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SFCE-METRO01 four-drug metronomic regimen phase II trial for pediatric extracranial tumor

The SFCE group has just published in Pediatric Blood and Cancer the second part of their metronomic phase II trial entitled SFCE METRO-01 four-drug metronomic regimen phase II trial for pediatric extracranial tumors.

This trial is based on a pilot study initialy published in Oncotarget. Treatment consisted of an eight-week cycle of :
- oral celecoxib b.i.d.,
- weekly vinblastine,
- oral cyclophosphamide for three weeks
- alternating with oral methotrexate for three weeks,
- with a two-week rest.

The first part of the trial reported significant activity in Low Grade Glioma. Here, the authors report on the activity in the remaining cohorts. 44 evaluable patients after two cycles, of the 50 patients initially included : 9 in STS, 11 in BS, 11 in Misc., and 19 in the NBL group. Twenty-four subjects (54%) successfully completed two cycles of MC without clinical signs of progression. The median number of cycles was 2 (range, 0.5–12).

Thus, Heng-Maillard and al. show that this four-drug metronomic regimen could be beneficial to some patients with NBL as 22% patients were stable for one year. Additionaly, 2 patients with metastatic a myoepithelial carcinoma and epithelioid hemangioendothelioma dysplayed a sustained benefit from the treatment.

Of note, it also confirms that bone sarcoma were not responsive to metronomic regimen as already reported before.

The full text article can be found here