MONDAY, June 6 (HealthDay News) -- The addition of ipilimumab to dacarbazine appears to improve survival in patients with previously untreated metastatic melanoma, and vemurafenib appears to improve survival in patients with metastatic melanoma and the BRAF V600E mutation, according to two studies published online June 5 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held from June 3 to 7 in Chicago.
Caroline Robert, M.D., Ph.D., of the Institute Gustave-Roussy in Villejuif, France, and colleagues randomized 502 patients with previously untreated metastatic melanoma, in a 1:1 ratio, to ipilimumab plus dacarbazine or dacarbazine plus placebo, given at one, four, seven, and 10 weeks, followed by dacarbazine alone every three weeks through week 22. Compared to those who received dacarbazine plus placebo, the researchers found that overall survival was significantly longer among those who received ipilimumab plus dacarbazine (11.2 versus 9.1 months). Grade 3 or 4 adverse events were more common among those who received ipilimumab plus dacarbazine as compared with those who received dacarbazine plus placebo (56.3 versus 27.5 percent).
In another study, Paul B. Chapman, M.D., of the Memorial Sloan-Kettering Cancer Center in New York City, and colleagues randomized 675 patients with previously untreated, metastatic melanoma with the BRAF V600E mutation to receive either oral vemurafenib or intravenous dacarbazine. Compared to those who received dacarbazine, the investigators found that vemurafenib improved rates of overall and progression-free survival at six months.
"The new understanding of molecular pathways changes the way we classify melanomas and influences therapy. The development of vemurafenib is an example of the translation of these concepts into clinical practice," writes the author of an accompanying editorial. "For patients with metastatic melanoma with the BRAF V600E mutation, the availability of vemurafenib is a major defining moment that will have an important effect on survival and quality of life."
The first study was funded by Bristol-Myers Squibb; several authors disclosed financial ties to the company. The second study was funded by Hoffmann-La Roche; several authors disclosed financial ties to Hoffmann-La Roche and other pharmaceutical companies.
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