Phase I/II study of selective cyclooxygenase-2 inhibitor celecoxib as a radiation sensitizer in patients with unresectable brain metastases.

摘要: PurposeThe primary goal of this phase I/II study was to evaluate the feasibility, safety and efficacy celecoxib administered concomitant radiotherapy treat unresectable BM. Patients methods: with measurable BM by CT or MRI, unresectability criteria a neurosurgeon RPA-RTOG class II were eligible. Celecoxib at 400 mg/day during entire course radiotherapy. All patients irradiated 60Co beams whole-brain dose 32 Gy (20 fractions 1.6 each two times day 6 h interval between treatments) followed 22.4 boost (same fractionation schedule) over evident lesions. Results: Twenty-seven treated. The concurrent regimen well tolerated 15 cases mild dyspepsia. Alopecia (NCI grades 1–2) most important side effect. Three presented rash/desquamation moderate intensity. Radiological responses occurred in 18 25 valuable (72), five complete (CR). Symptomatic reported 27 (92.6), 20 CR. overall response rate (considering plus partial responses) 66.7. Percentile 50 for time-to-progression, time-to-neurological-progression functional-independence-time 3, 6.25 6.7 months, respectively. Median survival time 8.7 months. Conclusion: Our initial results suggest that is safe possible active treatment Further investigation randomized trial warranted validate its clinical utility.