In the Journals

Sorafenib with TACE improves response to HCC, not overall survival

Sorafenib combined with conventional transarterial chemoembolization for patients with advanced hepatocellular carcinoma improved time to progression, progression-free survival, and tumor response rate compared with sorafenib alone, according to a recently published study.

“Unlike previous studies comparing TACE alone and TACE plus sorafenib in patients with unresectable HCC, this study comparing [the combined therapy (SOR+T)] versus sorafenib alone demonstrated that SOR+T did not meet the expected primary endpoint of an improved [overall survival] in patients with advanced HCC,” Joong-Won Park, MD, PhD, from the National Cancer Center in South Korea, and colleagues wrote “However, SOR+T statistically improved all secondary outcomes.”

Park and colleagues enrolled and randomly assigned patients to receive the SOR+T combination therapy (n = 170) or sorafenib alone (n = 169) in a phase 3 multicenter study.

At follow-up, median OS was not significantly different between the SOR+T group and the monotherapy group (12.8 vs. 10.8 months).

However, the SOR+T group had significantly better time to progression (HR = 0.674; 95% CI, 0.533-0.852), progression-free survival (HR = 0.733; 95% CI, 0.589-0.912), and tumor response rate outcomes (47.3% vs. 60.6%; P = .0053) compared with the monotherapy group.

Patients who had previously undergone TACE treatment had better OS rates compared with those who did not, but the difference was not significant compared with the monotherapy group.

Patients in the SOR+T group had a higher rate of adverse events compared with the sorafenib monotherapy group (96.7% vs. 90.4%; P = .0227). Most of the grade 3 and grade 4 events in the combined therapy group included increased aspartate aminotransferase (27.5% vs. 4.8%; P < .0001) and alanine aminotransferase (20.3% vs. 3.6%; P < .0001), ascites (11.8% vs. 4.2%; P = .0117), hyperbilirubinemia (11.8% vs. 3.0%; P = .0024), and hand-foot skin reaction (10.5% vs. 11.4%; P = .7923) compared with monotherapy patients.

The combination therapy group also had a nonsignificant trend for more serious adverse events (33.3% vs. 19.8%).

“This study showed that SOR+T may have a worse prognosis than sorafenib alone in about half of patients randomized to Arm C [and that] the AE risk of concurrent combination TACE treatment is common,” Park and colleagues concluded. “The initiation of sorafenib therapy at reduced dosages was associated with better tolerance but not inferior OS.” – by Talitha Bennett

Disclosure: Park reports financial connections with Bayer, Bristol-Myers Squibb, Cue, Eisai, Midatech, Ono and Roche. Please see the full study for the other authors’ relevant financial disclosures.

Sorafenib combined with conventional transarterial chemoembolization for patients with advanced hepatocellular carcinoma improved time to progression, progression-free survival, and tumor response rate compared with sorafenib alone, according to a recently published study.

“Unlike previous studies comparing TACE alone and TACE plus sorafenib in patients with unresectable HCC, this study comparing [the combined therapy (SOR+T)] versus sorafenib alone demonstrated that SOR+T did not meet the expected primary endpoint of an improved [overall survival] in patients with advanced HCC,” Joong-Won Park, MD, PhD, from the National Cancer Center in South Korea, and colleagues wrote “However, SOR+T statistically improved all secondary outcomes.”

Park and colleagues enrolled and randomly assigned patients to receive the SOR+T combination therapy (n = 170) or sorafenib alone (n = 169) in a phase 3 multicenter study.

At follow-up, median OS was not significantly different between the SOR+T group and the monotherapy group (12.8 vs. 10.8 months).

However, the SOR+T group had significantly better time to progression (HR = 0.674; 95% CI, 0.533-0.852), progression-free survival (HR = 0.733; 95% CI, 0.589-0.912), and tumor response rate outcomes (47.3% vs. 60.6%; P = .0053) compared with the monotherapy group.

Patients who had previously undergone TACE treatment had better OS rates compared with those who did not, but the difference was not significant compared with the monotherapy group.

Patients in the SOR+T group had a higher rate of adverse events compared with the sorafenib monotherapy group (96.7% vs. 90.4%; P = .0227). Most of the grade 3 and grade 4 events in the combined therapy group included increased aspartate aminotransferase (27.5% vs. 4.8%; P < .0001) and alanine aminotransferase (20.3% vs. 3.6%; P < .0001), ascites (11.8% vs. 4.2%; P = .0117), hyperbilirubinemia (11.8% vs. 3.0%; P = .0024), and hand-foot skin reaction (10.5% vs. 11.4%; P = .7923) compared with monotherapy patients.

The combination therapy group also had a nonsignificant trend for more serious adverse events (33.3% vs. 19.8%).

“This study showed that SOR+T may have a worse prognosis than sorafenib alone in about half of patients randomized to Arm C [and that] the AE risk of concurrent combination TACE treatment is common,” Park and colleagues concluded. “The initiation of sorafenib therapy at reduced dosages was associated with better tolerance but not inferior OS.” – by Talitha Bennett

Disclosure: Park reports financial connections with Bayer, Bristol-Myers Squibb, Cue, Eisai, Midatech, Ono and Roche. Please see the full study for the other authors’ relevant financial disclosures.