Table 1.
Select Studies of Intralesional Therapiesa
| First Author on Study | Treatment | Documented Bystander Effect | No. of Participants | Dosing | Dosing Interval | Treatment Duration | CR, % | PR, % | SD, % | PD, % |
|---|---|---|---|---|---|---|---|---|---|---|
| Bedikian16 | Velimogene aliplasmid | Yes | 127 | 0.5–2 mg | Once weekly | 6 wk | 3 | 9 | 25 | 63 |
| Stopeck19 | Velimogene aliplasmid | No | 51 | 10 μg | Wk 1–4, 8, 9 | ≤ 6 cycles | 2 | 16 | 24 | 59 |
| Gonzalez27 | Velimogene aliplasmid | No | 77 | 10 μg | Once weekly for 6 wk | ≤ 3 cycles | 3 | 7 | 23 | 68 |
| Karakousis28 | BCG | No | 8 | 0.1 mL of 4 × 10″ to 9 × 10″ viable organisms/mL) | NA | Once | 75 | 0 | 0 | 25 |
| Kidner41 | BCG/Imiquimod | No | 19 | 3 × 106 cfu/5% | 5–7 d/wk for every 2 wk | 2 injections titrated to local inflammation | 56 | 11 | 33 | 0 |
| Marty33 | ECT/Bleo | No | 41b | ≤ 1000 IU/cm3 tumor depending on tumor size | NA | Once | 73 | 11 | 11 | 5 |
| ECT/Cis | ≤ 2 mg/cm3 depending on tumor size | |||||||||
| Byrne20 | ECT/Bleo vs Bleo vs ECT | No | 19 | 1 U/mL tumor volume | 4, 8, or 12 wk | 4, 8, or 12 wk | 72 | 5 | 18 | 5 |
| Heller32 | ECT/Bleo vs Bleo vs electroporation | No | 34 | 0.025 U, 1250 V/cm | Once | Once | 89 | 10 | 1 | 0 |
| Mir31 | ECT/Bleo | No | 20 | 18 or 27 U/m2, 1300 V/cm | Once | Once | 53 | 39 | 8 | 0 |
| Ridolfi34 | GMCSF, IL-2 | No | 16 | 150 ng, 3 million IU | Every 21 d | 6 cycles | 0 | 13 | 69 | 19 |
| Boyd46 | IL-2 | No | 39 | 10.4 MIU | Biweekly | 4 cycles | 51 | 31 | 18 (SD/PD)c | |
| Weide18 | IL-2 | No | 48 | 0.3–6.0 MIU | 3 times a wk | 1–32 wk | 69 | NR | NR | NR |
| Thompson23 | 10% rose bengal | Yes | 80 | NA | Wk 1, 8, 12, 16 | ≤ 4 cycles | 26 | 25 | 18 | 31 |
| Yes | 20 | NA | Once | 1 cycle | 20 | 20 | 35 | 25 | ||
| Senzer38 | Talimogene laherparepvec | Yes | 50 | 106 PFU first dose, then 108 PFU thereafter | First interval 3 wk, then every 2 wk | ≤ 24 | 16 | 10 | 24 | 50 |
| Andtbacka39 | Talimogene laherparepvec | No | 295 | 106 PFU first dose, then 108 PFU thereafter | First interval 3 wk, then every 2 wk | NR | 11 | 16 | 73 (SD/PD)c | |
| GMCSF | No | 141 | 125 μg/m2 | Daily × 14 d every 4 wk | NR | 1 | 5 | 94 (SD/PD)c | ||
Only studies with sufficient data regarding responses are included.
Multiple tumor types are included, but responses are not split for study patients with melanoma and without melanoma. Bleo/Cis is equally effective.
Responses were not split out.
Bleo = bleomycin, Cis = cisplatin, CR = complete response, ECT = electrochemotherapy, GMCSF = granulocyte macrophage colony-stimulating factor, IL-2 = interleukin 2, NA = not applicable, NR = not reported, PD = progression of disease, PFU = plaque-forming unit, PR = partial response, SD = stable disease.