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

doi:10.1038/s41416-019-0533-3

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

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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 (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.

Original language	English
Pages (from-to)	372-377
Number of pages	6
Journal	British Journal of Cancer
Volume	121
Issue number	5
DOIs	https://doi.org/10.1038/s41416-019-0533-3
Publication status	Published - 27 Aug 2019

Keywords

MOLECULAR-WEIGHT HEPARIN
POSITRON-EMISSION-TOMOGRAPHY
SURVIVAL
MULTICENTER
THERAPY
SCAN
PET

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Groen, H. J. M., van der Heijden, E. H. F. M., Klinkenberg, T. J., Biesma, B., Aerts, J., Verhagen, A., Kloosterziel, C., Pieterman, R., van den Borne, B., Smit, H. J. M., Hoekstra, O., Schramel, F. M. N. H., van der Noort, V., van Tinteren, H., Smit, E. F., Dingemans, A.-M. C., & NVALT Study Group (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

@article{24eb4a4890b141faa8cbec070dd26ed4,

title = "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",

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 (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.",

keywords = "MOLECULAR-WEIGHT HEPARIN, POSITRON-EMISSION-TOMOGRAPHY, SURVIVAL, MULTICENTER, THERAPY, SCAN, PET",

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

note = "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: {\textcopyright} 2019, The Author(s), under exclusive licence to Cancer Research UK.",

year = "2019",

month = aug,

day = "27",

doi = "10.1038/s41416-019-0533-3",

language = "English",

volume = "121",

pages = "372--377",

journal = "British Journal of Cancer",

issn = "0007-0920",

publisher = "Springer",

number = "5",

}

Groen, HJM, van der Heijden, EHFM, Klinkenberg, TJ, Biesma, B, Aerts, J, Verhagen, A, Kloosterziel, C, Pieterman, R, van den Borne, B, Smit, HJM, Hoekstra, O, Schramel, FMNH, van der Noort, V, van Tinteren, H, Smit, EF, Dingemans, A-MC & NVALT Study Group 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, vol. 121, no. 5, pp. 372-377. https://doi.org/10.1038/s41416-019-0533-3

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. / Groen, Harry J. M.; van der Heijden, Erik H. F. M.; Klinkenberg, Theo J. et al.
In: British Journal of Cancer, Vol. 121, No. 5, 27.08.2019, p. 372-377.

Research output: Contribution to journal › Article › Academic › peer-review

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

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 (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

SN - 0007-0920

VL - 121

SP - 372

EP - 377

JO - British Journal of Cancer

JF - British Journal of Cancer

IS - 5

ER -

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

Abstract

Keywords

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