Quality of life and symptoms in patients undergoing CRS-HIPEC with or without perioperative systemic treatment for colorectal peritoneal metastases: Results from the randomised CAIRO6 trial

Background To investigate the effect of perioperative systemic therapy in addition to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) on quality of life (QoL) and symptoms during and after treatment for colorectal peritoneal metastases. Methods During this phase II, randomized, controlled trial, all consecutive patients were randomized 1:1 for a) CRS-HIPEC (control group) and b) CRS-HIPEC with perioperative systemic treatment (experimental group). Analyses were performed on the per-protocol study population. QoL and symptoms were measured at baseline, after neoadjuvant treatment (experimental group only), and at 3 and 6 months after surgery. The EORTC QLQ-C30, QLQ-CR29, and EQ5D-5L questionnaires were used. Results Eighty patients were included: 43 in the control group and 37 in the experimental group. Response rates were 100%, 94.9%, 83.5%, and 74.9% at baseline, after neoadjuvant treatment, at 3 and 6 months after surgery, respectively. The C30 summary score, EQ-VAS score, and index score were similar between the groups at baseline, at 3 and at 6 months after CRS-HIPEC. Also, all EORTC QLQ-C30 and CR29 functional and symptom scores were not significantly different between the groups at any point. In the experimental group, higher index scores were observed in patients who received adjuvant systemic treatment compared with patients who did not at 6 months after surgery. Conclusion Perioperative systemic therapy in patients undergoing CRS-HIPEC for colorectal peritoneal metastases did not significantly deteriorate QoL or worsen symptoms. Furthermore, in both groups, all QoL and symptom scores returned to baseline values at 3 or 6 months after surgery. Legal entity responsible for the study The authors. Funding This study is funded by the Dutch Cancer Society (KWF), Catharina Research Fund, and Hoffman-La Roche. Hoffman-La Roche awarded an unrestricted scientific grant for this investigator-initiated study. The funding bodies have no role in the design of the study, in the collection, analysis, and interpretation of data, and in writing the manuscripts. Disclosure The presenting author has declared no conflicts of interest.