Anti-tumour effect of low molecular weight heparin in localised lung cancer: a phase III clinical trial
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 comple...
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| Vydáno v: | The European respiratory journal Ročník 52; číslo 4 |
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| Médium: | Journal Article |
| Jazyk: | angličtina |
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England
01.10.2018
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| ISSN: | 1399-3003, 1399-3003 |
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| 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
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. |
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| AbstractList | 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
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. 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.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. |
| Author | Stern, Jean-Baptiste Monnet, Isabelle Oliviero, Gérard Prevost, Alain Falcoz, Pierre-Emmanuel Izadifar, Armine Chatellier, Gilles Meyer, Guy Besse, Benjamin Petitpretz, Patrick Westeel, Virginie Revel, Marie-Pierre Chouaid, Christos Girard, Philippe Aquilanti, Sandro Pavy, Gérard Azarian, Reza Soria, Jean-Charles Jabot, Laurence Descourt, Renaud Decroisette, Chantal Giraud, Frederique Charles-Nelson, Anaïs Tredaniel, Jean Dennewald, Georges Tourani, Jean-Marc Alifano, Marco Pichon, Eric Dixmier, Adrien Doubre, Hélène Lamour, Corinne Taillade, Laurent Dehette, Stéphanie Friard, Sylvie Fabre, Elizabeth |
| Author_xml | – sequence: 1 givenname: Guy surname: Meyer fullname: Meyer, Guy organization: INNOVTE, Saint Etienne, France – sequence: 2 givenname: Benjamin surname: Besse fullname: Besse, Benjamin organization: Université Paris Sud, Le Kremlin Bicetre, France – sequence: 3 givenname: Hélène surname: Doubre fullname: Doubre, Hélène organization: Hôpital Foch, Suresnes, France – sequence: 4 givenname: Anaïs surname: Charles-Nelson fullname: Charles-Nelson, Anaïs organization: Hôpital Européen Georges Pompidou, AP-HP, Paris, France – sequence: 5 givenname: Sandro surname: Aquilanti fullname: Aquilanti, Sandro organization: Hôpital privé Arras les Bonettes, Arras, France – sequence: 6 givenname: Armine surname: Izadifar fullname: Izadifar, Armine organization: Centre Cardiologique du Nord, Saint Denis, France – sequence: 7 givenname: Reza surname: Azarian fullname: Azarian, Reza organization: Hôpital André Mignot, Versailles, France – sequence: 8 givenname: Isabelle surname: Monnet fullname: Monnet, Isabelle organization: Centre Hospitalier Intercommunal de Créteil, Créteil, France – sequence: 9 givenname: Corinne surname: Lamour fullname: Lamour, Corinne organization: Université de Poitiers, Poitiers, France – sequence: 10 givenname: Renaud surname: Descourt fullname: Descourt, Renaud organization: Hôpital Morvan, CHU de Brest, Brest, France – sequence: 11 givenname: Gérard surname: Oliviero fullname: Oliviero, Gérard organization: Hôpital de Longjumeau, Longjumeau, France – sequence: 12 givenname: Laurent surname: Taillade fullname: Taillade, Laurent organization: Hôpital de la Pitié Salpétrière, AP-HP, Paris, France – sequence: 13 givenname: Christos surname: Chouaid fullname: Chouaid, Christos organization: Centre Hospitalier Intercommunal de Créteil, Créteil, France – sequence: 14 givenname: Frederique surname: Giraud fullname: Giraud, Frederique organization: Hôpital Cochin, AP-HP, Paris, France – sequence: 15 givenname: Pierre-Emmanuel surname: Falcoz fullname: Falcoz, Pierre-Emmanuel organization: CHU de Strasbourg, Strasbourg, France – sequence: 16 givenname: Marie-Pierre surname: Revel fullname: Revel, Marie-Pierre organization: Hôpital Cochin, AP-HP, Paris, France – sequence: 17 givenname: Virginie surname: Westeel fullname: Westeel, Virginie organization: CHU de Besançon, Besançon, France – sequence: 18 givenname: Adrien surname: Dixmier fullname: Dixmier, Adrien organization: Centre hospitalier régional d'Orléans, Orléans, France – sequence: 19 givenname: Jean surname: Tredaniel fullname: Tredaniel, Jean organization: Hopital Saint-Joseph, Paris, France – sequence: 20 givenname: Stéphanie surname: Dehette fullname: Dehette, Stéphanie organization: Centre hospitalier de Compiègne, Compiègne, France – sequence: 21 givenname: Chantal surname: Decroisette fullname: Decroisette, Chantal organization: Centre hospitalier régional d'Annecy, Annecy, France – sequence: 22 givenname: Alain surname: Prevost fullname: Prevost, Alain organization: Institut Jean Godinot, Reims, France – sequence: 23 givenname: Eric surname: Pichon fullname: Pichon, Eric organization: CHU de Tours, hôpital Bretonneux, Tours, France – sequence: 24 givenname: Elizabeth surname: Fabre fullname: Fabre, Elizabeth organization: Hôpital Européen Georges Pompidou, AP-HP, Paris, France – sequence: 25 givenname: Jean-Charles surname: Soria fullname: Soria, Jean-Charles organization: Université Paris Sud, Le Kremlin Bicetre, France – sequence: 26 givenname: Sylvie surname: Friard fullname: Friard, Sylvie organization: Hôpital Foch, Suresnes, France – sequence: 27 givenname: Jean-Baptiste surname: Stern fullname: Stern, Jean-Baptiste organization: Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris, Paris, France – sequence: 28 givenname: Laurence surname: Jabot fullname: Jabot, Laurence organization: Centre Hospitalier Intercommunal de Créteil, Créteil, France – sequence: 29 givenname: Georges surname: Dennewald fullname: Dennewald, Georges organization: Centre Cardiologique du Nord, Saint Denis, France – sequence: 30 givenname: Gérard surname: Pavy fullname: Pavy, Gérard organization: Hôpital privé Arras les Bonettes, Arras, France – sequence: 31 givenname: Patrick surname: Petitpretz fullname: Petitpretz, Patrick organization: Hôpital André Mignot, Versailles, France – sequence: 32 givenname: Jean-Marc surname: Tourani fullname: Tourani, Jean-Marc organization: Université de Poitiers, Poitiers, France – sequence: 33 givenname: Marco surname: Alifano fullname: Alifano, Marco organization: Hôpital Cochin, AP-HP, Paris, France – sequence: 34 givenname: Gilles surname: Chatellier fullname: Chatellier, Gilles organization: INSERM U 970 and CIC 1418, Paris, France – sequence: 35 givenname: Philippe surname: Girard fullname: Girard, Philippe organization: Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris, Paris, France |
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| Title | Anti-tumour effect of low molecular weight heparin in localised lung cancer: a phase III clinical trial |
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