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Outcomes in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q treated with lenalidomide: a subset analysis from the MDS-004 study.

Giagounidis A, Mufti GJ, Mittelman M, Sanz G, Platzbecker U, Muus P, Selleslag D, Beyne-Rauzy O, te Boekhorst P, del Cañizo C, Guerci-Bresler A, Nilsson L, Lübbert M, Quesnel B, Ganser A, Bowen D, Schlegelberger B, Göhring G, Fu T, Benettaib B, Hellström-Lindberg E, Fenaux P - Eur. J. Haematol. (2014)

Bottom Line: In a 6-month landmark analysis, overall survival was longer in lenalidomide-treated patients with RBC-TI ≥182 d vs. non-responders (P = 0.0072).The most common grade 3-4 adverse event was myelosuppression.These data support the clinical benefits and acceptable safety profile of lenalidomide in transfusion-dependent patients with IPSS-defined Low-/Int-1-risk MDS with isolated del(5q).

View Article: PubMed Central - PubMed

Affiliation: Marien Hospital Düsseldorf, Düsseldorf, Germany.

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Progression to AML in patients with isolated del(5q) (intent-to-treat population) by: (A) randomised treatment group; (B) 6-month landmark analysis according to RBC-TI ≥182 d; and (C) cytogenetic response (major + minor response). *Of the 43 patients randomised to LEN 5 mg, 25 crossed over to LEN 10 mg in the open-label extension phase. †Of the 45 patients randomised to placebo, 38 crossed over to LEN 5 mg in the open-label extension phase. AML, acute myeloid leukaemia; LEN, lenalidomide; RBC-TI, red blood cell-transfusion independence.
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fig02: Progression to AML in patients with isolated del(5q) (intent-to-treat population) by: (A) randomised treatment group; (B) 6-month landmark analysis according to RBC-TI ≥182 d; and (C) cytogenetic response (major + minor response). *Of the 43 patients randomised to LEN 5 mg, 25 crossed over to LEN 10 mg in the open-label extension phase. †Of the 45 patients randomised to placebo, 38 crossed over to LEN 5 mg in the open-label extension phase. AML, acute myeloid leukaemia; LEN, lenalidomide; RBC-TI, red blood cell-transfusion independence.

Mentions: Progression to AML by randomised treatment group is presented in Fig.2A. The estimated 2–year cumulative risk of progression to AML was 12.6% (95%CI: 5.4–27.7), 17.4% (95%CI: 8.7–33.3) and 16.7% (95%CI: 8.3–32.0) in the lenalidomide 10 mg, lenalidomide 5 mg and placebo groups, respectively. The estimated 4-yr cumulative risk of progression to AML was 30.6% (95%CI: 18.1–48.8), 35.4% (95%CI: 21.4–54.6) and 43.3% (95%CI: 27.6–63.1) in the lenalidomide 10 mg, lenalidomide 5 mg and placebo groups, respectively. Of the seven patients randomised to placebo, who did not cross over to receive lenalidomide 5 mg in the open-label extension phase, 3 (42.9%) progressed to AML.


Outcomes in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q treated with lenalidomide: a subset analysis from the MDS-004 study.

Giagounidis A, Mufti GJ, Mittelman M, Sanz G, Platzbecker U, Muus P, Selleslag D, Beyne-Rauzy O, te Boekhorst P, del Cañizo C, Guerci-Bresler A, Nilsson L, Lübbert M, Quesnel B, Ganser A, Bowen D, Schlegelberger B, Göhring G, Fu T, Benettaib B, Hellström-Lindberg E, Fenaux P - Eur. J. Haematol. (2014)

Progression to AML in patients with isolated del(5q) (intent-to-treat population) by: (A) randomised treatment group; (B) 6-month landmark analysis according to RBC-TI ≥182 d; and (C) cytogenetic response (major + minor response). *Of the 43 patients randomised to LEN 5 mg, 25 crossed over to LEN 10 mg in the open-label extension phase. †Of the 45 patients randomised to placebo, 38 crossed over to LEN 5 mg in the open-label extension phase. AML, acute myeloid leukaemia; LEN, lenalidomide; RBC-TI, red blood cell-transfusion independence.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4232868&req=5

fig02: Progression to AML in patients with isolated del(5q) (intent-to-treat population) by: (A) randomised treatment group; (B) 6-month landmark analysis according to RBC-TI ≥182 d; and (C) cytogenetic response (major + minor response). *Of the 43 patients randomised to LEN 5 mg, 25 crossed over to LEN 10 mg in the open-label extension phase. †Of the 45 patients randomised to placebo, 38 crossed over to LEN 5 mg in the open-label extension phase. AML, acute myeloid leukaemia; LEN, lenalidomide; RBC-TI, red blood cell-transfusion independence.
Mentions: Progression to AML by randomised treatment group is presented in Fig.2A. The estimated 2–year cumulative risk of progression to AML was 12.6% (95%CI: 5.4–27.7), 17.4% (95%CI: 8.7–33.3) and 16.7% (95%CI: 8.3–32.0) in the lenalidomide 10 mg, lenalidomide 5 mg and placebo groups, respectively. The estimated 4-yr cumulative risk of progression to AML was 30.6% (95%CI: 18.1–48.8), 35.4% (95%CI: 21.4–54.6) and 43.3% (95%CI: 27.6–63.1) in the lenalidomide 10 mg, lenalidomide 5 mg and placebo groups, respectively. Of the seven patients randomised to placebo, who did not cross over to receive lenalidomide 5 mg in the open-label extension phase, 3 (42.9%) progressed to AML.

Bottom Line: In a 6-month landmark analysis, overall survival was longer in lenalidomide-treated patients with RBC-TI ≥182 d vs. non-responders (P = 0.0072).The most common grade 3-4 adverse event was myelosuppression.These data support the clinical benefits and acceptable safety profile of lenalidomide in transfusion-dependent patients with IPSS-defined Low-/Int-1-risk MDS with isolated del(5q).

View Article: PubMed Central - PubMed

Affiliation: Marien Hospital Düsseldorf, Düsseldorf, Germany.

Show MeSH
Related in: MedlinePlus