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Liver cancer study links sorafenib response with dermatologic adverse events

Researchers observed a low rate of complete response to sorafenib treatment for hepatocellular carcinoma in a recent retrospective study; however, nearly all patients who achieved complete response also developed dermatologic adverse events, which may provide a correlation between toxicity and treatment response.

“On-target sorafenib toxicity may have a predominant but underestimated role in the prediction of outcome. In this regard, we reported that dermatologic adverse events within the first 60 days is a predictor of better overall survival,” Jordi Rimola, MD, PhD, from the Barcelona Clinic Liver Cancer Group, and colleagues wrote.

“[Early dermatologic adverse events] can be a link between clinical events and the understudied sorafenib mechanism of action,” the researchers wrote. “The mechanism for the benefits associated with dermatologic adverse events is unknown but is very likely related to an immune modulation induced by any of the targets affected by sorafenib.”

Sorafenib is manufactured as Nexavar by Bayer in the United States.

To evaluate complete response rates following sorafenib therapy for HCC, Rimola and colleagues retrospectively reviewed patient data from October 2007 to March 2014. The researchers collected data on 1,119 patients with HCC from 13 centers in Spain.

Twenty patients achieved complete response with sorafenib, although eight patients were excluded from final analysis.

Three of the 12 patients included in the study underwent surgery for treatment of HCC, two underwent radiofrequency and one underwent chemoembolization.

Eleven patients developed dermatologic adverse events within the first 60 days of treatment. The patient without any dermatologic adverse events had initiated sorafenib at half dose.

Median overall survival was 85.8 months (range, 67.8-103.8 months), median treatment duration was 40.1 months (range, 7.6-83.6 months), and median time from treatment initiation to complete response was 13.3 months (range, 0.9-33.3 months).

Seven patients discontinued sorafenib after complete response: three due to vascular events, two by patient decision and two due to liver decompensation. Five of those who discontinued treatment developed HCC recurrence. Median time from discontinuation to recurrence was 16.9 months (range, 8.5-73 months). One patient who continued treatment after complete response also developed HCC recurrence.

“The main question in clinical practice is whether sorafenib should be stopped upon detection of [complete response] or if treatment should be kept in place without time limits. There is no answer to this question, but our data suggest that clinicians should be very careful and critically assess all aspects,” Rimola and colleagues concluded. “After securing the existence of [complete response], it is important to note that we had only one recurrence in patients kept under treatment, whereas recurrence was observed in five of the seven patients in whom the drug was interrupted. According to these observations, it seems sound to keep sorafenib in place until intolerance or adverse events promote its interruption.” – by Talitha Bennett

Disclosure: Rimola reports no relevant financial disclosures. Please see the full study for the other researchers’ relevant financial disclosures.