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Multicenter Study
. 2024 Jul 22:63:581-585.
doi: 10.2340/1651-226X.2024.40207.

The effect of tinzaparin on biomarkers in FIGO stages III-IV ovarian cancer patients undergoing neoadjuvant chemotherapy - the TABANETOC trial: study protocol for a randomized clinical multicenter trial

Anna Karlsson  1 , Gabriel Lindahl  2 , Anna-Clara Spetz Holm  3 , Karin Bergmark  4 , Pernilla Dahm Kähler  5 , Boglarka Fekete  4 , Ulrika Ottander  6 , Charlotte Öfverman  7 , Pernilla Israelsson  7 , Laila Falknäs  8 , Anders Rosenmüller  9 , Malena Tiefenthal Thrane  10 , Shefqet Halili  11 , Tomas L Lindahl  12 , Maria C Jenmalm  13 , Preben Kjølhede  3
Affiliations
Multicenter Study

The effect of tinzaparin on biomarkers in FIGO stages III-IV ovarian cancer patients undergoing neoadjuvant chemotherapy - the TABANETOC trial: study protocol for a randomized clinical multicenter trial

Anna Karlsson et al. Acta Oncol. .

Abstract

Background: Tinzaparin, a low-molecular weight heparin (LMWH), has shown anti-neoplastic properties in animal models and in in vitro studies of human cancer cell lines. The reduction of CA-125 levels during neoadjuvant chemotherapy (NACT) in patients with epithelial ovarian cancer (EOC) co-varies with the prognosis; the larger the decrease in CA-125, the better the prognosis.

Purpose: This study aims to evaluate the potential anti-neoplastic effects of tinzaparin by investigating changes in serum CA-125 levels in advanced EOC patients who receive NACT.

Material and methods: This is an open randomized multicenter pilot trial. Forty patients with EOC selected to receive NACT will be randomized 1:1 to receive daily addition of tinzaparin or no tinzaparin. The processing and treatment of the patients will otherwise follow the recommendations in the Swedish National Guidelines for Ovarian Cancer. Before every cycle of chemotherapy, preoperatively, and 3 weeks after the last cycle of chemotherapy, a panel of biomarkers, including CA-125, will be measured.

Patients: Inclusion criteria are women aged 18 years or older, World Health Organization performance status 0-1, histologically confirmed high-grade serous, endometrioid or clear cell EOC, International Federation of Gynecology and Obstetrics (FIGO) stages III-IV. In addition, a CA-125 level of ≥ 250 kIE/L at diagnosis. Exclusion criteria are contraindications to LMWH, ongoing or recent treatment with unfractionated heparin, LMWH, warfarin or non-vitamin K antagonist oral anticoagulants.

Interpretation: This study will make an important contribution to the knowledge of the anti-neoplastic effects of tinzaparin in EOC patients and may thus guide the planning of a future study on the impact of tinzaparin on survival in EOC.

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Conflict of interest statement

None of the authors have conflicts of interest to declare.

Figures

Figure 1
Figure 1
Flow chart of the TABANETOC trial. (a) All operated patients (in the treatment group as well as in the control group) will be treated with tinzaparin (Innohep®) for 28 days starting the day before surgery as clinical routine. After the 28 days of postoperative treatment they will continue with tinzaparin/no tinzaparin according to the initial allocation. (b) In some cases surgery will be performed after the third cycle of chemotherapy. (c) Some patients will receive a seventh cycle of chemotherapy. Biomarkers will be measured at that visit as well. CT: adjuvant chemotherapy; IDS: interval debulking surgery; NACT: neoadjuvant chemotherapy with a taxane/platinum doublet regimen; sc: subcutaneous.
See this image and copyright information in PMC

References

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