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Safety, efficacy of sorafenib exposure inconsistent in HCC, RCC patients
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There was no apparent relationship between exposure to sorafenib and safety and efficacy among patients with hepatocellular carcinoma or renal cell carcinoma, according to data presented at the European Society for Medical Oncology 2014 Congress in Madrid.
Researchers performed retrospective analyses of patients with hepatocellular carcinoma from the phase 3 SHARP trial (n=299) and patients with renal cell carcinoma from the phase 3 TARGET trial (n=451). Patients from SHARP (n=164) and TARGET (n=67) provided plasma samples after sorafenib therapy that researchers used to determine any relationships between the safety and efficacy with sorafenib exposure.
No significant differences in overall survival rates in the SHARP trial were observed among the high- and low-exposure groups (high vs. medium exposure, 426 days vs. 339 days; medium vs. low exposure, 339 days vs. 290 days). Adverse events including alopecia (23% vs. 7%), hand-foot skin reaction (HFSR; 33% vs. 24%) and diarrhea (69% vs. 40%), were greater among patients in the high-exposure group. Incidence rates for hypertension, fatigue and pruritus, however, did not increase among high-exposure patients.
In the TARGET trial, no difference was observed in progression-free survival among patients with high vs. low sorafenib exposure (HR=0.84; 95% CI, 0.43-1.64; median PFS was 219 vs. 167 days). The severity of adverse events was independent of a patient’s exposure to RCC, with rates of HFSR, rash and hypertension similar in both groups.
“Exposure-response analysis of RCC and HCC patients enrolled in pivotal sorafenib trials indicates that no clear or consistent relationship exists between plasma concentrations or exposure of sorafenib with safety or efficacy outcomes,” the researchers wrote.
For more information:
Lettieri J. Abstract #485P. Presented at: European Society for Medical Oncology 2014 Congress; Sept. 26-30; Madrid.
Disclosure: See the abstract for a full list of relevant financial disclosures.