A presentation this afternoon at ASCO’s annual meeting this afternoon in
(We need to distinguish primary liver cancer—which originates in the liver and is known by its medical name hepatocellular carcinoma—from cancers that spread to the liver from other organs, such as breast, lung and colon cancer.)
The report is important because up until now there have been no really effective chemotherapeutic agents to treat this form of cancer. In addition, this treatment is given by mouth, and the side effects were relatively modest. In fact, the same level of side effects occurred both in the patients who took the drug, and those who took a placebo.
The researchers are going to report that the patients who took sorafenib lived a median of 10.7 months, while those who took the placebo (or dummy pill) lived a median of 7.9 months. (Median is a statistical measure that means half of the patients lived longer than a particular time, while half the patients died before that time).
Looked at another way, the patients who took sorafenib took about 5.5 months until their disease showed that it was progressing. Those on the placebo had evidence of disease progression at 2.8 months.
In essence, the drug increased the survival of the typical patients with primary liver cancer about 2.8 months.
That doesn’t sound like much, but it is likely a real finding. In fact, if you understand what median means, some of the patients in this trial probably lived longer than the 10.7 months.
And, if you have read my blog previously, you have seen me write that the history of improvements in the treatment of cancer happen much more often in small increments and not in big “one-time” gains.
This report is also important for some of the other considerations beyond extending life for 2.8 months.
First, if you read the information above correctly, you will note that in this particular international clinical trial, the drug was compared to a placebo. A placebo, more commonly called a “dummy pill” or a “sugar pill” is essentially a pill with no active ingredient and not intended to have a beneficial therapeutic effect.
I am not aware of many clinical trials in cancer that compare a new drug for treating a cancer against a placebo. You just don’t see that happen very often in cancer research these days.
So why a placebo? After all, although liver cancer is less common in the
I checked my trusted resource on the topic—the National Comprehensive Cancer Network website—to see what they recommended for standard chemotherapy treatment.
In fact, for metastatic or recurrent or unresectable primary liver cancer, there IS no standard chemotherapy listed. Nothing at all.
They do recommend clinical trials or best supportive care (that is medical language for making someone comfortable but not actively treating them with chemotherapy or other modalities) if someone can’t be treated with standard methods or has recurrent disease.
So the bottom line is that we don’t have much to offer patients in these circumstances.
That is not to say we don’t have treatments to offer patients with liver cancer. But those treatments are more surgically oriented such as surgically removing the cancer when possible, or even transplanting the liver in a patient with liver cancer who meets certain criteria.
There are other techniques as well where doctors can “ablate” the cancer by using freezing techniques, microwave or what is called radiofrequency ablation, for example.
Liver cancer is becoming more common in the
This is, according to one of my colleagues, one of the cancers that is increasing most rapidly in the
This is a cancer that is known to primarily be caused by infection with Hepatitis B and Hepatitis C.
Fortunately, in this country, we have a decreasing incidence of hepatitis, in no small part because we are able to offer immunization against hepatitis B to our children. We have also significantly improved our ability to test blood transfusions for these viruses, which used to be a significant means of transmission on this virus.
But we also must keep in mind that primary liver cancer is a significant world-wide health risk, in no small part due to the fact that immunization is not widely practiced, and personal and medical hygiene habits are much worse in many developing countries than they are here in the United States.
In fact, in 2005, my colleagues at the American Cancer Society who write Cancer Facts and Figures provided an entire special section of this valued reference book devoted to the topic of infectious causes of cancer in the world. Liver cancer was the lead topic of discussion.
That monograph contained some interesting statistics:
In 2005, it was estimated there would be 667,000 cases of primary liver cancer throughout the world, making liver cancer the 6th most common cancer in the world. It is the 18th most common cancer in the
83% of the new cases of liver cancer occur in developing countries., but in the
In the developing countries, 37% of the new cases of liver cancer are attributable to hepatitis B infection, 25% to hepatitis C, and 10% to liver fluke infections.
Sharing of needles, poor personal hygiene and direct person-to-person transmission account for many of the hepatitis B and hepatitis C infections.
So what does all of this mean?
We are fortunate to have a new drug that is clearly effective—albeit modestly—in the treatment of this previously untreatable disease. That offers some hope, but more importantly signals the opportunities for real advances in the treatment of primary liver cancer.
We also need to understand this is a disease that, although certainly of concern in the
Liver cancer is a disease that would occur less frequently if we had an effective international immunization strategy and an educational strategy focused on good health and hygiene behaviors and improvements in medical care delivery systems (such as avoiding the reuse of needles in medical settings).
But this is difficult to accomplish, and many barriers are in place which prevent the adoption of these simple, inexpensive and effective approaches to reducing these infections and in turn reducing the incidence of primary liver cancer.
How we are going to be able to get the benefits of this new drug to developing countries where it is most needed remains the unanswerable question. This drug is expensive, and probably far beyond the means of those who need it most.
And that raises the larger issue that I have discussed previously, namely how are we going to be able to afford our miracles.
We need to develop a sustainable economic/business model that works for everyone: the companies that discover, market and manufacture these drugs; the insurers and governments who pay for the drugs; and, most importantly, the patients who need the drugs.
Finding a solution to that conundrum is, in my personal opinion, probably one of the most important issues we face in cancer treatment today.