Adjuvant intensity-modulated whole abdominal radiotherapy for high-risk patients with ovarian cancer FIGO stage III– first results of a prospective phase-II-study
Mené sur 20 patientes atteintes d'un cancer de l'ovaire de stade III en phase de rémission complète après une chirurgie cytoréductive et une chimiothérapie par carboplatine-paclitaxel, cet essai multicentrique de phase II évalue la tolérabilité et la toxicité d'une radiothérapie de consolidation ciblant l'ensemble de l'abdomen
Purpose : To assess treatment tolerance and toxicity rates of 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. Methods/Design : The xxx study is a multicenter single-arm phase-II-trial. 20 patients with optimally debulked ovarian cancer FIGO stage III with complete remission after chemotherapy were treated with intensity-modulated WART as a consolidation therapy. A total dose of 30 Gy in 20 fractions of 1.5 Gy was applied to the entire peritoneal cavity. Primary endpoint was treatment tolerability defined as lack of any CTC AE Grade 4 toxicity within 10 weeks after start of treatment; secondary objectives were acute and chronic toxicity, quality of life, rates of therapy disruption and abortion, progression-free and overall survival. Results : Intensity-modulated WART resulted in excellent coverage of the whole peritoneal cavity with effective sparing of all organs at risk. The primary analysis included all 20 enrolled patients of which 19 did not experience CTC Grade 4 toxicity. Only one patient experienced acute Grade 4 hematological toxicity. Thus, the tolerability rate of intensity-modulated WART was significantly higher than 70%. No gastrointestinal acute toxicities > Grade 2 have been observed. During WART mean global health status decreased for 18.1 points (95%-CI: 7.1-29.0). 6 weeks after WART global health status already increased with a no lower difference of 4.6 (-11.1-20.4), compared to baseline. Similar characteristics were observed for all function scale scores. Conclusion : Intensity-modulated WART after aggressive surgery and carboplatin/paclitaxel chemotherapy is associated with an acceptable risk of acute toxicity and a treatment tolerability rate significantly higher than 70%. Together with our knowledge about clinical feasibility meaning excellent coverage of the PTV and effective sparing of OARs, intensity-modulated WART could offer a new therapeutic option for consolidation treatment of patients with advanced ovarian cancer.