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Tumor Growth Rate as a Validated Early Radiological Biomarker Able to Reflect Treatment-Induced Changes in Neuroendocrine Tumors: The GREPONET-2 Study.
Lamarca, Angela; Ronot, Maxime; Moalla, Salma; Crona, Joakim; Opalinska, Marta; Lopez Lopez, Carlos; Pezzutti, Daniela; Najran, Pavan; Carvhalo, Luciana; Bezerra, Regis Otaviano Franca; Borg, Philip; Vietti Violi, Naik; Vidal Trueba, Hector; de Mestier, Louis; Scaefer, Niklaus; Baudin, Eric; Sundin, Anders; Costa, Frederico; Pavel, Marianne; Dromain, Clarisse.
Afiliação
  • Lamarca A; Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, United Kingdom. angela.lamarca@christie.nhs.uk.
  • Ronot M; Department of Radiology, Beaujon University Hospital, Clichy, France.
  • Moalla S; Department of Radiology, Institute Gustave Roussy, Paris, France.
  • Crona J; Department of Medical Sciences, Uppsala University Hospital, Uppsala, Sweden.
  • Opalinska M; Nuclear Medicine Unit, Department of Endocrinology, University Hospital, Krakow, Poland.
  • Lopez Lopez C; Department of Medical Oncology, Hospital Universitario Marques de Valdecilla, Santander, Spain.
  • Pezzutti D; Department of Radiology, Israelita Albert Einstein Hospital, São Paulo, Brazil.
  • Najran P; Department of Radiology, The Christie NHS Foundation Trust, Manchester, United Kingdom.
  • Carvhalo L; Department of Medical Oncology, Sirio-Libanes Hospital, São Paulo, Brazil.
  • Bezerra ROF; Department of Radiology, Sirio-Libanes Hospital, São Paulo, Brazil and São Paulo Cancer Institute Octavio Frias de Oliveira (ICESP), São Paulo, Brazil.
  • Borg P; Department of Radiology, The Christie NHS Foundation Trust, Manchester, United Kingdom.
  • Vietti Violi N; Department of Radiology, CHUV University Hospital, Lausanne, Switzerland.
  • Vidal Trueba H; Department of Radiology, Hospital Universitario Marques de Valdecilla, Santander, Spain.
  • de Mestier L; Department of Gastroenterology, Beujon University Hospital, Clichy, France.
  • Scaefer N; Department of Medical Oncology, CHUV University Hospital, Lausanne, Switzerland.
  • Baudin E; Department of Nuclear Medicine, Institute Gustave Roussy, Paris, France.
  • Sundin A; Department of Radiology, Institution of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.
  • Costa F; Department of Medical Oncology; Sirio-Libanes Hospital, São Paulo, Brazil.
  • Pavel M; Department of Endocrinology, Universitatsklinikum Erlangen, Erlangen, Germany.
  • Dromain C; Department of Radiology, CHUV University Hospital, Lausanne, Switzerland.
Clin Cancer Res ; 25(22): 6692-6699, 2019 11 15.
Article em En | MEDLINE | ID: mdl-31375514
PURPOSE: Tumor growth rate (TGR) represents the percentage change in tumor 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 neuroendocrine tumors (NET). EXPERIMENTAL DESIGN: Patients from 7 centers with advanced grade (G) 1/2 NETs from the pancreas (P)/small bowel (SB) initiating ST/WW were eligible. Computed tomography (CT)/MRI performed at prebaseline, baseline, and 3(±1) months of study entry were retrospectively reviewed. Aim-1: explore treatment-induced changes in TGR (ΔTGR3m-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: Of 785 patients screened, 127 were eligible. Mean (SD) TGR0 and TGR3m were 5.4%/m (14.9) and -1.4%/m (11.8), respectively. Mean (SD) ΔTGR3m-BL paired-difference was -6.8%/m (19.3; P < 0.001). Most marked ΔTGR3m-BL [mean (SD)] were identified with targeted therapies [-11.3%/m (4.7); P = 0.0237] and chemotherapy [-7.9%/m (3.4); P = 0.0261]. Multivariable analysis confirmed the absence of previous treatment (OR = 4.65; 95% CI, 1.31-16.52; P = 0.018) and low TGR3m (continuous variable; OR 1.09; 95% CI, 1.01-1.19; P = 0.042) to be independent predictors of radiologic objective response. When the multivariable survival analysis for PFS (Cox regression) was adjusted to grade (P = 0.004) and stage (P = 0.017), TGR3m ≥ 0.8 (vs. <0.8) maintained its significance as a prognostic factor (P < 0.001), whereas TGR0 and ΔTGR3m-BL did not. TGR3m ≥ 0.8%/m was confirmed as an independent prognostic factor for PFS [external validation; Aim-2; multivariable HR 2.21 (95% CI, 1.21-3.70; P = 0.003)]. CONCLUSIONS: TGR has a role as a biomarker for monitoring response to therapy for early identification of treatment-induced changes and for early prediction of PFS and radiologic objective response.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Radiografia / Biomarcadores / Tumores Neuroendócrinos Tipo de estudo: Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies / Screening_studies Limite: Female / Humans / Male Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Radiografia / Biomarcadores / Tumores Neuroendócrinos Tipo de estudo: Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies / Screening_studies Limite: Female / Humans / Male Idioma: En Ano de publicação: 2019 Tipo de documento: Article