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

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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.

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Most cited references 19

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FDG PET and PET/CT: EANM procedure guidelines for tumour PET imaging: version 1.0

Ronald Boellaard, Mike J. O’Doherty, Wolfgang A. Weber … (2009)

The aim of this guideline is to provide a minimum standard for the acquisition and interpretation of PET and PET/CT scans with [18F]-fluorodeoxyglucose (FDG). This guideline will therefore address general information about [18F]-fluorodeoxyglucose (FDG) positron emission tomography-computed tomography (PET/CT) and is provided to help the physician and physicist to assist to carrying out, interpret, and document quantitative FDG PET/CT examinations, but will concentrate on the optimisation of diagnostic quality and quantitative information.

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Long-term results of the international adjuvant lung cancer trial evaluating adjuvant Cisplatin-based chemotherapy in resected lung cancer.

Mirosław Kozłowski, Rodrigo Arriagada, Jean-Christophe Pignon … (2010)

PURPOSE Based on 5-year or shorter-term follow-up data in recent randomized trials, adjuvant cisplatin-based chemotherapy is now generally recommended after complete surgical resection for patients with non-small-cell lung cancer (NSCLC). We evaluated the results of the International Adjuvant Lung Cancer Trial study with three additional years of follow-up. PATIENTS AND METHODS Patients with completely resected NSCLC were randomly assigned to three or four cycles of cisplatin-based chemotherapy or to observation. Cox models were used to evaluate treatment effect according to follow-up duration. Results The trial included 1,867 patients with a median follow-up of 7.5 years. Results showed a beneficial effect of adjuvant chemotherapy on overall survival (hazard ratio [HR], 0.91; 95% CI, 0.81 to 1.02; P = .10) and on disease-free survival (HR, 0.88; 95% CI, 0.78 to 0.98; P = .02). However, there was a significant difference between the results of overall survival before and after 5 years of follow-up (HR, 0.86; 95% CI, 0.76 to 0.97; P = .01 v HR, 1.45; 95% CI, 1.02 to 2.07; P = .04) with P = .006 for interaction. Similar results were observed for disease-free survival. The analysis of non-lung cancer deaths for the whole period showed an HR of 1.34 (95% CI, 0.99 to 1.81; P = .06). CONCLUSION These results confirm the significant efficacy of adjuvant chemotherapy at 5 years. The difference in results beyond 5 years of follow-up underscores the need for the long-term follow-up of other adjuvant lung cancer trials and for a better identification of patients deriving long-term benefit from adjuvant chemotherapy.

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Randomized phase III trial of vinorelbine plus cisplatin compared with observation in completely resected stage IB and II non-small-cell lung cancer: updated survival analysis of JBR-10.

David Gandara, Yvon Cormier, John A. Shepherd … (2010)

PURPOSE Adjuvant cisplatin-based chemotherapy (ACT) is now an accepted standard for completely resected stage II and III A non-small-cell lung cancer (NSCLC). Long-term follow-up is important to document persistent benefit and late toxicity. We report here updated overall survival (OS) and disease-specific survival (DSS) data. PATIENTS AND METHODS Patients with completely resected stage IB (T2N0, n = 219) or II (T1-2N1, n = 263) NSCLC were randomly assigned to receive 4 cycles of vinorelbine/cisplatin or observation. All efficacy analyses were performed on an intention-to-treat basis. Results Median follow-up was 9.3 years (range, 5.8 to 13.8; 33 lost to follow-up); there were 271 deaths in 482 randomly assigned patients. ACT continues to show a benefit (hazard ratio [HR], 0.78; 95% CI, 0.61 to 0.99; P = .04). There was a trend for interaction with disease stage (P = .09; HR for stage II, 0.68; 95% CI, 0.5 to 0.92; P = .01; stage IB, HR, 1.03; 95% CI, 0.7 to 1.52; P = .87). ACT resulted in significantly prolonged DSS (HR, 0.73; 95% CI, 0.55 to 0.97; P = .03). Observation was associated with significantly higher risk of death from lung cancer (P = .02), with no difference in rates of death from other causes or second primary malignancies between the arms. CONCLUSION Prolonged follow-up of patients from the JBR.10 trial continues to show a benefit in survival for adjuvant chemotherapy. This benefit appears to be confined to N1 patients. There was no increase in death from other causes in the chemotherapy arm.

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Author and article information

Contributors

Harry J. M. Groen: +0031503616161 , h.j.m.groen@umcg.nl

Journal

Journal ID (nlm-ta): Br J Cancer

Journal ID (iso-abbrev): Br. J. Cancer

Title: British Journal of Cancer

Publisher: Nature Publishing Group UK (London )

ISSN (Print): 0007-0920

ISSN (Electronic): 1532-1827

Publication date (Electronic): 24 July 2019

Publication date (Print): 27 August 2019

Volume: 121

Issue: 5

Pages: 372-377

Affiliations

[1 ]ISNI 0000 0004 0407 1981, GRID grid.4830.f, Department of Pulmonary Disease, , University of Groningen and University Medical Center Groningen, ; Hanzeplein 1, Box 30.001, 9700 RB Groningen, Netherlands

[2 ]ISNI 0000 0004 0444 9382, GRID grid.10417.33, Department of Pulmonary Diseases, , Radboud University Medical Center, ; Geert Grooteplein Zuid 10, 6525 GA Nijmegen, Netherlands

[3 ]ISNI 0000 0000 9558 4598, GRID grid.4494.d, Department of Cardiothoracic Surgery, , University of Groningen and University Medical Center Groningen, ; Hanzeplein 1, Box 30.001, 9700 RB Groningen, Netherlands

[4 ]ISNI 0000 0004 0501 9798, GRID grid.413508.b, Department of Pulmonary Diseases, , Jeroen Bosch Hospital, ; Henri Dunantstraat 1, 5223 GZ ‘s-Hertogenbosch, Netherlands

[5 ]ISNI 000000040459992X, GRID grid.5645.2, Department of Pulmonary Diseases, , Erasmus Medical Center, ; Dr Molewaterplein 40, 3015 GD Rotterdam, Netherlands

[6 ]ISNI 0000 0004 0444 9382, GRID grid.10417.33, Department of Cardiothoracic Surgery, , Radboud University Medical Center, ; Geert Grooteplein Zuid 10, 6525 GA Nijmegen, Netherlands

[7 ]ISNI 0000 0001 0547 5927, GRID grid.452600.5, Department of Pulmonary Diseases, , Isala Hospital, ; Dokter van Heesweg 2, 8025 AB Zwolle, Netherlands

[8 ]Department of Pulmonary Diseases, Ommelander Hospital Group, Pastorieweg 1, 9679 BJ Scheemda, Netherlands

[9 ]ISNI 0000 0004 0398 8384, GRID grid.413532.2, Department of Pulmonary Diseases, , Catharina Hospital, ; Michelangelolaan 2, 5623 EJ Eindhoven, Netherlands

[10 ]GRID grid.415930.a, Department of Pulmonary Diseases, , Rijnstate Hospital, ; Wagnerlaan 55, 6815 AD Arnhem, Netherlands

[11 ]Department of Nuclear Medicine, Amsterdam University Medical Center, De Boelelaan 1117, 1081 HVAmsterdam, Netherlands

[12 ]ISNI 0000 0004 0622 1269, GRID grid.415960.f, Department of Pulmonary Diseases, , St Antonius Hospital, ; Koekoekslaan 1, 3435 CM Nieuwegein, Netherlands

[13 ]GRID grid.430814.a, Department of Biometrics, , Antoni van Leeuwenhoek Hospital, ; Plesmanlaan 121, 1066 CX Amsterdam, Netherlands

[14 ]GRID grid.430814.a, Department of Thoracic Oncology, , Antoni van Leeuwenhoek Hospital, ; Plesmanlaan 121, 1066 CX Amsterdam, Netherlands

[15 ]ISNI 0000 0004 0480 1382, GRID grid.412966.e, Department of Pulmonary Diseases, , Maastricht University Medical Center, ; P. Debijelaan 25, 6229 HX Maastricht, Netherlands

Article

Publisher ID: 533

DOI: 10.1038/s41416-019-0533-3

PMC ID: 6738047

PubMed ID: 31337877

SO-VID: 1b97ed51-4817-4605-95d6-96a69794b6ac

License:

This work is published under the standard license to publish agreement. After 12 months the work will become freely available and the license terms will switch to a Creative Commons Attribution 4.0 International (CC BY 4.0).

History

Date received : 1 November 2018

Date revision received : 13 June 2019

Date accepted : 4 July 2019

Funding

Funded by: FundRef https://doi.org/10.13039/100010806, Amgen Inc. | Amgen Nederland (Amgen B.V. Netherlands);

Funded by: FundRef https://doi.org/10.13039/100004337, Roche (F. Hoffmann-La Roche Ltd);

Funded by: FundRef https://doi.org/10.13039/501100004622, KWF Kankerbestrijding (Dutch Cancer Society);

Funded by: FundRef https://doi.org/10.13039/100004312, Eli Lilly and Company (Lilly);

Funded by: Eli Lilly Nederland BV Papendorpseweg 83, NL - 3528 BJ Utrecht Roche Nederland B.V. Beneluxlaan 2a 3446 GR Woerden Amgen B.V. Minervum 7061 | P.O. Box 3345 | 4800 DH Breda | The Netherlands KWF is the Dutch Cancer Foundation who supported this study with datamanagement and statistical support.

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ScienceOpen disciplines: Oncology & Radiotherapy

Keywords: non-small-cell lung cancer

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ScienceOpen disciplines: Oncology & Radiotherapy

Keywords: non-small-cell lung cancer

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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

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Abstract

Background

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Clinical trial registration

Related collections

Karger: Oncology

Most cited references 19

FDG PET and PET/CT: EANM procedure guidelines for tumour PET imaging: version 1.0

Long-term results of the international adjuvant lung cancer trial evaluating adjuvant Cisplatin-based chemotherapy in resected lung cancer.

Randomized phase III trial of vinorelbine plus cisplatin compared with observation in completely resected stage IB and II non-small-cell lung cancer: updated survival analysis of JBR-10.

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