TY - JOUR
AU1 - Balaña, Carmen
AU2 - Gil, Miguel
AU3 - Perez, Pedro
AU4 - Reynes, Gaspar
AU5 - Gallego, Oscar
AU6 - Ribalta, Teresa
AU7 - Capellades, Jaume
AU8 - Gonzalez, Sofia
AU9 - Verger, Eugenia
AB - Sunitinib is a tyrosine kinase inhibitor with direct anti-tumor and anti-angiogenesis activity targeting VEGFR 1–2, PDGFR α–β, c-kit, bFGF, (CSF-1), FLT3 and RET. The present trial examined the activity of sunitinib in 12 patients with newly diagnosed, non-resectable glioblastoma. Patients (≤75 years of age with performance status [PS] ≥2 and minimental status [MMS] ≥25) were treated post-biopsy with sunitinib 37.5 mg daily for 8 weeks pre-radiotherapy, during radiotherapy (60 Gy, 6 weeks) and post-radiotherapy until disease progression. The primary endpoints were overall response rate (ORR; RANO criteria) after 8 weeks of sunitinib and patient tolerance. Secondary endpoints were percentage of patients free of neurological deterioration pre-radiotherapy, percentage of patients completing radiotherapy, progression-free survival (PFS), overall survival (OS), and 1-year survival. A Simon 2-stage design (12 →20) based on ORR was applied to calculate the number of patients needed to detect at least 10 % response with α error of 0.05 and β error of 0.10. The trial was closed because it did not meet minimal activity criteria. ORR was 0 % with only 1/12 patients (8.3 %) achieving stable disease after sunitinib treatment. No patient showed reduction in gadolinium enhancement. The most frequent G3/4 toxicities were fatigue (24.9 %) and diarrhea (16.6 %); one patient died of a CNS hemorrhage; 10/12 patients (83.3 %) deteriorated neurologically before radiation therapy; median PFS was 7.7 weeks (95 % CI: 7.2–8.2); median OS was 12.8 weeks (95 % CI: 0.5–23.8 weeks); 1-year survival was 0 %. Sunitinib has no activity as monotherapy in glioblastoma, and further investigation of its efficacy in this setting is unwarranted.
TI - Sunitinib administered prior to radiotherapy in patients with non-resectable glioblastoma: results of a Phase II study
JF - Targeted Oncology
DO - 10.1007/s11523-014-0305-1
DA - 2014-01-15
UR - https://www.deepdyve.com/lp/springer-journals/sunitinib-administered-prior-to-radiotherapy-in-patients-with-non-sC2pMkjwBc
SP - 321
EP - 329
VL - 9
IS - 4
DP - DeepDyve
ER -