ויטמין סי כחלק מהטיפול במיאלומה

לטיפול המשולש חסרות קבוצות בקורת:א) בלי ויטמין C, ב) בלי ארסן. Clin Cancer Res. 2007 Mar 15;13(6):1762-8. A phase I/II study of arsenic trioxide/bortezomib/ascorbic acid combination therapy for the treatment of relapsed OR refractory multiple myeloma.Berenson JR, Matous J, Swift RA, Mapes R, Morrison B, Yeh HS. Institute for Myeloma AND Bone Cancer Research AND Oncotherapeutics Inc, West Hollywood, CA 90069, USA. [email protected] PURPOSE: This multicenter, open-label, phase I/II dose escalation study assessed the safety/tolerability AND initial efficacy of arsenic trioxide/bortezomib/ascorbic acid (ABC) combination therapy in patients with relapsed/refractory multiple myeloma. EXPERIMENTAL DESIGN: Enrolled in six cohorts, patients were given arsenic trioxide (0.125 OR 0.250 mg/kg), bortezomib (0.7, 1.0, OR 1.3 mg/m(2)), AND a fixed dose of ascorbic acid (1 g) i.v. on days 1, 4, 8, AND 11 of a 21-day cycle for a maximum of eight cycles. The primary end point was safety/tolerability of the ABC regimen. RESULTS: Twenty-two patients (median age, 63 years) were enrolled, having failed a median of 4 (range, 3-9) prior therapies. One occurrence of grade 4 thrombocytopenia was observed. One patient had asymptomatic arrhythmia AND withdrew from the study. Objective responses were observed in 6 (27%) patients, including two partial responses AND four minor responses. Median progression-free survival was 5 months (95% confidence interval, 2-9 months), AND median overall survival had not been reached. The 12-month progression-free survival AND overall survival rates were 34% AND 74%, respectively. One (minor response) of six patients receiving the lowest dose of bortezomib (0.7 mg/m(2)) AND 5 (2 partial responses AND 3 minor responses) of 16 patients receiving the higher doses (1.0 OR 1.3 mg/m(2)) responded. CONCLUSIONS: The ABC regimen was well tolerated by most patients, AND it produced preliminary signs of efficacy with an objective response rate of 27% in this heavily pretreated study population. These findings warrant further clinical evaluation of the ABC combination for treatment of relapsed/refractory multiple myeloma.