September 18, 2013

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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