Modified FOLFIRINOX for resected pancreatic cancer: Opportunities and challenges

Table 1 Comparison of six phase III clinical trials of gemcitabine alone in patients with resected pancreatic cancer

Trial	PRODIGE-24[1]	CONKO-001[9]	ESPAC-3[10]	JASPAC 01[13]	ESPAC-4[11]	CONKO-005[12]
Variable
No. of patients	246	179	537	190	366	217
Tumor grade, n (%)
Well differentiated	79 (32.1)	10 (5.6)	66 (12.3)	NA	30 (8.2)	9 (4.1)
Moderately differentiated	125 (50.8)	103 (57.5)	336 (62.6)	NA	192 (52.5)	128 (59)
Poorly differentiated/undifferentiated	29 (11.8)	63 (35.2)	127 (23.6)	NA	142 (38.8)	74 (34.1)
Disease free survival - mo
Median	12.8	13.4	14.3	11.3	13.1	11.4
95%CI	11.7-15.2	11.4-15.3	13.5-15.6	9.7-13.6	11.6-15.3	9.2-13.6
Overall survival - mo
Median	35.0	22.1	23.6	25.5	25.5	26.5
95%CI	28.7-43.9	18.4-25.8	21.4-26.4	22.5-29.6	22.7-27.9	22.4-30.6

NA: Not available; CI: Confidence interval.

Table 2 Ongoing clinical trials of replacing part of the FOLFIRINOX regimen with Xeloda/S-1/Nanoliposomal Irinotecan for pancreatic cancer registered in ClinicalTrials.gov

Country	Title	Regimen	Phase	Cancer stage	Estimated enrollment	Study completion date	Source
China	The combination chemotherapy of S-1, irinotecan, and oxaliplatin as first line chemotherapy for pancreatic cancer	S-1, irinotecan, and oxaliplatin	II	Unresectable or metastatic	65	December 2019	NCT03403101
United States	Neoadjuvant capecitabine, oxaliplatin, and irinotecan chemotherapy in the treatment of pancreatic adenocarcinoma	Capecitabine, oxaliplatin, and irinotecan	II	Resectable, borderline and locally advanced	17	December 2022	NCT01760252
Singapore	Oxaliplatin, Xeloda, and irinotecan in pancreatic adenocarcinoma	Oxaliplatin, Xeloda, and irinotecan	I	Advanced and/or metastatic	90	June 2019	NCT02368860
Italy	A study of nanoliposomal irinotecan with 5-fluorouracil, levofolinic acid, and oxaliplatin in patients with resectable pancreatic cancer	Nanoliposomal irinotecan, oxaliplatin, leucovorin, and 5-fluorouracil	II	Resectable	67	January 2020	NCT03528785
United States	Study of nanoliposomal irinotecan-containing regimens in patients with previously untreated, metastatic pancreatic adenocarcinoma	Nanoliposomal irinotecan, oxaliplatin, leucovorin, and 5-fluorouracil	II	Metastatic	56	February 2020	NCT02551991