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

Overview

Journal Ther Adv Med Oncol

Specialty Oncology

Date 2019 Jun 18

PMID 31205501

Citations 43

Authors

Florian Struller

Philipp Horvath

Wiebke Solass

Frank-Jurgen Weinreich

Dirk Strumberg

Marios K Kokkalis

Imma Fischer

Christoph Meisner

Alfred Konigsrainer

Marc A Reymond

Affiliations

Soon will be listed here.

Abstract

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: 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 and doxorubicin 1.5 mg/m (PIPAC C/D) every 6 weeks. Patients with bowel obstruction or extraperitoneal metastasis were ineligible. The primary endpoint was clinical benefit rate (CBR) by Response Evaluation Criteria in Solid Tumors based on clinical records. Secondary endpoints included overall survival (OS), median time to progression (TTP), peritoneal carcinomatosis index (PCI), histological regression and ascites volume. Safety and tolerability were assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4, quality of life (QoL) by EORTC-QLQ30 questionnaire.

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: 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.

Citing Articles

Emerging Trends in the Management of Gastric Malignancy with Peritoneal Dissemination: Same Disease, Heterogeneous Prognosis.

Mela E, Theodorou A, Kimpizi D, Konstantinou K, Belimezakis N, Schizas D Cancers (Basel). 2025; 17(1.

PMID: 39796744 PMC: 11719794. DOI: 10.3390/cancers17010117.

Evolution in the Surgical Management of Gastric Cancer Peritoneal Metastases.

Krell M, Ranjbar S, Gitlin S, Alvarez Vega D, Wilson R, Thrasher K Cancers (Basel). 2025; 17(1.

PMID: 39796727 PMC: 11719528. DOI: 10.3390/cancers17010100.

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Gastric Cancer Peritoneal Metastases: Results from the Lithuanian PIPAC Program.

Luksta M, Bausys A, Gendvilaite N, Bickaite K, Rackauskas R, Paskonis M Cancers (Basel). 2024; 16(17).

PMID: 39272850 PMC: 11394265. DOI: 10.3390/cancers16172992.

Impact of PIPAC-Oxaliplatin on Functional Recovery, Good Days, and Survival in a Refractory Colorectal and Appendiceal Carcinomatosis: Secondary Analysis of the US PIPAC Collaborative Phase 1 Trial.

Waheed M, Ruel N, Whelan R, Fakih M, Fong Y, Deperalta D Ann Surg Oncol. 2024; 31(12):7998-8007.

PMID: 39271567 PMC: 11467104. DOI: 10.1245/s10434-024-15980-9.

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in the Treatment of Gastric Cancer: Feasibility, Efficacy and Safety-A Systematic Review and Meta-Analysis.

Ramalho-Vasconcelos F, Gomes R, Bouca-Machado R, Aral M, Nogueiro J, Bouca-Machado T J Clin Med. 2024; 13(11).

PMID: 38893031 PMC: 11173180. DOI: 10.3390/jcm13113320.

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