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M. Stahl et al.
There was a total of 570 patients in the 22 included studies. The average median age was 62.0 years (range 12- 87 years). Among the studies that reported IPSS scores, 360 (80.9%) patients had IPSS scores of low- or intermedi- ate-1, while 71 patients (16.0%) had intermediate-2 and high IPSS scores. The median duration of follow up of individual studies, where reported, was 16.4 months (range 0-60 months).
Assessment of study quality
Except for three studies,18,29,35 all studies included in this
meta-analysis used a single-arm design. Study quality was assessed using the Downs and Black checklist. Assessments for individual studies are provided in Online Supplementary Table S1.
Rates of overall response and complete remission
The ORR was reported by all 22 studies (Figure 2A). Overall, the ORR was 42.5% (95%CI: 36.1-49.2%). There was a significant heterogeneity among the various studies, with a Cochran’s Q statistic of 80% (P<0.001) and an I2 statistic of 74%.
AB
Figure 2. Overall and complete response rates to various forms of immunosuppressive therapy (IST). Forest plots of odds ratios (squares, proportional to study weights used in meta-analysis, 95% confidence intervals) for various forms of IST with the summary measures (center line of diamond) and associated confidence intervals (lateral tips of diamond) for overall response rate (ORR) and complete response (CR) rate are shown in panel (A) and (B), respectively.
Table 2. Cyclosporine A.
Author Year
Yamada T et al. 2003
Ogata M et al. 2004
Ishikawa T et al. 2007
Treatment and treatment schedule
Methylprednisolone 1000mg for 3 doses followed by oral taper
+/- CsA 4-5mg/kg for trough of 100-200 ng/ml
CsA 1.1-6.0 mg/kg until disease
progression or intolerable
side effects
CsA titrated to trough 150-200ng/ml for 32 weeks
N
18
12
20
IPSS risk category
Intermediate-1: 72% Intermediate 2: 6%
Not reported
Low: 10% Intermediate-1: 90%
FAB/WHO classification
RA: 56% CMML: 11% RAEB-I: 33%
RA: 92%
RAEB-I: 8%
RA: 40% RARS: 5% RCMD: 45% RAEB-I: 10%
Outcomes
CR: 6% PR: 11% TI: 18%
No CRs or PRs
HI-E: 58%
TI: 64%
No CRs or PRs HI-E: 42% TI: 40%
Adverse Ref. events
Not reported (29)
Not reported (52)
51 AEs (41) in 19 patients,
AE: adverse events; ATG: anti-thymocyte globulin; AZA: azacitidine;
for Adverse Events; HI-E: hematologic improvement-erythroid; IPSS:
mia with ringed sideroblasts; RAEB: refractory anemia with excess blasts; RCMD: refractory cytopenia with multilineage dysplasia; TI: transfusion independence.
CMML: chronic myelomonocytic leukemia; CR: complete remission; CTCAE: Common Terminology Criteria International Prognostic Scoring System; PR: partial remission; RA: refractory anemia; RARS: refractory ane-
AEs ≥ grade 3 in
4 patients (2 infectious)
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