Study | Year | Country | Study design | Patients | Population | Main underlying disease (%) | POS form | Indication of therapy | Assay method | Intervention following TDM result | Prophylaxis duration: (days) | Definition of successful outcome | Cut-off value of prophylaxis | AE incidence |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sengar | 2016 | India | SCP | 45 | A | AML | sus | P | HPLC | No | NA | EORTC/MSG | Css ≥ 0.7 | NA |
Döring | 2017 | Germany | SCR | 63 | C | HSCT | sus & tab | P | HPLC | No | median 106 | EORTC/MSG | Css ≥ 0.5 | hepatotoxicityd |
Liebenstein | 2017 | USA | SCR | 74 | A | AML | sus & tab | P | NA | Yes | 31 & 34 | EORTC/MSG | Css ≥ 0.7 | hepatotoxicity (4.1%) |
Tverdek | 2017 | USA | SCR | 76 | A | AML (55%) | tab & iv | P | NA | Yes | median 8 | EORTC/MSG | Css ≥ 0.7 | NA |
Thakuria | 2016 | UK | SCP | 26 | A | lung transplant | sus | P | LC-MS/MS | Yes | 36.1 | EORTC/MSG | Css ≥ 0.5 | 8/27 (29.6%) |
Vanstraelen | 2016 | Belgium | SCP | 14 | C | AML (50), ALL (36) | sus | P | HPLC | No | 21 (17–60) | NA | Css ≥ 0.7 | 0 |
Park | 2016 | Korea | MCP | 114 | A | AML (91), MDS (9) | sus | P | LC-MS/MS | Yes | ≥ 8 | EORTC/MSG | Css ≥ 0.5 | NA |
Cornely | 2016 | Global(15 countries) | MCP, phase III | 210 (Css is, available in 186) | NA | AML (54), MDS (3), HSCT (43) | tab | P | LC-MS/MS | No | ≥ 28 | EORTC/MSG | Css ≥ 0.5a, Css ≥ 0.7a | 84/210 (40%) |
Hummert | 2015 | USA | SCR | 29 | A | AML | sus | P | NA | Yes | 100 | NA | Css ≥ 0.5, Css ≥ 0.7 | 0 |
Chae | 2015 | Korea | SCP | 122 | A | AML (94) + MDS (6) | sus | P | LC-MS/MS | No | 25 (7–45) | EORTC/MSG | Css ≥ 0.5 | NA |
Maertens | 2014 | 3 European countries | MCP, phase III | 66 | A | AML (94) + MDS (6) | inj | P | LC-MS/MS | No | 1–14 | EORTC/MSG | Css ≥ 0.5 | 200 mg/d, 44%, 300 mg/d, 33% |
Duarte | 2014 | Western country | MCP, phase III | 54 | A | AML (91) + MDS (9) | tab | P | LC-MS/MS | No | NA, ≤ 28 | EORTC/MSG | Css > 0.5 | 24/54 (44.4%) |
Desplanques | 2014 | France | SCR | 43 | A | AML | sus | P | LC-MS/MS | No | NA | EORTC/MSG | Css > 0.5 | NA |
Bourdelin | 2014 | France | SCP | 35 | A + P | HM (AML 49%) | sus | P | HPLC | No | 5–42 | EORTC/MSG | Css ≥ 0.5 | NA |
Gross | 2013 | Germany | SCP | 31 (27 P + 4 T) | A | AML (74), MDS (6) | sus | P + T | HPLC | No | NA | EORTC/MSG | Css ≥ 0.7 | NA |
Cattaneo | 2013 | Italy | SCP | 50 | NA | AML | sus | P | NA | No | NA | EORTC/MSG | Css ≥ 0.5 | NA |
Tonini | 2013 | France | SCR | 29 | A | HSCT | sus | P | LC-MS/MS | No | NA, ≥ 7 | EORTC/MSG | Css ≥ 0.7 | NA |
Ross | 2012 | USA | SCP | 54 | A | AML (95), MDS (5) | sus | P | HPLC | No | NA, ≥ 7 | EORTC/MSG | Css ≥ 0.5, Css ≥ 0.7 | NA |
Pavan | 2012 | Italy | SCR | 50 | NA | AML | sus | P | HPLC | Yes | NA | EORTC/MSG | Css ≥ 0.5 | NA |
Hoenigl | 2012 | Austria | SCP | 34 (31 P + 3 T) | NA | AML/MDS (52), HSCT (48) for prophylaxis | sus | P + T | HPLC | No | NA | EORTC/MSG | Css ≥ 0.5 | Hepatotoxicity (8.8%) |
Eiden | 2012 | France | SCP | 63 (50 samples on d7) | A | leukemia (48%), multiple myeloma (22) | sus | P | HPLC | No | median 14 (3–307) | EORTC/MSG | Css ≥ 0.5 b, Css ≥ 0.7 b | Hepatotoxicity (6.3%) |
Shields | 2011 | USA | SCR | 17 (11 P + 6 T) | A | 16 lung transplant | sus | P + T | HPLC | Yes | NA | EORTC/MSG | Css ≥ 0.5, Css ≥ 0.7 | NA |
Fanci | 2011 | NA | SCP | 13 | NA | AML | sus | P | HPLC | No | mean 23 | NA | Css ≥ 0.5 | NA |
Bryant | 2011 | USA | SCR | 21 | A | AML (95) + MDS (5) | sus | P | HPLC | Yes | ≥ 7 | EORTC/MSG | Css ≥ 0.5, Css ≥ 0.7 | NA |
Welzen | 2011 | Netherlands | MCP, phase II | 12 | C | CGD | sus | P | HPLC | Yes | ≥ 30 | NA | Css ≥ 0.5c, Css ≥ 0.7c | 4/12 (33.3%) |
Lebeaux | 2009 | France | SCR | 54 (36 P + 18 T) | A | HM (69) | sus | P + T | HPLC | No | ≥ 5 | EORTC/MSG | Css ≥ 0.5 | Hepatotoxicity (7.4%) |
Ullmann & Jang | 2007 & 2010 | Global | RCT | 291 P (Css is available in 252) | NA(> 95% adult) | HSCT | sus | P | LC-MS/MS | No | mean 80 | EORTC/MSG | Css ≥ 0.7 | 107/301 (36%) |
Cornely & Jang | 2007 & 2010 | Global | RCT | 304 P (Css is available in 215) | NA | AML (84), MDS (16) | sus | P | LC-MS/MS | No | mean 29 | EORTC/MSG | Css ≥ 0.7 | 19/304 SAE (6.2%) |