Étude métro-SFCE, traitement métronomique composé de 4 médicaments dans les tumeurs solides réfractaires ou en rechute de l'enfant, cohorte des tumeurs extra-cérébrales.

Abstract : Objective: To investigate the anti-tumor activity of a 4-drug metronomic chemotherapy (MC) regimen in relapsing/progressing pediatric extracranial solid tumors (EST). Primary objective was progression-free survival after 2 cycles of therapy. Methods: Patients of ≥4 to 25 years of age with progressing EST and adequate organ function were eligible. Treatment consisted of an 8-week cycle of oral celecoxib BID, weekly vinblastine, and oral cyclophosphamide for 3 weeks alternating with oral methotrexate for 3 weeks, with a 2-week rest. Kepner- Chang two steps model was used with 10 patients in first stage. If primary objective was reached in 2 or more patients, 8 additional patients were included according to 4 groups: Neuroblastoma (NBL), Soft-tissue sarcoma (STS), Bone sarcoma (BS), Miscellaneous (Misc). IRB approval was obtained. Results: fourty-four patients were evaluable: two out of seven patients with STS had stable disease after 2 cycles, one with a metastatic hemangioendothelioma was treated for 24 months. One out of 9 Misc. (metastatic myoepithelial carcinoma) had stable disease for one year. The ten patients with BS had tumor progression. Four out of 18 patients with NBL stabilized: one stopped MC after 4 cycles being stable and 3 patients remained stable for 1 year. Grade 3 toxicity occurred in 18 patients and grade 4 in 15 patients. The most frequent toxicity was hematologic, essentially neutropenia. Conclusions: This MC has no activity in BS and limited though interesting activity in NBL with some patients being stable for > 1 year. It’s not possible to conclude concerning STS and Misc.
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https://dumas.ccsd.cnrs.fr/dumas-02093735
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Submitted on : Tuesday, April 9, 2019 - 10:58:10 AM
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Marie Amélie Heng. Étude métro-SFCE, traitement métronomique composé de 4 médicaments dans les tumeurs solides réfractaires ou en rechute de l'enfant, cohorte des tumeurs extra-cérébrales.. Sciences du Vivant [q-bio]. 2018. ⟨dumas-02093735⟩

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