397O - Antitumoral Effect of Low Molecular Weight Heparin in Localized Lung Cancer. A randomized phase III controlled trial (397O)

Date 19 November 2017
Event ESMO Asia 2017 Congress
Session Thoracic malignancies 2
Topics Non-Small-Cell Lung Cancer, Early Stage
Presenter Benjamin Besse
Citation Annals of Oncology (2017) 28 (suppl_10): x119-x121. 10.1093/annonc/mdx669
Authors B. Besse1, P. Girard2, H. Doubre3, A. Charles-Nelson4, S. Aquilanti5, A. Izadifar6, R. Azarian7, I. Monnet8, C. Lamour9, R. Descourt10, G. Oliviero11, L. Taillade12, C. Chouaid8, F. Giraud13, P. Falcoz14, M. Revel15, V. Westeel16, M. Alifano17, G. Chatellier18, G. Meyer19
  • 1Dept Of Cancer Medicine, Gustave Roussy Institut de Cancérologie, 94805 - Villejuif/FR
  • 2Thoraic, Institut Mutualiste Montsouris, Paris/FR
  • 3Thoracic, Hopital Foch, 92151 - Suresnes/FR
  • 4Thoraic, Hôpital Européen Georges Pompidou, Paris/FR
  • 5Thoracic, 7Hôpital privé Arras les Bonettes, Arras/FR
  • 6Thoracic, Centre Cardiologique du Nord, Saint-Denis/FR
  • 7Thoracic, Centre Hospitalier de Versailles - Hopital Andre Mignot, 78157 - Le Chesnay/FR
  • 8Thoracic, CH Intercommunal de Créteil, 94010 - Créteil/FR
  • 9Thoracic, CHU Poitiers, Jean Bernard Hôpital, 86021 - Poitiers/FR
  • 10Thoracic, C.H.U. Brest - Hôpital Morvan, 29609 - Brest/FR
  • 11Thoracic, Centre Hospitalier de Longjumeau, 91161 - Longjumeau/FR
  • 12Dept Of Cancer Medicine, 15Hôpital de la Pitié Salpétrière, Paris/FR
  • 13Thoracic, Hôpital Cochin, Paris/FR
  • 14Thoracic, CHU de Strasbourg, Strasbourg/FR
  • 15Radiology, Hôpital Cochin, Paris/FR
  • 16Thoracic, CHU Besançon, Hôpital Jean Minjoz, 25030 - Besançon/FR
  • 17Surgery, Hôpital Cochin, Paris/FR
  • 18Thoracic, Hôpital Européen Georges Pompidou, Paris/FR
  • 19Pneumology, Hopital European George Pompidou, 75015 - Paris/FR

Abstract

Background

Whether low molecular-weight heparins impact the survival of cancer patients remains controversial. We assessed the effect of tinzaparin on survival of patients with resected early-stage non-small cell lung cancer (NSCLC)

Methods

Patients with completely resected stage I, II or IIIA NSCLC were randomized within 8 weeks of surgery to usual care with or without tinzaparin 100 IU/kg daily for 12 weeks. The primary outcome was overall survival (OS). All clinical outcomes were centrally and blindly adjudicated.

Results

From August 2007 to June 2013, 549 patients were randomized to tinzaparin (n = 269) or control (n = 280). A total of 359 (65.4%) and 190 (34.6%) patients had stage I and II-III disease, respectively, and 220 patients (40.1%) received adjuvant chemotherapy. Median follow-up was 5.7 years. There was no significant difference in OS between groups (Hazard Ratio [HR], 1.24; 95% Confidence Interval [CI], 0.92 to 1.68; P = 0.17). Five-year OS was 74.2% (95% CI, 68.9% to 79.9%) and 68.2% (95% CI, 62.5% to 74.4%) in the control and tinzaparin groups, respectively. There was no difference in the cumulative incidence of recurrence between groups (subdistribution HR 0.94; 95% CI, 0.68 to 1.30; P = 0.70). In patients who received adjuvant chemotherapy, OS was lower in the tinzaparin group (HR, 1.78; 95%CI, 1.13 to 2.81; P = 0.013). Two patients in the tinzaparin group experienced serious bleeding during the treatment period.

Conclusions

Adjuvant tinzaparin at a dose of 100 IU/kg/d for 12 weeks had no detectable impact on overall and recurrence-free survival of patients with completely resected stage I-IIIA NSCLC.

Clinical trial identification

NCT00475098

Legal entity responsible for the study

Hôpital Européen Georges Pompidou, Paris, France

Legal entity responsible for the study

Hôpital Européen Georges Pompidou, Paris, France

Funding

Leo Pharma

Disclosure

All authors have declared no conflicts of interest.