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).
In: Surgical Endoscopy & Other Interventional Techniques, Jg. 36 (2022-06-01), Heft 6, S. 4486-4498
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Zugriff:
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/m2). 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. Trial Registration: Clinicaltrials.gov: NCT03246321; Netherlands trial register: NL6426. [ABSTRACT FROM AUTHOR]
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Titel: |
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).
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Autor/in / Beteiligte Person: | Lurvink, Robin J. ; Rovers, Koen P. ; Wassenaar, Emma C. E. ; Bakkers, Checca ; Burger, Jacobus W. A. ; Creemers, Geert-Jan M. ; Los, Maartje ; Mols, Floortje ; Wiezer, Marinus J. ; Nienhuijs, Simon W. ; Boerma, Djamila ; de Hingh, Ignace H. J. T. |
Zeitschrift: | Surgical Endoscopy & Other Interventional Techniques, Jg. 36 (2022-06-01), Heft 6, S. 4486-4498 |
Veröffentlichung: | 2022 |
Medientyp: | academicJournal |
ISSN: | 1866-6817 (print) |
DOI: | 10.1007/s00464-021-08802-6 |
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