Hypothesis
Does sorafenib increase the survival in cancer patient with hepatocellular carcinoma?

Sorafenib- oral multikinase inhibitor of vascular endothelial growth factor receptor, inhibits tumor cell proliferation

Methods
Study population- patients with advanced hepatocellular carcinoma
None of these people received previous systemic chemotherapy
Used child pugh classification??? Why not MELD score?? This is a definite drawback.

Study design
Multi center, randomized double blind, placebo controlled
Phase 3 trial

400 mg daily sorfenib
Placebo

Designed by Bayer- scary

Primary outcome
Symptomatic progression
Decrease in 4 or more points from the baseline score on patients response
Death

Secondary outcome
Time to radiologic progression

Statistical analysis
Intention to treat analysis- analysis is based on the intention to treat in the beginning
This is to avoid the cross over and drop out effects.
Every one who begins he treatment considered as a part of the trial

Patients
902 patients’ screened
602 met the eligibility criteria
Overall survival
143 vs 178 in the sorafenidb vs placebo
Total of 321 died
Survival 44%  vs 33%  sorafenib vs placebo
31% relative risk reduction
Overall survival by cox proportional hazard significant
Radiologic progression was lower in  sorafenib group

Discussion
Bottom line. You don’t have any choice. Take it.
FDA is dragging the foot in approving the cancer drugs, people are fed up
Not a great trial.
Some benefit is definitely there.