TY - JOUR
T1 - 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)
AU - Lurvink, Robin J.
AU - Rovers, Koen P.
AU - Wassenaar, Emma C. E.
AU - Bakkers, Checca
AU - Burger, Jacobus W. A.
AU - Creemers, Geert-Jan M.
AU - Los, Maartje
AU - Mols, Floortje
AU - Wiezer, Marinus J.
AU - Nienhuijs, Simon W.
AU - Boerma, Djamila
AU - de Hingh, Ignace H. J. T.
N1 - 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).
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - Colorectal neoplasms
KW - Peritoneal neoplasms
KW - Antineoplastic agents
KW - Oxaliplatin
KW - Patient-reported outcome measures
KW - Quality of life
KW - QUALITY-OF-LIFE
KW - EUROPEAN-ORGANIZATION
KW - CANCER PATIENTS
KW - CARCINOMATOSIS
KW - RATIONALE
KW - QUESTIONNAIRE
KW - SURVIVAL
KW - WOMEN
UR - https://clinicaltrials.gov/ct2/show/NCT03246321
UR - http://www.scopus.com/inward/record.url?scp=85118825243&partnerID=8YFLogxK
U2 - 10.1007/s00464-021-08802-6
DO - 10.1007/s00464-021-08802-6
M3 - Article
C2 - 34757489
VL - 36
SP - 4486
EP - 4498
JO - Surgical Endoscopy
JF - Surgical Endoscopy
SN - 0930-2794
IS - 6
ER -