Reactions 1290 - 27 Feb 2010

transfusions in addition to eptacog alfa twice daily for11 days. His coagulation parameters remained mostly SAntineoplasticsnormal during eptacog alfa therapy. His recovery was slowover the next 3 weeks, but there were no signs of furtherHaemorrhage in paediatric patients, treated withbleeding, so his chemotherapy was continued. During theeptacog alfa: 3 case reportsnext cycle, haemorrhage recurred but was partiallyThree paediatric patients developed haemorrhage duringcontrolled with eptacog alfa. He eventually died fromchemotherapy for various malignancies.multiple organ failure.The first patient was a full-term male neonate who had

severe hepatomegaly on the first day of life. After his liver Bilic E, et al. Recombinant activated factor VII controls chemotherapy-relatedhemorrhage in patients with solid intra-abdominal tumors: A report of threebiopsy showed hepatoblastoma, he received cisplatin,pediatric cases. Acta Clinica Croatica 48: 161-166, No. 2, Jun 2009 -doxorubicin [dosages not stated], albumin and bloodCroatia 803006079products. Despite supportive therapy, his clinical and

haematological status worsened [time to reaction onset notstated]; his haemoglobin dropped to 74 g/L and his plateletcount dropped to 30 × 109/L. His prothrombin timedecreased to 0.30, and his activated partial thromboplastintime increased to 74.3 seconds. His abdominal girthincreased from 44 to 48cm; a CT scan showedintraperitoneal haemorrhage. He started to show signs ofoedema and tachycardia, with imminent cardiorespiratoryinsufficiency. Supportive therapy temporarily improved hiscondition but his bleeding continued. Treatment witheptacog alfa [recombinant factor VIIa] resulted in completecessation of bleeding and significant clinical improvement.His bleeding parameters improved and his abdominal girthdecreased to 47cm. Blood transfusions were discontinued.After the last cycle of chemotherapy, a CT scan showedregression of the tumour. He was then referred for surgeryand made a full recovery after 3 years.

The second patient was an 8-year-old boy who had a3-week history of abdominal pain and vomiting; he wasdiagnosed with embryonic rhabdomyosarcoma. After hisfirst cycle of ifosfamide/vincristine/dactinomycin therapy[dosages and time to reaction onset not clearly stated], hedeveloped severe bone marrow aplasia, bilateralpneumonia, pulmonary oedema, sepsis, multi-organdysfunction syndrome and severe intraabdominal bleeding.He received blood transfusions but the bleeding persisted.On the third day after the first chemotherapy cycle, he hadpersistent GI bleeding, melena, and haematemesis. Anultrasound showed fluid accumulation within theabdominal cavity. He received eptacog alfa at 3-hourintervals which temporarily stopped the bleeding. He wastransferred to the ICU where he received four more doseseptacog alfa over the next 2 days. His bleeding stoppedafter the second day of eptacog alfa. He was then treatedfor iatrogenic bone marrow aplasia, sepsis and bilateralpneumonia. Three weeks after ICU admission, hiscondition stabilised and chemotherapy was continued withthe same agents. After debulking surgery and three morecycles of chemotherapy, the tumour became undetectable.Radiotherapy completed his treatment, and he eventuallymade a full recovery.

The third patient was a 15-month-old boy with a 2-weekhistory of anaemia, who was diagnosed with a non-classified malignant sarcoma with undifferentiatedrhabdoid components. Evidence of bleeding prompted anexploratory laparotomy, which revealed a non-resectabletumour with metastases. He received ifosfamide,vincristine and dactinomycin (CWS-96 protocol) [dosagesnot stated]. The following day he developed intraperitonealhaemorrhage. His haemoglobin dropped to 87 g/L and hisplatelet count increased to 714 × 109/L. He was transferredto the ICU for treatment of abdominal haemorrhage,haemorrhagic shock, restrictive respiratory insufficiencyand acute pulmonary oedema with pulmonaryhaemorrhage. Chemotherapy was restarted once hiscondition stabilised. On the following day, however, hedeveloped progressive intraperitoneal bleeding and hisclinical condition deteriorated. He received blood

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