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Phase II Trial of Irinotecan in Children With Relapsed or Refractory Rhabdomyosarcoma: A Joint Study of the French Society of Pediatric Oncology and the United Kingdom Children's Cancer Study Group

Gilles Vassal, Dominique Couanet, Elizabeth Stockdale, Anne Geoffray, Birgit Geoerger, Daniel Orbach, Fabienne Pichon, Jean Claude Gentet, Susan Picton, Christophe Bergeron, Laura Cisar, Sylvie Assadourian, Bruce Morland

From the Department of Pediatrics, Gustave Roussy Institute, Villejuif; Children's Hospital Lenval, Nice; Department of Pediatrics, Curie Institute, Paris; Department of Pediatrics, Oscar Lambret Center, Lille; Department of Pediatrics, La Timone Hospital, Marseille; Department of Pediatrics, Leon Berard Center, Lyon; Sanofi Aventis, Antony, France; Royal Aberdeen Children's Hospital, Aberdeen; Department of Pediatric Oncology, St James's University Hospital, Leeds; Birmingham Children's Hospital NHS Trust, Birmingham, United Kingdom; and Pfizer Inc, New York, NY

Address reprint requests to Gilles Vassal, MD, PhD, Department of Pediatrics, Institut Gustave Roussy, Rue Camille Desmoulins, 94805 Villejuif Cedex, France; e-mail: gvassal{at}igr.fr

Purpose This phase II study was designed to evaluate the efficacy of irinotecan administered intravenously once every 3 weeks in pediatric patients with recurrent or refractory rhabdomyosarcoma.

Patients and Methods A total of 35 patients younger than age 20 years, with refractory or relapsed rhabdomyosarcoma for which standard treatments have failed, received irinotecan at 600 mg/m² administered as a 60-minute infusion every 3 weeks. Concomitant treatments included atropine for cholinergic symptoms, loperamide for diarrhea at the first liquid stool, and preventive antiemetic treatment. Tumor response was assessed every two cycles until progression according to WHO criteria.

Results The best overall response rate to irinotecan was 11.4% (95% CI, 3.2 to 26.7%; 2.9% complete responses, 8.5% partial responses) from all patients recruited. The median times to progression and survival were 1.4 and 5.8 months, respectively. A total of 112 cycles were administered, with a median number of two cycles per patient (range, 1 to 16). The most common grade 3/4 toxicities were neutropenia (46%), abdominal pain or cramping (17%), cholinergic syndrome (14%), nausea/vomiting (11%), anemia (11%), thrombocytopenia (9%), and diarrhea (6%).

Conclusion In heavily pretreated children with a high tumor burden who have been treated with multiagent chemotherapy, irinotecan administered intravenously as a single agent, at 600 mg/m² every 3 weeks, showed an interesting objective response rate and a good tolerance profile in rhabdomyosarcoma.

Supported by Pfizer Inc.

Presented at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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