Phase II study of a protracted irinotecan schedule in children with refractory or recurrent soft tissue sarcoma

✍ Scribed by Gianni Bisogno; Riccardo Riccardi; Antonio Ruggiero; Giampaolo Arcamone; Arcangelo Prete; Gianmarco Surico; Massimo Provenzi; Patrizia Bertolini; Paolo Paolucci; Modesto Carli

• Publisher: John Wiley and Sons
• Year: 2006
• Tongue: English
• Weight: 85 KB
• Volume: 106
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/cncr.21629

✦ Synopsis

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/m^2^/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.