Patient-reported outcomes during repetitive oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy for isolated unresectable colorectal peritoneal metastases in a multicenter, single-arm, phase 2 trial (CRC-PIPAC)

Robin J. Lurvink, Koen P. Rovers, Emma C. E. Wassenaar, Checca Bakkers, Jacobus W. A. Burger, Geert-Jan M. Creemers, Maartje Los, Floortje Mols, Marinus J. Wiezer, Simon W. Nienhuijs, Djamila Boerma, Ignace H. J. T. de Hingh*

*Corresponding author for this work

Research output: Contribution to journalArticleScientificpeer-review

Abstract

Background 

CRC-PIPAC prospectively assessed repetitive oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy (PIPAC-OX) as a palliative monotherapy (i.e., without concomitant systemic therapy in between subsequent procedures) for unresectable colorectal peritoneal metastases (CPM). The present study explored patient-reported outcomes (PROs) during trial treatment. 

Methods 

In this single-arm phase 2 trial in two tertiary centers, patients with isolated unresectable CPM received 6-weekly PIPAC-OX (92 mg/m(2)). PROs (calculated from EQ-5D-5L, and EORTC QLQ-C30 and QLQ-CR29) were compared between baseline and 1 and 4 weeks after the first three procedures using linear mixed modeling with determination of clinical relevance (Cohen's D >= 0.50) of statistically significant differences. 

Results 

Twenty patients underwent 59 procedures (median 3 [range 1-6]). Several PROs solely worsened 1 week after the first procedure (index value - 0.10, p < 0.001; physical functioning - 20, p < 0.001; role functioning - 27, p < 0.001; social functioning - 18, p < 0.001; C30 summary score - 16, p < 0.001; appetite loss + 15, p = 0.007; diarrhea + 15, p = 0.002; urinary frequency + 13, p = 0.004; flatulence + 13, p = 0.001). These PROs returned to baseline at subsequent time points. Other PROs worsened 1 week after the first procedure (fatigue + 23, p < 0.001; pain + 29, p < 0.001; abdominal pain + 32, p < 0.001), second procedure (fatigue + 20, p < 0.001; pain + 21, p < 0.001; abdominal pain + 20, p = 0.002), and third procedure (pain + 22, p < 0.001; abdominal pain + 22, p = 0.002). Except for appetite loss, all changes were clinically relevant. All analyzed PROs returned to baseline 4 weeks after the third procedure. 

Conclusions 

Patients receiving repetitive PIPAC-OX monotherapy for unresectable CPM had clinically relevant but reversible worsening of several PROs, mainly 1 week after the first procedure.

Original languageEnglish
Number of pages13
JournalSurgical Endoscopy
DOIs
Publication statusE-pub ahead of print - 2022

Keywords

  • Colorectal neoplasms
  • Peritoneal neoplasms
  • Antineoplastic agents
  • Oxaliplatin
  • Patient-reported outcome measures
  • Quality of life
  • QUALITY-OF-LIFE
  • EUROPEAN-ORGANIZATION
  • CANCER PATIENTS
  • CARCINOMATOSIS
  • RATIONALE
  • QUESTIONNAIRE
  • SURVIVAL
  • WOMEN

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