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Folfirinox Adjuvant to Surgery in Pancreatic Cancer

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adjuvant modified FOLFIRINOX therapy in the PRODIGE 24 trial have now changed the standard of care for many patients with resectable tumors…

To say that Folfirinox (FOL) for early pancreatic cancer “blows away” oncologists is a bit much. After all, according to the study results below, “the majority of patients on this study still developed recurrence and ultimately died of pancreatic cancer.

Not to mention Folfirinox resulting is more serious adverse events aka side effects.

But I do allow that the study referenced below is a genuine advance for early pancreatic cancer patients. Let me first point out that pancreatic cancer patients in the study who underwent Folfirinox underwent a LOT of chemotherapy and therefore a LOT of toxicity.

This study uses “modified folfirinox” which essentially lowers the dose of chemo and therefore reduces the toxicity endured by the pancreatic cancer patient.

The good news is that early stage pancreatic cancer patients who underwent the modified Folfirininox therapy achieved longer OS, MFS, and cancer specific survival. All good.

The bad news is that modified Folfirinox therapy means increases in adverse events aka side effects. Even the study’s authors advise limiting which pancreatic cancer patients can handle the toxicity that comes with modified Folfirinox.

If you have been diagnosed with early pancreatic cancer and are considering undergoing this modified Folfirinox regimen, please consider the pancreatic cancer coaching program. It is free. You will learn about integrative pancreatic cancer therapies. Meaning evidence-based therapies to moderate the toxicity of chemotherapy. You will learn about managing your side effects, managing your diet, managing your mind-body health among others.

If you would like to learn more about the pancreatic cancer coaching program, please scroll down the page, post a question or comment and I will reply to you ASAP.

Thank you,

David Emerson

  • Cancer Survivor
  • Cancer Coach
  • Director PeopleBeatingCancer

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Blown Away’ By Adjuvant FOLFIRINOX in Pancreatic Cancer

“”Remarkable” results with a new adjuvant chemotherapy regimen in patients with earlier stage pancreatic cancer have already changed clinical practice, experts report.

After surgery, patients who received adjuvant chemotherapy with a regimen of modified FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) had significantly better outcomes than patients who were given gemcitabine(Gemzar, Eli Lilly) in the PRODIGE 24–ACCORD trial.

Details of the results were published online today in the New England Journal of Medicine.

“On average, the patients lived 20 months longer and were cancer free for 9 months longer compared with the standard of care, gemcitabine,” lead investigator Thierry Conroy, MD, director of the Institut de Cancérologie de Lorraine in France, told Medscape Medical News.

She pointed out that this trial was a culmination of more than 10 years of work that initially established FOLFIRINOX as standard treatment of advanced pancreatic cancer…

“The remarkable results that have been achieved with adjuvant modified FOLFIRINOX therapy in the PRODIGE 24 trial have now changed the standard of care for many patients with resectable tumors,” she writes…

Participants were between 18 and 79 years of age, with histologically confirmed pancreatic ductal adenocarcinoma who had undergone R0 or R1 resection within 3 to 12 weeks prior to randomization

Patients in the gemcitabine group received the standard dose on day 1, 8, and 15, every 28 days for 24 weeks (6 cycles). Patients in the modified FOLFIRINOX group received oxaliplatin, leucovorin, irinotecan, and fluorouracil every 14 days for 24 weeks (12 cycles)...

In the modified version of the FOLFIRINOX regimen, the 5-fluorouracil bolus was dropped and, based on a protocol-specified safety analysis, irinotecan dose was reduced from 180 mg/m2 to 150 mg/m2 after the enrollment of 162 patients. Conroy explained that the regular FOLFIRINOX regimen that is used in the advanced pancreatic cancer setting was more toxic, and that this modified regimen circumvented some of the toxicities seen...

The benefits of modified FOL (vs gemcitabine) extended to other secondary endpoints of

  • OS (median: 54.4 vs 35.0 months; HR for death, 0.64; P = .003);
  • metatatsis-free survival (MFS; median: 30.4 vs 17.7 months;
  • HR for distant disease or death, 0.59; P < .001); and
  • cancer-specific survival (median: not reached vs 36.4 months; HR for death due to treatment or treatment-related complication, 0.63; P = .003).

Three-year OS (63.4% vs 48.6%), MFS (48.2% vs 30.9%), and cancer-specific survival (66.2% vs 51.2%) was also significantly higher for patients in the modified FOLFIRINOX group…

Grade 3/4 adverse events were reported in a significantly higher proportion of patients on modified FOL (75.9% vs 52.9% on gemcitabine)…

Grade 3/4 adverse events significantly higher with modified FOL (vs gemcitabine) included

  • diarrhea (18.6% vs 3.7%),
  • increase in γ-glutamyltransferase level (18.3% vs 8.4%),
  • paresthesia (12.7% vs 5.4%),
  • fatigue (11.0% vs 4.6%),
  • sensory peripheral neuropathy (9.3% vs 8.7%),
  • nausea 5.5% vs 0.8%),
  • vomiting (5.1% vs 1.3%),
  • abdominal pain (3.4% vs 0.4%), and
  • mucositis (2.5% vs 0%).

Thrombocytopenia was significantly higher with gemcitabine (4.5% vs 1.3% for modified FOL). Although neutropenia was similar between the two groups, significantly more patients who received FOL also received granulocyte colony-stimulating factor (G-CSF 62.2% vs 3.7% for gemcitabine and G-CSF)…

“The modified FOLFIRINOX regimen is safe, there is no toxic death. With dose adjustments and delays, and skipping bolus 5-FU and reducing the dose of irinotecan are all accompanied with no reduction in the efficacy,” he said…

Kindler noted that advances in precision medicine have yet to make an impact in pancreatic cancer and only 8% of patients are cured. Surgery is the only potential cure, she notes, but only 15% to 20% of patients are candidates for resection and only 4% of patients will live for longer than 10 years…

Shah pointed out that as good as the data are, the majority of patients on this study still developed recurrence and ultimately died of pancreatic cancer…”





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