Adjuvant therapy with bemiparin in patients with limited-stage small cell lung cancer: results from the ABEL study.
BACKGROUND
The haemostatic system plays an important role in the process of cancer development and spread. Anticoagulants, mainly low molecular weight heparins, could prolong survival in cancer patients, particularly in patients with lung cancer, beyond prevention of thromboembolic events.


METHODS
In a multicenter, investigator-initiated, open-label, randomized, sequential study, 38 patients with newly-diagnosed, limited-stage small-cell lung cancer were randomized to receive standard chemoradiotherapy or the same therapy plus 3,500 IU daily of bemiparin for a maximum of 26 weeks. The primary outcome was progression-free survival.


RESULTS
The study was terminated early due to slow recruitment. Median progression-free survival was 272 days with chemoradiotherapy alone and 410 days in the bemiparin group; hazard ratio, 2.58 (95% confidence interval [CI], 1.15-5.80); p=0.022. Median overall survival was 345 days with chemoradiotherapy alone and 1133 days in the bemiparin group; hazard ratio, 2.96 (95% CI, 1.22-7.21); p=0.017. The rate of tumor response was similar in both study arms. There was no significant between-group difference in the rates of major bleeding. Toxicity related with the experimental treatment was minimal.


CONCLUSIONS
The addition of bemiparin to first line therapy with chemoradiotherapy significantly increases survival in patients with newly-diagnosed, limited-stage small-cell lung cancer. (Funded by the Instituto Científico y Tecnológico, University of Navarra. ClinicalTrials.gov identifier: NCT00324558).
Hematology Service, University Clinic of Navarra, Pamplona, Spain. Electronic address: rlecumber@unav.es.
R
R
Lecumberri
Oncology Department, Hospital de Cruces, Barakaldo, Spain.
G
G
López Vivanco
Oncology Deparment, Instituto Catalán de Oncología, Hospital Germans Trias i Pujol, Badalona, Spain.
A
A
Font
Hematology & Medical Oncology Department, Hospital Universitario Morales Meseguer, Murcia, Spain.
E
E
González Billalabeitia
Oncology Department, University Clinic of Navarra, Pamplona, Spain.
A
A
Gúrpide
Oncology Department, Hospital Universitario La Fé, Valencia, Spain.
J
J
Gómez Codina
Oncology Department, Hospital Clínico Lozano Blesa, Zaragoza, Spain.
D
D
Isla
Oncology Department, Hospital de Sagunto, Sagunto, Spain.
A
A
Galán
Oncology Department, Hospital Son Llatzer, Palma de Mallorca, Spain.
I
I
Bover
Oncology Department, Fundación Jiménez Díaz, Madrid, Spain.
M
M
Domine
Hematology & Medical Oncology Department, Hospital Universitario Morales Meseguer, Murcia, Spain.
V
V
Vicente
Oncology Deparment, Instituto Catalán de Oncología, Hospital Germans Trias i Pujol, Badalona, Spain.
R
R
Rosell
School of Medicine, University of Navarra, Pamplona, Spain.
E
E
Rocha
D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006470:Hemorrhage / Q000188:drug therapy; D006495:Heparin, Low-Molecular-Weight / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy; D008297:Male; D008875:Middle Aged; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000532:radiotherapy; D016019:Survival Analysis; D016896:Treatment Outcome
D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; D005047:Etoposide; D016190:Carboplatin; C411345:bemiparin; D002945:Cisplatin
Bemiparin; Bleeding; Low molecular weight heparin; Lung cancer; Survival; Venous thromboembolism