Sorafenib Effective in Asian-Pacific Liver Cancer Patients

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Sorafenib Effective in Asian-Pacific Liver Cancer Patients

June 16, 2008 (Chicago, Illinois) — The recent approval of sorafenib (Nexavar,

Onyx/Bayer) for use in liver cancer was based on a large placebo-controlled

trial conducted in Spain. Although these results were described as " dramatic, "

there remained concerns about whether the drug would be as effective in an Asian

population with a high incidence of hepatitis infection, poorer health status,

and more advanced stages of liver cancer.

" These lingering doubts have now been laid to rest, " said Margaret Tempero, MD,

from the University of California, San Francisco, speaking here recently at the

American Society of Clinical Oncology 44th Annual Meeting. The results from the

latest trial show that sorafenib is just as effective in this patient

population, " so we can stop worrying about this problem, " she said during a

discussion of the abstract at a " highlights of the day " session.

The latest results come from a phase 3 trial conducted in 226 Asian patients

with advanced hepatocellular carcinoma, and were presented at the meeting by

Ann-Lii Cheng, MD, PhD, from the National Taiwan University Hospital, in Taipei.

Sorafenib demonstrated a " clear survival benefit in Asia-Pacific patients and

had comparable results to last year's SHARP [sorafenib Hepatocellular Carcinoma

Assessment Randomized Protocol] trial, despite these patients in the

Asia-Pacific trial having poorer health status and more metastases, " she said in

a statement.

Liver cancer, resulting primarily from chronic hepatitis infections, is a

particular concern in the Asia-Pacific region, where more than 8% of the general

population is infected with hepatitis B and 2% to 4% is infected with hepatitis

C. More than half of all the cases of liver cancer diagnosed worldwide (>600,000

per year) are found in this region, with China, South Korea, Japan, and Taiwan

accounting for more than 400,000 of cases per year.

Latest Results Echo Previous Results

The SHARP trial, conducted in 602 patients, was presented at last year's ASCO

meeting. It showed a 44% improvement in overall survival, with a median overall

survival of 10.7 months for sorafenib and 7.9 months for placebo. It also showed

a 73% prolongation of time to progression, with a median time to progression of

24 weeks for sorafenib and 12 weeks for placebo. The trial was stopped early

because the results were so positive.

These results were greeted enthusiastically by experts at the 2007 meeting, who

pointed out that there was no widely accepted standard of care for advanced

liver cancer. Sorafenib has since been approved for this indication in more than

40 countries.

The latest results in Asian patients echo the results from the SHARP trial. Both

trials were sponsored by the manufacturer. Again, there was a significant

improvement in overall survival, 47.3% in this case, with a median overall

survival of 6.2 months for sorafenib and 4.1 months for placebo. There was also

a significant 74% improvement in time to progression, with a median time to

progression of 2.8 months for sorafenib and 1.4 months for placebo. In addition,

the disease control rate (comprised of complete and partial responses and stable

disease ≥12 weeks) was 35% for sorafenib and 16% for placebo.

The survival benefit was seen across multiple patient subgroups, including age,

extrahepatic spread, and/or macroscopic vascular invasion. Adverse reactions

were low to moderate in severity, the researchers said, and the most common

serious adverse effects were hand-and-foot reaction, diarrhea, alopecia,

fatigue, and rash/desquamation.

" These data provide further evidence that sorafenib is efficacious in liver

cancer across multiple geographic regions and independent of disease

characteristics and etiologies of underlying disease, " said , MD,

vice-president, Therapeutic Area Oncology at Bayer HealthCare Pharmaceuticals.

" Sorafenib has quickly become the systemic standard of care for liver cancer. "

American Society of Clinical Oncology (ASCO) 44th Annual Meeting. Abstract 4509.

Presented June 2, 2008.

_________________________________________________________________

The i’m Talkathon starts 6/24/08.  For now, give amongst yourselves.

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[Guest guest]

http://www.medscape.com/viewarticle/576128?sssdmh=dm1.360722 & src=nldne

Sorafenib Effective in Asian-Pacific Liver Cancer Patients

June 16, 2008 (Chicago, Illinois) — The recent approval of sorafenib (Nexavar,

Onyx/Bayer) for use in liver cancer was based on a large placebo-controlled

trial conducted in Spain. Although these results were described as " dramatic, "

there remained concerns about whether the drug would be as effective in an Asian

population with a high incidence of hepatitis infection, poorer health status,

and more advanced stages of liver cancer.

" These lingering doubts have now been laid to rest, " said Margaret Tempero, MD,

from the University of California, San Francisco, speaking here recently at the

American Society of Clinical Oncology 44th Annual Meeting. The results from the

latest trial show that sorafenib is just as effective in this patient

population, " so we can stop worrying about this problem, " she said during a

discussion of the abstract at a " highlights of the day " session.

The latest results come from a phase 3 trial conducted in 226 Asian patients

with advanced hepatocellular carcinoma, and were presented at the meeting by

Ann-Lii Cheng, MD, PhD, from the National Taiwan University Hospital, in Taipei.

Sorafenib demonstrated a " clear survival benefit in Asia-Pacific patients and

had comparable results to last year's SHARP [sorafenib Hepatocellular Carcinoma

Assessment Randomized Protocol] trial, despite these patients in the

Asia-Pacific trial having poorer health status and more metastases, " she said in

a statement.

Liver cancer, resulting primarily from chronic hepatitis infections, is a

particular concern in the Asia-Pacific region, where more than 8% of the general

population is infected with hepatitis B and 2% to 4% is infected with hepatitis

C. More than half of all the cases of liver cancer diagnosed worldwide (>600,000

per year) are found in this region, with China, South Korea, Japan, and Taiwan

accounting for more than 400,000 of cases per year.

Latest Results Echo Previous Results

The SHARP trial, conducted in 602 patients, was presented at last year's ASCO

meeting. It showed a 44% improvement in overall survival, with a median overall

survival of 10.7 months for sorafenib and 7.9 months for placebo. It also showed

a 73% prolongation of time to progression, with a median time to progression of

24 weeks for sorafenib and 12 weeks for placebo. The trial was stopped early

because the results were so positive.

These results were greeted enthusiastically by experts at the 2007 meeting, who

pointed out that there was no widely accepted standard of care for advanced

liver cancer. Sorafenib has since been approved for this indication in more than

40 countries.

The latest results in Asian patients echo the results from the SHARP trial. Both

trials were sponsored by the manufacturer. Again, there was a significant

improvement in overall survival, 47.3% in this case, with a median overall

survival of 6.2 months for sorafenib and 4.1 months for placebo. There was also

a significant 74% improvement in time to progression, with a median time to

progression of 2.8 months for sorafenib and 1.4 months for placebo. In addition,

the disease control rate (comprised of complete and partial responses and stable

disease ≥12 weeks) was 35% for sorafenib and 16% for placebo.

The survival benefit was seen across multiple patient subgroups, including age,

extrahepatic spread, and/or macroscopic vascular invasion. Adverse reactions

were low to moderate in severity, the researchers said, and the most common

serious adverse effects were hand-and-foot reaction, diarrhea, alopecia,

fatigue, and rash/desquamation.

" These data provide further evidence that sorafenib is efficacious in liver

cancer across multiple geographic regions and independent of disease

characteristics and etiologies of underlying disease, " said , MD,

vice-president, Therapeutic Area Oncology at Bayer HealthCare Pharmaceuticals.

" Sorafenib has quickly become the systemic standard of care for liver cancer. "

American Society of Clinical Oncology (ASCO) 44th Annual Meeting. Abstract 4509.

Presented June 2, 2008.

_________________________________________________________________

The i’m Talkathon starts 6/24/08.  For now, give amongst yourselves.

http://www.imtalkathon.com?source=TXT_EML_WLH_LearnMore_GiveAmongst