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Erivedge treatment for BCC associated with SCC risk

Patients treated with Erivedge for basal cell carcinoma had an increased risk for cutaneous squamous cell carcinomas, according to research published today in JAMA Dermatology.

Researchers searched electronic medical records to conduct a case-control study at Stanford Medical Center of 180 higher-risk patients (69.8% male) with basal cell carcinoma (BCC) diagnosed between 1998 and 2014. Analysis was conducted from Jan. 1 to Nov. 1, 2015.

There were 55 patients who had confirmed prior Erivedge (vismodegib, Genentech) treatment who made up the exposed participants or cases, while 125 patients who had never received a vismodegib treatment were controls. Vismodegib was the only smoothened inhibitor included in the study, since it was the first approved.

The overall rate of subsequent malignancy in the 180 study patients was 36.7% (66 of 180). The rate of subsequent malignancy was 29.1% (16 of 55) in the cases and 40% (50 of 125) in the controls.

The two cohorts were not significantly different when compared by sex, race, prior radiation therapy, chemotherapy and immunosuppression.

Cases had a younger mean age (52 years) than controls (59 years) at the time of BCC diagnosis (P < .001).  Significantly more cases (26.3%) than controls (0.8%) had basal cell nevus syndrome diagnoses (P < .001).

Cox proportion hazards regression analysis showed that there was a hazard ratio of 6.37 (95% CI, 3.39-11.96) for the patients exposed to vismodegib, which indicated increased risk for developing a nonBCC malignancy.

Squamous cell carcinomas (SCCs) made up most nonBCC malignancies (HR = 8.12; 95% CI, 3.89-16.97), accounting for age and basal cell nevus syndrome status.

“There was no significant increase in other cancers,” the researchers wrote.

“The potential conversion of [BCCs] to [cutaneous] SCCs after vismodegib exposure has been a concern for advanced lesions, and larger studies are needed to assess whether this phenomenon is occurring and leading to nonadvanced [cutaneous] SCCs,” the researchers concluded. “Larger multicenter studies are also required to evaluate whether longer duration of vismodegib exposure increases the risk of nonBCC malignancies.” – by Bruce Thiel

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