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Graillon, Thomas; Sanson, Marc; Campello, Chantal; Idbaih, Ahmed; Peyre, Matthieu; Peyrière, Hadrien; Basset, Noémie; Autran, Didier; Roche, Catherine; Kalamarides, Michel; Roche, Pierre-Hugues; Fuentes, Stéphane; Tabouret, Emeline; Barrie, Maryline; Cohen, Anita; Honoré, Stéphane; Boucekine, Mohamed; Baumstarck, Karine; Figarella-Branger, Dominique; Barlier, Anne; Dufour, Henry; Chinot, Olivier Louis
Clinical cancer research, 02/2020, Letnik: 26, Številka: 3Journal Article
Aggressive meningiomas that progress after surgery/radiotherapy represent an unmet medical need. Strong and constant expression of SSTR2A receptors and activation of the Pi3K/Akt/mTOR pathway have been demonstrated in meningiomas. The combination of everolimus, an mTOR inhibitor, and octreotide, a somatostatin agonist, has shown additive antitumor effect . The phase II CEVOREM trial investigated the efficacy of this combination on recurrent meningiomas. Patients with documented recurrent tumor progression ineligible for further surgery/radiotherapy were eligible to receive octreotide (30 mg/d, day 1) and everolimus (10 mg/d, days 1-28). The primary endpoint was the 6-month progression-free survival rate (PFS6). The secondary endpoints were overall survival, response rate, tumor growth rate according to central review, and safety. A total of 20 patients were enrolled, including 2 with World Health Organization (WHO) grade I tumors, 10 with WHO grade II tumors, and 8 with WHO grade III tumors; furthermore, 4 patients harbored germline mutation. The overall PFS6 was 55% 95% confidence interval (CI), 31.3%-73.5%, and overall 6- and 12-month survival rates were 90% (95% CI, 65.6%-97.4%) and 75% (95% CI, 50.0%-88.7%), respectively. A major decrease (>50%) was observed in the growth rate at 3 months in 78% of tumors. The median tumor growth rate decreased from 16.6%/3 months before inclusion to 0.02%/3 months at 3 months ( < 0.0002) and 0.48%/3 months at 6 months after treatment ( < 0.0003). The combination of everolimus and octreotide was associated with clinical and radiological activity in aggressive meningiomas and warrants further studies. Decrease in the tumor volume growth rate should be considered a complementary and sensitive endpoint to select potentially effective drugs for recurrent meningiomas.
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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in: SICRIS
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