Phase II study of a protracted irinotecan schedule in children with refractory or recurrent soft tissue sarcoma
- 20 December 2005
- Vol. 106 (3), 703-707
- https://doi.org/10.1002/cncr.21629
Abstract
BACKGROUND Irinotecan (CPT‐11) is a novel antineoplastic agent that takes effect by inhibiting topoisomerase I. The Italian Soft Tissue Sarcoma (STS) Committee performed a multiinstitutional Phase II study to evaluate its effect on STS. METHODS Over a 2‐year period between 2002 and 2004, 32 heavily pretreated patients were administered 60‐minute infusions of irinotecan at 20 mg/m2/day, for 5 days a week, for 2 consecutive weeks. The courses were repeated every 4 weeks for at least 2 courses, unless there were signs of toxicity or disease progression. Thirty patients, 13 with peripheral primitive neuroectodermal tumor (PNET), 12 with rhabdomyosarcoma (RMS), 3 with desmoplastic small round cell tumor (DSRCT), and 2 with other STS were evaluable for response. RESULTS A total of 79 cycles were delivered. The main regimen‐related toxicity was diarrhea, occurring in 58% of cycles with 9 episodes graded as 3 or 4. Grade 3–4 neutropenia was recorded in 10% of cycles. The overall response rate was 23% (2 complete remissions + 5 partial remissions of 30 patients), 38% for PNET and 16% for RMS. In addition, 4 minor responses were noted. CONCLUSIONS As a single agent in the treatment of recurrent and refractory STS, irinotecan administered on a daily ×5 ×2 schedule revealed a noteworthy response rate in a population of heavily pretreated patients, especially in the subset of patients with PNET. Its hematologic toxicity profile warrants further investigation in association with other myelotoxic agents. Cancer 2006. © 2005 American Cancer Society.Keywords
This publication has 8 references indexed in Scilit:
- Phase I Trial of Temozolomide and Protracted Irinotecan in Pediatric Patients with Refractory Solid TumorsClinical Cancer Research, 2004
- A Phase I Study of Irinotecan As a 3-Week Schedule in Children With Refractory or Recurrent Solid TumorsJournal of Clinical Oncology, 2003
- Irinotecan for Pediatric Solid Tumors: The Memorial Sloan-Kettering ExperienceJournal of Pediatric Hematology/Oncology, 2002
- Successful clinical response to irinotecan in desmoplastic round blue cell tumorMedical and Pediatric Oncology, 1999
- Direct Translation of a Protracted Irinotecan Schedule From a Xenograft Model to a Phase I Trial in ChildrenJournal of Clinical Oncology, 1999
- Therapeutic activity of CPT-11, a DNA-topoisomerase I inhibitor, against peripheral primitive neuroectodermal tumour and neuroblastoma xenograftsBritish Journal of Cancer, 1996
- Drug Evaluation: Oncologic, Endocrine & Metabolic: Irinotecan (CPT-11): Current status and perspectivesExpert Opinion on Investigational Drugs, 1996
- Efficacy of topoisomerase I inhibitors, topotecan and irinotecan, administered at low dose levels in protracted schedules to mice bearing xenografts of human tumorsCancer Chemotherapy and Pharmacology, 1995