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Encouraging results of phase 3 clinical trial of FOLFIRINOX regimen in pancreatic cancer

A paper published on May 12, 2011 in the New England Journal of Medicine reports that the combination chemotherapy regimen FOLFIRINOX showed promising results in metastatic pancreatic cancer patients, individuals whose disease has spread elsewhere in the body. This study was also presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago June 4-8, 2010. This finding represents the first positive Phase 3 pancreatic cancer clinical trial since 2005.

In the trial, conducted in France, metastatic pancreatic cancer patients were treated with a chemotherapy regimen called FOLFIRINOX, consisting of the drugs 5-FU, leucovorin, irinotecan, and oxaliplatin. Patients who received the FOLFIRINOX regimen were compared to patients treated with the standard of care, gemcitabine alone. In order to be eligible for this study, patients had to have pancreatic cancer with metastases, be of adequate health and strength, and not have received previous treatment with chemotherapy or radiation therapy. The study enrolled a total of 342 patients.

The very promising results of this trial showed that patients with metastatic pancreatic cancer treated with FOLFIRINOX survived 11.1 months, compared to 6.8 months for those treated with gemcitabine alone.

Patients treated with FOLFIRINOX experienced worse side effects than those treated with gemcitabine, but overall the toxicities were manageable, and did not interfere with the administration of treatment. Side effects associated with the FOLFIRINOX regimen included low white blood cell count (neutropenia), fever with low white blood cell count (febrile neutropenia), low platelet count (thrombocytopenia), vomiting, fatigue, diarrhea, and numbness or pain in the hands and feet known as peripheral neuropathy. Despite these side effects, questionnaires regarding patients’ quality of life suggested that those treated with FOLFIRINOX had a longer period of time before their quality of life worsened, as compared to patients treated with gemcitabine.

These results suggest that FOLFIRINOX is a treatment regimen that may be considered for patients with metastatic pancreatic cancer who are healthy enough to withstand potentially significant side effects.

The Pancreatic Cancer Action Network encourages all patients to consider clinical trials when exploring treatment options. For more information about ongoing clinical trials or other questions about pancreatic cancer diagnosis and treatment, please contact a Pancreatic Cancer Action Network Patient and Liaison Services (PALS) Associate toll-free at 877-272-6226 or email PALS Associates are available M-F 7am-5pm Pacific Time.

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