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. 2023 Feb:169:34-40.
doi: 10.1016/j.ygyno.2022.11.025. Epub 2022 Dec 7.

Flat-dose versus weight or body surface area-based methotrexate dosing in low-risk gestational trophoblastic neoplasia

Victoria L Parker  1 , Bryony F Cushen  2 , Annie Hills  3 , Kaveetha Kandiah  4 , Julia E Palmer  3 , Kamaljit Singh  3 , Barry W Hancock  3 , John A Tidy  3 , Matthew C Winter  5
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Free article

Flat-dose versus weight or body surface area-based methotrexate dosing in low-risk gestational trophoblastic neoplasia

Victoria L Parker et al. Gynecol Oncol. 2023 Feb.
Free article

Abstract

Background: Single-agent methotrexate (MTX) is commonly used as first-line treatment for low-risk gestational trophoblastic neoplasia (LR-GTN), although no international consensus exists on the optimal treatment regimen to maximise complete hCG response (CR) and minimise relapse rates. Current regimens differ in the route of administration, dose scheduling, and use of flat-dose, body surface area (BSA)- or weight-based dosing. In the UK a methotrexate-folinic acid (MTX-FA) 8-day 50 mg intramuscular flat-dose regimen is used, with 15 mg oral folinic acid rescue. In LR-GTN patients, we aim to determine the effect of MTX dose adjustment by BSA and weight upon chemotherapy response and disease relapse.

Methods: Between January 1973 and August 2020, 935 LR-GTN patients treated with first-line MTX-FA were identified from a single UK specialist trophoblastic centre. Of these, 364 were included, of which 178 (49%) had a CR to first-line MTX-FA. Subgroup analyses were performed upon: (i) patients who changed chemotherapy due to MTX toxicity (n = 33); and (ii) patients with a FIGO score of 5-6 (n = 85). Logistic regression analysis explored the relationship between BSA or weight adjusted MTX dosing and: (i) CR to first-line chemotherapy; (ii) incidence of disease relapse. Linear regression analyses assessed the correlation of BSA and weight with the number of MTX-FA cycles required to achieve CR.

Results: In LR-GTN patients, BSA and weight adjusted MTX-FA dosing did not influence CR to first-line chemotherapy or the incidence of disease relapse. The number of MTX cycles required to achieve CR was not associated with BSA or weight. These findings were maintained in a subgroup analysis of FIGO 5-6 patients. The incidence of MTX toxicity was not influenced by BSA or weight.

Conclusions: In the treatment of LR-GTN, dose individualisation using BSA or weight is not required, and fixed dosing continues to be preferred as the UK standard.

Keywords: Dose individualization; Gestational trophoblastic neoplasia; Low-risk; Methotrexate; Treatment resistance.

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Conflict of interest statement

Declaration of Competing Interest MCW reports consulting fees from Easai, Pfizer, Gilead, Novartis, Genomic Health and Roche, personal fees and non-financial support from Lilly outside the submitted work. The remaining authors have no conflicts of interest to declare.

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