Patients with small-cell lung cancer (SCLC) do not have improved overall survival (OS) with supraprophylactic doses of low-molecular weight heparin (LWMH) added to standard therapy, according to a study published in the Annals of Oncology.1
Coagulative disorders, such as venous thromboembolism (VTE), are frequent complications among patients with cancer and are significant contributors to poor outcomes. Previous study showed that anti-coagulants may not only have anti-tumorigenic activity, but also the potential to provide significant survival benefit for patients with SCLC.
For the phase 3 RASTEN trial (ClinicalTrials.gov Identifier: NCT00717938), researchers randomly assigned 377 patients with newly diagnosed SCLC to receive standard treatment (chemoradiotherapy) with or without daily supraprophylactic enoxaparin 1 mg/kg for 21 days. Follow-ups were performed every 2 months at the start of each chemotherapy cycle.
After a median follow-up of 41 months, there was no observable difference in OS, which was determined to be 10.6 months vs 11.3 months for patients in the experimental arm vs patients receiving standard treatment, respectively (hazard ratio [HR]; 95% CI, 0.89-1.38; P = .36).
The 1-year survival rate in the experimental arm was 48% vs 47% for the standard arm (HR, 0.98; 95% CI, 0.74-1.30; P = .92).
No significant difference in progression-free survival was observed (HR, 1.18; 95% CI, 0.95-1.46; P = .14).
Patients in the experimental arm reported significantly lower rates of VTE but also had higher rates of hemorrhagic events; both study arms reported instances of fatal bleeding.
The authors concluded that the study “provides strong evidence against the use of anticoagulant low molecular weight heparin (LMWH) as a tumor inhibiting agent in small cell lung cancer, and underlines the need for biomarkers to guide clinicians in tailoring individualized LMWH treatment.”
- Ek L, Gezelius E, Bergman B, et al. Randomized phase III trial of low molecular weight heparin enoxaparin in addition to standard treatment in small cell lung cancer: the RASTEN trial. Ann Oncol. 2017 Nov 2. doi: 10.1093/annonc/mdx716 [Epub ahead of print]