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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).
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.
Afiliación
  • Lurvink RJ; Department of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.
  • Rovers KP; Department of Research and Development, Netherlands Comprehensive Cancer Organization, Utrecht, The Netherlands.
  • Wassenaar ECE; Department of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.
  • Bakkers C; Department of Surgery, St. Antonius Hospital, PO Box 2500, 3430 EM, Nieuwegein, The Netherlands.
  • Burger JWA; Department of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.
  • Creemers GM; Department of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.
  • Los M; Department of Medical Oncology, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.
  • Mols F; Department of Medical Oncology, St. Antonius Hospital, PO Box 2500, 3430 EM, Nieuwegein, The Netherlands.
  • Wiezer MJ; Department of Research and Development, Netherlands Comprehensive Cancer Organization, Utrecht, The Netherlands.
  • Nienhuijs SW; Center of Research on Psychology in Somatic Disorders, Department of Medical and Clinical Psychology, Tilburg University, PO Box 90153, 5000 LE, Tilburg, The Netherlands.
  • Boerma D; Department of Surgery, St. Antonius Hospital, PO Box 2500, 3430 EM, Nieuwegein, The Netherlands.
  • de Hingh IHJT; Department of Surgery, Catharina Cancer Institute, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.
Surg Endosc ; 36(6): 4486-4498, 2022 06.
Article en En | MEDLINE | ID: mdl-34757489
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Peritoneales / Neoplasias Colorrectales Tipo de estudio: Clinical_trials / Prognostic_studies Aspecto: Patient_preference Límite: Humans Idioma: En Revista: Surg Endosc Asunto de la revista: DIAGNOSTICO POR IMAGEM / GASTROENTEROLOGIA Año: 2022 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Alemania
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Peritoneales / Neoplasias Colorrectales Tipo de estudio: Clinical_trials / Prognostic_studies Aspecto: Patient_preference Límite: Humans Idioma: En Revista: Surg Endosc Asunto de la revista: DIAGNOSTICO POR IMAGEM / GASTROENTEROLOGIA Año: 2022 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Alemania