PET/CT-tailored treatment of locally advanced oesophago-gastric
junction adenocarcinoma: a report on the feasibility of the
multicenter GastroPET study

J 2021

PET/CT-tailored treatment of locally advanced oesophago-gastric junction adenocarcinoma: a report on the feasibility of the multicenter GastroPET study

OBERMANNOVÁ, Radka; Iveta SELINGEROVÁ; Zdeněk ŘEHÁK; Václav JEDLIČKA; Marek SLÁVIK et. al.

Základní údaje

Originální název

PET/CT-tailored treatment of locally advanced oesophago-gastric junction adenocarcinoma: a report on the feasibility of the multicenter GastroPET study

Autoři

OBERMANNOVÁ, Radka (203 Česká republika, garant, domácí); Iveta SELINGEROVÁ (203 Česká republika, domácí); Zdeněk ŘEHÁK (203 Česká republika); Václav JEDLIČKA (203 Česká republika, domácí); Marek SLÁVIK (703 Slovensko); Pavel FABIAN (203 Česká republika); Ivo NOVOTNÝ (203 Česká republika); Milada ZEMANOVA (203 Česká republika); Hana STUDENTOVA (203 Česká republika); Peter GRELL (703 Slovensko, domácí); Lenka ZDRAŽILOVÁ DUBSKÁ (203 Česká republika); Regina DEMLOVÁ (203 Česká republika, domácí); Tomáš HARUSTIAK; Renata HEJNOVA (203 Česká republika); Igor KISS (203 Česká republika, domácí) a Rostislav VYZULA (203 Česká republika, domácí)

Vydání

THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY, LONDON, SAGE PUBLICATIONS LTD, 2021, 1758-8340

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30204 Oncology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

GastroPET

Impakt faktor

Impact factor: 5.485

Kód RIV

RIV/00216224:14110/21:00120205

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1177/17588359211065153

UT WoS

000730612700001

EID Scopus

2-s2.0-85121324294

Klíčová slova česky

localised oesophago-gastric junction adenocarcinoma; metabolic imaging; non-responders; PET; CT-guided preoperative treatment strategy

Klíčová slova anglicky

localised oesophago-gastric junction adenocarcinoma; metabolic imaging; non-responders; PET; CT-guided preoperative treatment strategy

Štítky

14110516, 14110811, 14110813, Excelence Science, MOÚ, MU, RIV, rivok

Příznaky

Recenzováno

Změněno: 16. 2. 2022 14:25, Mgr. Tereza Miškechová

Anotace

V originále

Background: Perioperative chemotherapy is a recommended treatment approach for localised oesophago-gastric junction adenocarcinoma, but not all patients respond to neoadjuvant chemotherapy. Early identification of non-responders and treatment adaptation in the preoperative period could improve outcomes. GastroPET is a national, multicentre phase II trial evaluating a (18)FDG-PET/CT-guided preoperative treatment strategy with the R0 resection rate as a primary endpoint. Here, we report on the accuracy of the methodology, the feasibility of the study design and patient safety data after enrolment of the first 63 patients. Methods: Patients with locally advanced oesophago-gastric junction adenocarcinoma (Siewert I - III) stage Ib-IIIc underwent baseline 18FDG-PET/CT scanning and re-evaluation after 14 days of oxaliplatinum-5FU-(docetaxel) chemotherapy. Responders were defined by a > 35% decrease in tumour FDG standardised uptake value (SUV)(average) from baseline. Responders continued with the same chemotherapy for 2 to 3 months prior to surgery. PET-non-responders switched to preoperative chemoradiotherapy [weekly carboplatin and paclitaxel with concurrent radiotherapy (45 Gy in 25 fractions)]. Here, we aim to confirm the feasibility of FDG-PET-based response assessment in a multicenter setting and to compare local versus central reading. In addition, we report on the feasibility of the study conduct and patient safety data. Results: A total of 64 patients received baseline and sequential 14-day 18FDG-PET/CT scanning. And, 63 were allocated to the respective treatment arm according to PET-response [35 (56%) responders and 28 (44%) non-responders]. The concordance of local versus central reading of SUV changes was 100%. Until the date of this analysis, 47 patients (28 responders and 19 non-responders) completed surgery. Postoperative complications of grade > 3 (Common Terminology Criteria for Adverse Events, CTCAE Version 5.0) were reported in five responders (18%; 95% CI: 7.9-36%) and two non-responders (11%; 95% CI: 2.9-31%), with no statistical difference (p = 0.685). One patient in each arm died after surgery, leading to a postoperative in-hospital mortality rate of 4.3% (2/47 patients; 95% CI: 1.2-14%). Conclusion: Local and central FDG-SUV quantification and PET-response assessment showed high concordance. This confirms the accuracy of a PET-response-guided treatment algorithm for locally advanced oesophago-gastric junction cancer in a multicenter setting. Preoperative treatment adaptation revealed feasible and safe for patients.

Návaznosti

NV17-29389A, projekt VaV

Název: Sekvenční FDG-PET a miRNA jako biomarker změny strategie předoperační léčby u lokálně pokročilého karcinomu žaludku a gastroesofageální junkce

90125, velká výzkumná infrastruktura

Název: BBMRI-CZ III

90128, velká výzkumná infrastruktura

Název: CZECRIN III

Citovat

OBERMANNOVÁ, Radka; Iveta SELINGEROVÁ; Zdeněk ŘEHÁK; Václav JEDLIČKA; Marek SLÁVIK; Pavel FABIAN; Ivo NOVOTNÝ; Milada ZEMANOVA; Hana STUDENTOVA; Peter GRELL; Lenka ZDRAŽILOVÁ DUBSKÁ; Regina DEMLOVÁ; Tomáš HARUSTIAK; Renata HEJNOVA; Igor KISS a Rostislav VYZULA. PET/CT-tailored treatment of locally advanced oesophago-gastric junction adenocarcinoma: a report on the feasibility of the multicenter GastroPET study. THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY. LONDON: SAGE PUBLICATIONS LTD, 2021, roč. 13, December 2021, s. 1-14. ISSN 1758-8340. Dostupné z: https://dx.doi.org/10.1177/17588359211065153.

@article{1818744,
   author = {Obermannová, Radka and Selingerová, Iveta and Řehák, Zdeněk and Jedlička, Václav and Slávik, Marek and Fabian, Pavel and Novotný, Ivo and Zemanova, Milada and Studentova, Hana and Grell, Peter and Zdražilová Dubská, Lenka and Demlová, Regina and Harustiak, Tomáš and Hejnova, Renata and Kiss, Igor and Vyzula, Rostislav},
   article_location = {LONDON},
   article_number = {December 2021},
   doi = {http://dx.doi.org/10.1177/17588359211065153},
   keywords = {localised oesophago-gastric junction adenocarcinoma; metabolic imaging; non-responders; PET; CT-guided preoperative treatment strategy},
   language = {eng},
   issn = {1758-8340},
   journal = {THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY},
   note = {GastroPET},
   title = {PET/CT-tailored treatment of locally advanced oesophago-gastric junction adenocarcinoma: a report on the feasibility of the multicenter GastroPET study},
   url = {https://journals.sagepub.com/doi/10.1177/17588359211065153},
   volume = {13},
   year = {2021}
}

TY  - JOUR
ID  - 1818744
AU  - Obermannová, Radka - Selingerová, Iveta - Řehák, Zdeněk - Jedlička, Václav - Slávik, Marek - Fabian, Pavel - Novotný, Ivo - Zemanova, Milada - Studentova, Hana - Grell, Peter - Zdražilová Dubská, Lenka - Demlová, Regina - Harustiak, Tomáš - Hejnova, Renata - Kiss, Igor - Vyzula, Rostislav
PY  - 2021
TI  - PET/CT-tailored treatment of locally advanced oesophago-gastric junction adenocarcinoma: a report on the feasibility of the multicenter GastroPET study
JF  - THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY
VL  - 13
IS  - December 2021
SP  - 1-14
EP  - 1-14
PB  - SAGE PUBLICATIONS LTD
SN  - 17588340
N1  - GastroPET
KW  - localised oesophago-gastric junction adenocarcinoma
KW  - metabolic imaging
KW  - non-responders
KW  - PET
KW  - CT-guided preoperative treatment strategy
UR  - https://journals.sagepub.com/doi/10.1177/17588359211065153
N2  - Background: Perioperative chemotherapy is a recommended treatment approach for localised oesophago-gastric junction adenocarcinoma, but not all patients respond to neoadjuvant chemotherapy. Early identification of non-responders and treatment adaptation in the preoperative period could improve outcomes. GastroPET is a national, multicentre phase II trial evaluating a (18)FDG-PET/CT-guided preoperative treatment strategy with the R0 resection rate as a primary endpoint. Here, we report on the accuracy of the methodology, the feasibility of the study design and patient safety data after enrolment of the first 63 patients. Methods: Patients with locally advanced oesophago-gastric junction adenocarcinoma (Siewert I - III) stage Ib-IIIc underwent baseline 18FDG-PET/CT scanning and re-evaluation after 14 days of oxaliplatinum-5FU-(docetaxel) chemotherapy. Responders were defined by a > 35% decrease in tumour FDG standardised uptake value (SUV)(average) from baseline. Responders continued with the same chemotherapy for 2 to 3 months prior to surgery. PET-non-responders switched to preoperative chemoradiotherapy [weekly carboplatin and paclitaxel with concurrent radiotherapy (45 Gy in 25 fractions)]. Here, we aim to confirm the feasibility of FDG-PET-based response assessment in a multicenter setting and to compare local versus central reading. In addition, we report on the feasibility of the study conduct and patient safety data. Results: A total of 64 patients received baseline and sequential 14-day 18FDG-PET/CT scanning. And, 63 were allocated to the respective treatment arm according to PET-response [35 (56%) responders and 28 (44%) non-responders]. The concordance of local versus central reading of SUV changes was 100%. Until the date of this analysis, 47 patients (28 responders and 19 non-responders) completed surgery. Postoperative complications of grade > 3 (Common Terminology Criteria for Adverse Events, CTCAE Version 5.0) were reported in five responders (18%; 95% CI: 7.9-36%) and two non-responders (11%; 95% CI: 2.9-31%), with no statistical difference (p = 0.685). One patient in each arm died after surgery, leading to a postoperative in-hospital mortality rate of 4.3% (2/47 patients; 95% CI: 1.2-14%). Conclusion: Local and central FDG-SUV quantification and PET-response assessment showed high concordance. This confirms the accuracy of a PET-response-guided treatment algorithm for locally advanced oesophago-gastric junction cancer in a multicenter setting. Preoperative treatment adaptation revealed feasible and safe for patients.
ER  -

OBERMANNOVÁ, Radka; Iveta SELINGEROVÁ; Zdeněk ŘEHÁK; Václav JEDLIČKA; Marek SLÁVIK; Pavel FABIAN; Ivo NOVOTNÝ; Milada ZEMANOVA; Hana STUDENTOVA; Peter GRELL; Lenka ZDRAŽILOVÁ DUBSKÁ; Regina DEMLOVÁ; Tomáš HARUSTIAK; Renata HEJNOVA; Igor KISS a Rostislav VYZULA. PET/CT-tailored treatment of locally advanced oesophago-gastric junction adenocarcinoma: a report on the feasibility of the multicenter GastroPET study. \textit{THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY}. LONDON: SAGE PUBLICATIONS LTD, 2021, roč.~13, December 2021, s.~1-14. ISSN~1758-8340. Dostupné z: https://dx.doi.org/10.1177/17588359211065153.

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