Sorafenib Improves Survival in Liver Cancer

[Guest guest]

http://www.medpagetoday.com/HematologyOncology/OtherCancers/12194

Sorafenib Improves Survival in Liver Cancer

By Bankhead, Staff Writer, MedPage Today

Published: December 16, 2008

Reviewed by Zalman S. Agus, MD; Emeritus Professor

University of Pennsylvania School of Medicine.

TAIPEI, Taiwan Dec. 16 -- Liver cancer patients in the Asia-Pacific region --

where most cases of the disease occur -- had significantly improved overall

survival when treated with sorafenib (Nexavar), investigators here reported.

Action Points

--------------------------------------------------------------------------------

Explain to patients that a new type of drug improved survival in Asian-Pacific

patients with advanced liver cancer.

Point out that the same drug has been shown to improve survival in liver cancer

patients from North America and Europe.

Median duration of survival improved by 50% in patients with advanced disease

who received the oral multikinase inhibitor sorafenib compared with those who

took placebo, Ann-Lii Cheng, M.D., of National Taiwan University Hospital and

colleagues reported online in The Lancet Oncology.

Time to progression also increased significantly with sorafenib therapy, they

said.

" Our study shows that sorafenib is a well-tolerated treatment option with an

acceptable safety profile for patients with advanced hepatocellular carcinoma

from the Asia-Pacific region, " the authors concluded.

More than 75% of cases of hepatocellular carcinoma occur in the Asia-Pacific

region, primarily as a consequence of chronic hepatitis B infection, the authors

noted. Surgical resection is associated with a five-year survival of 60% to 70%,

but more than 80% of patients have metastatic or inoperable disease at

diagnosis.

Conventional systemic therapy has failed to improve survival in patients with

advanced disease, they continued.

The multicenter, randomized phase III SHARP trial demonstrated improved overall

survival with sorafenib. However, time to symptomatic progression did not differ

from that of placebo-treated patients.

The SHARP trial involved patients from North America and Europe primarily.

Because the Chinese regulatory-approval process requires a study involving

patients from the Asia-Pacific region, Dr. Cheng's group conducted a study in

parallel with SHARP.

They enrolled 226 patients with unresectable or metastatic hepatocellular

carcinoma and no prior systemic therapy. The patients were randomized 2:1 to

sorafenib or placebo.

The trial had no predefined endpoints. Outcome assessments included overall

survival, time to progression, time to symptomatic progression, disease control

rate, and safety.

Patients treated with sorafenib had a median overall survival of 6.5 months

versus 4.2 months in the placebo group (HR 0.68, 95% CI 0.50 to 0.93, P=0.014).

Median time to progression was 2.8 months in the sorafenib group versus 1.4

months with placebo (HR 0.57, 95% CI 0.42 to 0.79, P=0.0005).

The time to symptomatic progression was 3.4 to 3.5 months in both groups.

" Sorafenib provided a clinical benefit in all preplanned subgroup analyses,

despite some patients having characteristics associated with poor prognosis, "

the authors said.

Treatment-related adverse events, dose reductions, and discontinuation because

of adverse events all occurred more often in the sorafenib group.

The most common grade 3-4 adverse events with sorafenib were hand-foot syndrome

(10.7%), diarrhea (6.0%), fatigue (3.4%), and hypertension (2.0%).

The rate of discontinuation because of adverse events was 19.5% in the sorafenib

group and 13.3% in the placebo group.

The study was supported by Bayer and Onyx.

Dr. Cheng disclosed commercial relationships with Bayer Schering Pharma, Pfizer,

and Merck Serono.

Several of the investigators are employees of Bayer Healthcare and Bayer

Schering Pharma.

Primary source: Lancet Oncology

Source reference:

Cheng AL, et al " Efficacy and safety of sorafenib in patients in the

Asia-Pacific region with advanced hepatocellular carcinoma: a phase III

randomized, double-blind, placebo-controlled trial. " Lancet Oncol 2008;

DOI:10.1016/S1470-2045(08)70285-7.

Related Article(s):

Sorafenib Extends Advanced Liver Cancer Survival

ASCO: Sorafenib (Nexavar) Improves Survival in Primary Liver Cancer

Sorafenib (Nexavar) Okayed for Inoperable Liver Cancer

[Guest guest]

http://www.medpagetoday.com/HematologyOncology/OtherCancers/12194

Sorafenib Improves Survival in Liver Cancer

By Bankhead, Staff Writer, MedPage Today

Published: December 16, 2008

Reviewed by Zalman S. Agus, MD; Emeritus Professor

University of Pennsylvania School of Medicine.

TAIPEI, Taiwan Dec. 16 -- Liver cancer patients in the Asia-Pacific region --

where most cases of the disease occur -- had significantly improved overall

survival when treated with sorafenib (Nexavar), investigators here reported.

Action Points

--------------------------------------------------------------------------------

Explain to patients that a new type of drug improved survival in Asian-Pacific

patients with advanced liver cancer.

Point out that the same drug has been shown to improve survival in liver cancer

patients from North America and Europe.

Median duration of survival improved by 50% in patients with advanced disease

who received the oral multikinase inhibitor sorafenib compared with those who

took placebo, Ann-Lii Cheng, M.D., of National Taiwan University Hospital and

colleagues reported online in The Lancet Oncology.

Time to progression also increased significantly with sorafenib therapy, they

said.

" Our study shows that sorafenib is a well-tolerated treatment option with an

acceptable safety profile for patients with advanced hepatocellular carcinoma

from the Asia-Pacific region, " the authors concluded.

More than 75% of cases of hepatocellular carcinoma occur in the Asia-Pacific

region, primarily as a consequence of chronic hepatitis B infection, the authors

noted. Surgical resection is associated with a five-year survival of 60% to 70%,

but more than 80% of patients have metastatic or inoperable disease at

diagnosis.

Conventional systemic therapy has failed to improve survival in patients with

advanced disease, they continued.

The multicenter, randomized phase III SHARP trial demonstrated improved overall

survival with sorafenib. However, time to symptomatic progression did not differ

from that of placebo-treated patients.

The SHARP trial involved patients from North America and Europe primarily.

Because the Chinese regulatory-approval process requires a study involving

patients from the Asia-Pacific region, Dr. Cheng's group conducted a study in

parallel with SHARP.

They enrolled 226 patients with unresectable or metastatic hepatocellular

carcinoma and no prior systemic therapy. The patients were randomized 2:1 to

sorafenib or placebo.

The trial had no predefined endpoints. Outcome assessments included overall

survival, time to progression, time to symptomatic progression, disease control

rate, and safety.

Patients treated with sorafenib had a median overall survival of 6.5 months

versus 4.2 months in the placebo group (HR 0.68, 95% CI 0.50 to 0.93, P=0.014).

Median time to progression was 2.8 months in the sorafenib group versus 1.4

months with placebo (HR 0.57, 95% CI 0.42 to 0.79, P=0.0005).

The time to symptomatic progression was 3.4 to 3.5 months in both groups.

" Sorafenib provided a clinical benefit in all preplanned subgroup analyses,

despite some patients having characteristics associated with poor prognosis, "

the authors said.

Treatment-related adverse events, dose reductions, and discontinuation because

of adverse events all occurred more often in the sorafenib group.

The most common grade 3-4 adverse events with sorafenib were hand-foot syndrome

(10.7%), diarrhea (6.0%), fatigue (3.4%), and hypertension (2.0%).

The rate of discontinuation because of adverse events was 19.5% in the sorafenib

group and 13.3% in the placebo group.

The study was supported by Bayer and Onyx.

Dr. Cheng disclosed commercial relationships with Bayer Schering Pharma, Pfizer,

and Merck Serono.

Several of the investigators are employees of Bayer Healthcare and Bayer

Schering Pharma.

Primary source: Lancet Oncology

Source reference:

Cheng AL, et al " Efficacy and safety of sorafenib in patients in the

Asia-Pacific region with advanced hepatocellular carcinoma: a phase III

randomized, double-blind, placebo-controlled trial. " Lancet Oncol 2008;

DOI:10.1016/S1470-2045(08)70285-7.

Related Article(s):

Sorafenib Extends Advanced Liver Cancer Survival

ASCO: Sorafenib (Nexavar) Improves Survival in Primary Liver Cancer

Sorafenib (Nexavar) Okayed for Inoperable Liver Cancer