Evidence map›Paper›PMID 31337877›Full record

Trial reportBritish journal of cancer2019

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 and 7 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
2.3field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 8 institutions in 2 countries.

Harry J M GroenDepartment of Pulmonary Disease, University of Groningen and University Medical Center Groningen, Hanzeplein 1, Box 30.001, 9700 RB, Groningen, Netherlands. h.j.m.groen@umcg.nl.
Erik H F M van der HeijdenDepartment of Pulmonary Diseases, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, Netherlands.
Theo J KlinkenbergDepartment of Cardiothoracic Surgery, University of Groningen and University Medical Center Groningen, Hanzeplein 1, Box 30.001, 9700 RB, Groningen, Netherlands.
Bonne BiesmaDepartment of Pulmonary Diseases, Jeroen Bosch Hospital, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch, Netherlands.
Joachim AertsDepartment of Pulmonary Diseases, Erasmus Medical Center, Dr Molewaterplein 40, 3015 GD, Rotterdam, Netherlands.
Ad VerhagenDepartment of Cardiothoracic Surgery, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, Netherlands.
Corinne KloosterzielDepartment of Pulmonary Diseases, Isala Hospital, Dokter van Heesweg 2, 8025 AB, Zwolle, Netherlands.
Remge PietermanDepartment of Pulmonary Diseases, Ommelander Hospital Group, Pastorieweg 1, 9679 BJ, Scheemda, Netherlands.
Ben van den BorneDepartment of Pulmonary Diseases, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, Netherlands.
Hans J M SmitDepartment of Pulmonary Diseases, Rijnstate Hospital, Wagnerlaan 55, 6815 AD, Arnhem, Netherlands.
Otto HoekstraDepartment of Nuclear Medicine, Amsterdam University Medical Center, De Boelelaan 1117, 1081, HVAmsterdam, Netherlands.
Frans M N H SchramelDepartment of Pulmonary Diseases, St Antonius Hospital, Koekoekslaan 1, 3435 CM, Nieuwegein, Netherlands.
Vincent van der NoortDepartment of Biometrics, Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, Netherlands.
Harm van TinterenDepartment of Biometrics, Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, Netherlands.
Egbert F SmitDepartment of Thoracic Oncology, Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, Netherlands.
Anne-Marie C DingemansDepartment of Pulmonary Diseases, Maastricht University Medical Center, P. Debijelaan 25, 6229 HX, Maastricht, Netherlands.
NVALT Study Group, the Netherlands
Radboud University Nijmegen · NLThe Netherlands Cancer Institute · NLUniversity Medical Center Groningen · NLAmsterdam University Medical Centers · NLErasmus MC · NLIsala · NLMaastricht University · NLSt. Antonius Ziekenhuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRetrospective studies suggest that low molecular weight heparin may delay the development of metastasis in patients with resected NSCLC.

methodsMulticentre 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).

resultsAmong 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).

conclusionsAdjuvant 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 registrationNetherlands Trial registry: NTR1250/1217.

Indexed as

PneumonectomyAgedAnticoagulantsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellChemotherapy, AdjuvantCisplatinDeoxycytidineDisease-Free SurvivalFemaleFluorodeoxyglucose F18GemcitabineHumansLung NeoplasmsMaleAnticoagulantsCisplatinDeoxycytidineFluorodeoxyglucose F18GemcitabineNadroparinPemetrexed

Identifiers

PMID31337877
PMCPMC6738047
OpenAlexW2963648628

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.