September 18, 2013

Dermatologic side effects from sorafenib linked to better HCC survival

Provided by Healio

September 18, 2013

Patients with hepatocellular carcinoma who experienced dermatologic side effects while treated with sorafenib had improved survival in a study presented at the International Liver Cancer Association Annual Conference in Washington, DC.

Researchers evaluated data from 147 patients with hepatocellular carcinoma treated with sorafenib for a median of 6.7 months between October 2007 and July 2011. Clinical and laboratory evaluations were performed monthly, with tumor staging after 4 weeks followed by every 8 weeks, for a median follow-up of 11.6 months. Ninety-seven percent of participants had cirrhosis, and 46% were HCV-positive.

Overall, the median time to progression (TTP) was 5.1 months for the cohort; median overall survival was 12.7 months. Dermatologic adverse events that occurred within 60 days of treatment (AED60) were observed in 79 patients, 37 of whom required a sorafenib dose modification.

Although dose modifications were significantly more common among AED60 patients (three modifications vs. two; P=.006), median time to progression (8.1 months vs. 3.9 months; P=.02) and overall survival (18.16 months vs. 10.1 months; P=.009) were better among these participants compared with those who did not experience AED60. No other evaluated categories of early adverse events were associated with treatment outcomes.

Multivariate analysis indicated a significant association between improved survival and any grade of AED60 (P=.039). When cases of early death were excluded from analysis, this association was upheld for incidence of AED60 that required sorafenib dose modification (above grade 1in severity) (P=.03).

“Development of dermatologic adverse events within 60 days of sorafenib initiation is associated with better survival,” the researchers concluded. “Therefore, this should not … discourage treatment maintenance. Likewise, second-line clinical trials should be designed and/or evaluated considering this information to avoid significant bias.”

Disclosure: Researchers Maria Reig, MD, and Alejandro Forner, MD, reported serving as consultants for Bayer Pharmaceuticals.

For more information:

Reig M. O-033: Dermatologic Adverse Events Within the First 60 Days of Sorafenib Treatment Are Associated with Better Overall Survival in Patients with Hepatocellular Carcinoma. Presented at: The International Liver Cancer Association Annual Conference 2013; Sept. 13-15, Washington, DC.


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