Originally published as JCO Early Release 10.1200/JCO.2005.03.209 on March 14 2005

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Phase II Trial of Neoadjuvant Vincristine, Ifosfamide, and Doxorubicin With Granulocyte Colony-Stimulating Factor Support in Children and Adolescents With Advanced-Stage Nonrhabdomyosarcomatous Soft Tissue Sarcomas: A Pediatric Oncology Group Study

Alberto S. Pappo, Meenakshi Devidas, Jessee Jenkins, Bhaskar Rao, Robert Marcus, Patrick Thomas, Mark Gebhardt, Charles Pratt, Holcombe E. Grier

From the Hospital for Sick Children Toronto, Toronto, Ontario, Canada; Pediatric Oncology Group Statistical Office, Gainesville; Tampa Children’s Hospital, Tampa, FL; St Jude Children’s Research Hospital, Memphis, TN; Children’s Healthcare of Atlanta, Emory University, Atlanta, GA; and Dana-Farber Cancer Institute, Boston, MA

Address reprint requests to Alberto S. Pappo, MD, The Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G1X8, Canada; e-mail: alberto.pappo{at}sickkids.ca

PURPOSE: To describe the response rate and survival of children and adolescents with unresected or metastatic nonrhabdomyosarcomatous soft tissue sarcomas (NRSTS) treated with vincristine, ifosfamide, and doxorubicin.

PATIENTS AND METHODS: Between September 1996 and June 2000, 39 eligible patients received vincristine (1.5 mg/m² weekly for 13 doses), ifosfamide (3 g/m² daily for 3 days every 3 weeks for seven cycles), doxorubicin (30 mg/m² daily for 2 days for six cycles), and mesna (750 mg/m² for four doses after ifosfamide). Granulocyte colony-stimulating factor was administered daily (5 µg/kg) after each cycle of chemotherapy. Radiotherapy was administered from weeks 7 through 12.

RESULTS: The median patient age at diagnosis was 11.7 years; the most common primary tumor site was lower extremity (36%); and synovial sarcoma was the predominant histology. More than three fourths of all tumors were 5 cm or greater at their largest diameters. The overall objective combined partial and complete response rate was 41% (95% CI, 25.7% to 56.7%). The estimated 3-year overall survival and progression-free survival rates (± standard deviation) for eligible patients were 59% ± 8.2% and 43.6% ± 7%, respectively. Patients with clinical group III disease had significantly better 3-year and progression-free survival rates compared with patients who presented with metastatic disease.

CONCLUSION: The vincristine, ifosfamide, and doxorubicin regimen was moderately active against pediatric NRSTS. Patients with synovial sarcoma had higher response rates than other patients, and patients with unresected disease had improved outcomes. Patients with metastatic disease continue to fare poorly, and newer approaches are indicated for these patients.

Deceased.

Grant numbers and participating institutions are listed in the Appendix. A complete listing of grant support for research conducted before the initiation of the COG grant is available at http://www.childrensoncologygroup.org/admin/grantinfo.htm.

Presented in part in abstract form at the 37th Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 12-15, 2001.

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

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