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Interferon Alpha Boosts Temozolomides's Efficacy in Metastatic Melanoma: Presented at ASCO

By Rabiya S. Tuma

CHICAGO, IL -- June 3, 2003 -- Temozolomide in combination with interferon alpha significantly increases response rates in patients with metastatic melanoma, although the combination increases the frequency of grade 3/4 haematological toxicity.

Although temozolomide monotherapy has been proven effective for treatment of melanoma, researchers have not tested its efficacy in combination with other drugs. The Dermatologic Cooperative Oncology Group (DeCOG) designed an international, randomised, phase III trial to compare the safety and efficacy of temozolomide as a single agent and in combination with interferon alpha.

The findings from this study were presented here May 31^st at the 39^th Annual Meeting of the American Society of Clinical Oncology.

A total of 294 patients enrolled in the ongoing study between December 1998 and January 2002. Inclusion criteria required the patients have metastatic melanoma stage M1 with no prior chemotherapy, no brain metastases, and a life expectancy of greater than 3 months.

Of 280 evaluable patients, 138 are being treated with the single agent and 142 with the combination. Patients treated with temozolomide alone receive 200 mg/m² on days 1 to 5 on a 4-week cycle, while those treated with the combination therapy receive the same regimen of temozolomide in addition to 5 MU/m² interferon on days 1 to 5 every 4 weeks.

In the single-agent arm, 2.2% of patients had a complete response and 11.6% had a partial response, compared with 8.5% and 15.5%, respectively, in the combination arm. Additionally, 24.6% and 17.6% had stable disease in the single and combination arms, respectively. This was a statistically significant difference in response rates, according to the researchers.

At analysis, however, the median overall survival was 7 months for patients in both arms.

The patients in the combination therapy arm had more frequent grade 3/4 haematological complications -- 34% compared with 9.6% in the monotherapy arm.

Based on these interim data, the researchers concluded that the objective response rate is significantly higher with the combination therapy but that there is not yet evidence for prolonged survival.


[Study title: Temozolomide in Combination With Interferon Alfa Versus Temozolomide Alone in Patients With Advanced Metastatic Melanoma: A Randomized Phase III Multicenter Study of the Dermatologic Cooperative Oncology Group (DeCOG). Abstract 2887]

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