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)
| Autor: | Ignace H. J. T. de Hingh, Emma C. E. Wassenaar, Marinus J. Wiezer, Geert-Jan Creemers, Koen P. Rovers, Floortje Mols, Jacobus W. A. Burger, Maartje Los, Robin J. Lurvink, Checca Bakkers, Simon W. Nienhuijs, Djamila Boerma |
|---|---|
| Přispěvatelé: | RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Epidemiologie, Medical and Clinical Psychology |
| Rok vydání: | 2021 |
| Předmět: |
Quality of life
medicine.medical_specialty Urinary system medicine.medical_treatment EUROPEAN-ORGANIZATION CARCINOMATOSIS QUESTIONNAIRE RATIONALE Gastroenterology Colorectal neoplasms QUALITY-OF-LIFE Internal medicine Antineoplastic agents medicine Humans Clinical significance Patient Reported Outcome Measures CANCER PATIENTS Fatigue Aerosols Chemotherapy business.industry WOMEN Hepatology humanities Abdominal Pain Oxaliplatin Peritoneal neoplasms Patient-reported outcome measures Concomitant SURVIVAL Surgery business Abdominal surgery medicine.drug |
| Zdroj: | Surgical endoscopy and other interventional techniques, 36(6), 4486-4498. Springer, Cham Surgical Endoscopy, 36(6), 4486-4498. Springer New York |
| ISSN: | 1432-2218 0930-2794 |
| Popis: | 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 p p p p 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 p p p p p = 0.002), and third procedure (pain + 22, p 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink