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ERJ前沿|低分子肝素在局部肺癌中的抗肿瘤性:III期临床试验

来源:慢性阻塞性肺病网 小南 2019-02-26 |
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摘要:
低分子肝素在局部肺癌中的抗肿瘤性:III期临床试验。

  素材来源:ERS欧洲呼吸学会

? ? ? ?中文导读

ERJ

  肝素的抗转移性是否有益于患有早期癌症的患者尚不清楚。 在这项III期试验中,发现肺癌切除患者辅用亭扎肝素对总体生存率和肿瘤复发没有影响。

ERJ

  AUTHOR INFORMATION

  Guy Meyer1,2,3,4, Benjamin Besse5,6, Hélène Doubre7, Ana?s Charles-Nelson1, Sandro Aquilanti8, Armine Izadifar9, Reza Azarian10, Isabelle Monnet11, Corinne Lamour12,13,

  Renaud Descourt14, Gérard Oliviero15, Laurent Taillade16, Christos Chouaid11, Frederique Giraud17,Pierre-Emmanuel Falcoz18, Marie-Pierre Revel2,17, Virginie Westeel19, Adrien Dixmier20,Jean Tredaniel2,21, Stéphanie Dehette22, Chantal Decroisette23, Alain Prevost24, Eric Pichon25, Elizabeth Fabre1, Jean-Charles Soria5,6, Sylvie Friard7, Jean-Baptiste Stern26,Laurence Jabot11, Georges Dennewald9, Gérard Pavy8, Patrick Petitpretz10, Jean-Marc Tourani12,13, Marco Alifano2,17, Gilles Chatellier1,2,3 and Philippe Girard26

  1H?pital Européen Georges Pompidou, AP-HP, Paris, France

  2Université Paris Descartes, Sorbonne Paris Cité, Paris, France

  3INSERM U 970 and CIC 1418, Paris, France

  4INNOVTE, Saint Etienne, France

  5Institut Gustave Roussy, Villejuif, France

  6Université Paris Sud, Le Kremlin Bicetre, France

  7H?pital Foch, Suresnes, France

  8H?pital privé Arras les Bonettes, Arras, France

  9Centre Cardiologique du Nord, Saint Denis, France

  10H?pital André Mignot, Versailles, France

  11Centre Hospitalier Intercommunal de Créteil, Créteil, France

  12CHU de Poitiers, Poitiers, France

  13Université de Poitiers, Poitiers, France

  14H?pital Morvan, CHU de Brest, Brest, France

  15H?pital de Longjumeau, Longjumeau, France

  16H?pital de la Pitié Salpétrière, AP-HP, Paris, France

  17H?pital Cochin, AP-HP, Paris, France

  18CHU de Strasbourg, Strasbourg, France

  19CHU de Besan?on, Besan?on, France

  20Centre hospitalier régional d'Orléans, Orléans, France

  21Hopital Saint-Joseph, Paris, France

  22Centre hospitalier de Compiègne, Compiègne, France

  23Centre hospitalier régional d'Annecy, Annecy, France

  24Institut Jean Godinot, Reims, France

  25CHU de Tours, h?pital Bretonneux, Tours, France

  26Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris, Paris, France

  Philippe Girard, Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris, 42 boulevard Jourdan, 75014, Paris, France. E-mail: philippe.girard@imm.fr

  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.

  肝素的抗肿瘤和抗转移特性尚未在早期癌症患者中进行测试。本研究的目标是探讨佐剂低分子量肝素(LMWH)亭扎肝素(tinzaparin)是否影响肿瘤切除术后的非小细胞肺癌(NSCLC)患者的存活率。

  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.

  完全外科切除I期,II期或IIIA期NSCLC的患者被随机分配为:1)接受皮下注射tinzaparin 100 IU·kg -1,每天一次,持续12周;或者2)除标准治疗外不进行任何其它治疗。该试验是开放-标记试验,对研究结果进行盲法中央评判。主要结果是总体生存率。

  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).

  549例患者随机接受亭扎肝素(n = 269)或对照组(n = 280),年龄(均值±标准差)为61.6 ± 8.9岁,190例(34.6%)患者为II-III期疾病,220例(40.1%)患者接受辅助化疗。中位随访时间为5.7年。组间总生存率无显着差异(风险比(HR)1.24,95%CI 0.92-1.68; p = 0.17)。组间复发累积发生率无差异(亚分布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.

  对于完全外科切除的I-IIIA期NSCLC患者,佐剂丁扎肝素对总体生存率和无复发生存率无明显影响。这些结果不支持LMWH作为抗肿瘤剂的进一步临床评价。

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