In the mid-90s, Von Hoff et al. published several papers of their medical research that demonstrated the survival advantage of the drug-agent gemcitabine (sold in the U.S. as Gemzar; developed by Eli Lilly and Company) as first line therapy in the treatment of advanced pancreatic cancer (ductal adenocarcinoma of the pancreas) over the use of somewhat ineffective but standard monotherapy for pancreatic cancer for years, fluorouracil (known as 5-FU). Quickly, gemcitabine became the standard of care treatment for pancreatic cancer, although research continued and gemcitabine and other drugs either singly or in combination were studied extensively.
The next major breakthrough in the chemotherapy treatment of advanced pancreatic cancer came in May 2011 by French researchers with the publication of data regarding the use of the 4-drug regimen (including 5-FU) known as FOLFIRINOX. At a point afterwards, the NCCN began to recommend the FOLFIRINOX regimen as first line therapy for advanced pancreatic cancer.
Then in 2013, Von Hoff and others published their research which demonstrated that Abraxane (Nab-paclitaxel; by Celgene) plus gemcitabine gave survival advantage in patient with advanced pancreatic cancer over gemcitabine alone. Soon thereafter, the U.S. FDA approved the Abraxane plus gemcitabine combination for the treatment of advanced pancreatic cancer.
One point to note is that the central drug in each of the two key drug combinations for chemotherapy of advanced pancreatic cancer involve one or the other of the past drugs that were used alone: 5-FU and gemcitabine.
Gemcitabine is a nucleoside analogue that inhibits an enzyme required for a pathway that is necessary for successful DNA synthesis. It is also approved in the U.S. for the treatment of such conditions as breast, lung, bladder and ovarian cancer.
The side effects of gemcitabine alone, depending on personal response, and given that it IS a chemotherapy are often relatively mild compared to certain other drugs, and can include such conditions as fever, flu-like symptoms, fatigue, GI problems, rashes, hair loss, weakness, and shortness of breath.
There are studies that suggest that the gemcitabine plus Abraxane regimen is generally better tolerated than the FOLFIRINOX regimen in many patient with pancreatic cancer.
Since the development of gemcitabine + Abraxane for the treatment of pancreatic cancer, there have been many innovative studies using this combination in creative ways. We have commented on gemcitabine alone and in combination frequently in the Pancreatica Blog.