Details

Autor(en) / Beteiligte

• 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.

Titel

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)

Ist Teil von

• Surgical endoscopy, 2022-06, Vol.36 (6), p.4486-4498

Ort / Verlag

New York: Springer US

Erscheinungsjahr

2022

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.