Baseline Appetite Associated With Outcomes in Metastatic Pancreatic Ductal Adenocarcinoma
A study reported post-hoc subgroup analyses of the international phase 3 NAPOLI-1 trial.
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A decreased appetite at baseline was associated with shorter survival among patients with metastatic pancreatic ductal adenocarcinoma (PDAC), according to results of a post-hoc analysis of a phase 3 trial presented at the ESMO World Congress on Gastrointestinal Cancer 2018.1
The international phase 3 NAPOLI-1 trial (ClinicalTrials.gov Identifier: NCT01494506) demonstrated that the addition of liposomal irinotecan to 5-flurouracil (5-FU) plus leucovorin significantly prolonged median overall survival (OS) compared with 5-FU and leucovorin (6.1 vs 4.2 months; hazard ratio [HR], 0.67; P = .012) among patients with metastatic PDAC. This study reported the findings of several post-hoc subgroup analyses.
OS was significantly shorter for patients with decreased appetite at baseline, with a median OS of 3.6 months compared with 5.3 months among those with normal appetite (HR, 1.65; P < .001).
Other analyses, including primary tumor location, need for a biliary stent, and prior response to therapy were not associated with survival outcomes. Liposomal irinotecan plus 5-FU and leucovorin, however, significantly prolonged survival, regardless of primary tumor location or presence of a biliary stent, compared with 5-FU and leucovorin (HR, 0.39-0.88 across groups).
There was no difference in the rates of drug-related adverse events, dose modifications, or drug discontinuations between the subgroups, and the rates were similar to those observed in the NAPOLI-1 primary analysis.
The authors concluded that only decreased appetite at baseline was prognostic for survival with liposomal irinotecan, 5-FU, and leucovorin for patients who progressed after gemcitabine-based treatment of metastatic PDAC. They noted that the “results indicate that appropriate management is essential in patient with decreased appetite.”
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- Macarulla Mercadé T, Lee K, Lakatos G, et al. Selected subgroup analyses of liposomal irinotecan (nal-IRI) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) in the global NAPOLI-1 phase III trial. Ann Oncol. 2018;29 (suppl 5;abstr O-004):v101. doi:10.1093/annonc/mdy149