Randomised phase 3 study of adjuvant chemotherapy with or without nadroparin in patients with completely resected non-small-cell lung cancer: the NVALT-8 study

Harry J. M. Groen, Erik H. F. M. van der Heijden, Theo J. Klinkenberg, Bonne Biesma, Joachim Aerts, Ad Verhagen, Corinne Kloosterziel, Remge Pieterman, Ben van den Borne, Hans J. M. Smit, Otto Hoekstra, Frans M. N. H. Schramel, Vincent van der Noort, Harm van Tinteren, Egbert F. Smit, Anne-Marie C. Dingemans, NVALT Study Group, the Netherlands

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Abstract

Background: Retrospective studies suggest that low molecular weight heparin may delay the development of metastasis in patients with resected NSCLC. Methods: Multicentre phase 3 study with patients with completely resected NSCLC who were randomised after surgery to receive chemotherapy with or without nadroparin. The main exclusion criteria were R1/2 and wedge/segmental resection. FDG-PET was required. The primary endpoint was recurrence-free survival (RFS). Results: Among 235 registered patients, 202 were randomised (nadroparin: n = 100; control n = 102). Slow accrual enabled a decrease in the number of patients needed from 600 to 202, providing 80% power to compare RFS with 94 events (α = 0.05; 2-sided). There were no differences in bleeding events between the two groups. The median RFS was 65.2 months (95% CI, 36—NA) in the nadroparin arm and 37.7 months (95% CI, 22.7—NA) in the control arm (HR 0.77 (95% CI, 0.53–1.13, P = 0.19). FDG-PET SUVmax ≥10 predicted a greater likelihood of recurrence in the first year (HR 0.48, 95% CI 0.22–0.9, P = 0.05). Conclusions: Adjuvant nadroparin did not improve RFS in patients with resected NSCLC. In this study, a high SUVmax predicted a greater likelihood of recurrence in the first year. Clinical trial registration: Netherlands Trial registry: NTR1250/1217.
Original languageEnglish
Pages (from-to)372-377
JournalBritish Journal of Cancer
Volume121
Issue number5
DOIs
Publication statusPublished - 27 Aug 2019

Cite this

Groen, H. J. M., van der Heijden, E. H. F. M., Klinkenberg, T. J., Biesma, B., Aerts, J., Verhagen, A., ... NVALT Study Group, the Netherlands (2019). Randomised phase 3 study of adjuvant chemotherapy with or without nadroparin in patients with completely resected non-small-cell lung cancer: the NVALT-8 study. British Journal of Cancer, 121(5), 372-377. https://doi.org/10.1038/s41416-019-0533-3