A randomized clinical trial on the anti-tumoral effects of low molecular weight heparin in the treatment of esophageal cancer

Kermani, Ali Taghizadeh, Hosseini, Sare, Fanipakdel, Azar, Mashhad, Mona Joudi, Rezayat, Kambiz Akhavan, Zardadi, Mahdi, Gholami, Arezoo, Javadinia, Seyed Alireza, Ferns, Gordon and Avan, Amir (2019) A randomized clinical trial on the anti-tumoral effects of low molecular weight heparin in the treatment of esophageal cancer. Journal of Cellular Physiology, 234 (4). pp. 4191-4199. ISSN 0021-9541

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Abstract

The current treatment approaches for esophageal cancer are associated with poor survival, and there are ongoing efforts to find new and more effective therapeutic strategies. There are several reports on the antitumoral effects of low‐molecular‐weight heparins (LMWHs). We have assessed the possible survival benefit of LMWHs in esophageal malignancies. This was a randomized, single‐blind, multicenter, Phase II clinical trial on nonmetastatic esophageal cancer candidate for neoadjuvant chemoradiotherapy. Patients were randomly assigned to the chemoradiotherapy‐only arm or chemoradiotherapy plus enoxaparin arm using 1:1 allocation. Radiotherapy was delivered in 1.8‐Gy daily fractions to a dose of 50.4 Gy in both groups. Paclitaxel 50 mg/m2 and carboplatin (AUC 2) were administered weekly, concurrent with radiotherapy. In the intervention group, patients received enoxaparin (40 mg) and chemoradiation daily. 4–6 weeks after treatment, all patients underwent esophagectomy. After a median follow up of 7 months, estimated 1 year disease‐free survival (DFS) in the intervention group was 78.9% and was 70% in the control groups ( p = 0.5). Toxicity from the experimental treatment was minimal, and there were no treatment‐related deaths. A pathologically complete response in intervention and control group was 64.8% and 62.5%, respectively ( p = 0.9). There was a nonsignificant trend toward improved survival by the addition of enoxaparin to the concurrent chemoradiotherapy regimen. However, 1 y DFS of both groups were high as expected. A longer follow‐up and a larger sample size are required.delivered in 1.8-Gy daily fractions to a dose of 50.4 Gy in both groups. Paclitaxel 50 mg/m2 and carboplatin (AUC 2) were administered weekly concurrent with radiotherapy. In the intervention group, patients received enoxaparin (40 mg) daily as well as chemoradiation. Four to six weeks after treatment, all patients underwent esophagectomy. After a median follow up of 7 months,estimated one year disease free survival (1y DFS) in the intervention group was 78.9% and in the control groups was 70% (p=0.5). Toxicity from the experimental treatment was minimal and there were no treatment-related deaths. A Pathologically complete response in intervention and control group was 64.8% and 62.5%, respectively (p=0.9). There was a non-significant trend toward improved survival by the addition of enoxaparin to the concurrent chemoradiotherapy regimen. However, 1y DFS of both groups were high as expected. A longer follow-up and larger sample size is required.

Item Type: Article
Schools and Departments: Brighton and Sussex Medical School > Brighton and Sussex Medical School
Brighton and Sussex Medical School > Division of Medical Education
Depositing User: Elizabeth Renvoize
Date Deposited: 20 Jul 2018 12:52
Last Modified: 26 Oct 2019 01:00
URI: http://sro.sussex.ac.uk/id/eprint/77292

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