Pressurized intraperitoneal aerosol chemotherapy with low-dose cisplatin and doxorubicin (PIPAC C/D) in patients with gastric cancer and peritoneal metastasis: a phase II study.
Cisplatin
doxorubicin
gastric cancer
histological regression
intraperitoneal chemotherapy
objective tumor response
peritoneal metastasis
pressurized intraperitoneal aerosol chemotherapy (PIPAC)
Journal
Therapeutic advances in medical oncology
ISSN: 1758-8340
Titre abrégé: Ther Adv Med Oncol
Pays: England
ID NLM: 101510808
Informations de publication
Date de publication:
2019
2019
Historique:
received:
22
08
2018
accepted:
04
04
2019
entrez:
18
6
2019
pubmed:
18
6
2019
medline:
18
6
2019
Statut:
epublish
Résumé
Efficacy of second-line systemic chemotherapy in recurrent gastric cancer with peritoneal metastasis (RGCPM) is limited. We assessed the feasibility, safety and possible efficacy of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with RGCPM after ⩾1 line of palliative intravenous chemotherapy. In this open-label, single-arm, monocentric phase II ICH-GCP clinical trial, patients were scheduled for three courses of PIPAC with cisplatin 7.5 mg/m A total of 25 patients were enrolled and available for the analysis of the primary endpoint. Of those 25 patients, 10 (40%) had a radiological complete, partial response or stable disease. Median OS [intention to treat (ITT)] was 6.7 months, median TTP was 2.7 months. Complete or major regression on histology were observed in 9/25 patients (36%, ITT) or 6/6 [100%, per protocol (PP)] patients. There were no suspected unexpected serious adverse reactions, no treatment-related deaths, no CTCAE grade 4 toxicity and three (12%) grade 3 toxicities. Changes in the QLQ-C30 scores during PIPAC C/D therapy were small and not significant. PIPAC C/D was well tolerated and active in patients with RGCPM. Survival was encouraging. Randomized controlled trials should now be designed in this indication.
Sections du résumé
BACKGROUND
BACKGROUND
Efficacy of second-line systemic chemotherapy in recurrent gastric cancer with peritoneal metastasis (RGCPM) is limited. We assessed the feasibility, safety and possible efficacy of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with RGCPM after ⩾1 line of palliative intravenous chemotherapy.
METHODS
METHODS
In this open-label, single-arm, monocentric phase II ICH-GCP clinical trial, patients were scheduled for three courses of PIPAC with cisplatin 7.5 mg/m
RESULTS
RESULTS
A total of 25 patients were enrolled and available for the analysis of the primary endpoint. Of those 25 patients, 10 (40%) had a radiological complete, partial response or stable disease. Median OS [intention to treat (ITT)] was 6.7 months, median TTP was 2.7 months. Complete or major regression on histology were observed in 9/25 patients (36%, ITT) or 6/6 [100%, per protocol (PP)] patients. There were no suspected unexpected serious adverse reactions, no treatment-related deaths, no CTCAE grade 4 toxicity and three (12%) grade 3 toxicities. Changes in the QLQ-C30 scores during PIPAC C/D therapy were small and not significant.
CONCLUSIONS
CONCLUSIONS
PIPAC C/D was well tolerated and active in patients with RGCPM. Survival was encouraging. Randomized controlled trials should now be designed in this indication.
Identifiants
pubmed: 31205501
doi: 10.1177/1758835919846402
pii: 10.1177_1758835919846402
pmc: PMC6535725
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1758835919846402Déclaration de conflit d'intérêts
Conflict of interest statement: Marc André Reymond is a holder of patents related to PIPAC C/D technology and a shareholder of Capnomed GmbH, Zimmern, Germany. The other authors have no potential conflict of interests.
Références
Surg Endosc. 2000 Jan;14(1):51-5
pubmed: 10653236
Semin Radiat Oncol. 2002 Apr;12(2):150-61
pubmed: 11979416
World J Gastroenterol. 2006 May 28;12(20):3237-42
pubmed: 16718845
Eur J Cancer. 2009 Jan;45(2):228-47
pubmed: 19097774
Int J Cancer. 2010 Dec 15;127(12):2893-917
pubmed: 21351269
J Surg Oncol. 2011 Nov 1;104(6):692-8
pubmed: 21713780
Eur J Cancer. 2011 Oct;47(15):2306-14
pubmed: 21742485
Surg Endosc. 2012 Mar;26(3):847-52
pubmed: 22042585
World J Surg Oncol. 2011 Dec 21;9:171
pubmed: 22188796
J Clin Oncol. 2012 May 1;30(13):1513-8
pubmed: 22412140
Surg Endosc. 2012 Jul;26(7):1849-55
pubmed: 22580869
Ann Surg Oncol. 2014 Feb;21(2):553-9
pubmed: 24006094
J Clin Oncol. 2013 Dec 10;31(35):4438-44
pubmed: 24190112
Lancet Oncol. 2014 Jan;15(1):78-86
pubmed: 24332238
Ann Surg Oncol. 2014 May;21(5):1739-48
pubmed: 24419755
J Psychosoc Oncol. 2014;32(4):413-30
pubmed: 24798117
Lancet Oncol. 2014 Oct;15(11):1224-35
pubmed: 25240821
Gynecol Oncol. 2015 May;137(2):223-8
pubmed: 25701703
Gastric Cancer. 2016 Jul;19(3):902-10
pubmed: 26386560
J Gastrointest Surg. 2016 Feb;20(2):367-73
pubmed: 26511950
Ann Surg Oncol. 2016 Jun;23(6):1971-9
pubmed: 26753751
Ann Surg Oncol. 2016 Nov;23(12):3972-3977
pubmed: 27313067
Gastric Cancer. 2017 Mar;20(Suppl 1):122-127
pubmed: 27766496
Transl Gastroenterol Hepatol. 2016 Aug 12;1:63
pubmed: 28138629
Br J Surg. 2017 May;104(6):669-678
pubmed: 28407227
Eur J Surg Oncol. 2017 Jun;43(6):1102-1109
pubmed: 28431896
Crit Rev Oncol Hematol. 2017 Aug;116:68-81
pubmed: 28693801
Arch Gynecol Obstet. 2018 Aug;298(2):243-257
pubmed: 29869089
Eur J Surg Oncol. 2018 Nov;44(11):1793-1799
pubmed: 29871821
Ther Adv Med Oncol. 2018 Jun 01;10:1758835918777036
pubmed: 29899763
Surg Oncol Clin N Am. 2018 Jul;27(3):519-537
pubmed: 29935687
Pleura Peritoneum. 2016 Jun 1;1(2):99-107
pubmed: 30911613
Pleura Peritoneum. 2016 Sep 1;1(3):159-166
pubmed: 30911619
Pleura Peritoneum. 2017 Jun 1;2(2):103-109
pubmed: 30911638
Pleura Peritoneum. 2018 Mar 21;3(1):20180103
pubmed: 30911653
Pleura Peritoneum. 2018 Jun 08;3(2):20180113
pubmed: 30911658
Pleura Peritoneum. 2018 Jun 21;3(2):20180116
pubmed: 30911659
Cancer Treat Res. 1996;82:359-74
pubmed: 8849962