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, R.J.
AU - Rovers, K.P.
AU - Wassenaar, E.C.E.
AU - Bakkers, C.
AU - Burger, J.W.A.
AU - Creemers, G.J.M.
AU - Los, M.
AU - Mols, F.
AU - Wiezer, M.J.
AU - Nienhuijs, S.W.
AU - Boerma, D.
AU - de Hingh, I.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). The funders had no role in the study design, in the collection, analysis and interpretation of data, in the writing of the report, and in the decision to submit the article for publication.
Funding Information:
Robin J. Lurvink, Koen P. Rovers, Emma C.E. Wassenaar, Checca Bakkers, Jacobus W.A. Burger, Geert-Jan M. Creemers, Maartje Los, Floortje Mols, Marinus J. Wiezer, Simon W. Nienhuijs, and Djamila Boerma have no conflicts of interest or financial ties to disclose. Ignace H.J.T. de Hingh: an unrestricted research grant outside the submitted work from RanD/QPS and Roche, paid to the institute.
Publisher Copyright:
© 2021, The Author(s).
PY - 2022/6
Y1 - 2022/6
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.
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.
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
U2 - 10.1007/s00464-021-08802-6
DO - 10.1007/s00464-021-08802-6
M3 - Article
C2 - 34757489
SN - 0930-2794
VL - 36
SP - 4486
EP - 4498
JO - Surgical endoscopy and other interventional techniques
JF - Surgical endoscopy and other interventional techniques
IS - 6
ER -