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Chemotherapy Regimen Extends Survival in Advanced Pancreatic Cancer


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A four-drug chemotherapy regimen has produced the longest improvement in survival ever seen in a phase III clinical trial of people with metastatic pancreatic cancer, one of the deadliest types of cancer. People who received the regimen, called FOLFIRINOX, lived approximately four months longer than those treated with the current standard of care, gemcitabine (11.1 months compared with 6.8 months). Results from the trial were published in the New England Journal of Medicine.

The regimen includes the drugs fluorouracil (also known as 5-FU), leucovorin, irinotecan, and oxaliplatin. Because of serious side effects, the treatment is not suitable for all people with metastatic disease, several pancreatic cancer researchers caution. But for those who are candidates, based on having what is called a good performance status, the regimen will likely become the standard of care, the researchers note.

Nearly one-third of participants in the FOLFIRINOX arm of the trial had some tumor shrinkage.

“Clearly these are the best results we’ve seen to date for advanced pancreatic cancer patients in terms of response rate and overall outcome,” says Dr. Al Benson of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, who was not involved with the study. “But this is a potentially very toxic combination,” he continues, “so there has to be a note of caution when considering patients for this regimen.”

Results from the trial were somewhat unexpected. Over the last few decades, numerous chemotherapy drugs have been tested alone and in various combinations in people with pancreatic cancer, almost always with little or no impact on disease progression or survival.

Clinicians and patients still have to weigh the risks versus the benefits of treatment, stresses Dr. Jack Welch of the National Cancer Institute’s Division of Cancer Treatment and Diagnosis. “But the benefit of the FOLFIRINOX regimen is really hard to overstate in terms of what’s been accomplished in pancreatic cancer to date.”

In addition to the improvement in overall survival, nearly one-third of participants in the FOLFIRINOX arm of the trial had some tumor shrinkage, compared with only nine percent of those in the gemcitabine arm.

Researchers are now looking to build on the success of the FOLFIRINOX regimen. FOLFIRNOX’s efficacy opens up new avenues of investigation, stresses Dr. Welch, including using it as a backbone on which to piggyback other treatments, particularly targeted therapies that don’t have overlapping toxicities.

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This article was published in Coping® with Cancer magazine, July/August 2011.