Sentinel lymph node mapping and intraoperative assessment in a
prospective, international, multicentre, observational trial of
patients with cervical cancer: The SENTIX trial

J 2020

Sentinel lymph node mapping and intraoperative assessment in a prospective, international, multicentre, observational trial of patients with cervical cancer: The SENTIX trial

CIBULA, David, Roman KOCIAN, Andrea PLAIKNER, Jiří JARKOVSKÝ, Jaroslav KLAT et. al.

Basic information

Original name

Sentinel lymph node mapping and intraoperative assessment in a prospective, international, multicentre, observational trial of patients with cervical cancer: The SENTIX trial

Authors

CIBULA, David (203 Czech Republic, guarantor), Roman KOCIAN (203 Czech Republic), Andrea PLAIKNER (276 Germany), Jiří JARKOVSKÝ (203 Czech Republic, belonging to the institution), Jaroslav KLAT (203 Czech Republic), Ignacio ZAPARDIEL (724 Spain), Radovan PILKA (203 Czech Republic), Aureli TORNE (724 Spain), Borek SEHNAL (203 Czech Republic), Marcela OSTOJICH (32 Argentina), Almerinda PETIZ (40 Austria), Octavio A. SANCHEZ (724 Spain), Jiri PRESL (203 Czech Republic), Alessandro BUDA (380 Italy), Francesco RASPAGLIESI (380 Italy), Peter KASCAK (703 Slovakia), Luc VAN LONKHUIJZEN (528 Netherlands), Marc BARAHONA (724 Spain), Luboš MINÁŘ (203 Czech Republic, belonging to the institution), Pawel BLECHARZ (616 Poland), Maja PAKIZ (705 Slovenia), Dariusz WYDRA (616 Poland), Leon C. SNYMAN (710 South Africa), Kamil ZALEWSKI (616 Poland), Cristina ZORRERO (724 Spain), Havelka HAVELKA (203 Czech Republic), Mikulas REDECHA (703 Slovakia), Alla VINNYTSKA (804 Ukraine), Ignace VERGOTE (56 Belgium), Solveig TINGULSTAD (578 Norway), Martin MICHAL (203 Czech Republic), Barbara KIPP (756 Switzerland), Slama SLAMA (203 Czech Republic), Simone MARNITZ (276 Germany), Sylva BAJSOVA (203 Czech Republic), Alicia HERNANDEZ (724 Spain), Daniela FISCHEROVA (203 Czech Republic), Kristyna NEMEJCOVA (203 Czech Republic) and Christhardt KOHLER (276 Germany)

Edition

European Journal of Cancer, Oxford, Elsevier Science Inc. 2020, 0959-8049

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30204 Oncology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 9.162

RIV identification code

RIV/00216224:14110/20:00116468

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.ejca.2020.06.034

UT WoS

000566726800008

Keywords in English

Cervical cancer; Sentinel lymph node; Frozen section; Mapping; Ultrastaging; Micrometastases

Abstract

V originále

Background: SENTIX (ENGOT-CX2/CEEGOG-CX1) is an international, multi centre, prospective observational trial evaluating sentinel lymph node (SLN) biopsy without pelvic lymph node dissection in patients with early-stage cervical cancer. We report the final preplanned analysis of the secondary end-points: SLN mapping and outcomes of intraoperative SLN pathology. Methods: Forty-seven sites (18 countries) with experience of SLN biopsy participated in SENTIX. We preregistered patients with stage IA1/lymphovascular space invasion-positive to IB2 (4 cm or smaller or 2 cm or smaller for fertility-sparing treatment) cervical cancer without suspicious lymph nodes on imaging before surgery. SLN frozen section assessment and pathological ultrastaging were mandatory. Patients were registered postoperatively if SLN were bilaterally detected in the pelvis, and frozen sections were negative. Trial registration: ClinicalTrials.gov (NCT02494063). Results: We analysed data for 395 preregistered patients. Bilateral detection was achieved in 91% (355/395), and it was unaffected by tumour size, tumour stage or body mass index, but it was lower in older patients, in patients who underwent open surgery, and in sites with fewer cases. No SLN were found outside the seven anatomical pelvic regions. Most SLN and positive SLN were localised below the common iliac artery bifurcation. Single positive SLN above the iliac bifurcation were found in 2% of cases. Frozen sections failed to detect 54% of positive lymph nodes (pN1), including 28% of cases with macrometastases and 90% with micrometastases. Interpretation: SLN biopsy can achieve high bilateral SLN detection in patients with tumours of 4 cm or smaller. At experienced centres, all SLN were found in the pelvis, and most were located below the iliac vessel bifurcation. SLN frozen section assessment is an unreliable tool for intraoperative triage because it only detects about half of N1 cases. (C) 2020 The Author(s). Published by Elsevier Ltd.

Citovat

CIBULA, David, Roman KOCIAN, Andrea PLAIKNER, Jiří JARKOVSKÝ, Jaroslav KLAT, Ignacio ZAPARDIEL, Radovan PILKA, Aureli TORNE, Borek SEHNAL, Marcela OSTOJICH, Almerinda PETIZ, Octavio A. SANCHEZ, Jiri PRESL, Alessandro BUDA, Francesco RASPAGLIESI, Peter KASCAK, Luc VAN LONKHUIJZEN, Marc BARAHONA, Luboš MINÁŘ, Pawel BLECHARZ, Maja PAKIZ, Dariusz WYDRA, Leon C. SNYMAN, Kamil ZALEWSKI, Cristina ZORRERO, Havelka HAVELKA, Mikulas REDECHA, Alla VINNYTSKA, Ignace VERGOTE, Solveig TINGULSTAD, Martin MICHAL, Barbara KIPP, Slama SLAMA, Simone MARNITZ, Sylva BAJSOVA, Alicia HERNANDEZ, Daniela FISCHEROVA, Kristyna NEMEJCOVA and Christhardt KOHLER. Sentinel lymph node mapping and intraoperative assessment in a prospective, international, multicentre, observational trial of patients with cervical cancer: The SENTIX trial. European Journal of Cancer. Oxford: Elsevier Science Inc., 2020, vol. 137, SEP 2020, p. 69-80. ISSN 0959-8049. Available from: https://dx.doi.org/10.1016/j.ejca.2020.06.034.

@article{1680201,
   author = {Cibula, David and Kocian, Roman and Plaikner, Andrea and Jarkovský, Jiří and Klat, Jaroslav and Zapardiel, Ignacio and Pilka, Radovan and Torne, Aureli and Sehnal, Borek and Ostojich, Marcela and Petiz, Almerinda and Sanchez, Octavio A. and Presl, Jiri and Buda, Alessandro and Raspagliesi, Francesco and Kascak, Peter and van Lonkhuijzen, Luc and Barahona, Marc and Minář, Luboš and Blecharz, Pawel and Pakiz, Maja and Wydra, Dariusz and Snyman, Leon C. and Zalewski, Kamil and Zorrero, Cristina and Havelka, Havelka and Redecha, Mikulas and Vinnytska, Alla and Vergote, Ignace and Tingulstad, Solveig and Michal, Martin and Kipp, Barbara and Slama, Slama and Marnitz, Simone and Bajsova, Sylva and Hernandez, Alicia and Fischerova, Daniela and Nemejcova, Kristyna and Kohler, Christhardt},
   article_location = {Oxford},
   article_number = {SEP 2020},
   doi = {http://dx.doi.org/10.1016/j.ejca.2020.06.034},
   keywords = {Cervical cancer; Sentinel lymph node; Frozen section; Mapping; Ultrastaging; Micrometastases},
   language = {eng},
   issn = {0959-8049},
   journal = {European Journal of Cancer},
   title = {Sentinel lymph node mapping and intraoperative assessment in a prospective, international, multicentre, observational trial of patients with cervical cancer: The SENTIX trial},
   url = {https://www.ejcancer.com/article/S0959-8049(20)30367-1/pdf},
   volume = {137},
   year = {2020}
}

TY  - JOUR
ID  - 1680201
AU  - Cibula, David - Kocian, Roman - Plaikner, Andrea - Jarkovský, Jiří - Klat, Jaroslav - Zapardiel, Ignacio - Pilka, Radovan - Torne, Aureli - Sehnal, Borek - Ostojich, Marcela - Petiz, Almerinda - Sanchez, Octavio A. - Presl, Jiri - Buda, Alessandro - Raspagliesi, Francesco - Kascak, Peter - van Lonkhuijzen, Luc - Barahona, Marc - Minář, Luboš - Blecharz, Pawel - Pakiz, Maja - Wydra, Dariusz - Snyman, Leon C. - Zalewski, Kamil - Zorrero, Cristina - Havelka, Havelka - Redecha, Mikulas - Vinnytska, Alla - Vergote, Ignace - Tingulstad, Solveig - Michal, Martin - Kipp, Barbara - Slama, Slama - Marnitz, Simone - Bajsova, Sylva - Hernandez, Alicia - Fischerova, Daniela - Nemejcova, Kristyna - Kohler, Christhardt
PY  - 2020
TI  - Sentinel lymph node mapping and intraoperative assessment in a prospective, international, multicentre, observational trial of patients with cervical cancer: The SENTIX trial
JF  - European Journal of Cancer
VL  - 137
IS  - SEP 2020
SP  - 69-80
EP  - 69-80
PB  - Elsevier Science Inc.
SN  - 09598049
KW  - Cervical cancer
KW  - Sentinel lymph node
KW  - Frozen section
KW  - Mapping
KW  - Ultrastaging
KW  - Micrometastases
UR  - https://www.ejcancer.com/article/S0959-8049(20)30367-1/pdf
L2  - https://www.ejcancer.com/article/S0959-8049(20)30367-1/pdf
N2  - Background: SENTIX (ENGOT-CX2/CEEGOG-CX1) is an international, multi centre, prospective observational trial evaluating sentinel lymph node (SLN) biopsy without pelvic lymph node dissection in patients with early-stage cervical cancer. We report the final preplanned analysis of the secondary end-points: SLN mapping and outcomes of intraoperative SLN pathology. Methods: Forty-seven sites (18 countries) with experience of SLN biopsy participated in SENTIX. We preregistered patients with stage IA1/lymphovascular space invasion-positive to IB2 (4 cm or smaller or 2 cm or smaller for fertility-sparing treatment) cervical cancer without suspicious lymph nodes on imaging before surgery. SLN frozen section assessment and pathological ultrastaging were mandatory. Patients were registered postoperatively if SLN were bilaterally detected in the pelvis, and frozen sections were negative. Trial registration: ClinicalTrials.gov (NCT02494063). Results: We analysed data for 395 preregistered patients. Bilateral detection was achieved in 91% (355/395), and it was unaffected by tumour size, tumour stage or body mass index, but it was lower in older patients, in patients who underwent open surgery, and in sites with fewer cases. No SLN were found outside the seven anatomical pelvic regions. Most SLN and positive SLN were localised below the common iliac artery bifurcation. Single positive SLN above the iliac bifurcation were found in 2% of cases. Frozen sections failed to detect 54% of positive lymph nodes (pN1), including 28% of cases with macrometastases and 90% with micrometastases. Interpretation: SLN biopsy can achieve high bilateral SLN detection in patients with tumours of 4 cm or smaller. At experienced centres, all SLN were found in the pelvis, and most were located below the iliac vessel bifurcation. SLN frozen section assessment is an unreliable tool for intraoperative triage because it only detects about half of N1 cases. (C) 2020 The Author(s). Published by Elsevier Ltd.
ER  -

CIBULA, David, Roman KOCIAN, Andrea PLAIKNER, Jiří JARKOVSKÝ, Jaroslav KLAT, Ignacio ZAPARDIEL, Radovan PILKA, Aureli TORNE, Borek SEHNAL, Marcela OSTOJICH, Almerinda PETIZ, Octavio A. SANCHEZ, Jiri PRESL, Alessandro BUDA, Francesco RASPAGLIESI, Peter KASCAK, Luc VAN LONKHUIJZEN, Marc BARAHONA, Luboš MINÁŘ, Pawel BLECHARZ, Maja PAKIZ, Dariusz WYDRA, Leon C. SNYMAN, Kamil ZALEWSKI, Cristina ZORRERO, Havelka HAVELKA, Mikulas REDECHA, Alla VINNYTSKA, Ignace VERGOTE, Solveig TINGULSTAD, Martin MICHAL, Barbara KIPP, Slama SLAMA, Simone MARNITZ, Sylva BAJSOVA, Alicia HERNANDEZ, Daniela FISCHEROVA, Kristyna NEMEJCOVA and Christhardt KOHLER. Sentinel lymph node mapping and intraoperative assessment in a prospective, international, multicentre, observational trial of patients with cervical cancer: The SENTIX trial. \textit{European Journal of Cancer}. Oxford: Elsevier Science Inc., 2020, vol.~137, SEP 2020, p.~69-80. ISSN~0959-8049. Available from: https://dx.doi.org/10.1016/j.ejca.2020.06.034.

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