Medicare beneficiaries with HCC show short survival on Nexavar

In a new study, Medicare beneficiaries with advanced hepatocellular carcinoma treated with Nexavar only had a median survival of 3 months.

“No drug that results in a 3-month survival can be thought to be offering a meaningful life expectancy. … Our patients deserve to know that the promise of nearly a year of life may not be their reality,” Hanna K. Sanoff, MD, MPH, associate professor and section chief of the UNC School of Medicine Gastrointestinal Medical Oncology Program, said in a press release.

Sanoff and colleagues evaluated data of 1,532 patients with advanced HCC found in the Surveillance Epidemiology and End Results-Medicare linkage database between 2008 and 2011. Survival of patients treated with Nexavar (sorafenib, Bayer HealthCare; n = 422) after HCC diagnosis was compared with patients who were never treated. The patients who received sorafenib were further analyzed based on when they began treatment: within 60 days (n = 314), between 61 and 90 days (n = 56) or 90 days after diagnosis of HCC (n = 52).

Patients who initiated treatment before 60 days and who survived to that landmark (n = 242), as well as 565 patients not treated and survived 60 days from diagnosis, were included as the propensity score-matched sample used for the effectiveness comparison.  

Results showed the median survival in all treated patients (n = 422) was 3 months. Patients who had two or more prescriptions filled had a greater survival of 5 months (n = 234).

“Even with restriction to patients filling more than one prescription, which biases the analysis toward sorafenib benefit by excluding patients dying during that first month of therapy, the median survival was only 5 months. We further found that the survival of sorafenib-treated patients was not significantly better than that of patients not undergoing HCC treatment,” the researchers wrote.

Among patients who received sorafenib as subsequent therapy, they had less advanced cancer and were more likely to have prediagnosis alpha-fetoprotein screening (n = 232), indicating a better prognosis than other patients. These patients had a median survival of 9 months from the first prescription fill date.

In the effectiveness comparison cohort, the median survival from the 60-day landmark was 3 months for the treated patients compared with 2 months in untreated patients (adjusted HR = 0.95; 95% CI, 0.78-1.16).

“The findings of a median survival of only 3 months in Medicare beneficiaries with HCC prescribed sorafenib as first-line therapy highlight the questionable value of sorafenib in this population,” the researchers wrote. “Patients should be cautioned that outside of the narrow confines of randomized trials, their life expectancy may be very short, and any benefit of sorafenib is likely to be quite small.”

The researchers concluded that the lower survival rate was likely due to a sicker general population, according to a press release. Further analysis in this study suggested that patients in the study with earlier stage disease might be more likely to benefit from taking the drug.

“We need to question who we prescribe this to, not only because of the cost of the drugs from a side effect perspective, but also the actual financial cost,” Sanoff said in the release. – by Melinda Stevens

Disclosure: Sanoff reports consulting and advising for Amgen and receiving research funds from Bayer and Novartis. Please see the study for all other researchers' relevant financial disclosures.