Quality-adjusted survival with combination nal-IRIFU/LV vs 5-FU/LV alone in metastatic pancreatic cancer patients previously treated with gemcitabine-based therapy: A Q-TWiST analysis

Uwe Pelzer, Jean Frédéric Blanc, Davide Melisi, Antonio Cubillo, Daniel D. Von Hoff, Andrea Wang-Gillam, Li Tzong Chen, Jens T. Siveke, Yin Wan, Caitlyn T. Solem, Marc F. Botteman, Yoojung Yang, Floris A. De Jong, Richard A. Hubner

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11 Scopus citations

Abstract

Background: In the NAPOLI-1 Phase 3 trial, nal-IRIfluorouracil and leucovorin (5-FU/LV) significantly improved median overall survival (6.1 vs 4.2 months, P=0.012) and progression-free survival (3.1 vs 1.5 months, P=0.0001) vs 5-FU/LV alone in metastatic pancreatic adenocarcinoma patients previously treated with gemcitabine-based therapy. This analysis evaluated between treatment differences in quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST). Methods: Overall survival was partitioned into time with grade ≥3 toxicity (TOX), disease progression (REL), and time without disease progression symptoms or grade ≥3 toxicity (TWiST). Mean Q-TWiST was calculated by weighting time spent by a utility of 1.0 for TWiST and 0.5 for TOX and REL. In threshold analyses, utility for TOX and REL were varied from 0.0 to 1.0. Results: Patients in nal-IRIFU/LV (n=117) vs 5-FU/LV (n=119) had significantly more mean time in TWiST (3.4 vs 2.4 months) and TOX (1.0 vs 0.3 months) but similar REL (2.5 vs 2.7 months). In the base case, nal-IRIFU/LV patients had 1.3 months (95% CI, 0.4-2.1; 5.1 vs 3.9) greater Q-TWiST (threshold analyses range: 0.9-1.6 months). Conclusions: Within NAPOLI-1, nal-IRIFU/LV resulted in statistically significant and clinically meaningful gains in quality-adjusted survival vs 5-FU/LV alone.

Original languageEnglish
Pages (from-to)1247-1253
Number of pages7
JournalBritish Journal of Cancer
Volume116
Issue number10
DOIs
StatePublished - May 9 2017

Keywords

  • NAPOLI-1
  • Q-TWiST
  • clinical trial
  • metastatic pancreatic cancer

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    Pelzer, U., Blanc, J. F., Melisi, D., Cubillo, A., Von Hoff, D. D., Wang-Gillam, A., Chen, L. T., Siveke, J. T., Wan, Y., Solem, C. T., Botteman, M. F., Yang, Y., De Jong, F. A., & Hubner, R. A. (2017). Quality-adjusted survival with combination nal-IRIFU/LV vs 5-FU/LV alone in metastatic pancreatic cancer patients previously treated with gemcitabine-based therapy: A Q-TWiST analysis. British Journal of Cancer, 116(10), 1247-1253. https://doi.org/10.1038/bjc.2017.67