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

• Published in: Cancer 2006-02, Vol.106 (3), p.703-707
• Main Authors: Bisogno, Gianni, Riccardi, Riccardo, Ruggiero, Antonio, Arcamone, Giampaolo, Prete, Arcangelo, Surico, Gianmarco, Provenzi, Massimo, Bertolini, Patrizia, Paolucci, Paolo, Carli, Modesto
• Format: Article
• Language: English
• Subjects: Adolescent; Antineoplastic Agents, Phytogenic - administration & dosage; Antineoplastic Agents, Phytogenic - adverse effects; Biological and medical sciences; Camptothecin - administration & dosage; Camptothecin - adverse effects; Camptothecin - analogs & derivatives; Child; Child, Preschool; Dermatology; desmoplastic small round cell tumor; Disease Progression; Drug Administration Schedule; Female; Humans; Infant; Infusions, Intravenous; irinotecan; Male; Medical sciences; Neutropenia - chemically induced; peripheral neuroectodermal tumor; rhabdomyosarcoma; Sarcoma - drug therapy; Sarcoma - pathology; Soft Tissue Neoplasms - drug therapy; Soft Tissue Neoplasms - pathology; soft tissue sarcoma; Treatment Outcome; Tumors; Tumors of the skin and soft tissue. Premalignant lesions
• ISSN: 0008-543X; 1097-0142
• DOI: 10.1002/cncr.21629

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. A phase II study of irinotecan administered intravenously every day for 5 days in 2 consecutive weeks, conducted in pediatric patients with relapsed soft tissue sarcoma, demonstrated an interesting response rate in a population of heavily pretreated patients, especially in the subset of patients with peripheral primitive neuroectodermal tumor.