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- W2763680379 abstract "Background: 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. Methods: 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. Results: 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. Conclusions: 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: NCT00426257 Legal entity responsible for the study: The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital Funding: None Disclosure: All authors have declared no conflicts of interest." @default.
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- W2763680379 date "2017-09-01" @default.
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- W2763680379 title "Health-related quality of life after hyperthermic intraperitoneal chemotherapy (HIPEC) for stage III ovarian cancer: Results of the phase III OVHIPEC study" @default.
- W2763680379 doi "https://doi.org/10.1093/annonc/mdx440.037" @default.
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