Anti-tumour effect of low molecular weight heparin in localised lung cancer: a phase III clinical trial
Guy Meyer, Benjamin Besse, Hélène Doubre, Anaïs Charles-Nelson, Sandro Aquilanti, Armine Izadifar, Reza Azarian, Isabelle Monnet, Corinne Lamour, Renaud Descourt, Gérard Oliviero, Laurent Taillade, Christos Chouaid, Frederique Giraud, Pierre-Emmanuel Falcoz, Marie-Pierre Revel, Virginie Westeel, Adrien Dixmier, Jean Tredaniel, Stéphanie Dehette, Chantal Decroisette, Alain Prevost, Eric Pichon, Elizabeth Fabre, Jean-Charles Soria, Sylvie Friard, Jean-Baptiste Stern, Laurence Jabot, Georges Dennewald, Gérard Pavy, Patrick Petitpretz, Jean-Marc Tourani, Marco Alifano, Gilles Chatellier, Philippe Girard, Guy Meyer, Benjamin Besse, Hélène Doubre, Anaïs Charles-Nelson, Sandro Aquilanti, Armine Izadifar, Reza Azarian, Isabelle Monnet, Corinne Lamour, Renaud Descourt, Gérard Oliviero, Laurent Taillade, Christos Chouaid, Frederique Giraud, Pierre-Emmanuel Falcoz, Marie-Pierre Revel, Virginie Westeel, Adrien Dixmier, Jean Tredaniel, Stéphanie Dehette, Chantal Decroisette, Alain Prevost, Eric Pichon, Elizabeth Fabre, Jean-Charles Soria, Sylvie Friard, Jean-Baptiste Stern, Laurence Jabot, Georges Dennewald, Gérard Pavy, Patrick Petitpretz, Jean-Marc Tourani, Marco Alifano, Gilles Chatellier, Philippe Girard
Abstract
The anti-tumour and anti-metastatic properties of heparins have not been tested in patients with early stage cancer. Whether adjuvant low molecular weight heparin (LMWH) tinzaparin impacts the survival of patients with resected non-small cell lung cancer (NSCLC) was investigated.Patients with completely resected stage I, II or IIIA NSCLC were randomly allocated to receive subcutaneous tinzaparin 100 IU·kg-1 once a day for 12 weeks or no treatment in addition to standard of care. The trial was open-label with blinded central adjudication of study outcomes. The primary outcome was overall survival.In 549 patients randomised to tinzaparin (n=269) or control (n=280), mean±sd age was 61.6±8.9 years, 190 (34.6%) patients had stage II-III disease, and 220 (40.1%) patients received adjuvant chemotherapy. Median follow-up was 5.7 years. There was no significant difference in overall survival between groups (hazard ratio (HR) 1.24, 95% CI 0.92-1.68; p=0.17). There was no difference in the cumulative incidence of recurrence between groups (subdistribution HR 0.94, 95% CI 0.68-1.30; p=0.70).Adjuvant tinzaparin had no detectable impact on overall and recurrence-free survival of patients with completely resected stage I-IIIA NSCLC. These results do not support further clinical evaluation of LMWHs as anti-tumour agents.
Trial registration: ClinicalTrials.gov NCT00475098.
Conflict of interest statement
Conflict of interest: G. Meyer reports grants and non-financial support from Leo Pharma, outside the submitted work. Conflict of interest: B. Besse has nothing to disclose. Conflict of interest: H. Doubre has nothing to disclose. Conflict of interest: A. Charles-Nelson has nothing to disclose. Conflict of interest: S. Aquilanti reports non-financial support from Leo Pharma, outside the submitted work. Conflict of interest: A. Izadifar has nothing to disclose. Conflict of interest: R. Azarian has nothing to disclose. Conflict of interest: I. Monnet has nothing to disclose. Conflict of interest: C. Lamour has nothing to disclose. Conflict of interest: R. Descourt has nothing to disclose. Conflict of interest: G. Oliviero has nothing to disclose. Conflict of interest: L. Taillade has nothing to disclose. Conflict of interest: C. Chouaid has nothing to disclose. Conflict of interest: F. Giraud has nothing to disclose. Conflict of interest: P-E. Falcoz has nothing to disclose. Conflict of interest: M-P. Revel has nothing to disclose. Conflict of interest: V. Westeel has nothing to disclose. Conflict of interest: A. Dixmier has nothing to disclose. Conflict of interest: J. Tredaniel has nothing to disclose. Conflict of interest: S. Dehette has nothing to disclose. Conflict of interest: C. Decroisette has nothing to disclose. Conflict of interest: A. Prevost has nothing to disclose. Conflict of interest: E. Pichon has nothing to disclose. Conflict of interest: E. Fabre has nothing to disclose. Conflict of interest: J-C. Soria has nothing to disclose. Conflict of interest: S. Friard has nothing to disclose. Conflict of interest: J-B. Stern has nothing to disclose. Conflict of interest: L. Jabot has nothing to disclose. Conflict of interest: G. Dennewald has nothing to disclose. Conflict of interest: G. Pavy has nothing to disclose. Conflict of interest: P. Petitpretz has nothing to disclose. Conflict of interest: J-M. Tourani has nothing to disclose. Conflict of interest: M. Alifano has nothing to disclose. Conflict of interest: Dr. Chatellier has nothing to disclose. Conflict of interest: P. Girard reports personal fees and non-financial support from Leo Pharma, outside the submitted work.
Copyright ©ERS 2018.
Source: PubMed