Idarubicin and cytarabine in combination with gemtuzumab ozogamicin (IAGO) for untreated patients with high-risk MDS or AML evolved from MDS: ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2015-09-26

AUTHORS

Theo de Witte, Stefan Suciu, Liv Meert, Constantijn Halkes, Dominik Selleslag, Dominique Bron, Sergio Amadori, Roel Willemze, Petra Muus, Frédéric Baron

ABSTRACT

The primary objective of this trial was to assess the feasibility, toxicity profile, and antitumor activity of gemtuzumab ozogamicin (GO) combined with a chemotherapy remission-induction regimen in adults with untreated high-risk myelodysplastic syndrome (HR-MDS) or secondary acute myeloid leukemia (sAML). In this phase II trial, 30 patients with median age of 58 years received 1 day of GO as a 1-h infusion at the dose level of 5 mg/m2 on day 7 of the remission-induction course further consisting of a continuous infusion of cytarabine 100 mg/m2/day for 10 days and idarubicin 12 mg/m2/day on days 1, 3, and 5. A consolidation course, consisting of intermediate-dose cytarabine (A) and idarubicin (I) followed by hematopoietic stem cell transplantation (HSCT) was planned for patients in complete remission (CR). The primary endpoints were response rate (CR/CRi) and severe toxicity rate. The secondary endpoint(s) were survival and progression-free survival (PFS) from start of treatment. Thirteen patients (43 %) achieved CR (eight patients) or CR with incomplete hematopoietic recovery (CRi) (five patients). In patients who achieved CR or CRi, the median time to recovery of neutrophils to 0.5 × 109/l and of platelets to >50 × 109/l was 29 and 30 days, respectively. Grade 3 to 4 severe toxicities occurred in nine patients. The most prominent was liver toxicity, as shown by elevated bilirubin levels in 16 patients and one case of nonfatal veno-occlusive disease (VOD). All 13 patients with CR/CRi received consolidation therapy, which was followed by allogeneic HSCT in five patients and autologous HSCT in three patients. According to the statistical design of the study, the idarubicin and cytarabine in combination with gemtuzumab ozogamicin (IAGO) regimen did not show sufficient activity to warrant further exploration of this regimen in adult patients with HR-MDS or sAML. More... »

PAGES

1981-1989

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00277-015-2486-9

DOI

http://dx.doi.org/10.1007/s00277-015-2486-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1049512718

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/26410352


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31 schema:description The primary objective of this trial was to assess the feasibility, toxicity profile, and antitumor activity of gemtuzumab ozogamicin (GO) combined with a chemotherapy remission-induction regimen in adults with untreated high-risk myelodysplastic syndrome (HR-MDS) or secondary acute myeloid leukemia (sAML). In this phase II trial, 30 patients with median age of 58 years received 1 day of GO as a 1-h infusion at the dose level of 5 mg/m2 on day 7 of the remission-induction course further consisting of a continuous infusion of cytarabine 100 mg/m2/day for 10 days and idarubicin 12 mg/m2/day on days 1, 3, and 5. A consolidation course, consisting of intermediate-dose cytarabine (A) and idarubicin (I) followed by hematopoietic stem cell transplantation (HSCT) was planned for patients in complete remission (CR). The primary endpoints were response rate (CR/CRi) and severe toxicity rate. The secondary endpoint(s) were survival and progression-free survival (PFS) from start of treatment. Thirteen patients (43 %) achieved CR (eight patients) or CR with incomplete hematopoietic recovery (CRi) (five patients). In patients who achieved CR or CRi, the median time to recovery of neutrophils to 0.5 × 109/l and of platelets to >50 × 109/l was 29 and 30 days, respectively. Grade 3 to 4 severe toxicities occurred in nine patients. The most prominent was liver toxicity, as shown by elevated bilirubin levels in 16 patients and one case of nonfatal veno-occlusive disease (VOD). All 13 patients with CR/CRi received consolidation therapy, which was followed by allogeneic HSCT in five patients and autologous HSCT in three patients. According to the statistical design of the study, the idarubicin and cytarabine in combination with gemtuzumab ozogamicin (IAGO) regimen did not show sufficient activity to warrant further exploration of this regimen in adult patients with HR-MDS or sAML.
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65 cytarabine
66 cytarabine 100
67 day 1
68 day 7
69 days
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76 feasibility
77 further exploration
78 gemtuzumab ozogamicin
79 grade 3
80 group
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82 hematopoietic stem cell transplantation
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84 high-risk myelodysplastic syndrome
85 idarubicin
86 idarubicin 12
87 incomplete hematopoietic recovery
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89 intermediate-dose cytarabine
90 leukemia
91 leukemia group
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93 liver toxicity
94 m2
95 m2/day
96 median age
97 median time
98 myelodysplastic syndrome
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102 ozogamicin
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109 profile
110 progression-free survival
111 rate
112 recovery
113 recovery of neutrophils
114 regimen
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118 response rate
119 secondary acute myeloid leukemia
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122 start
123 start of treatment
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125 stem cell transplantation
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128 survival
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135 transplantation
136 treatment
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139 veno-occlusive disease
140 years
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