Baseline Appetite Associated With Outcomes in Metastatic Pancreatic Ductal Adenocarcinoma

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A study reported post-hoc subgroup analyses of the international phase 3 NAPOLI-1 trial.
A study reported post-hoc subgroup analyses of the international phase 3 NAPOLI-1 trial.
The following article features coverage from the ESMO World Congress on Gastrointestinal Cancer 2018 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.

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.”

Read more of Cancer Therapy Advisor's coverage of the ESMO World Congress on Gastrointestinal Cancer 2018 meeting by visiting the conference page.

Reference

  1. 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

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