Clinical Cancer Research AACR Conference on Cancer Prevention Infection and Cancer: Biology, Therapeutics, and Prevention
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Clinical Cancer Research Vol. 8, 2775-2781, September 2002
© 2002 American Association for Cancer Research


Clinical Trials

Maintenance Biotherapy for Metastatic Melanoma with Interleukin-2 and Granulocyte Macrophage-Colony Stimulating Factor Improves Survival for Patients Responding to Induction Concurrent Biochemotherapy1

Steven J. O’Day2, Peter D. Boasberg, Lawrence Piro, Timothy S. Kristedja, He-Jing Wang, Maureen Martin, Regina Deck, Patricia Ames, Kelly Shinn, Hannah Kim, Patricia Fournier and Guy Gammon

John Wayne Cancer Institute, Santa Monica, California 90404 [S. J. O., P. D. B., L. P., T. S. K., H-J. W., M. M., R. D., P. A., K. S., H. K., P. F.], and CancerVax Corporation, Carlsbad, California 92008 [G. G.]

Purpose: A prospective Phase II study of a novel maintenancebiotherapy regimen after induction biochemotherapy was conducted in patients with metastatic melanoma in efforts to maintain responses and improve survival.

Experimental Design: Thirty-three patients with poor prognosis metastatic melanoma who achieved a partial response (PR) or stable disease (SD) to induction concurrent biochemotherapy were treated with chronic low-dose interleukin (IL)-2 and granulocyte macrophage-colony stimulating factor, and intermittent pulses of intermediate/high-dose decrescendo IL-2 over a 12-month period. The outcome of these patients was compared with a control group of patients at our institution who were treated recently with induction biochemotherapy and achieved a PR or SD.

Results: Five patients (15%) achieved a complete response, and 4 patients (12%) maintained SD for at least 6 months on maintenance biotherapy. The median progression-free survival (PFS) and overall survival (OS) were 8.1 months and 18.5 months, respectively, compared with historical controls, which were PFS 5.9 months (P = 0.0015) and OS 9.3 months (P = 0.0004). Administration of maintenance biotherapy was a significant predictor of PFS (P = 0.0008) and OS (P = 0.0001) in multivariate and matched-pair analyses (P = 0.002). The maintenance biotherapy regimen was well tolerated with no dose-limiting acute or cumulative toxicities.

Conclusion: In this single institution study, maintenance biotherapy with IL-2 and granulocyte macrophage colony-stimulating factor in patients achieving PR or SD to induction biochemotherapy improved PFS and OS compared with historical controls. A larger multicenter Phase II trial has been initiated in an effort to confirm these results.




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HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Cancer Research Clinical Cancer Research
Cancer Epidemiology Biomarkers & Prevention Molecular Cancer Therapeutics
Molecular Cancer Research Cancer Prevention Research
Cancer Prevention Journals Portal Cancer Reviews Online
Annual Meeting Education Book Meeting Abstracts Online
Copyright © 2002 by the American Association for Cancer Research.