Gemtuzumab ozogamicin as postconsolidation therapy does not prevent relapse in children with AML: results from NOPHO-AML 2004

Hasle, Henrik; Abrahamsson, Jonas; Forestier, Erik; Ha, Shau Yin; Heldrup, Jesper; Jahnukainen, Kirsi; Jónsson, Òlafur G.; Lausen, Birgitte; Palle, Josefine; Zeller, Bernward

doi:10.1182/blood-2012-03-416701

Cited by 102 publications

(74 citation statements)

References 32 publications

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“…GO is occasionally combined with other chemotherapeutics, such as fludarabine, anthracyclines, cyclophosphamide, busulfan and cytarabine [22,23,30]. When single dose of GO as part of combination therapy increases, incidence of VOD does not change significantly (r 2 = 0.023, p = 0.675) (Figure 4) also not for total dose of gemtuzumab (r 2 = 0.159, p = 0.253) ( Figure 5).…”

Section: Resultsmentioning

confidence: 93%

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Dose-related efficacy and toxicity of gemtuzumab ozogamicin in pediatric acute myeloid leukemia

Parigger

Zwaan

Reinhardt

et al. 2016

Expert Review of Anticancer Therapy

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Gemtuzumab ozogamicin, an anti-tumour antibiotic linked to an anti-CD33 antibody (Mylotarg®), has been well studied in AML in adults but to a lesser extent in children. No review has yet been published on the dose-related toxicity and efficacy of gemtuzumab ozogamicin in pediatric AML patients. Here we looked at 14 studies then scatterplots and linear regressions were used to estimate the relationship between the dose of gemtuzumab and its toxicity and efficacy. A nonsignificant increase in bilirubin level and in incidence of veno-occlusive disease was seen with higher doses of gemtuzumab ozogamicin when used as single-agent. In terms of efficacy, even a low dose of 3 mg/m 2 of gemtuzumab ozogamicin can have antileukemic effect, but available data do not allow conclusions on its dose-dependency. Data indicate that higher doses of gemtuzumab ozogamicin account for more adverse events. The data do not show that a high dose is required for anti-leukemic efficacy of gemtuzumab ozogamicin. This study also indicates that there seems to be a role for gemtuzumab ozogamicin in the treatment of pediatric AML and further studies are required to assess its optimal dose, schedule and balance between efficacy and side-effects. ARTICLE HISTORY

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Section: Resultsmentioning

confidence: 93%

“…Twenty-seven articles were included based on their abstracts. After reading full-text articles, 14 studies were included in this study [4,[21][22][23][24][25][26][27][28][29][30][31][32][33].…”

Section: Search Strategymentioning

confidence: 99%

Dose-related efficacy and toxicity of gemtuzumab ozogamicin in pediatric acute myeloid leukemia

Parigger

Zwaan

Reinhardt

et al. 2016

Expert Review of Anticancer Therapy

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“…21 Patients received prophylactic sulfamethoxazole/trimethoprim 2-3 days per week. Prophylactic fluconazole was recommended until one month after the last course.…”

Section: Treatment Planmentioning

confidence: 99%

Effect of age and body weight on toxicity and survival in pediatric acute myeloid leukemia: results from NOPHO-AML 2004

Løhmann

Abrahamsson²,

et al. 2016

Haematologica

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T reatment for pediatric acute myeloid leukemia is very toxic and the association between outcome and age and Body Mass Index is unclear. We investigated effect of age and Body Mass Index on toxicity and survival in pediatric acute myeloid leukemia. We studied all patients who completed first induction course of NOPHO-AML 2004 (n=318). Toxicity following induction and consolidation courses (n=6) was analyzed. The probabilities of toxicity and death were determined using time-to-event analyses with Cox multivariate proportional hazard regression for comparative analyses. Age 10-17 years was associated with sepsis with hypotension [hazard ratio 2.3 (95% confidence interval 1.1-4.6)]. Being overweight (>1 standard deviation) was associated with requiring supplemental oxygen [1.9 (1.0-3.5)]. The 5-year event-free and overall survival were 47% and 71%. Children aged 10-17 years showed a trend for inferior 5-year overall survival compared to children aged 2-9 (64% vs. 76%; P=0.07). Infants showed a trend for superior 5-year event-free survival (66% vs. 43%; P=0.06). Overweight children aged 10-17 years showed a trend for superior survival [5-year event-free survival 59% vs. 40% (P=0.09) and 5-year overall survival 78% vs. 56% (P=0.06)] compared to healthy weight children aged 10-17 years. In conclusion, children aged 10-17 years and overweight children had a higher risk of grade 3-4 toxicity. Children aged 10-17 years showed inferior survival, but, unexpectedly, in this age group overweight children tended to have increased survival. This suggests different pharmacokinetics of chemotherapeutic drugs in adolescents and warrants further studies.

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“…Начальные исследования III стадии не по-казали значительного улучшения в бессобытийной и общей выживаемости при детском ОМЛ, но из-вестно о позитивном результате в отношении реф-рактерных и рецидивировавших пациентов, кроме того, отмечена его эффективность в снижении уровня минимальной остаточной болезни после проведения таргетной терапии [25].…”

Section: перспективы оптимизации лечения острого мие-лобластного лейкозаunclassified

Acute myeloid leukemia in children. Prospects for the optimization of treatment (review)

Румянцев¹

2017

Ross. ž. det. gematol. onkol.

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Gemtuzumab ozogamicin as postconsolidation therapy does not prevent relapse in children with AML: results from NOPHO-AML 2004

Cited by 102 publications

References 32 publications

Dose-related efficacy and toxicity of gemtuzumab ozogamicin in pediatric acute myeloid leukemia

Dose-related efficacy and toxicity of gemtuzumab ozogamicin in pediatric acute myeloid leukemia

Effect of age and body weight on toxicity and survival in pediatric acute myeloid leukemia: results from NOPHO-AML 2004

Acute myeloid leukemia in children. Prospects for the optimization of treatment (review)

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