Physica medica : PM : an international journal devoted to the applications of physics to medicine and biology : official journal of the Italian Association of Biomedical Physics (AIFB) · 2026
Lesional dosimetry in 131I refractory metastatic differentiated thyroid cancer with BRAFp.V600E or RAS mutation treated with trametinib +/- dabrafenib followed by radioactive iodine.
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод пока не подготовлен
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Anizan Nadège, Pignard Alexandre, Borget Isabelle, Lamartina Livia, Schlumberger Martin, Broggio David, Leboulleux Sophie, Lamart Stéphanie
Аннотация
PURPOSE: In the MERAIODE phase II prospective trial (NCT03244956), patients with radioactive iodine refractory metastatic differentiated thyroid cancer (DTC) were treated with trametinib +/- dabrafenib before the administration of 5.5 GBq of 131I. A post-therapeutic lesional dosimetry study was conducted to assess the correlation between lesion absorbed doses and tumour response.
METHODS: Absorbed doses (AD) were calculated from four planar images acquired 1, 2, 3 and 4 days after 131I administration and normalized using a day-4 SPECT/CT. Lesional 131I activity was quantified on SPECT using a single calibration factor and a 50%SUVmax threshold segmentation. Lesion volumes were manually segmented on diagnostic CT scans acquired prior 131I and at 3, 6 and 9 months. Lesions were categorised using a 3D extrapolated RECIST 1.1 classification based on volumetric changes.
RESULTS: Median AD was higher in BRAFp.V600E mutated lesions (n = 19; 393.5 Gy [20.4-2906.3]) than in RAS mutated lesions (n = 6; 35.3 Gy [6.9-76.0]; p = 0.0005). At 6 months, 58% of BRAFp.V600E mutated lesions showed partial/complete response with a higher median AD (896 Gy) than stable/progressive lesions (183 Gy; p = 0.006). Eighty per cent of lesions receiving an AD above 393 Gy were classified as responders, whereas all lesions receiving an AD above 478 Gy were classified as responders.
CONCLUSION: The median AD was significantly higher in the BRAFp.V600E mutated DTC lesions than in the RAS mutated DTC lesions. BRAFp.V600E mutated DTC lesions with a partial and complete response received significantly higher doses than other lesions.
TRIAL REGISTRATION: NCT03244956, https://clinicaltrials.gov/study/NCT03244956.
METHODS: Absorbed doses (AD) were calculated from four planar images acquired 1, 2, 3 and 4 days after 131I administration and normalized using a day-4 SPECT/CT. Lesional 131I activity was quantified on SPECT using a single calibration factor and a 50%SUVmax threshold segmentation. Lesion volumes were manually segmented on diagnostic CT scans acquired prior 131I and at 3, 6 and 9 months. Lesions were categorised using a 3D extrapolated RECIST 1.1 classification based on volumetric changes.
RESULTS: Median AD was higher in BRAFp.V600E mutated lesions (n = 19; 393.5 Gy [20.4-2906.3]) than in RAS mutated lesions (n = 6; 35.3 Gy [6.9-76.0]; p = 0.0005). At 6 months, 58% of BRAFp.V600E mutated lesions showed partial/complete response with a higher median AD (896 Gy) than stable/progressive lesions (183 Gy; p = 0.006). Eighty per cent of lesions receiving an AD above 393 Gy were classified as responders, whereas all lesions receiving an AD above 478 Gy were classified as responders.
CONCLUSION: The median AD was significantly higher in the BRAFp.V600E mutated DTC lesions than in the RAS mutated DTC lesions. BRAFp.V600E mutated DTC lesions with a partial and complete response received significantly higher doses than other lesions.
TRIAL REGISTRATION: NCT03244956, https://clinicaltrials.gov/study/NCT03244956.