RASTEN May Rule Out High-Dose Enoxaparin For SCLC Patients

Routine addition of enoxaparin to chemotherapy for small-cell lung cancer does not improve overall survival

medwireNews: Small-cell lung cancer participants of the RASTEN trial did not derive a significant survival benefit with use of a supraprophylactic dose of the low molecular weight heparin (LMWH) enoxaparin.

“At present, the use of LMWH in cancer includes primary prophylaxis in patients at high risk of VTE [venous thromboembolism], in patients diagnosed with VTE, and as secondary prophylaxis”, explain Mattias Belting, from Lund University in Sweden, and co-investigators.

 “The present study provides strong support against a more general use of LMWH as a tumor-inhibiting agent, and underlines the need for risk biomarkers to guide clinicians in tailoring individualized LMWH treatment”, they emphasize.

Following reports indicating a possible survival benefit in SCLC patients using anticoagulation therapy, the team randomly assigned 186 of 377 SCLC patients undergoing platinum-based chemotherapy with or without radiotherapy to receive daily enoxaparin 1 mg/kg between days 1 and 21 of chemotherapy. The remaining patients received chemotherapy alone.

The majority of the enoxaparin-treated patients (85%) and controls (87%) completed at least four cycles of chemotherapy, the authors report in the Annals of Oncology.

After a median of 41 months’ follow-up, overall survival did not significantly differ between the enoxaparin and control arms, at 10.6 versus 11.3 months. One-year survival was achieved by 48% and 47% of patients, respectively.

This OS pattern continued when examining subgroups of patients with extensive or limited SCLC and progression-free survival was also comparable between the trial arms.

Enoxaparin use was associated with a significant reduction in VTE events over the first 6 months (2.5 vs 8.5%, hazard ratio=0.31).

“However, whether this difference was clinically relevant in terms of decreased morbidity and increased quality of life was not assessed in the present study”, Mattias Belting et al comment.

 There was a higher rate of haemorrhagic episodes (27 vs eight) with enoxaparin use, although both groups sustained fatal bleeding events (three vs one).

 “A potential overestimation of total hemorrhages in the enoxaparin group may stem from a more vigilant registration of low grade events in the treatment arm”, the researchers admit.

 Reference

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; Advance online publication 2 November 2017. doi: https://doi.org/10.1093/annonc/mdx716

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