Randomized clinical trial of extensive intraoperative peritoneal lavage versus standard treatment for resectable advanced gastric cancer (CCOG 1102 trial).

Tytuł:: Randomized clinical trial of extensive intraoperative peritoneal lavage versus standard treatment for resectable advanced gastric cancer (CCOG 1102 trial).
Autorzy:: Misawa K; Department of Gastroenterological Surgery, Aichi Cancer Centre Hospital, Nagoya, Japan.
Mochizuki Y; Department of Surgery, Komaki Municipal Hospital, Komaki, Japan.
Sakai M; Department of Surgery, Ichinomiya Municipal Hospital, Ichinomiya, Japan.
Teramoto H; Department of General Surgery, Yokkaichi Municipal Hospital, Yokkaichi, Japan.
Morimoto D; Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.; Department of Surgery, JA Kainan Hospital, Yatomi, Japan.
Nakayama H; Department of Surgery, National Hospital Organization Nagoya Medical Centre, Nagoya, Japan.
Tanaka N; Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.; Department of Surgery, JA Aichi Konan Kosei Hospital, Konan, Japan.
Matsui T; Department of Gastroenterological Surgery, Aichi Cancer Centre, Aichi Hospital, Okazaki, Japan.
Ito Y; Department of Gastroenterological Surgery, Aichi Cancer Centre Hospital, Nagoya, Japan.
Ito S; Department of Gastroenterological Surgery, Aichi Cancer Centre Hospital, Nagoya, Japan.
Tanaka K; Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Uemura K; Department of Biostatistics and Bioinformatics, Interfaculty Initiative in Information Studies, University of Tokyo, Tokyo, Japan.
Morita S; Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Kodera Y; Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Corporate Authors:: Chubu Clinical Oncology Group
Źródło:: The British journal of surgery [Br J Surg] 2019 Nov; Vol. 106 (12), pp. 1602-1610. Date of Electronic Publication: 2019 Oct 01.
Typ publikacji:: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial
Język:: English
Imprint Name(s):: Publication: 2021- : [Oxford] : Oxford University Press
Original Publication: [Bristol, England : Baltimore : John Wright & Sons ; Williams & Wilkins Co.
MeSH Terms:: Gastrectomy*
Intraoperative Care*
Peritoneal Lavage*
Adenocarcinoma/*surgery
Stomach Neoplasms/*surgery
Adenocarcinoma/drug therapy ; Adenocarcinoma/mortality ; Adenocarcinoma/secondary ; Aged ; Chemotherapy, Adjuvant ; Disease-Free Survival ; Female ; Humans ; Male ; Middle Aged ; Peritoneal Neoplasms/secondary ; Recurrence ; Stomach Neoplasms/drug therapy ; Stomach Neoplasms/mortality ; Stomach Neoplasms/pathology
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Contributed Indexing:: Local Abstract: [Publisher, Spanish; Castilian] Se ha descrito que un lavado peritoneal extenso intraoperatorio (extensive intraoperative peritoneal lavage, EIPL) proporciona un beneficio en la supervivencia en pacientes con cáncer gástrico con citología peritoneal positiva. La hipótesis de este estudio era que el EIPL podría disminuir la recidiva peritoneal en pacientes con cáncer gástrico avanzado sometidos a cirugía con intención curativa. MÉTODOS: Ensayo clínico fase 3, abierto, multicéntrico y aleatorizado para evaluar los efectos de un lavado peritoneal extenso intraoperatorio (EIPL) frente a tratamiento estándar tras gastrectomía curativa por cáncer gástrico ≥T3 resecable. La variable de resultado primaria fue la supervivencia libre de enfermedad (disease-free survival, DFS), y las variables de resultado secundarias fueron la supervivencia global (overall survival, OS), la supervivencia libre de recidiva peritoneal y la incidencia de efectos adversos. [Publisher, Spanish; Castilian] Entre julio de 2011 y enero de 2014, se reclutaron 314 pacientes de 15 instituciones y se analizaron los datos de 295 pacientes (145 en el grupo con EIPL y 150 en el grupo sin EIPL). La DFS a los 3 años fue 63,9% (i.c. del 95% 55,5-71,2) en el grupo con EIPL y 59,7% (i.c. del 95% 51,3-67,1) en el grupo control (cociente de riesgos instantáneos, hazard ratio, HR 0,81 (i.c. del 95% 0,57-1,16), P = 0,249). La OS a los 3 años fue 75,0% (i.c. del 95% 67,1-81,3) en el grupo con EIPL y 73,7% (i.c. del 95% 65,9-80,1) en el grupo control (HR 0,91 i.c. del 95% 0,60-1,37), P = 0,634). No se observaron diferencias estadísticamente significativas entre los dos grupos en la supervivencia libre de recidiva peritoneal (P = 0,676, HR 0,92 (i.c. del 95% 0,62-1,36). No se observaron complicaciones intraoperatorias relacionadas con EIPL. CONCLUSIÓN: El EIPL no mejoró la supervivencia o la recidiva peritoneal en pacientes sometidos a gastrectomía por cáncer gástrico avanzado.
Entry Date(s):: Date Created: 20191002 Date Completed: 20200408 Latest Revision: 20200408
Update Code:: 20240105
DOI:: 10.1002/bjs.11303
PMID:: 31573086
: Czasopismo naukowe

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Background: A survival benefit of extensive intraoperative peritoneal lavage (EIPL) has been reported in patients with gastric cancer with positive peritoneal cytology. The hypothesis of this study was that EIPL may reduce peritoneal recurrence in patients with advanced gastric cancer who undergo surgery with curative intent.
Methods: This was an open-label, multi-institutional, randomized, phase 3 trial to assess the effects of EIPL versus standard treatment after curative gastrectomy for resectable gastric cancer of T3 status or above. The primary endpoint was disease-free survival (DFS); secondary endpoints were overall survival, peritoneal recurrence-free survival and incidence of adverse events.
Results: Between July 2011 and January 2014, 314 patients were enrolled from 15 institutions and 295 patients were analysed (145 and 150 in the EIPL and no-EIPL groups respectively). The 3-year DFS rate was 63·9 (95 per cent c.i. 55·5 to 71·2) per cent in the EIPL group and 59·7 (51·3 to 67·1) per cent in the control group (hazard ratio (HR) 0·81, 95 per cent c.i. 0·57 to 1·16; P = 0·249). The 3-year overall survival rate was 75·0 (67·1 to 81·3) per cent in the EIPL group and 73·7 (65·9 to 80·1) per cent in the control group (HR 0·91, 0·60 to 1·37; P = 0·634). Peritoneal recurrence-free survival was not significantly different between the two groups (HR 0·92, 0·62 to 1·36; P = 0·676). No intraoperative complications related to EIPL were observed.
Conclusion: EIPL did not improve survival or peritoneal recurrence in patients who underwent gastrectomy for advanced gastric cancer. Registration number: 000005907 (http://www.umin.ac.jp/ctr/index.htm).
(© 2019 BJS Society Ltd Published by John Wiley & Sons Ltd.)

Erratum in: Br J Surg. 2020 Jan;107(1):120. (PMID: 31869461)

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