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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.
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.
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. Trial registration: Clinicaltrials.gov: NCT03246321; Netherlands trial register: NL6426.
Description
Funding Information: This work was supported by the Catharina Research Foundation (Grant Number: 2017-5) and the St. Antonius Research Foundation (Grant Number: 17.4).
Date
2022
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Research Projects
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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, SDG 3 - Good Health and Well-being
Citation
Lurvink, R J, Rovers, K P, Wassenaar, E C E, Bakkers, C, Burger, J W A, Creemers, G-J M, Los, M, Mols, F, Wiezer, M J, Nienhuijs, S W, Boerma, D & de Hingh, I H J T 2022, '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)', Surgical Endoscopy and Other Interventional Techniques, vol. 36, no. 6, pp. 4486-4498. https://doi.org/10.1007/s00464-021-08802-6