MERAIODE: A Phase II Redifferentiation Trial with Trametinib and 131 I in Metastatic Radioactive Iodine Refractory RAS Mutated Differentiated thyroid Cancer - HAL Accéder directement au contenu
Article dans une revue Clinical Cancer Research Année : 2023

MERAIODE: A Phase II Redifferentiation Trial with Trametinib and 131 I in Metastatic Radioactive Iodine Refractory RAS Mutated Differentiated thyroid Cancer

Claire Bournaud
Georges Lion
Sarah Betrian
Christophe Sajous
Yann Godbert

Résumé

Abstract Purpose: To evaluate the efficacy and safety of dabrafenib-trametinib-131I for the treatment of radioactive iodine refractory metastatic differentiated thyroid cancer (DTC) with a BRAF p.V600E mutation. Patients and Methods: A prospective phase II trial including patients with RECIST progression within 18 months and no lesion > 3 cm. Following a baseline recombinant human (rh)TSH-stimulated diagnostic whole-body scan (dc1-WBS), dabrafenib and trametinib were given for 42 days. A second rhTSH-stimulated dc WBS (dc2-WBS) was done at day 28 and 131I (5.5 GBq–150 mCi after rhTSH) was administered at day 35. Primary endpoint was the 6-month RECIST objective response rate. In case of partial response (PR) at 6 or 12 months, a second treatment course could be given. Among 24 enrolled patients, 21 were evaluable at 6 months. Results: Abnormal 131I uptake was present on 5%, 65%, and 95% of the dc1-WBS, dc2-WBS, and post-therapy scans, respectively. At 6 months, PR was achieved in 38%, stable disease in 52%, and progressive disease (PD) in 10%. Ten patients received a second treatment course: one complete response and 6 PRs were observed at 6 months. The median progression-free survival (PFS) was not reached. The 12- and 24-month PFS were 82% and 68%, respectively. One death due to PD occurred at 24 months. Adverse events (AE) occurred in 96% of the patients, with 10 grade 3–4 AEs in 7 patients. Conclusions: Dabrafenib-trametinib is effective in BRAF p.V600E-mutated DTC patients for restoring 131I uptake with PR observed 6 months after 131I administration in 38% of the patients.
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inserm-04552345, version 1 (19-04-2024)

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Sophie Leboulleux, Christine Do Cao, Slimane Zerdoud, Marie Attard, Claire Bournaud, et al.. MERAIODE: A Phase II Redifferentiation Trial with Trametinib and 131 I in Metastatic Radioactive Iodine Refractory RAS Mutated Differentiated thyroid Cancer. Clinical Cancer Research, 2023, 29 (13), pp.2401-2409. ⟨10.1158/1078-0432.CCR-23-0046⟩. ⟨inserm-04552345⟩
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