In the OVHIPEC study (NCT00426257), the addition of HIPEC to interval cytoreductive surgery (CRS) significantly improved recurrence-free (HR 0.66, 95% CI 0.50-0.87) and overall survival (HR 0.67, 95% CI 0.48-0.94) in patients with stage III ovarian cancer. We report the results of the health-related quality of life (HRQOL) analysis of patients in the OVHIPEC study.
Patients who had at least stable disease after 3 cycles of carboplatin and paclitaxel were randomly assigned to receive interval CRS with (n = 122) or without (n = 123) HIPEC using cisplatin. Patients in both arms received 3 additional cycles of carboplatin/paclitaxel post-operatively. HRQOL was assessed using the EORTC core questionnaire (the QLQ-C30) and the ovarian and colorectal cancer modules (QLQ-OV28 and QLQ-CR38). HRQOL assessments were planned at least 2 weeks prior to surgery, after surgery, following the 6th chemotherapy cycle, and every three months thereafter until a maximum of two years of follow-up. HRQOL data were analysed using a mixed effect model. Current preliminary results pertain to the QLQ-C30 summary score, and the fatigue, neuropathy, micturition and gastrointestinal symptom scale scores for up to 1 year of follow-up or time of recurrence.
Of 245 randomized patients, 201 (82%) had at least one evaluable HRQOL assessment (93 for CRS arm, 108 for CRS+HIPEC arm). A linear mixed effects analysis indicated a significant group difference in QLQ-C30 summary scores over time (p = 0.047). The CRS group had modest improvement in overall HRQOL over time, while the CRS+HIPEC group remained largely unchanged. In both arms, the overall HRQOL scores were relatively high, both at baseline and during follow-up. No significant group differences over time were observed for fatigue, neuropathy, micturition or gastrointestinal symptoms.
Preliminary results indicate that patients in this trial had relatively high overall HRQOL scores, that tended to improve more over time in the CRS arm compared to the CRS+HIPEC arm. Future analyses will yield additional information about the specific patterns of HRQOL and symptom effects over the course of the trial.
Clinical trial identification
Legal entity responsible for the study
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
All authors have declared no conflicts of interest.