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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
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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
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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
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Journal Article
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
2024
Overview
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.
Publisher
Springer International Publishing,Springer Nature B.V
Subject
/ Aerosols
/ Aged
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Appendiceal Neoplasms - drug therapy
/ Appendiceal Neoplasms - mortality
/ Appendiceal Neoplasms - pathology
/ Appendiceal Neoplasms - therapy
/ Appendix
/ Colorectal Neoplasms - drug therapy
/ Colorectal Neoplasms - mortality
/ Colorectal Neoplasms - pathology
/ Female
/ Humans
/ Male
/ Medicine
/ Oncology
/ Oxaliplatin - administration & dosage
/ Patients
/ Peritoneal Neoplasms - drug therapy
/ Peritoneal Neoplasms - mortality
/ Peritoneal Neoplasms - secondary
/ Peritoneal Surface Malignancy
/ Surgery
/ Survival
