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Why am I not getting FOLFIRINOX after my pancreatectomy?

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Over the past two decades, it has been increasingly recognized that patients who undergo pancreatectomy for pancreatic cancer do better when they are administered chemotherapy after their operation.

Prior to the 1990s, there was only one drug administered to patients with pancreatic cancer at all—5FU. In 1997, however, a study showed that patients with inoperable pancreatic cancer lived longer and had fewer symptoms when treated with a new drug called gemcitabine than when they were treated with 5FU. Based on the results of this study, gemcitabine quickly became standard treatment for patients with inoperable pancreatic cancer. But its value when given after surgery was unknown. So over 50% of patients who got an operation in the 80s and 90s never received any treatment after surgery—even at major surgical hospitals. 

In 2007, a large study of over three hundred patients was performed in Germany and Austria. The study randomized patients who had undergone curative surgery to receive either nothing (“observation”) or gemcitabine. The duration of time that elapsed between surgery and cancer relapse of patients who received gemcitabine was significantly longer than that of those who did not. Although another large European study showed that gemcitabine was no better than 5-FU when given after surgery, gemcitabine became standard postoperative therapy worldwide largely based on the results of this trial.

Last year, another European study showed that patients with inoperable pancreatic cancer who received a combination of drugs—called FOLFIRINOX—lived even longer than patients who received gemcitabine. In fact, the survival of patients who received FOLFIRINOX was almost twice as long as that of patients who received gemcitabine! Given the failure of multiple other otherwise promising regimens when compared to gemcitabine, this was remarkable. This was a truly revolutionary study that generated an understandable amount of excitement among doctors and patients worldwide.

Based on the great results of this recent clinical trial, it might seem intuitive that FOLFIRINOX should now be given to all patients after surgery instead of gemcitabine. Many of my patients who have heard of this regimen certainly think so and ask me for it each week. And perhaps they are right. But no studies have yet been performed to prove it. 

It can’t necessarily be assumed that just because FOLFIRINOX is better than gemcitabine in patients who don’t get surgery that it will work as well in patients who do. For example, re-read the first two paragraphs in this blog post. The important trials I mentioned showed that gemcitabine was better than 5-FU for patients with inoperable cancer but that gemcitabine was no better than 5-FU when given after surgery! The same may be true for FOLFIRINOX versus gemcitabine.

There are many issues that need to be considered. For example, the operation to remove pancreatic cancer is a big one, and not every patient is strong enough to receive chemotherapy afterward. This is very important, because FOLFIRINOX has more side effects than gemcitabine does. So it’s not clear whether the regimen can be delivered safely and effectively after a big operation. It is unknown at this point whether patients recovering from major surgery can tolerate a dose of the drugs sufficient to be active. 

It is also unclear whether the inoperable patients studied in the FOLFIRINOX trial were otherwise similar enough to patients who get an operation for pancreatic cancer to know whether the drug can be given as effectively. Most patients who undergo surgery for pancreatic cancer have tumors of the head of the pancreas. Most patients in the FOLFIRINOX study, however, had tumors of the tail of the pancreas. There are small but significant differences between these groups that may affect how the drugs can be administered in the perioperative period.

Several groups are rallying to develop trials to analyze the effectiveness of this new regimen in patients who undergo surgery. A group I am involved with, for example, is looking at whether this new regimen can be used before surgery to improve survival rates. Other groups are evaluating its use after surgery. These trials are clearly important and have the potential to change the standard of care for patients with operable pancreatic cancer.

Until then, gemcitabine remains the cornerstone of standard postoperative therapy. Many oncologists give other drugs in addition to it and, particularly in American hospitals, radiation is often used as well. But it is important to recognize that, at least at this time, we don’t know whether FOLFIRINOX is better than gemcitabine or not. Only experience, time and aggressive development of and enrollment into new clinical trials will tell.


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