified, ORR objective response rate, SPD sum of the products of the largest diameters of target lesions
aNumber of patients with objective responses divided by the total number of patients in the category
bExcept for transformed mycosis fungoides