Table 1.
Study | N | Age (years) | Sex, % male | Disease (C/I/A) | Intervention arm | Comparator arm | Follow-up (days) | IL-2 dose |
---|---|---|---|---|---|---|---|---|
Amendola27 | 22 | µ = 36 | 55 | HIV (I) | rIL-2 + ART | ATR | 196 | 1 MIU/day |
Arnó28 | 25 | µ = 35 (23–48) | 80 | HIV (I) | rIL-2 + ART | ART | 252 | 6 MIU/day first cycle, reduced to 3 MIU/day |
Artillo29 | 30 | µ = 29 | NA | Chronic HBV hepatitis (I) | rIL-2 | Placebo | 140 | 0.9–3.6 MIU/day |
Bruch30 | 37 | µ = 45 (23–60) | 83 | Chronic HBV hepatitis (I) | rIL-2 + IFN alpha-2b | IFN alpha-2b | 243 | 0.3–1.5 MCU/day |
Carr31 | 115 | µ = 38 | 98 | HIV (I) | PEG rIL-2 + ART | ART | ~ 280 (median) | 0.5–4.25 MIU/day |
De Paoli32 | 22 | µ = 40 | 77 | HIV (I) | rIL-2 + RTIs + Indinavir | RTIs + Indinavir | 672 | 6 MIU/day |
Hartemann33 | 25 | µ = 31 (19–51) | NA | Type 1 diabetes (A) | rIL-2 | Placebo | 60 | 0.33–3 MIU/day |
Johnson34 | 110 | µ = 27 | 68 | Confirmed tuberculosis (HIV-) (I) | rIL-2 + standard chemotherapy | Standard chemotherapy | 365 | 450,000 IU/day |
Lalezari35 | 115 | µ = 41 | 96 | HIV (I) | rIL-2 + ART | ART | 183 | 1.2 MIU/m2/day |
Li36 | 40 | µ = 47 (20–65) | NA | Breast cancer (C) | rIL-2 + postoperative standard care | postoperative standard care | 7 | 1 MIU/day |
Losso37 | 71 | µ = 34 | 79 | HIV (I) | rIL-2 + ART | ART | 168 | 3 MIU/day |
Mantovani38 | 33 | µ = 56 (38–72) | 87 | Head and neck squamous-cell carcinoma (C) | rIL-2 + classical Al Sarraf treatment | Classical Al Sarraf treatment | ~487 | 4.5 MIU/day |
Marchetti39 | 22 | µ = 36 (28–55) | 72 | HIV (I) | rIL-2 + HAART | HAART | 336 | 3 MIU/day |
Nichols40 | 25 | µ = 72 (50–88) | 64 | Colorectal cancer, Dukes’ stage A-D (C) | rIL-2 + Standard surgery | Standard surgery | 10 | 1.8 MIU/m2/ twice daily |
Nicholson41 | 41 | µ = 47 | NA | Melanoma (C) | rIL-2 + SRL172 | SRL172 | 183 | 6 MIU/day |
Perillo42 | 32 | µ = 48 (33–63) | 0 | Breast cancer/Ovarian cancer(C) | rIL-2 + G-CSF + EPO | G-CSF + EPO | 100 | 200,000 IU/m2/day |
Procopio43 | 128 | M = 63 (52–69) | 74 | Renal cell carcinoma (C) | rIL-2 + oral sorafenib | Oral sorafenib | 821 | 4.5 MIU/day |
Ridolfi44 | 241 | M = 62 (32–76) | 76 | Non-small-cell lung cancer (C) | rIL-2 + gemcitabine + cisplatin | Gemcitabine + cisplatin | 973 | 3 MIU/day |
Ruxrungtham45 | 72 | µ = 31 (19–58) | 32 | HIV (I) | rIL-2 + ART | ART | 168 | 3 MIU/day |
Shen46 | 50 | µ = 45 | 62 | Multidrug-resistant tuberculosis, resistant to isoniazid and rifampicin (I) | rIL-2 + multidrug chemotherapy | Multidrug chemotherapy | 730 | 500,000 IU/day |
Smith47 | 44 | µ = 41 (22–63) | 93 | HIV (I) | rIL-2 + placebo vaccine | placebo vaccine | 25 | 1.2 MIU/m2/day |
rIL-2 + vCP1452 vaccine | vCP1452 vaccine | |||||||
Vogler48 | 115 | M = 38 (24–70) | 85 | HIV (I) | rIL-2 + ART | ART | 168 | 1 MIU/day |
Woodson49 | 40 | µ = 55 (25–77) | 62 | Melanoma (C) | rIL-2 + six peptide vaccinations | Six peptide vaccinations | 28 | 3 MIU/m2/day |
Zanussi50 | 10 | µ = 30 (23–54) | 70 | HIV (I) | rIL-2 + HAART | HAART | 168 | 6 MIU/day |
µ: Mean (range); M: median (range); (C/I/A): Cancer/Infection/autoimmune disease; MIU: Million international units, IU: International units; MCU: Million Cetus units (Cetus was the company which was first involved in the development of rIL-2); NA: Not available; HAART: Highly active antiretroviral therapy; RTI: Reverse-transcriptase inhibitors; PEG rIL-2: Polyethylene glycol-modified interleukin-2; ART: Anti-retroviral therapy; G-CSF: Granulocyte-colony stimulating factor; EPO: Erythropoietin; IFN: Interferon; HBsAG: Surface antigen of the hepatitis B virus; HBV: Hepatitis B virus; rIL-2: recombinant interleukin 2; Classical Al Sarraf treatment: (100 mg/m2 cisplatin i.v. as a 60-min infusion on day 1, with a standard pre- and post-hydration protocol with forced diuresis by 250 ml 18% mannitol, plus 1000 mg m−2 day−1 5-fluorouracil on days 1–5 (120 h) as a continuous infusion).