Importance of landscape exploration and progress in molecular therapies and precision medicine for pancreatic ductal adenocarcinoma

Table 2 Summary of second-line therapies for pancreatic cancer and the results of phase III clinical trials

Clinical trial identifier	Year	Patients	Study phase	Tumor stage	Treatment regimen	Median OS (months)	Median PFS (months)	Ref.
NAPOLI-1 NCT01494506	2016	417	Phase III	mPDAC	Nanoliposomal irinotecan with fluorouracil and folinic acid	6.1 vs 4.2	NA	[66]
MPACT	2021	378	Phase III	mPDAC	Liposomal irinotecan + fluorouracil/leucovorin vs FOLFIRINOX	9.8 vs 6.6	3.7 vs 4.6	[68]
PANCREOX NCT01121848	2016	108	Phase III	LAPC	Nanoliposomal irinotecan + fluorouracil and folinic acid	6.1 vs 9.9	3.1 vs 2.9	[69]
MPACT	2015	57		mPDAC	Nab-paclitaxel plus gemcitabine	8.8	5.1	[71]
NCT05074589	2022	298	Phase III	mPDAC	Liposomal formulation of irinotecan plus 5-fluorouracil and folinic acid, or placebo plus 5-fluorouracil and folinic acid	7.39 vs 4.99	4.21 vs 1.48	[73]
NCT01834235	2023	78	Phase III	APDAC	Gemcitabine and nab-paclitaxel	6.6 vs 5.0	2.7 vs 3.4	[74]
NAPOLI-1	2024	115	Phase III	APDAC	Nanoliposomal irinotecan and 5-fluorouracil/leucovorin	8.4 vs 7.9	3.6 vs 3.4	[75]
NAPOLI-1	2023	296	Phase III	APDAC	Nanoliposomal irinotecan plus 5-fluorouracil/leucovorin	6 vs 12	12.4 vs NA	[76]

OS: Overall survival; PFS: Progression-free survival; mPDAC: Metastatic pancreatic ductal adenocarcinoma; NA: Not available; LAPC: Locally advanced pancreatic cancer; APDAC: Advanced pancreatic ductal adenocarcinoma.