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[Cancer Research 62, 4996-5000, September 1, 2002]
© 2002 American Association for Cancer Research

Experimental Therapeutics

Proteasome Inhibitor PS-341 Inhibits Human Myeloma Cell Growth in Vivo and Prolongs Survival in a Murine Model1

Richard LeBlanc2, Laurence P. Catley2, Teru Hideshima, Suzanne Lentzsch, Constantine S. Mitsiades, Nicholas Mitsiades, Donna Neuberg, Olga Goloubeva, Christine S. Pien, Julian Adams, Deepak Gupta, Paul G. Richardson, Nikhil C. Munshi and Kenneth C. Anderson3

Jerome Lipper Multiple Myeloma Center, Department of Adult Oncology [R. L., L. P. C., T. H., S. L., C. S. M., N. M., D. G., P. G. R., N. C. M., K. C. A.], and Department of Biostatistical Science [D. N., O. G.], Dana-Farber Cancer Institute, Boston, Massachusetts 02115; Department of Medicine, Harvard Medical School, Boston, Massachusetts, 02115 [R. L., L. P. C., T. H., S. L., C. S. M., N. M., D. G., P. G. R., N. C. M., K. C. A.]; and Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts 02139 [C. S. P., J. A.]

The proteasome is a ubiquitous and essential intracellular enzyme that degrades many proteins regulating cell cycle, apoptosis, transcription, cell adhesion,angiogenesis, and antigen presentation. We have shown recently that the proteasome inhibitor PS-341 inhibits growth, induces apoptosis, and overcomes drug resistance in human myeloma cells in vitro. In this study, we examined the efficacy, toxicity, and in vivo mechanism of action of PS-341 using a human plasmacytoma xenograft mouse model. One hundred immunodeficient (beige-nude-xid) mice were used in two independent experiments. The mice were injected s.c. with 3 x 107 RPMI-8226 myeloma cells. When tumors became measurable (9.2 days; range, 6–13 days after tumor injection), mice were assigned to treatment groups receiving PS-341 0.05 mg/kg (n = 13), 0.1 mg/kg (n = 15), 0.5 mg/kg (n = 14), or 1.0 mg/kg (n = 14) twice weekly via tail vein, or to control groups (n = 13) receiving the vehicle only. Significant inhibition of tumor growth, even with some complete tumor regression, was observed in PS-341-treated mice. The median overall survival was also significantly prolonged compared with controls (30 and 34 days for high dose-treated mice versus 14 days for controls; P < 0.0001). PS-341 was well tolerated up to 0.5 mg/kg, but some mice treated at 1.0 mg/kg became moribund and lost weight. Analysis of tumors harvested from treated animals showed that PS-341 induced apoptosis and decreased angiogenesis in vivo. These studies therefore demonstrate that PS-341 has significant in vivo antimyeloma activity at doses that are well tolerated in a murine model, confirming our in vitro data and further supporting the early clinical promise of PS-341 to overcome drug resistance and improve patient outcome.




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