TY - JOUR
T1 - Perioperative Systemic Therapy Versus Cytoreductive Surgery and HIPEC Alone for Resectable Colorectal Peritoneal Metastases: Patient-Reported Outcomes of a Randomized Phase II Trial
AU - Bakkers, C.
AU - Rovers, K.P.
AU - Rijken, A.
AU - Simkens, G.A.A.M.
AU - Bonhof, C.S.
AU - Nienhuijs, S.W.
AU - Burger, J.W.A.
AU - Creemers, G.J.M.
AU - Brandt-Kerkhof, A.R.M.
AU - Tuynman, J.B.
AU - Aalbers, A.G.J.
AU - Wiezer, M.J.
AU - de Reuver, P.R.
AU - van Grevenstein, W.M.U.
AU - Hemmer, P.H.J.
AU - Punt, C.J.A.
AU - Tanis, P.J.
AU - Mols, F.
AU - de Hingh, I.H.J.T.
AU - Dutch Peritoneal Oncology Group
AU - Dutch Colorectal Cancer Group
N1 - 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.
Funding Information:
Collaborators of the Dutch Peritoneal Oncology Group and the Dutch Colorectal Cancer Group: A. M. J. Thijs, R. J. Lurvink, E. V. E. Madsen, E. van Meerten, M. Kusters, K. S. Versteeg, N. F. M. Kok, T. E. Buffart, D. Boerma, M. Los, J. H. W. de Wilt, H. M. W. Verheul, S. Kruijff, D. J. A. de Groot, M. Koopman.
Funding Information:
This work was supported by the Dutch Cancer Society (Grant Number 10795); and Hoffman-La Roche (Grant Number ML39718).
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/5
Y1 - 2023/5
N2 - 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.
AB - 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.
KW - QUALITY-OF-LIFE
KW - HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY
KW - CANCER
KW - CARCINOMATOSIS
U2 - 10.1245/s10434-023-13116-z
DO - 10.1245/s10434-023-13116-z
M3 - Article
C2 - 36754943
SN - 1068-9265
VL - 30
SP - 2678
EP - 2688
JO - Annals of Surgical Oncology
JF - Annals of Surgical Oncology
IS - 5
ER -