Phase II investigation of docetaxel in pediatric patients with recurrent solid tumors: A report from the children's oncology group

Theodore Zwerdling, Mark Krailo, Philip Monteleone, Rebecca Byrd, Judith Sato, Rose Dunaway, Nita Seibel, Zhengjia Chen, John Strain, Gregory Reaman

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Abstract

BACKGROUND. Docetaxel, which is an antitubulin agent, has demonstrable activity against murine and human tumors. The current study was designed to determine response rates to docetaxel in various strata of recurrent solid tumors of childhood and to assess toxicity in a group of patients who were assigned to receive it. METHODS. Docetaxel was given at a dose of 125 mg/m 2 once every 21 days as a 1-hour intravenous infusion for a maximum of 12 courses. From January 1997 to November 2001, 109 male patients and 68 female patients (total, 177 patients) were enrolled, and 173 patients were eligible. The median patient age at entry was 13 years (range, 1-27 yrs). One hundred sixty patients were evaluable for response. RESULTS. There were no deaths attributable to study drug. Hematologic toxicity was common during therapy. Dermatologic, neurologic, pulmonary, and infectious side effects as well as edema were significant. One patient each had acute myeloid leukemia, acute lymphoid leukemia, and high-grade glioma reported as secondary malignancies. One patient with osteosarcoma and 1 patient with rhabdomyosarcoma achieved a complete response. Partial responses were observed in patients with Ewing sarcoma (3 patients), osteosarcoma (1 patient), squamous cell carcinoma (1 patient), and medulloblastoma (1 patient). Seventeen patients had stable disease. The 1-year and 5-year overall survival rates for the 160 evaluable patients were 24% (standard error = 4%) and 6% (standard error = 2%), respectively. CONCLUSIONS. Docetaxel demonstrated activity in patients with recurrent Ewing sarcoma but was found to be ineffective for treating the other types of recurrent solid tumors that were studied.

Original languageEnglish (US)
Pages (from-to)1821-1828
Number of pages8
JournalCancer
Volume106
Issue number8
DOIs
StatePublished - May 15 2006

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docetaxel
Pediatrics
Neoplasms
Ewing's Sarcoma
Osteosarcoma

Keywords

  • Docetaxel
  • Ewing sarcoma activity
  • Neutropenia
  • Phase II
  • Recurrent pediatric solid tumors

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase II investigation of docetaxel in pediatric patients with recurrent solid tumors : A report from the children's oncology group. / Zwerdling, Theodore; Krailo, Mark; Monteleone, Philip; Byrd, Rebecca; Sato, Judith; Dunaway, Rose; Seibel, Nita; Chen, Zhengjia; Strain, John; Reaman, Gregory.

In: Cancer, Vol. 106, No. 8, 15.05.2006, p. 1821-1828.

Research output: Contribution to journalArticle

Zwerdling, T, Krailo, M, Monteleone, P, Byrd, R, Sato, J, Dunaway, R, Seibel, N, Chen, Z, Strain, J & Reaman, G 2006, 'Phase II investigation of docetaxel in pediatric patients with recurrent solid tumors: A report from the children's oncology group', Cancer, vol. 106, no. 8, pp. 1821-1828. https://doi.org/10.1002/cncr.21779
Zwerdling, Theodore ; Krailo, Mark ; Monteleone, Philip ; Byrd, Rebecca ; Sato, Judith ; Dunaway, Rose ; Seibel, Nita ; Chen, Zhengjia ; Strain, John ; Reaman, Gregory. / Phase II investigation of docetaxel in pediatric patients with recurrent solid tumors : A report from the children's oncology group. In: Cancer. 2006 ; Vol. 106, No. 8. pp. 1821-1828.
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T2 - A report from the children's oncology group

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AU - Krailo, Mark

AU - Monteleone, Philip

AU - Byrd, Rebecca

AU - Sato, Judith

AU - Dunaway, Rose

AU - Seibel, Nita

AU - Chen, Zhengjia

AU - Strain, John

AU - Reaman, Gregory

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N2 - BACKGROUND. Docetaxel, which is an antitubulin agent, has demonstrable activity against murine and human tumors. The current study was designed to determine response rates to docetaxel in various strata of recurrent solid tumors of childhood and to assess toxicity in a group of patients who were assigned to receive it. METHODS. Docetaxel was given at a dose of 125 mg/m 2 once every 21 days as a 1-hour intravenous infusion for a maximum of 12 courses. From January 1997 to November 2001, 109 male patients and 68 female patients (total, 177 patients) were enrolled, and 173 patients were eligible. The median patient age at entry was 13 years (range, 1-27 yrs). One hundred sixty patients were evaluable for response. RESULTS. There were no deaths attributable to study drug. Hematologic toxicity was common during therapy. Dermatologic, neurologic, pulmonary, and infectious side effects as well as edema were significant. One patient each had acute myeloid leukemia, acute lymphoid leukemia, and high-grade glioma reported as secondary malignancies. One patient with osteosarcoma and 1 patient with rhabdomyosarcoma achieved a complete response. Partial responses were observed in patients with Ewing sarcoma (3 patients), osteosarcoma (1 patient), squamous cell carcinoma (1 patient), and medulloblastoma (1 patient). Seventeen patients had stable disease. The 1-year and 5-year overall survival rates for the 160 evaluable patients were 24% (standard error = 4%) and 6% (standard error = 2%), respectively. CONCLUSIONS. Docetaxel demonstrated activity in patients with recurrent Ewing sarcoma but was found to be ineffective for treating the other types of recurrent solid tumors that were studied.

AB - BACKGROUND. Docetaxel, which is an antitubulin agent, has demonstrable activity against murine and human tumors. The current study was designed to determine response rates to docetaxel in various strata of recurrent solid tumors of childhood and to assess toxicity in a group of patients who were assigned to receive it. METHODS. Docetaxel was given at a dose of 125 mg/m 2 once every 21 days as a 1-hour intravenous infusion for a maximum of 12 courses. From January 1997 to November 2001, 109 male patients and 68 female patients (total, 177 patients) were enrolled, and 173 patients were eligible. The median patient age at entry was 13 years (range, 1-27 yrs). One hundred sixty patients were evaluable for response. RESULTS. There were no deaths attributable to study drug. Hematologic toxicity was common during therapy. Dermatologic, neurologic, pulmonary, and infectious side effects as well as edema were significant. One patient each had acute myeloid leukemia, acute lymphoid leukemia, and high-grade glioma reported as secondary malignancies. One patient with osteosarcoma and 1 patient with rhabdomyosarcoma achieved a complete response. Partial responses were observed in patients with Ewing sarcoma (3 patients), osteosarcoma (1 patient), squamous cell carcinoma (1 patient), and medulloblastoma (1 patient). Seventeen patients had stable disease. The 1-year and 5-year overall survival rates for the 160 evaluable patients were 24% (standard error = 4%) and 6% (standard error = 2%), respectively. CONCLUSIONS. Docetaxel demonstrated activity in patients with recurrent Ewing sarcoma but was found to be ineffective for treating the other types of recurrent solid tumors that were studied.

KW - Docetaxel

KW - Ewing sarcoma activity

KW - Neutropenia

KW - Phase II

KW - Recurrent pediatric solid tumors

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