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 - 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.
AU - NVALT Study Group
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 (a = 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.
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 (a = 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.
KW - MOLECULAR-WEIGHT HEPARIN
KW - POSITRON-EMISSION-TOMOGRAPHY
KW - SURVIVAL
KW - MULTICENTER
KW - THERAPY
KW - SCAN
KW - PET
U2 - 10.1038/s41416-019-0533-3
DO - 10.1038/s41416-019-0533-3
M3 - Article
C2 - 31337877
VL - 121
SP - 372
EP - 377
JO - British Journal of Cancer
JF - British Journal of Cancer
SN - 0007-0920
IS - 5
ER -