Compared with gemcitabine, a modified FOLFIRINOX regimen improved survival rates over five years of follow-up for patients with pancreatic ductal adenocarcinoma who underwent resection, although all patients may not be suitable for this treatment, an expert said.
Patients with resected pancreatic ductal adenocarcinoma, a type of pancreatic cancer, who were treated with a modified FOLFIRINOX regimen in the adjuvant setting had significantly longer survival rates compared to those treated with gemcitabine, according to five-year follow-up data from a phase 3 study.
The risk of cancer recurrence after pancreatic resection was reduced by 34% with a modified FOLFIRINOX adjuvant chemotherapy regimen. Additionally, chemotherapy plus FOLFIRINOX resulted in a median disease-free survival (time a patient survives after treatment without signs or symptoms of their cancer) of 21.4 months versus 12.8 months with gemcitabine.
“These data cover mainly the results of treatment on pancreatic cancer, but also the occurrence of another cancer or death by any cause,” said Dr. Thierry Conroy, lead author on this study and medical oncologist and director at the Institut de Cancerologie de Lorraine in Vandoeuvre-lès-Nancy, France, in an interview with CURE®. “However, the main point is that with six years of follow-up, more patients are alive without relapse in the (modified) FOLFIRINOX (regimen) group.”
FOLFIRINOX has been a treatment option for patients with resected pancreatic ductal adenocarcinoma since early data from this study were reported in 2018. These data confirm the usage of this treatment with longer follow up.
“Since the early publication in 2018 (with less than three-year follow-up), (the modified) FOLFIRINOX regimen is now a major option in routine practice (all) over the world in fit patients,” Conroy said. “The present publication confirmed our results with a median follow-up of 69.7 months.”
The study — which was published in JAMA Oncology— included 493 patients (43.8% women; mean age, 62 years) with pancreatic ductal adenocarcinoma who underwent pancreatic resection up to 12 weeks before receiving their assigned treatment. Patients were assigned who either a modified FOLFIRINOX regimen (oxaliplatin, irinotecan, leucovorin and fluorouracil) or gemcitabine as adjuvant therapy. Both groups received treatment for 24 weeks.
The primary goal of this study was to assess disease-free survival. In addition, secondary goals of the study included overall survival (time from diagnosis or treatment start when patients are alive), metastasis-free survival (time from treatment assignment to first distant metastasis or all-cause death) and cancer-specific survival.
Five-year disease-free survival for the modified FOLFIRINOX and gemcitabine groups was 26.1% and 19%, respectively. Additionally, five-year overall survival rates were 43.2% and 31.4%.
The median metastasis-free survival for patients assigned the modified FOLFIRINOX regimen was 29.4 months compared with 17.7 months in those assigned gemcitabine. Patients in the modified FOLFIRINOX group had a median cancer-specific survival of 54.7 months versus 36.3 months in the gemcitabine group.
“We also showed that completion of all cycles of adjuvant chemotherapy in this study was associated with improved overall survival, and this is an important message for patients,” Conroy noted.
Researchers also performed an analysis to determine whether there were favorable factors for overall survival. The factors identified from the analysis included the modified FOLFIRINOX regimen, age, tumor grade, tumor staging and larger volume center. In contrast, a shorter relapse delay may indicate a negative effect on overall survival.
Of note, side effects were more favorable with gemcitabine than FOLFIRINOX; however, all were manageable and were consistent with previous data.
Conroy added that, if possible, patients with pancreatic cancer should be treated with this regimen, although this research is limited. This study was conducted with patients who have good performance status, recovered from surgery within 12 weeks and have no cardiac failure to fluorouracil, a type of chemotherapy. Patients who do not meet those requirements and are frail with severe heart disease should consider other options, Conroy concluded.
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