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Phase II study of gemcitabine combined with oxaliplatin in relapsed or refractory paediatric solid malignancies: An innovative therapy for children with Cancer European Consortium Study

2010; Elsevier BV; Volume: 47; Issue: 2 Linguagem: Inglês

10.1016/j.ejca.2010.09.015

1879-0852

Birgit Geoerger, Julia Chisholm, Marie‐Cécile Le Deley, Jean‐Claude Gentet, C. Michel Zwaan, Nathalie Dias, T. Jaspan, Kieran Mc Hugh, D. Couanet, Sharon F. Hain, Annick S. Devos, Riccardo Riccardi, Cesare Colosimo, Joachim Boos, Didier Frappaz, Pierre Leblond, Isabelle Aerts, Gilles Vassal,

Neuroendocrine Tumor Research Advances

Aim To assess objective response rates after 4 cycles of gemcitabine in combination with oxaliplatin in children and adolescents with relapsed or refractory solid tumours. Methods This multicentre, non-randomised Phase II study included five strata: neuroblastoma, osteosarcoma, medulloblastoma and other CNS tumours strata with two-stage Simon designs and a miscellaneous, extra-cranial solid tumour stratum with descriptive design. Eligibility criteria included: age 6 months to 21 years; measurable, relapsed or refractory solid malignancy; no more than one previous salvage therapy. Gemcitabine was administered intravenously at 1000 mg/m2 over 100 min followed by oxaliplatin at 100 mg/m2 over 120 min on Day 1 of a 14-d cycle. Tumour response was assessed every 4 cycles according to WHO criteria. Results Ninety-three out of 95 patients enrolled in 25 centres received treatment: 12 neuroblastoma; 12 osteosarcoma; 14 medulloblastoma; 13 other CNS tumours and 42 miscellaneous non-CNS solid tumours. Median age was 11.7 years (range, 1.3–20.8 years). Tumour control (CR + PR + SD) at 4 cycles was obtained in 30/93 evaluable patients (32.3%; 95% confidence interval (CI), 22.9–42.7%), including four PR: 1/12 patients with osteosarcoma, 1/12 with medulloblastoma, 1/12 with rhabdomyosarcoma and 1/4 with other sarcoma. Five out of 12 eligible patients with neuroblastoma experienced stable disease. During a total of 481 treatment cycles (median 4, range 1–24 per patient), the most common treatment-related toxicities were haematologic (leukopenia, neutropenia, thrombocytopenia) and neurological (dysesthesia, paresthesia). Concluding statement The gemcitabine–oxaliplatin combination administered in a bi-weekly schedule has acceptable safety profile with limited activity in children with relapsed or refractory solid tumours.