Table 1.
Main clinical and hematological data of the four patients included in the study.
| UPN | Age at DX and Sex | Sampling Time Points | Hb (g/dL) | WBC (×109/L) | Platelets (×109/L) | ANC (×109/L) | BM Blasts (%) | Karyotype, SNP-A and FISH (ISCN) | IPSS-R | Treatment |
|---|---|---|---|---|---|---|---|---|---|---|
| P1 | 79 Female |
DX | 10.8 | 3.20 | 221 | 1.10 | 1.0 | 46,XX,del(5)(q13q33)[15]/46,XX[2] arr[hg19] 5q14.3q34(89575437-163450743)x1 nuc ish(D5S1518Ex2,D5S1976x2,EGR1x1,RPS14x1)[63/100] |
1 Very low |
SINTRA-REV (Placebo) |
| 1st FU (14 months after diagnosis) | 10.2 | 3.20 | 252 | 1.00 | 0.0 | 46,XX,del(5)(q13q33)[17]/46,XX[3] nuc ish(D5S1518Ex2,D5S1976x2,EGR1x1,RPS14x1)[80/100] |
1 Very low |
|||
| 2nd FU (33 months after diagnosis) | 9.1 | 3.60 | 374 | 1.10 | 3.0 | 46,XX,del(5)(q13q33)[20] nuc ish(D5S1518Ex2,D5S1976x2,EGR1x1,RPS14x1)[88/100] |
3 Low |
|||
| P2 | 69 Female |
PRE: 4 years after diagnosis (never received treatment) | 8.8 | 4.10 | 233 | 2.10 | 0.5 | 46,XX,del(5)(q22q33)[6]/46,XX[14] arr[hg19] 5q21.2q34(102986652-162755919)x1, Xp22.31(6449753-8135644)x1 FISH: NA |
2 Low |
SINTRA-REV (Lenalidomide) |
| 1st FU (14 months after diagnosis) | 9.3 | 4.60 | 262 | 1.52 | 0.5 | 46,XX[20] nuc ish(D5S1518E,D5S1976,EGR1,RPS14)x2[100] |
2 Low |
|||
| 2nd FU (22 months after diagnosis) | 8.4 | 5.20 | 353 | 1.80 | 1.0 | 46,XX[20] FISH: NA |
2 Low |
|||
| P3 | 77 Female |
PRE: 2 years after diagnosis (previously: support treatment) | 10.5 | 6.40 | 166 | 3.90 | 1.5 | 46,XX,t(1;1)(p35;p36),del(5)(q12q33)[20] arr[hg19] 5q14.3q34(86255729-166126310)x1 FISH: NA |
2 Low |
Lenalidomide |
| P4 | 83 Female |
DX | 9.3 | 3.95 | 262 | 2.44 | 3.0 | 46,XX,del(5)(q13q32)[9]/46,XX[11] arr[hg19] 5q21.3q34(107937392-165840296)x1 nuc ish(D5S1518Ex2,D5S1976x2,EGR1x1,RPS14x1)[32/100] |
3 Low |
Lenalidomide |
| 1st FU (20 months after diagnosis) | 11.7 | 3.66 | 106 | 1.47 | 4.0 | 46,XX,del(5)(q13q32)[9]/46,XX[11] nuc ish(D5S1518Ex2,D5S1976x2,EGR1x1,RPS14x1)[29/100] |
2 Low |
FISH: XL 5q31/5q33/5p15 locus-specific deletion probe was used to detect 5q deletions (D-5081-100-TC, MetaSystems Probes). SINTRA-REV: phase III multicenter, randomized, double blind and controlled with placebo clinical trial and with two arms designed to assess the efficiency and toxicity of the scheme Lenalidomide versus observation in a series of 60 patients with low risk myelodysplastic syndrome associated to 5q deletion with anemia (Hb ≤ 12 g/dL) but without the need of transfusion. Abbreviations: ANC: absolute neutrophil count; BM: bone marrow; DX: diagnosis; FISH: fluorescence in situ hybridization; FU: follow-up; Hb: hemoglobin; IPSS-R: Revised International Prognostic Scoring System; NA: not available; PRE: pre-treatment; SNP-A: single nucleotide polymorphism arrays; UPN: unique patient number; WBC: white blood cells.