TY - JOUR
T1 - Anti-tumour effect of low molecular weight heparin in localised lung cancer
T2 - A phase III clinical trial
AU - Meyer, Guy
AU - Besse, Benjamin
AU - Doubre, Hélène
AU - Charles-Nelson, Anaïs
AU - Aquilanti, Sandro
AU - Izadifar, Armine
AU - Azarian, Reza
AU - Monnet, Isabelle
AU - Lamour, Corinne
AU - Descourt, Renaud
AU - Oliviero, Gérard
AU - Taillade, Laurent
AU - Chouaid, Christos
AU - Giraud, Frederique
AU - Falcoz, Pierre Emmanuel
AU - Revel, Marie Pierre
AU - Westeel, Virginie
AU - Dixmier, Adrien
AU - Tredaniel, Jean
AU - Dehette, Stéphanie
AU - Decroisette, Chantal
AU - Prevost, Alain
AU - Pichon, Eric
AU - Fabre, Elizabeth
AU - Soria, Jean Charles
AU - Friard, Sylvie
AU - Stern, Jean Baptiste
AU - Jabot, Laurence
AU - Dennewald, Georges
AU - Pavy, Gérard
AU - Petitpretz, Patrick
AU - Tourani, Jean Marc
AU - Alifano, Marco
AU - Chatellier, Gilles
AU - Girard, Philippe
N1 - Funding Information:
Support statement: The trial was sponsored by the Assistance Publique-Hôpitaux de Paris and funded by two grants from the Programme Hospitalier de Recherche Clinique, French Ministry of Health, (PHRC AOM05185 and PHRC AOM12612). Leo Pharma provided the drug and an additional grant. Funding information for this article has been deposited with the Crossref Funder Registry.
Funding Information:
The study was supported by two grants issued by the French Ministry of Health (PHRC AOM05185 and PHRC AOM12612). The funder had no role in study design, data collection, data gathering, data interpretation, or writing of the manuscript. Leo Pharma provided the study drug and a complementary grant but had no role in the study design, conduct of the study, data analysis and decision to submit the manuscript.
Funding Information:
The trial was sponsored by the Assistance Publique-Hôpitaux de Paris and funded by two grants from the Programme Hospitalier de Recherche Clinique, French Ministry of Health, (PHRC AOM05185 and PHRC AOM12612). Leo Pharma provided the drug and an additional grant. Funding information for this article has been deposited with the Crossref Funder Registry.
Publisher Copyright:
Copyright ©ERS 2018.
PY - 2018/10/1
Y1 - 2018/10/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85054423702&partnerID=8YFLogxK
U2 - 10.1183/13993003.01220-2018
DO - 10.1183/13993003.01220-2018
M3 - Article
C2 - 30262574
AN - SCOPUS:85054423702
SN - 0903-1936
VL - 52
JO - European Respiratory Journal
JF - European Respiratory Journal
IS - 4
M1 - 1801220
ER -
