Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in multimodal therapy for patients with oligometastatic peritoneal gastric cancer: a randomized multicenter phase III trial PIPAC VEROne

被引：24
作者：
Casella, Francesco [1 ]
Bencivenga, Maria [1 ]
Rosati, Riccardo [2 ]
Fumagalli, Uberto Romario [3 ]
Marrelli, Daniele [4 ]
Pacelli, Fabio [5 ]
Macri, Antonio [6 ]
Donini, Annibale [7 ]
Torroni, Lorena [8 ]
Pavarana, Michele [9 ]
De Manzoni, Giovanni [1 ]
机构：
[1] Univ Verona, Dept & Surg, Gen & Upper GI Surg Div, Odontostomatol Maternal & Child Sci, Piazzale A Stefani 1, Verona, Veneto, Italy
[2] San Raffaele Vita Salute Univ, San Raffaele Hosp, Dept Surg, Milan, Italy
[3] European Inst Oncol, Digest Surg, Milan, Italy
[4] Univ Siena, Siena Univ Hosp, Dept Surg, Siena, Italy
[5] Fdn Policlin Univ A Gemelli, Surg Unit Peritoneum & Retroperitoneum Surg, IRCCS, Rome, Italy
[6] Univ Messina, Peritoneal Surface Malignancy & Soft Tissue Sarco, Messina, Italy
[7] Univ Perugia, Santa Maria Della Misericordia Hosp, Gen & Emergency Surg, Perugia, Italy
[8] Univ Verona, Dept Diagnost & Publ Hlth, Unit Epidemiol & Med Stat, Verona, Italy
[9] Univ Verona, Dept Oncol, Verona, Italy
来源：
PLEURA AND PERITONEUM | 2022年 / 7卷 / 03期
关键词：
gastric cancer; intraperitoneal chemotherapy; peritoneal metastases; PIPAC; systemic chemotherapy; LOW-DOSE CISPLATIN; METASTASIS; DOXORUBICIN;
D O I：
10.1515/pp-2022-0111
中图分类号：
R73 [肿瘤学];
学科分类号：
100214 ;
摘要：
Objectives: Peritoneal carcinomatosis is the most frequent site of metastases in patients with gastric cancer. Current standard treatment is palliative systemic chemotherapy with very poor prognosis. Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) resulted in long-term benefits in selected patients. Among patients with peritoneal carcinomatosis, a distinctive subset is oligometastatic disease which is characterized by low metastatic burden. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a recent technique of intraperitoneal chemotherapy used in combination with systemic chemotherapy with promising results. Methods: PIPAC VER- One is a prospective, randomized, multicenter phase III clinical trial that aims to evaluate the effectiveness of the use of PIPAC in combination with systemic chemotherapy in patients with gastric cancer and synchronous positive peritoneal cytology and/or limited peritoneal metastases (peritoneal cancer index [PCI] <= 6). Patients will be randomized into two arms: arm A (control) treated with standard systemic chemotherapy and arm B (experimental) treated with a bidirectional scheme including PIPAC and systemic chemotherapy. Results: Primary endpoint is the secondary resectability rate. Secondary endpoints are: overall survival (OS), pregression-free survival (PFS), disease-free survival (DFS), histological response assessed both on primary tumor and peritoneal lesions, quality of life (QoL), complication rate (CTCAE v5), and incremental cost-effectiveness ratios (ICER). Conclusions: The role of PIPAC in multimodal treatment for oligometastatic gastric cancer will be investigated in this trial.
引用
收藏
页码：135 / 141
页数：7
相关论文
共 18 条
[1]   The RENAISSANCE (AIO-FLOT5) trial: effect of chemotherapy alone vs. chemotherapy followed by surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction - a phase III trial of the German AIO/CAO-V/CAOGI [J].
Al-Batran, Salah-Eddin ;
Goetze, Thorsten O. ;
Mueller, Daniel W. ;
Vogel, Arndt ;
Winkler, Michael ;
Lorenzen, Sylvie ;
Novotny, Alexander ;
Pauligk, Claudia ;
Homann, Nils ;
Jungbluth, Thomas ;
Reissfelder, Christoph ;
Caca, Karel ;
Retter, Steffen ;
Horndasch, Eva ;
Gumpp, Julia ;
Bolling, Claus ;
Fuchs, Karl-Hermann ;
Blau, Wolfgang ;
Padberg, Winfried ;
Pohl, Michael ;
Wunsch, Andreas ;
Michl, Patrick ;
Mannes, Frank ;
Schwarzbach, Matthias ;
Schmalenberg, Harald ;
Hohaus, Michael ;
Scholz, Christian ;
Benckert, Christoph ;
Knorrenschild, Jorge Riera ;
Kanngiesser, Veit ;
Zander, Thomas ;
Alakus, Hakan ;
Hofheinz, Ralf-Dieter ;
Roedel, Claus ;
Shah, Manish A. ;
Sasako, Mitsuru ;
Lorenz, Dietmar ;
Izbicki, Jakob ;
Bechstein, Wolf O. ;
Lang, Hauke ;
Moenig, Stefan P. .
BMC CANCER, 2017, 17
[2]   Effect of Neoadjuvant Chemotherapy Followed by Surgical Resection on Survival in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Cancer The AIO-FLOT3 Trial [J].
Al-Batran, Salah-Eddin ;
Homann, Nils ;
Pauligk, Claudia ;
Illerhaus, Gerald ;
Martens, Uwe M. ;
Stoehlmacher, Jan ;
Schmalenberg, Harald ;
Luley, Kim B. ;
Prasnikar, Nicole ;
Egger, Matthias ;
Probst, Stephan ;
Messmann, Helmut ;
Moehler, Markus ;
Fischbach, Wolfgang ;
Hartmann, Joerg T. ;
Mayer, Frank ;
Hoeffkes, Heinz-Gert ;
Koenigsmann, Michael ;
Arnold, Dirk ;
Kraus, Thomas W. ;
Grimm, Kersten ;
Berkhoff, Stefan ;
Post, Stefan ;
Jager, Elke ;
Bechstein, Wolf ;
Ronellenfitsch, Ulrich ;
Moenig, Stefan ;
Hofheinz, Ralf D. .
JAMA ONCOLOGY, 2017, 3 (09) :1237-1244
[3]   Pressurized intraperitoneal aerosol chemotherapy (PIPAC) for unresectable peritoneal metastasis from gastric cancer [J].
Alyami, Mohammad ;
Bonnot, Pierre-Emmanuel ;
Mercier, Frederic ;
Laplace, Nathalie ;
Villeneuve, Laurent ;
Passot, Guillaume ;
Bakrin, Naoual ;
Kepenekian, Vahan ;
Glehen, Olivier .
EJSO, 2021, 47 (01) :123-127
[4]   Multicentric initial experience with the use of the pressurized intraperitoneal aerosol chemotherapy (PIPAC) in the management of unresectable peritoneal carcinomatosis [J].
Alyami, Mohammad ;
Gagniere, Johan ;
Sgarbura, Olivia ;
Cabelguenne, Delphine ;
Villeneuve, Laurent ;
Pezet, Denis ;
Quenet, Francois ;
Glehen, Olivier ;
Bakrin, Naoual ;
Passot, Guillaume .
EJSO, 2017, 43 (11) :2178-2183
[5]   Prognosis of poorly cohesive gastric cancer after complete cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (CYTO-CHIP study) [J].
Bonnot, P. E. ;
Lintis, A. ;
Mercier, F. ;
Benzerdjeb, N. ;
Passot, G. ;
Pocard, M. ;
Meunier, B. ;
Bereder, J. M. ;
Abboud, K. ;
Marchal, F. ;
Quenet, F. ;
Goere, D. ;
Msika, S. ;
Arvieux, C. ;
Pirro, N. ;
Wernert, R. ;
Rat, P. ;
Gagniere, J. ;
Lefevre, J. H. ;
Courvoisier, T. ;
Kianmanesh, R. ;
Vaudoyer, D. ;
Rivoire, M. ;
Meeus, P. ;
Villeneuve, L. ;
Piessen, G. ;
Glehen, O. .
BRITISH JOURNAL OF SURGERY, 2021, 108 (10) :1225-1235
[6]   The Italian Research Group for Gastric Cancer (GIRCG) guidelines for gastric cancer staging and treatment: 2015 [J].
De Manzoni, Giovanni ;
Marrelli, Daniele ;
Baiocchi, Gian Luca ;
Morgagni, Paolo ;
Saragoni, Luca ;
Degiuli, Maurizio ;
Donini, Annibale ;
Fumagalli, Uberto ;
Mazzei, Maria Antonietta ;
Pacelli, Fabio ;
Tomezzoli, Anna ;
Berselli, Mattia ;
Catalano, Filippo ;
Di Leo, Alberto ;
Framarini, Massimo ;
Giacopuzzi, Simone ;
Graziosi, Luigina ;
Marchet, Alberto ;
Marini, Mario ;
Milandri, Carlo ;
Mura, Gianni ;
Orsenigo, Elena ;
Quagliuolo, Vittorio ;
Rausei, Stefano ;
Ricci, Riccardo ;
Rosa, Fausto ;
Roviello, Giandomenico ;
Sansonetti, Andrea ;
Sgroi, Giovanni ;
Tiberio, Guido Alberto Massimo ;
Verlato, Giuseppe ;
Vindigni, Carla ;
Rosati, Riccardo ;
Roviello, Franco .
GASTRIC CANCER, 2017, 20 (01) :20-30
[7]   Systemic chemotherapy and pressurized intraperitoneal aerosol chemotherapy (PIPAC): A bidirectional approach for gastric cancer peritoneal metastasis [J].
Di Giorgio, Andrea ;
Schena, Carlo Alberto ;
El Halabieh, Miriam Attalla ;
Abatini, Carlo ;
Vita, Emanuele ;
Strippoli, Antonia ;
Inzani, Frediano ;
Rodolfino, Elena ;
Romano, Bruno ;
Pacelli, Fabio ;
Rotolo, Stefano .
SURGICAL ONCOLOGY-OXFORD, 2020, 34 :270-275
[8]   How to Perform Safe and Technically Optimized Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC): Experience After a Consecutive Series of 1200 Procedures [J].
Giger-Pabst, Urs ;
Tempfer, Clemens B. .
JOURNAL OF GASTROINTESTINAL SURGERY, 2018, 22 (12) :2187-2193
[9]   Staging laparoscopy and Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) for peritoneal metastasis: safe access to the abdomen [J].
Glatz, Torben ;
Horvath, Philipp ;
Lang, Sven A. ;
Archid, Rami ;
Nadiradze, Giorgi .
PLEURA AND PERITONEUM, 2019, 4 (01)
[10]   Looking for a strategy in treating peritoneal gastric cancer carcinomatosis: an Italian multicenter Gastric Cancer Research group's analysis [J].
Graziosi, Luigina ;
Marino, Elisabetta ;
Bencivenga, Maria ;
D'Ignazio, Alessia ;
Solaini, Leonardo ;
Ministrini, Silvia ;
Caprioli, Michela ;
Sacco, Michele ;
Marrelli, Daniele ;
Mura, Gianni ;
Degiuli, Maurizio ;
Morgagni, Paolo ;
Tiberio, Guido Alberto Massimo ;
De Manzoni, Giovanni ;
Roviello, Franco ;
Donini, Annibale .
WORLD JOURNAL OF SURGICAL ONCOLOGY, 2021, 19 (01)
12