Abstract

BackgroundTo assess late toxicity, quality of life and oncological outcome after consolidative whole abdominal radiotherapy (WART) following cytoreductive surgery and carboplatin/paclitaxel chemotherapy in high risk patients with advanced ovarian cancer FIGO stage III using IMRT (Intensity modulated radiation therapy).MethodsThe OVAR-IMRT-02 study is a multi-center single-arm phase-II-trial. Twenty patients with optimally debulked ovarian cancer stage FIGO III with complete remission after chemotherapy were treated with intensity modulated WART. A total dose of 30 Gy in 20 fractions was applied to the entire peritoneal cavity. Primary endpoint was treatment tolerability; secondary objectives were acute and chronic toxicities, quality of life, rates of therapy disruption/abortion, progression-free survival (PFS) and overall survival (OS).ResultsAll patients completed treatment and 10/20 patients (50%) reached the final study follow-up of 36 months. Late side effects consisted of °1-°2 lower limb edema (44.5%), with one patient (5.6%) showing °3 edema. Three patients (16.7%) showed elevated gamma-Glutamyltransferase. There were no severe late side effects regarding renal or hepatic function or any gastrointestinal toxicity greater than °2. During WART, mean global health status decreased by 18.1 points (95%-CI: 7.1–29.0), but completely normalized after 6 months. The same trend was observed for the function scale scores. Kaplan-Meier-estimated 1-, 2- and 3-year PFS was 74, 51 and 40%, respectively. 1-, 2- and 3-year OS was 89, 83 and 83%, respectively.ConclusionsIntensity modulated WART after aggressive surgery and carboplatin/paclitaxel chemotherapy is associated with an acceptable risk of acute and late toxicity and minor impact on long-term quality of life. Together with the promising results for PFS and OS, intensity modulated WART could offer a new therapeutic option for consolidation treatment of patients with advanced ovarian cancer.Trial registrationThe study is registered with ClinicalTrials.gov (NCT01180504). Registered 12 August 2010 – retrospectively registered.

Highlights

  • To assess late toxicity, quality of life and oncological outcome after consolidative whole abdominal radiotherapy (WART) following cytoreductive surgery and carboplatin/paclitaxel chemotherapy in high risk patients with advanced ovarian cancer Fédération Internationale de Gynécologie et d‘Obstétrique (FIGO) stage III using intensity modulated radiation therapy (IMRT) (Intensity modulated radiation therapy)

  • First-line treatment of advanced ovarian cancer patients consists of radical cytoreductive surgery (“no residual tumor”) and a platinum- and taxane-based chemotherapy (6 cycles of platinum-based chemotherapy in combination with paclitaxel 175 mg/m2) [5,6,7,8,9,10,11,12,13,14,15,16,17,18]

  • We report the final results of late toxicities and quality of life, as well as progression-free survival (PFS) and Overall survival (OS)

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Summary

Introduction

Quality of life and oncological outcome after consolidative whole abdominal radiotherapy (WART) following cytoreductive surgery and carboplatin/paclitaxel chemotherapy in high risk patients with advanced ovarian cancer FIGO stage III using IMRT (Intensity modulated radiation therapy). 75–80% of patients with advanced stage ovarian cancer relapse after a median interval of 18–24 months [4], the abdominal cavity being the main location of recurrence. Simultaneous followed by consolidative administration of bevacizumab for 12–15 months can be considered in stage IIIB-IV patients with high risk for recurrence, accepting reduced quality of life [19,20,21]

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