Characteristics of the patients
. | . | . | . | . | . | . | . | . | Response . | . | . | . | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patient no. . | Diagnosis . | Stage . | Previous treatment . | Age, y . | Sex . | Cohort . | Dose, tp's . | No. of injections . | Injected lesion . | Noninjected lesion . | Overall . | Duration, mos.* . | |||
| 1 | Mycosis fungoides | Ib | Topical steroids, PUVA, IFN-α, acitretin, bexarotene | 84 | M | 1 | 3 × 109 | 3 | PR | SD | PR | 6 | |||
| 2 | Mycosis fungoides | IIa | Topical steroids, PUVA, imiquimod | 67 | F | 1 | 3 × 109 | 12 | CR | CR | CR | 1 | |||
| 3 | Granulomatous slack skin | IIb | Topical steroids, PUVA, IFN-α, acitretin, imiquimod | 26 | M | 1 | 3 × 109 | 12 | SD | SD | SD | NE | |||
| 4 | Mycosis fungoides | IIb | Topical steroids, PUVA, IFN-α, acitretin, radiotherapy | 54 | F | 2 | 3 × 1010 | 3 | SD | PD | PD | NE | |||
| 5 | Sézary syndrome | III | Topical steroids, calcipotriole, PUVA, IFN-α, acitretin, methotrexate | 57 | M | 2 | 3 × 1010 | 9 | SD | SD | SD | NE | |||
| 6 | Lymphomatoid papulosis | NA | Topical steroids, PUVA | 40 | F | 2 | 3 × 1010 | 5 | CR | CR | CR | 3 | |||
| 7 | Sézary syndrome | III | Topical steroids, PUVA | 68 | M | 3 | 3 × 1011 | 3 | SD | SD | SD | NE | |||
| 8 | Marginal zone B-cell lymphoma | NA | Topical steroids, antibiotics | 34 | M | 3 | 3 × 1011 | 9 | PR | NE† | NE† | 5 | |||
| 9 | Follicular center cell B-cell lymphoma | NA | Radiotherapy, rituximab | 34 | M | 3 | 3 × 1011 | 3 | CR | SD | PR | 1 | |||
. | . | . | . | . | . | . | . | . | Response . | . | . | . | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patient no. . | Diagnosis . | Stage . | Previous treatment . | Age, y . | Sex . | Cohort . | Dose, tp's . | No. of injections . | Injected lesion . | Noninjected lesion . | Overall . | Duration, mos.* . | |||
| 1 | Mycosis fungoides | Ib | Topical steroids, PUVA, IFN-α, acitretin, bexarotene | 84 | M | 1 | 3 × 109 | 3 | PR | SD | PR | 6 | |||
| 2 | Mycosis fungoides | IIa | Topical steroids, PUVA, imiquimod | 67 | F | 1 | 3 × 109 | 12 | CR | CR | CR | 1 | |||
| 3 | Granulomatous slack skin | IIb | Topical steroids, PUVA, IFN-α, acitretin, imiquimod | 26 | M | 1 | 3 × 109 | 12 | SD | SD | SD | NE | |||
| 4 | Mycosis fungoides | IIb | Topical steroids, PUVA, IFN-α, acitretin, radiotherapy | 54 | F | 2 | 3 × 1010 | 3 | SD | PD | PD | NE | |||
| 5 | Sézary syndrome | III | Topical steroids, calcipotriole, PUVA, IFN-α, acitretin, methotrexate | 57 | M | 2 | 3 × 1010 | 9 | SD | SD | SD | NE | |||
| 6 | Lymphomatoid papulosis | NA | Topical steroids, PUVA | 40 | F | 2 | 3 × 1010 | 5 | CR | CR | CR | 3 | |||
| 7 | Sézary syndrome | III | Topical steroids, PUVA | 68 | M | 3 | 3 × 1011 | 3 | SD | SD | SD | NE | |||
| 8 | Marginal zone B-cell lymphoma | NA | Topical steroids, antibiotics | 34 | M | 3 | 3 × 1011 | 9 | PR | NE† | NE† | 5 | |||
| 9 | Follicular center cell B-cell lymphoma | NA | Radiotherapy, rituximab | 34 | M | 3 | 3 × 1011 | 3 | CR | SD | PR | 1 | |||
PUVA indicates psoralen ultraviolet A treatment (psoralen and UVA light); PR, a > 50% decrease in the size of preexisting lesions, also assigned if > 50% of nodular or plaquelike lesions become macules without evidence of internal involvement; SD, any response that did not meet the criteria for CR, PR, or PD; CR, the absence of detectable residual disease; NE, not evaluated in patients with SD; PD, the appearance of new lesions, an increase of > 25% of preexisting lesions, a change from macular to plaquelike or nodular in > 25% of preexisting lesions, or any evidence of internal organ involvement; and NA, not applicable.
Response duration is defined as a recurrence-free period upon completion of TG1042 treatment.
Not evaluable due to the absence of other lesions.