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- W1930509780 abstract "8512 Background: In Phase I/II studies, T and the combination of T+C each demonstrated promising activity against recurrent neuroblastoma, so a randomized study was performed. Methods: Eligible patients were <21 yrs with evaluable disease at first recurrence after a first regimen of aggressive chemotherapy. 73 patients had prior stem cell transplants. 13 patients received “therapeutic window” deferoxamine for 3–6 weeks as part of the study. T+C received T 0.75mg/m2+C 250mg/m2+MESNA 150 mg/m2 daily×5d q21d. T received T 2.4mg/m2/d×5d q21d. Best response according to the International Neuroblastoma Response Criteria was analyzed in a two-stage sequential design. In the calculation of time to progressive disease, patients taken off study for stem cell transplant, refusal, or unrelated death were censored at that time. Results: Target accrual 118, accrual 123, eligible 119 patients (1996–2001). Hematopoietic toxicity was the same in both arms. Deferoxamine had no effect on outcome. There were 11 (19%) CR+PR on T, 18 (31%) on T+C; 19 (32%) CR+PR+MR on T, 26 (45%) on T+C. At least eight more responders in T+C than in T were required by the two-stage design in order to conclude superiority of T+C; with only seven, there is insufficient evidence to reach such a conclusion. For both EFS and S treatment comparisons, the curves were not significantly different. However, the time to disease progression was significantly longer for T+C. The 2-year Progression-Free Survival rates (+/- standard error) were 16%+/-6% (T) vs. 36%+/-9% (T+C), p=0.0379. Conclusions: There is a trend toward better results with T+C than T. Incorporation of the combination into front line treatment plans deserves further exploration. No significant financial relationships to disclose." @default.
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- W1930509780 date "2004-07-15" @default.
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- W1930509780 title "Recurrent neuroblastoma: Randomized treatment with topotecan + cyclophosphamide (T+C) vs. topotecan alone(T). A POG/CCG Intergroup Study" @default.
- W1930509780 doi "https://doi.org/10.1200/jco.2004.22.90140.8512" @default.
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