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Clinical Trial
. 2024 Nov;31(12):7998-8007.
doi: 10.1245/s10434-024-15980-9. Epub 2024 Sep 13.

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

Muhammad Talha Waheed #  1 , Nora Ruel #  2 , Richard L Whelan  3 , Marwan Fakih  4 , Yuman Fong  1 , Danielle Deperalta  3 , Amit Merchea  5 , Virginia Sun  6 , Robert Krouse  7 , Thanh H Dellinger  8 , Mustafa Raoof  9
Affiliations
Clinical Trial

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

Muhammad Talha Waheed et al. Ann Surg Oncol. 2024 Nov.

Abstract

Background: Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is a novel, minimally invasive, safe, and repeatable method to treat carcinomatosis. Evidence regarding the clinical benefit (quality of life and survival) of PIPAC compared with that of conventional standard therapy (ST) is lacking.

Methods: This is the secondary analysis of the phase 1 US-PIPAC trial for refractory colorectal and appendiceal carcinomatosis. A PIPAC cohort was compared with a retrospective cohort of consecutive patients receiving ST. The primary outcome was number of good days (number of days alive and out of the hospital). The secondary outcomes were overall survival (OS), progression-free survival (PFS), health-related quality of life (HRQoL), and objective functional recovery (daily step count).

Results: The study included 32 patients (PIPAC, 12; ST, 20) with similar baseline characteristics. Compared with the ST cohort, the PIPAC cohort had lower median inpatient hospital stays (> 24 h) within 6 months (0 vs 1; p = 0.015) and 1 year (1 vs 2; p = 0.052) and higher median good days at 6 months (181 vs 131 days; p = 0.042) and 1 year (323 vs 131 days; p = 0.032). There was no worsening of HRQoL after repeated PIPACs. Step counts diminished immediately after PIPAC but returned to baseline within 2-4 weeks. Kaplan-Meier analysis demonstrated a favorable association between receipt of PIPAC and OS (median, 11.3 vs 5.1 months; p = 0.036).

Conclusion: Compared with ST, PIPAC was associated with higher number of good days, reduced hospitalization burden, and longer OS without a negative impact on HRQoL with repeated PIPACs. These findings are foundational for evaluation of PIPAC in a randomized clinical trial.

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Conflict of interest statement

Marwan Fakih was involved in relevant financial activities outside the submitted work for AbbVie, Inc., AstraZeneca, Bayer Corporation, Bristol Myers Squibb, Eisai Inc., Entos, Inc.,; Incyte Corporation, Janssen, Merck, Mirati, Nouscom, Pfizer, Inc., Roche/Genentech, Taiho Oncology, and Xenthera, Inc. Yuman Fong is a scientific advisor to Medtronics, Imugene, Vergent Biosciences, XDemics, Theromics, Eureka Biologics, Iovance Biotherapeutics, and Savato Health. Thanh Dellinger received PIPAC nebulizers free of charge for this trial at City of Hope by Reger Inc company. Mustafa Raoof received grant funding from Exact biosciences for an investigator-initiated trial. Richard Whelan is a consultant for the Applied Medical Corporation with regard to endoscopic submucosal dissection (ESD), which is an advanced endoscopic procedure. He also is seeking support from this company for an investigator-initiated ex vivo animal study regarding ESD. This consultant work has nothing to do with PIPAC, peritoneal metastases, or the U.S. phase 1 study described in this report. Notably, this company also makes a type of laparoscopic port with an inflatable balloon near the tip. This happens to be the disposable port preferred by most surgeons performing PIPAC. The specific type of equipment used during PIPAC is not the subject matter of this report, nor is it germaine to the report. Richard Whelan has no relationship with Applied Medical regarding their laparoscopic ports or the PIPAC procedure. The remaining authors have no conflicts of interest.

Figures

Fig. 1
Fig. 1
Swimmers’ plot of the two cohorts (ST, standard therapy; n = 32)
Fig. 2
Fig. 2
Kaplan-Meier analysis of overall survival (OS) stratified by cohort type (ST, standard therapy; n = 32)
Fig. 3
Fig. 3
Kaplan-Meier analysis of progression-free survival (PFS) stratified by cohort type (ST, standard therapy; n = 32)
Fig. 4
Fig. 4
EQ-5D-5L and MDASI for SD versus PD patients (SD, stable disease; PD, progressive disease; n = 12). EQ-5D-5L, EuroQol five-dimensional descriptive system; MDASI, MD Anderson Symptom Index
Fig. 5
Fig. 5
Step-count data for SD vs PD patients (SD, stable disease; PD, progressive disease; n = 6)
See this image and copyright information in PMC

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