Tumour growth rate as a validated early radiological biomarker able to reflect treatment-induced changes in neuroendocrine tumours; the GREPONET-2 study
Lamarca, Angela Ronot, M Moalla, S Crona, J Opalinska, M Lopez, LC Pezzutti, D Najran, Pavan Carvalho, LFDP Bezerra, ROF
Lamarca, Angela
Ronot, M
Moalla, S
Crona, J
Opalinska, M
Lopez, LC
Pezzutti, D
Najran, Pavan
Carvalho, LFDP
Bezerra, ROF
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Abstract
PURPOSE:
TGR represents the percentage change in tumour volume per month (%/m). Previous results from the GREPONET study showed that TGR measured after 3 months (TGR3m) of starting systemic treatment (ST) or watch and wait (WW) was an early biomarker predicting progression-free survival (PFS) in NETs.
EXPERIMENTAL DESIGN:
Pts from7 centres with advanced grade(G) 1/2 NETs from the pancreas(P)/small bowel(SB) initiating ST/WW were eligible. Computed tomography (CT) / magnetic resonance imaging (MRI) performed at pre-baseline, baseline and 3(+/-1) months of study entry were retrospectively reviewed. Aim-1: explore treatment-induced changes in TGR (?TGR3m-BL) (paired T-test) and Aim-2: validate TGR3m (<0.8%/m vs ?0.8%/m) as an early biomarker in an independent cohort (Kaplan-Meier/Cox Regression).
RESULTS:
Out of 785 pts screened, 127 were eligible. Mean (SD) TGR0 and TGR3m were 5.4%/m (14.9) and -1.4%/m (11.8), respectively. Mean(SD) ?TGR3m-BL paired-difference was -6.8%/m(19.3) (p<0.001). Most marked ?TGR3m-BL (mean (SD);p) were identified with targeted therapies (-11.3%/m(4.7);0.0237) and chemotherapy (-7.9%/m(3.4);0.0261). Multivariable analysis confirmed the absence of previous treatment (Odds Ratio (OR) 4.65 (95%CI 1.31-16.52); p-value0.018) and low TGR3m (continuous variable; OR 1.09 (95%CI 1.01-1.19); p-value0.042) to be independent predictors of radiological objective response. When the multivariable Cox Regression was adjusted to grade (p-value 0.004) and stage (p-value0.017), TGR3m?0.8 (vs.<0.8) maintained its significance (p<0.001), while TGR0 and ?TGR3m-BL did not. TGR3m was confirmed as an independent prognosis factor for PFS (external validation; Aim-2) (multivariable HR 2.21 (95%CI 1.21-3.70); p-value0.003).
CONCLUSIONS:
TGR has a role as biomarker for monitoring response to therapy for early prediction of PFS and radiological objective response.
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Date
2019
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Article
Citation
Lamarca A, Ronot M, Moalla S, Crona J, Opalinska M, Lopez Lopez C, et al. Tumour growth rate as a validated early radiological biomarker able to reflect treatment-induced changes in neuroendocrine tumours; the GREPONET-2 study. Clin Cancer Res. 2019 Aug 2.