Preoperative image-guided identification of response to neoadjuvant chemoradiotherapy in esophageal cancer (PRIDE): a multicenter observational study

PRIDE Study Gup; A. S. Borggreve; S. Mook; M. Verheij; V. E. M. Mul; J. J. Bergman; A. Bartels-Rutten; L. C. ter Beek; R. G. H. Beets-Tan; R. J. Bennink; M. I. van Berge Henegouwen; L. A. A. Brosens; I. L. Defize; J. M. van Dieren; H. Dijkstra; R. van Hillegersberg; M. C. Hulshof; H. W. M. van Laarhoven; M. G. E. H. Lam; A. L. H. M. W. van Lier; C. T. Muijs; W. B. Nagengast; A. J. Nederveen; W. Noordzij; J. T. M. Plukker; P. S. N. van Rossum; J. P. Ruurda; J. W. van Sandick; B. L. A. M. Weusten; F. E. M. Voncken; D. Yakar; G. J. Meijer

doi:10.1186/s12885-018-4892-6

Preoperative image-guided identification of response to neoadjuvant chemoradiotherapy in esophageal cancer (PRIDE): a multicenter observational study

PRIDE Study Gup, A. S. Borggreve^*, S. Mook, M. Verheij, V. E. M. Mul, J. J. Bergman, A. Bartels-Rutten, L. C. ter Beek, R. G. H. Beets-Tan, R. J. Bennink, M. I. van Berge Henegouwen, L. A. A. Brosens, I. L. Defize, J. M. van Dieren, H. Dijkstra, R. van Hillegersberg, M. C. Hulshof, H. W. M. van Laarhoven, M. G. E. H. Lam, A. L. H. M. W. van LierC. T. Muijs, W. B. Nagengast, A. J. Nederveen, W. Noordzij, J. T. M. Plukker, P. S. N. van Rossum, J. P. Ruurda, J. W. van Sandick, B. L. A. M. Weusten, F. E. M. Voncken, D. Yakar, G. J. Meijer

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BackgroundNearly one third of patients undergoing neoadjuvant chemoradiotherapy (nCRT) for locally advanced esophageal cancer have a pathologic complete response (pCR) of the primary tumor upon histopathological evaluation of the resection specimen. The primary aim of this study is to develop a model that predicts the probability of pCR to nCRT in esophageal cancer, based on diffusion-weighted magnetic resonance imaging (DW-MRI), dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and F-18-fluorodeoxyglucose positron emission tomography with computed tomography (F-18-FDG PET-CT). Accurate response prediction could lead to a patient-tailored approach with omission of surgery in the future in case of predicted pCR or additional neoadjuvant treatment in case of non-pCR.MethodsThe PRIDE study is a prospective, single arm, observational multicenter study designed to develop a multimodal prediction model for histopathological response to nCRT for esophageal cancer. A total of 200 patients with locally advanced esophageal cancer - of which at least 130 patients with adenocarcinoma and at least 61 patients with squamous cell carcinoma - scheduled to receive nCRT followed by esophagectomy will be included. The primary modalities to be incorporated in the prediction model are quantitative parameters derived from MRI and F-18-FDG PET-CT scans, which will be acquired at fixed intervals before, during and after nCRT. Secondary modalities include blood samples for analysis of the presence of circulating tumor DNA (ctDNA) at 3 time-points (before, during and after nCRT), and an endoscopy with (random) bite-on-bite biopsies of the primary tumor site and other suspected lesions in the esophagus as well as an endoscopic ultrasonography (EUS) with fine needle aspiration of suspected lymph nodes after finishing nCRT. The main study endpoint is the performance of the model for pCR prediction. Secondary endpoints include progression-free and overall survival.DiscussionIf the multimodal PRIDE concept provides high predictive performance for pCR, the results of this study will play an important role in accurate identification of esophageal cancer patients with a pCR to nCRT. These patients might benefit from a patient-tailored approach with omission of surgery in the future. Vice versa, patients with non-pCR might benefit from additional neoadjuvant treatment, or ineffective therapy could be stopped.Trial registrationThe article reports on a health care intervention on human participants and was prospectively registered on March 22, 2018 under ClinicalTrials.gov Identifier: NCT03474341.

Originele taal-2	English
Artikelnummer	1006
Aantal pagina's	10
Tijdschrift	BMC Cancer
Volume	18
DOI's	https://doi.org/10.1186/s12885-018-4892-6
Status	Published - 20-okt.-2018

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PRIDE Study Gup, Borggreve, A. S., Mook, S., Verheij, M., Mul, V. E. M., Bergman, J. J., Bartels-Rutten, A., ter Beek, L. C., Beets-Tan, R. G. H., Bennink, R. J., Henegouwen, M. I. V. B., Brosens, L. A. A., Defize, I. L., van Dieren, J. M., Dijkstra, H., van Hillegersberg, R., Hulshof, M. C., van Laarhoven, H. W. M., Lam, M. G. E. H., ... Meijer, G. J. (2018). Preoperative image-guided identification of response to neoadjuvant chemoradiotherapy in esophageal cancer (PRIDE): a multicenter observational study. BMC Cancer, 18, [1006]. https://doi.org/10.1186/s12885-018-4892-6

@article{d33c4528f7174daeaab741b011943f6b,

title = "Preoperative image-guided identification of response to neoadjuvant chemoradiotherapy in esophageal cancer (PRIDE): a multicenter observational study",

abstract = "BackgroundNearly one third of patients undergoing neoadjuvant chemoradiotherapy (nCRT) for locally advanced esophageal cancer have a pathologic complete response (pCR) of the primary tumor upon histopathological evaluation of the resection specimen. The primary aim of this study is to develop a model that predicts the probability of pCR to nCRT in esophageal cancer, based on diffusion-weighted magnetic resonance imaging (DW-MRI), dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and F-18-fluorodeoxyglucose positron emission tomography with computed tomography (F-18-FDG PET-CT). Accurate response prediction could lead to a patient-tailored approach with omission of surgery in the future in case of predicted pCR or additional neoadjuvant treatment in case of non-pCR.MethodsThe PRIDE study is a prospective, single arm, observational multicenter study designed to develop a multimodal prediction model for histopathological response to nCRT for esophageal cancer. A total of 200 patients with locally advanced esophageal cancer - of which at least 130 patients with adenocarcinoma and at least 61 patients with squamous cell carcinoma - scheduled to receive nCRT followed by esophagectomy will be included. The primary modalities to be incorporated in the prediction model are quantitative parameters derived from MRI and F-18-FDG PET-CT scans, which will be acquired at fixed intervals before, during and after nCRT. Secondary modalities include blood samples for analysis of the presence of circulating tumor DNA (ctDNA) at 3 time-points (before, during and after nCRT), and an endoscopy with (random) bite-on-bite biopsies of the primary tumor site and other suspected lesions in the esophagus as well as an endoscopic ultrasonography (EUS) with fine needle aspiration of suspected lymph nodes after finishing nCRT. The main study endpoint is the performance of the model for pCR prediction. Secondary endpoints include progression-free and overall survival.DiscussionIf the multimodal PRIDE concept provides high predictive performance for pCR, the results of this study will play an important role in accurate identification of esophageal cancer patients with a pCR to nCRT. These patients might benefit from a patient-tailored approach with omission of surgery in the future. Vice versa, patients with non-pCR might benefit from additional neoadjuvant treatment, or ineffective therapy could be stopped.Trial registrationThe article reports on a health care intervention on human participants and was prospectively registered on March 22, 2018 under ClinicalTrials.gov Identifier: NCT03474341.",

keywords = "Esophageal cancer, Neoadjuvant chemoradiotherapy, Pathologic complete response, Image-guided, MRI, DW-MRI, DCE-MRI, PET-CT, ctDNA, PATHOLOGICAL COMPLETE RESPONSE, POSITRON-EMISSION-TOMOGRAPHY, CIRCULATING TUMOR-CELLS, FDG-PET, PERIOPERATIVE CHEMOTHERAPY, GASTROESOPHAGEAL CANCER, JUNCTIONAL CANCER, FREE DNA, PREDICTION, SURGERY",

author = "{PRIDE Study Gup} and Borggreve, {A. S.} and S. Mook and M. Verheij and Mul, {V. E. M.} and Bergman, {J. J.} and A. Bartels-Rutten and {ter Beek}, {L. C.} and Beets-Tan, {R. G. H.} and Bennink, {R. J.} and Henegouwen, {M. I. van Berge} and Brosens, {L. A. A.} and Defize, {I. L.} and {van Dieren}, {J. M.} and H. Dijkstra and {van Hillegersberg}, R. and Hulshof, {M. C.} and {van Laarhoven}, {H. W. M.} and Lam, {M. G. E. H.} and {van Lier}, {A. L. H. M. W.} and Muijs, {C. T.} and Nagengast, {W. B.} and Nederveen, {A. J.} and W. Noordzij and Plukker, {J. T. M.} and {van Rossum}, {P. S. N.} and Ruurda, {J. P.} and {van Sandick}, {J. W.} and Weusten, {B. L. A. M.} and Voncken, {F. E. M.} and D. Yakar and Meijer, {G. J.} and G{\"u}rsah Kats-Ugurlu",

year = "2018",

month = oct,

day = "20",

doi = "10.1186/s12885-018-4892-6",

language = "English",

volume = "18",

journal = "BMC Cancer",

issn = "1471-2407",

publisher = "BMC",

}

PRIDE Study Gup, Borggreve, AS, Mook, S, Verheij, M, Mul, VEM, Bergman, JJ, Bartels-Rutten, A, ter Beek, LC, Beets-Tan, RGH, Bennink, RJ, Henegouwen, MIVB, Brosens, LAA, Defize, IL, van Dieren, JM, Dijkstra, H, van Hillegersberg, R, Hulshof, MC, van Laarhoven, HWM, Lam, MGEH, van Lier, ALHMW, Muijs, CT , Nagengast, WB, Nederveen, AJ, Noordzij, W , Plukker, JTM, van Rossum, PSN, Ruurda, JP, van Sandick, JW, Weusten, BLAM, Voncken, FEM, Yakar, D & Meijer, GJ 2018, 'Preoperative image-guided identification of response to neoadjuvant chemoradiotherapy in esophageal cancer (PRIDE): a multicenter observational study', BMC Cancer, vol. 18, 1006. https://doi.org/10.1186/s12885-018-4892-6

TY - JOUR

T1 - Preoperative image-guided identification of response to neoadjuvant chemoradiotherapy in esophageal cancer (PRIDE)

T2 - a multicenter observational study

AU - PRIDE Study Gup

AU - Borggreve, A. S.

AU - Mook, S.

AU - Verheij, M.

AU - Mul, V. E. M.

AU - Bergman, J. J.

AU - Bartels-Rutten, A.

AU - ter Beek, L. C.

AU - Beets-Tan, R. G. H.

AU - Bennink, R. J.

AU - Henegouwen, M. I. van Berge

AU - Brosens, L. A. A.

AU - Defize, I. L.

AU - van Dieren, J. M.

AU - Dijkstra, H.

AU - van Hillegersberg, R.

AU - Hulshof, M. C.

AU - van Laarhoven, H. W. M.

AU - Lam, M. G. E. H.

AU - van Lier, A. L. H. M. W.

AU - Muijs, C. T.

AU - Nagengast, W. B.

AU - Nederveen, A. J.

AU - Noordzij, W.

AU - Plukker, J. T. M.

AU - van Rossum, P. S. N.

AU - Ruurda, J. P.

AU - van Sandick, J. W.

AU - Weusten, B. L. A. M.

AU - Voncken, F. E. M.

AU - Yakar, D.

AU - Meijer, G. J.

AU - Kats-Ugurlu, Gürsah

PY - 2018/10/20

Y1 - 2018/10/20

N2 - BackgroundNearly one third of patients undergoing neoadjuvant chemoradiotherapy (nCRT) for locally advanced esophageal cancer have a pathologic complete response (pCR) of the primary tumor upon histopathological evaluation of the resection specimen. The primary aim of this study is to develop a model that predicts the probability of pCR to nCRT in esophageal cancer, based on diffusion-weighted magnetic resonance imaging (DW-MRI), dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and F-18-fluorodeoxyglucose positron emission tomography with computed tomography (F-18-FDG PET-CT). Accurate response prediction could lead to a patient-tailored approach with omission of surgery in the future in case of predicted pCR or additional neoadjuvant treatment in case of non-pCR.MethodsThe PRIDE study is a prospective, single arm, observational multicenter study designed to develop a multimodal prediction model for histopathological response to nCRT for esophageal cancer. A total of 200 patients with locally advanced esophageal cancer - of which at least 130 patients with adenocarcinoma and at least 61 patients with squamous cell carcinoma - scheduled to receive nCRT followed by esophagectomy will be included. The primary modalities to be incorporated in the prediction model are quantitative parameters derived from MRI and F-18-FDG PET-CT scans, which will be acquired at fixed intervals before, during and after nCRT. Secondary modalities include blood samples for analysis of the presence of circulating tumor DNA (ctDNA) at 3 time-points (before, during and after nCRT), and an endoscopy with (random) bite-on-bite biopsies of the primary tumor site and other suspected lesions in the esophagus as well as an endoscopic ultrasonography (EUS) with fine needle aspiration of suspected lymph nodes after finishing nCRT. The main study endpoint is the performance of the model for pCR prediction. Secondary endpoints include progression-free and overall survival.DiscussionIf the multimodal PRIDE concept provides high predictive performance for pCR, the results of this study will play an important role in accurate identification of esophageal cancer patients with a pCR to nCRT. These patients might benefit from a patient-tailored approach with omission of surgery in the future. Vice versa, patients with non-pCR might benefit from additional neoadjuvant treatment, or ineffective therapy could be stopped.Trial registrationThe article reports on a health care intervention on human participants and was prospectively registered on March 22, 2018 under ClinicalTrials.gov Identifier: NCT03474341.

AB - BackgroundNearly one third of patients undergoing neoadjuvant chemoradiotherapy (nCRT) for locally advanced esophageal cancer have a pathologic complete response (pCR) of the primary tumor upon histopathological evaluation of the resection specimen. The primary aim of this study is to develop a model that predicts the probability of pCR to nCRT in esophageal cancer, based on diffusion-weighted magnetic resonance imaging (DW-MRI), dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and F-18-fluorodeoxyglucose positron emission tomography with computed tomography (F-18-FDG PET-CT). Accurate response prediction could lead to a patient-tailored approach with omission of surgery in the future in case of predicted pCR or additional neoadjuvant treatment in case of non-pCR.MethodsThe PRIDE study is a prospective, single arm, observational multicenter study designed to develop a multimodal prediction model for histopathological response to nCRT for esophageal cancer. A total of 200 patients with locally advanced esophageal cancer - of which at least 130 patients with adenocarcinoma and at least 61 patients with squamous cell carcinoma - scheduled to receive nCRT followed by esophagectomy will be included. The primary modalities to be incorporated in the prediction model are quantitative parameters derived from MRI and F-18-FDG PET-CT scans, which will be acquired at fixed intervals before, during and after nCRT. Secondary modalities include blood samples for analysis of the presence of circulating tumor DNA (ctDNA) at 3 time-points (before, during and after nCRT), and an endoscopy with (random) bite-on-bite biopsies of the primary tumor site and other suspected lesions in the esophagus as well as an endoscopic ultrasonography (EUS) with fine needle aspiration of suspected lymph nodes after finishing nCRT. The main study endpoint is the performance of the model for pCR prediction. Secondary endpoints include progression-free and overall survival.DiscussionIf the multimodal PRIDE concept provides high predictive performance for pCR, the results of this study will play an important role in accurate identification of esophageal cancer patients with a pCR to nCRT. These patients might benefit from a patient-tailored approach with omission of surgery in the future. Vice versa, patients with non-pCR might benefit from additional neoadjuvant treatment, or ineffective therapy could be stopped.Trial registrationThe article reports on a health care intervention on human participants and was prospectively registered on March 22, 2018 under ClinicalTrials.gov Identifier: NCT03474341.

KW - Esophageal cancer

KW - Neoadjuvant chemoradiotherapy

KW - Pathologic complete response

KW - Image-guided

KW - MRI

KW - DW-MRI

KW - DCE-MRI

KW - PET-CT

KW - ctDNA

KW - PATHOLOGICAL COMPLETE RESPONSE

KW - POSITRON-EMISSION-TOMOGRAPHY

KW - CIRCULATING TUMOR-CELLS

KW - FDG-PET

KW - PERIOPERATIVE CHEMOTHERAPY

KW - GASTROESOPHAGEAL CANCER

KW - JUNCTIONAL CANCER

KW - FREE DNA

KW - PREDICTION

KW - SURGERY

U2 - 10.1186/s12885-018-4892-6

DO - 10.1186/s12885-018-4892-6

M3 - Article

SN - 1471-2407

VL - 18

JO - BMC Cancer

JF - BMC Cancer

M1 - 1006

ER -