Table 1 Characteristics of full studies reported in literature articles included in the systematic review
From: Systematic review of azacitidine regimens in myelodysplastic syndrome and acute myeloid leukemia
Study ID | Design | N | Inclusion criteria | Schedule | Cycles | Comparator | Concomitant therapy |
|---|---|---|---|---|---|---|---|
Fenaux et al. [3] | RCT^ | 179 | adults > = 18 with FAB diagnosis high risk MDS | 7–0-0 | 9 | CCR*: BSC, Ara-C, intensive chemo | none |
Silverman et al. [13] | RCT | 309 | those used for the 3 clinical trials | 7–0-0 | 3 | BSC | none |
Lyons et al. [14] | RCT | 151 | age > =18 with FAB‡ diagnosis RA/RARS/RAEB/RAEB-T/CMML and life expectancy >7 months | 5–0-0, 5–2-2, 5–2-5 | 6 | none | none |
Xicoy et al. [15] | OR^^ | 107 | MDS patients older than 75 treated with AZA | 5–0-0, 5–2-2, 7–0-0 | 8 | none | none |
Garcia-Delgadoa et al. [16] | OR | 200 | age > =18 with either WHO-defined MDS or confirmed diagnosis of de novo/secondary AML with 20–30% blasts according to WHO who received at least 1 cycle of AZA | 5–0-0, 7–0-0, 5–2-2 | 6, 8, 8 | none | none |
Sadashiv et al. [24] | OP^* | 15 | newly diagnosed AML who were deemed poor candidates for induction therapy and had an ECOG ≤2 | 5–0-0 | 5 | none | none |
Minoia et al. [25] | OR | 18 | therapy related MDS and AML not eligible for intensive chemotherapy | 7–0-0 | 6 | none | none |
Drummond et al. [26] | OP | 30 | CMML-2 or CMML-1 patient with symptomatic marrow failure or proliferative disease | 5–2-2 | 7 | none | none |
Fianchi et al. [27] | OR | 31 | consecutive patients receiving 5-aza | 7–0-0 | 4 | none | none |
Ballya et al. [28] | OR | 62 | patients with diagnosis of MDS, CMML, or AML treated with AZA | 7–0-0 | 8 | none | none |
Breccia et al. [29] | OP | 38 | WHO-diagnosed MDS patients treated with AZA†outside clinical trial | 5–2-2 | 5 | none | none |
Breccia et al. [30] | OP | 60 | unselected WHO†‖-diagnosed MDS/CMML | 5–2-2 | 6 | none | none |
Douvali et al. [31] | OR | 42 | intermediate-2/high risk MDS patients with normal hepatic function, ECOG 0–2 | 7–0-0 | 5.5 | none | G-CSF |
Duong et al. [32] | OR | 84 | patients with diagnosis of MDS or AML previously treated with chemotherapy having received at least 1 dose of AZA | 7–0-0 | 4.5 | none | none |
Ettou et al. [33] | OR | 169 | consecutive patients treated with AZA between 2005 and 2011 | 7–0-0 | 6 | none | none |
Fianchi et al. [34] | OR | 50 | patients with therapy-related myeloproliferative neoplasms | 7–0-0 | 4 | none | ESA†* (8%), AML IC†** (12%) |
Fil et al. [35] | OP | 32 | age > =18 with IPSS††low/int-1 MDS and one or more of: (i) symptomatic anemia requiring RBC transfusion-supportive therapy, previously unresponsive to EPO or not expected to respond to EPO, (ii) thrombocytopenia requiring platelet transfusion, (iii) > 3 months ANC** less than 1.5 | 5–0-0 | 8 | none | none |
Gryna et al. [36] | OR | 48 | MDS patients, previous cytokine therapy allowed, ECOG <2 included | 7–0-0 | 6 | none | none |
Itzykson et al. [37] | OR | 86 | MDS and AML patients treated with AZA | 7–0-0 | 6 | none | none |
Itzykson et al. [38] | OR | 282 | IPSS Int-2/hi MDS patients as well as AML patients with blasts <30% | 7–0-0, 5–0-0 | 6 | none | none |
O’Reilly et al. [23] | OR | 47 | elderly AML patients | 5–0-0 | 5 | none | none |
Lee et al. [39] | OR | 75 | MDS patients treated with AZA | 7–0-0 | 5 | Decitabine | none |
Lee et al. [40] | OR | 203 | patients needed to have an International Prognostic Scoring System (IPSS) lower risk score (IPSS low or intermediate-1) with significant cytopenia, or a higher risk score (IPSS intermediate-2 or high) | 7–0-0 | 5 | Decitabine | none |
Al-Ali et al. [41] | OP | 40 | patients >18, life expectancy >2 months, with WHO-defined AML | 5–0-0 | 3 | none | none |
Martin et al. [42] | OP | 22 | age > =18 with diagnosis of MDS based on FAB criteria, ECOG status <=2, adequate renal and hepatic function, no chemotherapy withing 4 weeks of enrollment | 5–0-0 | 4.5 | none | none |
Moon et al. [43] | OR | 129 | MDS patients treated with Azacitidine | 7–0-0 | 3 | none | G-CSF, EPO |
Muller-Thomas et al. [44] | OR | 32 | MDS and sAML patients treated with Azacitidine | 7–0-0 | 4 | none | RA†***, VA in 2 patients |
Muller-Thomas et al. [45] | OP | 100 | MDS patients treated with Azacitidine | 7–0-0 | 4 | none | none |
O’Reilly et al. [46] | OR | 32 | consecutive treatment-naïve patients treated with AZA between 2006 and 2012 | 5–0-0 | 9 | none | none |
Ozbalak et al. [47] | OR | 25 | MDS, AML, and CMML patients not eligible for chemotherapy treated with azacitidine | 7–0-0 | 8 | none | none |
Papoutselis et al. [48] | OR | 87 | late-stage MDS, ECOG 0–2 | 7–0-0 | 6 | BSC | G-CSF |
Pierdomenico et al. [49] | OR | 50 | consecutive patients treated with AZA between 2005 and 2011 | 5–0-0 | 7.5 | none | none |
Tobiasson et al. [50] | OP | 30 | age greater than 18 with IPSS low/int-1 or mixed MDS/myeloproliferative disorder, CMML less than 10% marrow blasts or RARS | 5–0-0 | 6 | none | none |
Diamantopoulos et al. [51] | OR | 44 | higher risk MDS or AML with 20–30% bone marrow blasts | 7–0-0 | 5 | none | none |
Passweg et al. [24] | OP | 45 | elderly or frail patients with AML not eligible for intensive chemotherapy | 5–0-0 | 4 | none | none |
van der Helm et al. [25] | OR | 55 | newly diagnosed AML receiving upfront treatment with 5-aza | 7–0-0 | 6 | none | none |
van der Helm et al. [26] | OR | 26 | newly diagnosed AML | 7–0-0 | 6 | none | none |