Originally published as JCO Early Release 10.1200/JCO.2005.02.5791 on October 31 2005

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Low-Dose Outpatient Chemobiotherapy With Temozolomide, Granulocyte-Macrophage Colony Stimulating Factor, Interferon-2b, and Recombinant Interleukin-2 for the Treatment of Metastatic Melanoma

Robert W. Weber, Steven O'Day, Madalene Rose, Regina Deck, Patricia Ames, James Good, John Meyer, Robert Allen, Sharon Trautvetter, Molly Timmerman, Scott Cruickshank, Mary Cook, Rene Gonzalez, Lynn E. Spitler

From the Northern California Melanoma Center, St. Francis Memorial Hospital, San Francisco; Cancer Institute Medical Group affiliated with John Wayne Cancer Institute, Santa Monica, CA; and the University of Colorado Cancer Center, Denver, CO

Address correspondence to Lynn E. Spitler, MD, Northern California Melanoma Center, Saint Francis Memorial Hospital, 900 Hyde St, San Francisco, CA 94109; e-mail: NCMC{at}chw.edu.

PURPOSE: The objective of this study was to further investigate the efficacy and safety of low-dose outpatient chemobiotherapy in patients with unresectable metastatic melanoma.

PATIENTS AND METHODS: Thirty-one patients with histologically confirmed unresectable measurable metastatic melanoma were enrolled onto an open-label, multicenter phase II study. The treatment regimen consisted of oral temozolomide followed by subcutaneous biotherapy with granulocyte macrophage colony-stimulating factor, interferon-alfa, and recombinant interleukin-2 (rIL-2).

RESULTS: Twenty-eight patients (90%) had M1c disease, and 58% had three or more sites of metastasis. Four patients (13%), all with M1c disease, had a complete response, and four patients had a partial response. The median progression-free survival was 4.9 months and the median overall survival was 13.1 months. Two patients (6%) developed CNS metastasis as the first site of disease progression, and 7 (23%) of 30 experienced CNS progression after receiving chemobiotherapy. A total of 112 cycles of therapy were administered. Toxicity occurred in 78% of the cycles and was grade 1 or 2 in the majority of cases and easily managed. Grade 4 toxicity occurred in 3% of the cycles.

CONCLUSION: This low-dose chemobiotherapy combination produces clinical responses in patients with metastatic melanoma, even in those with M1c disease, is well tolerated, and allows home dosing. It offers a reasonable alternative to high-dose regimens, such as high-dose biochemotherapy or rIL-2 requiring prolonged periods of hospitalization, or single agent outpatient regimens, such as dacarbazine, which is usually not effective in patients with M1c disease. Furthermore, it may protect against the development of brain metastases.

Supported by the Melanoma Research Institute, Tiburon, CA; Berlex Oncology, Seattle, WA; Schering-Plough Corp, Kenilworth, NJ; and Chiron Corp, Emeryville, CA.

L.E.S. is a member of the Cogenix Speaker's Bureau, supported by Berlex Oncology, Seattle, WA. L.E.S. and R.A. are members of the Board of Directors of the Melanoma Research Institute, Tiburon, CA.

Presented at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003, and at the 41st Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 13-17, 2005.

Terms in blue are defined in the glossary, found at the end of this issue and online at www.jco.org.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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