1. Median disease-free survival is longer in patients receiving mFOLFIRINOX as compared to those receiving gemcitabine.

2. Median overall survival is longer in patients on mFOLFIRINOX compared to gemcitabine.

Evidence Rating Level: 1 (Excellent)

Study Rundown: One of the leading causes of cancer-related deaths globally is pancreatic ductal adenocarcinoma (PDAC). It has been shown that adjuvant chemotherapy in patients with resected PDAC can improve survival outcomes. Previous studies showed that adjuvant treatment with gemcitabine improved outcomes when compared with only observation. This randomized controlled study presents the updated 5-year survival outcomes comparing a modified FOLFIRINOX (mFOLFIRINOX) chemotherapy treatment and gemcitabine as adjuvant treatment post-resection of PDAC. The previous outcomes were reported after 3 years. The primary outcome of interest was disease-free survival (DFS) and secondary outcomes included overall survival (OS). Additionally, prognostic factors associated with OS were identified. After a median follow-up of 69.7months, the median DFS in the mFOLFIRINOX group was 21.4 months, as compared to 12.8 months in the gemcitabine group. The 5-year DFS was 26.1% in the mFOLFIRINOX group compared to 19.0% in the gemcitabine group. The median OS was 53.5 months for patients receiving mFOLFIRINOX and 35.5 months for those receiving gemcitabine. The 5-year OS rate was 43.2% for mFOLFIRINOX and 31.4% for gemcitabine. Some of the prognostic factors for OS included an age less than 70 years old, and having lower tumour stage, well-differentiated tumour grade. Limitations to this study include an upper age limit to the study population of 79 years, so results should be applied to age groups greater than this with caution. Additionally, the patients in this study had good performance status, whereas in routine practice a significant proportion of patients receiving pancreatectomy have reduced performance status, so these results may not be directly applicable in those cases. Overall, the results from this study suggest that treatment with adjuvant mFOLFIRINOX after resection for PDAC significantly improves survival outcomes as compared to treatment with gemcitabine.

Click to read the study in JAMA Oncology

Relevant Reading: FOLFIRINOX or gemcitabine as adjuvant therapy for pancreatic cancer

In-Depth [randomized controlled trial]: This open-label, phase 3, randomized controlled trial was conducted out of 77 healthcare centres across Canada and France. The study enrolled 493 adult patients between the ages 18-79 years old and randomly assigned them to receive either adjuvant mFOLFIRINOX or gemcitabine. There were 247 patients in the mFOLFIRINOX group and 246 in the gemcitabine group. The median duration of follow-up was 69.7 months. In the mFOLFIRINOX group, median DFS was 21.4 months (inter-quartile range (IQR), 9.9-70.0 months) compared with 12.8 months (IQR, 7.9-29.8 months) in the gemcitabine group. The 5-year DFS rate for patients receiving mFOLFIRINOX was 26.1% (95% confidence interval (CI), 20.5% to 32.1%) and in the gemcitabine group it was 19.0% (95% CI, 14.3% to 24.3%). The median OS was 53.5 months in the mFOLFIRINOX group (IQR, 22.4-NE) as compared to 35.5 months in the gemcitabine group (IQR, 20.3-80.8 months) (stratified hazard ratio (HR), 0.68; 95% CI, 0.54 to 0.85). The 5-year OS was 43.2% in the mFOLFIRINOX group (95% CI, 36.5%-49.7%) as compared to 31.4% (95% CI, 25.5%-37.5%) in the gemcitabine group.

Image: PD

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