Table 1.
Patient Demographics and Clinical Characteristics
| Characteristic | Cohort 1 (n = 27) |
All Patients (N = 71) |
||
|---|---|---|---|---|
| No. of Patients | % | No. of Patients | % | |
| Sex | ||||
| Male | 20 | 48 | ||
| Female | 7 | 23 | ||
| Age, years | ||||
| Median | 57 | 57 | ||
| Range | 31-77 | 28-84 | ||
| < 50 | 5 | 20 | ||
| ≥ 50 | 22 | 51 | ||
| Disease stage at time of enrollment | ||||
| IA | 0 | 1 | ||
| IB | 2 | 6 | ||
| IIA | 0 | 2 | ||
| IIB | 5 | 15 | ||
| IIIA | 2 | 3 | ||
| IIIB | 0 | 3 | ||
| IVA | 14 | 28 | ||
| IVB | 4 | 13 | ||
| ECOG performance status | ||||
| 0 | 5 | 16 | ||
| 1 | 16 | 45 | ||
| 2 | 6 | 10 | ||
| Elevated LDH | 10 | 30 | ||
| Low albumin | 8 | 43 | ||
| No. of prior therapies* | ||||
| Median | 3 | 4 | ||
| Range | 1-11 | 0-14 | ||
| Previous topical therapies | 17 | 63 | 43 | 61 |
| PUVA | 16 | 59 | 39 | 55 |
| Topical NM | 7 | 26 | 16 | 23 |
| Topical bexarotene | 3 | 11 | 4 | 6 |
| Topical steroids | 4 | 15 | 11 | 15 |
| Previous radiation therapy† | 15 | 56 | 40 | 56 |
| Localized radiotherapy | 12 | 44 | 32 | 45 |
| TSEB | 6 | 22 | 13 | 18 |
| Previous extracorporeal photopheresis | 4 | 15 | 16 | 23 |
| Previous biologic therapies | 22 | 81 | 48 | 68 |
| IFN | 9 | 33 | 23 | 32 |
| Denileukin diftitox | 6 | 22 | 14 | 20 |
| Alemtuzumab | 1 | 4 | 4 | 6 |
| Anti-Tac antibody | 1 | 4 | 5 | 7 |
| Oral corticosteroids | 6 | 22 | 18 | 25 |
| Retinoid: oral bexarotene | 12 | 44 | 32 | 45 |
| Retinoid: other‡ | 5 | 19 | 10 | 14 |
| Previous systemic chemotherapy regimens§ | 13 | 48 | 46 | 65 |
| 0 | 14 | 52 | 25 | 35 |
| 1 | 11 | 41 | 20 | 28 |
| 2 | 2 | 7 | 14 | 20 |
| > 2 | 0 | 0 | 12 | 17 |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase; PUVA, psoralen plus ultraviolet A therapy; NM, nitrogen mustard; TSEB, total skin electron beam; IFN, interferon.
Other treatments not listed include cyclosporine, tacrolimus, azathioprine, remicade, dendritic cell vaccine, and peldesine.
Some patients had both localized radiation and TSEB.
Other retinoids include isotretinoin, acitretin, and etretinate. Three patients received bexarotene as well as another retinoid.
Chemotherapies included monotherapy such as chlorambucil, cladribine, fludarabine, gemcitabine, liposomal doxorubicin, methotrexate, or pentostatin and combination therapy such as cyclophosphamide, doxorubicin, vincristine, and prednisone; infusional etoposide, vincristine, and doxorubicin with bolus cyclophosphamide; and cyclophosphamide, vincristine, and prednisone.