TY - JOUR
T1 - Randomised phase 3 study of adjuvant chemotherapy with or without nadroparin in patients with completely resected non-small-cell lung cancer
T2 - the NVALT-8 study
AU - the NVALT Study Group, the Netherlands
AU - Groen, Harry J.M.
AU - van der Heijden, Erik H.F.M.
AU - Klinkenberg, Theo J.
AU - Biesma, Bonne
AU - Aerts, Joachim
AU - Verhagen, Ad
AU - Kloosterziel, Corinne
AU - Pieterman, Remge
AU - van den Borne, Ben
AU - Smit, Hans J.M.
AU - Hoekstra, Otto
AU - Schramel, Frans M.N.H.
AU - van der Noort, Vincent
AU - van Tinteren, Harm
AU - Smit, Egbert F.
AU - Dingemans, Anne Marie C.
N1 - Funding Information:
Funding: This work was financially supported with regard to the drug supply and data management by Eli Lilly, Amgen, Roche, and the Dutch Cancer Society.
Publisher Copyright:
© 2019, The Author(s), under exclusive licence to Cancer Research UK.
PY - 2019/8/27
Y1 - 2019/8/27
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/85069659848
U2 - 10.1038/s41416-019-0533-3
DO - 10.1038/s41416-019-0533-3
M3 - Article
C2 - 31337877
SN - 0007-0920
VL - 121
SP - 372
EP - 377
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 5
ER -
