Table 2.
Response results and toxicity profiles
| Measure | No of patients (%)a | 95% CI |
|---|---|---|
| Best response | ||
| Complete response | 4 (18.2) | 2.1–34.3 |
| Partial response | 12 (54.5) | 33.7–75.3 |
| Stable disease | 4 (18.2) | 2.1–34.3 |
| Progressive disease | 1 (4.5) | 0.0–13.6 |
| Not available | 1 (4.5) | 0.0–13.6 |
| Objective response | 16 (72.7) | 54.1–91.3 |
| Duration of objective response, months (range) | 4.4 (1.0–17.4) | NA |
| Survival outcome | ||
| Median PFS, months | 5.7 | NA |
| Median OS, months | NR | NA |
| 1-year expected survival rate, % | 67.2 | NA |
| Toxicity profilesb (grade 3/4) | ||
| Hematologic | ||
| Neutropenia (neutrophil<1,000/mm3) | 7 (31.8) | 12.3–51.3 |
| Thrombocytopenia (platelet<50,000/mm3) | 3 (13.6) | 0.0–27.9 |
| Non-hematologic | ||
| Pneumonia | 1 (4.5) | 0.0–13.6 |
| Hemorrhagic cystitis | 1 (4.5) | 0.0–13.6 |
| Nausea | 1 (4.5) | 0.0–13.6 |
| Constipation | 1 (4.5) | 0.0–13.6 |
| Muscle pain | 1 (4.5) | 0.0–13.6 |
| Sensory neuropathy | 0 (0) | NA |
| Dose reduction of brentuximab | 4 (18.2) | 2.1–34.3 |
a
Notes: Unless otherwise indicated;
b
toxicity profiles were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0.
Abbreviations: CI, confidence interval; NA, not applicable; NR, not reached; OS, overall survival; PFS, progression free survival.