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Z.R. Rogers et al.
no clonal abnormalities at presentation, but who subse- quently developed abnormalities at follow up, the median time to observe an abnormality was 25.2 months (range: 4.3-71.0 months; IQ range: 5.3-66.6 months). Interestingly, only four patients had BM pathology reports confirming the diagnosis of myelodysplastic syndrome of whom two proceeded to HSCT prior to further clonal evolution. One patient developed acute lymphoblastic leukemia and three developed acute myeloid leukemia.
Complications
Complications following initiation of IST were com- mon with bleeding (gastrointestinal, intracranial, hema- turia or other significant hemorrhage) being most frequent and reported in 74 (23.6%) of all subjects (23.5% of hATG/CyA subjects). Infections, including bacteremia, fungal infections, cellulitis, meningitis, or pneumonia, were reported in 177 (56.4%) of all subjects (53.4% of hATG/CyA subjects). Renal failure requiring dialysis was reported in five patients (1.6%), all in the hATG/CyA group (1.9%). Causes of death classified by type of thera- py and survival interval are detailed in Online Supplementary Table S2.
Outcomes after second-line therapy
Subsequent treatments following upfront hATG/CyA are summarized in Table 8.
Overall, 110 of 314 (35%) subjects received a second treatment, 35 of the 110 a third treatment, and three a fourth therapy.
Of the 38 patients undergoing HSCT for second-line therapy, response to initial treatment with hATG/CyA was as follows: 31 had refractory disease and seven had relapsed disease. Of the seven patients undergoing HSCT for relapsed disease, responses to initial hATG/CyA at three months and six months were as follows: one CR and six NR at three months; three CR, one VGPR, two NR, and one NE at six months. Of the 52 patients receiv- ing a second IST treatment, response to initial treatment with hATG/CyA was as follows: 36 had refractory dis- ease, 15 had relapsed disease, and one patient lacked avail- able response data. Of the 15 patients undergoing second IST for relapsed disease, responses to initial hATG/CyA at three months and six months were as follows: one CR, one VGPR, one PR, and 12 NR at three months; one CR, four VGPR, five PR, and five NR at six months. Two addi- tional patients received tacrolimus for relapsed disease.
AB
CD
Figure 3. Immunosuppressive therapy: survival. Kaplan-Meier analysis of overall survival for (A) all subjects or (B) subjects treated with horse anti-thymocyte globulin (rATG) / cyclosporine (CyA). Kaplan-Meier analysis of event-free survival for (C) all subjects or (D) subjects treated with hATG/CyA.
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haematologica | 2019; 104(10)