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• W2103443571 abstract "Purpose The Children's Oncology Group conducted this phase II study to assess the efficacy and toxicity of gemcitabine and vinorelbine (GV) in pediatric patients with heavily pretreated relapsed/refractory Hodgkin's disease. Both agents have significant single-agent response rates in this setting. Methods GV was given on days 1 and 8 of each 21-day treatment cycle: vinorelbine 25 mg/m 2 /dose administered via intravenous (IV) push before gemcitabine 1,000 mg/m 2 /dose IV over 100 minutes. Any patients who demonstrated a measurable response (complete response [CR], very good partial response [VGPR], or partial response [PR]) were considered to have experienced a response to GV. Response was evaluated after every two cycles. A two-stage minimax rule was used to test the null hypothesis that the response rate is ≤ 40% against an alternative hypothesis of a response rate more than 65%. Results Thirty eligible patients with a median age of 17.7 years (range, 10.7 to 29.4 years) were enrolled. All patients had received at least two prior chemotherapy regimens, and 17 patients had undergone prior autologous stem-cell transplantation. Hematologic toxicity was predominant in all treatment cycles. Nonhematologic grade 3 to 4 toxicity, including elevated hepatic enzymes and hyperbilirubinemia, was less common. Pericardial and pleural effusions developed in one patient after cycles 4 and 5 of GV, consistent with gemcitabine-induced radiation recall. There were no toxic deaths. Measurable responses were seen in 19 (76%) of 25 assessable patients (95% exact binomial CI, 55% to 91%), including six CRs, 11 VGPRs, and two PRs. Conclusion GV is an effective and well-tolerated reinduction regimen for children with relapsed or refractory Hodgkin's disease." @default.
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• W2103443571 date "2009-03-20" @default.
• W2103443571 modified "2023-10-17" @default.
• W2103443571 title "Phase II Study of Weekly Gemcitabine and Vinorelbine for Children With Recurrent or Refractory Hodgkin's Disease: A Children's Oncology Group Report" @default.
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• W2103443571 doi "https://doi.org/10.1200/jco.2008.20.3778" @default.
• W2103443571 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/2668553" @default.
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