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Perioperative systemic therapy versus cytoreductive surgery and HIPEC alone for resectable colorectal peritoneal metastases: Patient reported outcomes of a randomized phase II trial
Dutch Peritoneal Oncology Group and the Dutch Colorectal Cancer Group
Dutch Peritoneal Oncology Group and the Dutch Colorectal Cancer Group
Abstract
Background As part of a randomized phase II trial in patients with isolated resectable colorectal peritoneal metastases (CPMs), the present study compared patient-reported outcomes (PROs) of patients treated with perioperative systemic therapy versus cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS–HIPEC) alone. Also, PROs of patients receiving perioperative systemic therapy were explored. Patients and Methods Eligible patients were randomized to perioperative systemic therapy (experimental) or CRS–HIPEC alone (control). PROs were assessed using EORTC QLQ-C30, QLQ-CR29, and EQ-5D-5L questionnaires at baseline, after neoadjuvant treatment (experimental), and at 3 and 6 months postoperatively. Linear mixed modeling was used to compare five predefined PROs (visual analog scale, global health status, physical functioning, fatigue, C30 summary score) between arms and to longitudinally analyze PROs in the experimental arm. Results Of 79 analyzed patients, 37 (47%) received perioperative systemic therapy. All predefined PROs were comparable between arms at all timepoints and returned to baseline at 3 or 6 months postoperatively. The experimental arm had worsening of fatigue [mean difference (MD) + 14, p = 0.001], loss of appetite (MD + 15, p = 0.003), hair loss (MD + 18, p < 0.001), and loss of taste (MD + 27, p < 0.001) after neoadjuvant treatment. Except for loss of appetite, these PROs returned to baseline at 3 or 6 months postoperatively. Conclusions In patients with resectable CPM randomized to perioperative systemic therapy or CRS–HIPEC alone, PROs were comparable between arms and returned to baseline postoperatively. Together with the trial’s previously reported feasibility and safety data, these findings show acceptable tolerability of perioperative systemic therapy in this setting.
Description
Funding Information: Prof. I.H.J.T. de Hingh received grants (paid to institute) from QP&S/RanD Biotech for research unrelated to the submitted work. Prof. Dr. P.J. Tanis received an unrestricted research grant from Allergan (LifeCell) unrelated to the submitted work. Prof. C.J.A. Punt has an advisory role for Nordic Pharma. All remaining authors have declared no conflicts of interest. This work was supported by the Dutch Cancer Society (Grant Number 10795); and Hoffman-La Roche (Grant Number ML39718).
Date
2023
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Research Projects
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Keywords
Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Colorectal Neoplasms/pathology, Combined Modality Therapy, Cytoreduction Surgical Procedures, Humans, Hyperthermia, Induced, Hyperthermic Intraperitoneal Chemotherapy, Patient Reported Outcome Measures, Peritoneal Neoplasms/secondary, Survival Rate, SDG 3 - Good Health and Well-being
Citation
Dutch Peritoneal Oncology Group and the Dutch Colorectal Cancer Group 2023, 'Perioperative systemic therapy versus cytoreductive surgery and HIPEC alone for resectable colorectal peritoneal metastases : Patient reported outcomes of a randomized phase II trial', Annals of Surgical Oncology, vol. 30, no. 5, pp. 2678-2688. https://doi.org/10.1245/s10434-023-13116-z
License
info:eu-repo/semantics/openAccess