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A phase II window study of irinotecan (CPT-11) in high risk Ewing sarcoma: a Euro-E.W.I.N.G. study
B Morland1, K Platt, J S Whelan
1Department of Oncology, Birmingham Children's Hospital, Birmingham, UK.
Background:
The prognosis for patients with nonpulmonary metastatic Ewing sarcoma remains poor with survival in the order of 15-20%. The need to introduce effective new agents into clinical practice is clear. Based on a preclinical rationale of responses in xenografts and backed by a phase I study in children, the Euro-E.W.I.N.G consortium planned a phase II window study of irinotecan in newly diagnosed high risk metastatic patients with Ewing sarcoma.
Procedures:
Patients were recruited between April 2004 and December 2007. Two courses of irinotecan were administered at a dose of 600 mg/m(2) as a 1 hour infusion at 21 day intervals. Response evaluation was determined after the second course of treatment by radiological assessment of primary and metastatic sites and, where appropriate bone marrow sampling.
Results:
Twenty-three patients were recruited. Two patients were deemed inevaluable for response. Five patients (24%) demonstrated a partial response. Grade 3 or 4 diarrhoea was seen in 4/43 course of treatment and was managed with loperamide.
Conclusions:
This is the first report of single agent irinotecan activity in an untreated population of patients with Ewing sarcoma. In common with other paediatric tumours and other camptothecin analogues such as topotecan, single agent activity is only modest. The exact role for the use of irinotecan in patients with ES, dose schedule and combinations with other agents still requires further investigation.
Insights
Single agent irinotecan showed modest activity in treating metastatic Ewing sarcoma, with 24% partial response rate. Further research is needed to determine its role and optimal use in patients.
Area of Science:
- Pediatric Oncology
- Medical Oncology
- Pharmacology
Background:
- Ewing sarcoma with nonpulmonary metastases has a poor prognosis (15-20% survival).
- There is a critical need for novel therapeutic agents.
- Preclinical data and Phase I studies supported irinotecan's potential.
Purpose of the Study:
- To evaluate the efficacy of irinotecan as a single agent in newly diagnosed, high-risk metastatic Ewing sarcoma patients.
- To assess response rates and toxicity of irinotecan in this population.
Main Methods:
- A Phase II window study conducted by the Euro-E.W.I.N.G consortium.
- 23 patients received two 600 mg/m(2) doses of irinotecan every 21 days.
- Response was assessed radiologically and via bone marrow sampling after two courses.
Main Results:
- Five out of 23 patients (24%) achieved a partial response.
- Grade 3 or 4 diarrhea occurred in 4/43 treatment courses, managed with loperamide.
- Two patients were inevaluable for response.
Conclusions:
- This study is the first to report single-agent irinotecan activity in untreated metastatic Ewing sarcoma.
- The observed activity was modest, similar to other topoisomerase I inhibitors.
- Further investigation is required to define irinotecan's role, optimal dosing, and combination strategies.
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