GICS 2017. Abstract 303: Efficacy and safety of liposomal irinotecan (nal-IRI) + 5-fluorouracil and leucovorin (5-FU/LV) in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC) who previously received gemcitabine (gem)-based therapy: Post-hoc analysis of the NAPOLI-1 trial
Li-Tzong Chen et al.
Results: Of 117 pts in the nal-IRI+5-FU/LV arm, 53 (45%) previously received gem monotherapy and 64 (55%) previously received gem combo including erlotinib (n = 9) or nab-paclitaxel (n = 20). Of the 119 pts in the 5-FU/LV arm, 55 (46%) previously received gem monotherapy and 64 (54%) previously received gem combo including erlotinib (n = 17) or nab-paclitaxel (n = 11). Nal-IRI+5-FU/LV improved median OS, median PFS, and ORR vs 5-FU/LV, regardless of prior therapy (Table). Grade ≥3 treatment-emergent adverse events were not influenced by prior treatment. Clinical trial information: NCT01494506
Conclusions: These results show consistent benefit of nal-IRI+5-FU/LV treatment across subgroups of pts who previously received gem therapy and support the ASCO guidelines recommending nal-IRI+5-FU/LV for this pt population. These analyses may be limited by the small sample size of treatment arms.
CARE™ FACULTY PERSPECTIVE: Gemcitabine containing regimens, either as a single agent or in combination with nab-paclitaxel remain appropriate treatment options in Canada for first line treatment of patients with pancreatic cancer. In particular, combination therapy has demonstrated improved overall survival and QoL in appropriately selected patients resulting in its adoption as one of the gold-standard therapies for first line treatment.i Moreover, it appears that first line treatment with a gemcitabine containing combination regimen may also be a predictor of receiving second line therapy thus potentially leading to improved outcomes.ii However, despite the recent advances in the management of advanced cancers, patients with pancreatic cancer continue to have relatively few therapeutic options in the second line setting and have generally poor outcomes. This type of data is certainly encouraging and demonstrates that the addition of liposomal irinotecan to infusional 5FU/LV improves both PFS and OS vs 5FU/LV alone. It should be noted however, that the comparator chemotherapy arm was not our typical standard and was different from that used in the experimental arm. In addition, given the population at hand, it would have been ideal to have a group managed with palliative care alone to further highlight the likelihood of treatment effect. This trial highlighted the importance of first line therapy in the probability of receiving second line therapy and thus achieving an OS benefit. It will be interesting to see how payers will interpret this data given that in Ontario, the non-liposomal irinotecan-containing regimen FOLFIRI is not considered evidenced-informed for this indication and is not yet reimbursed.
