Randomized phase III study to evaluate the impact of secondary cytoreductive surgery in recurrent ovarian cancer – final analysis of AGO DESKTOP III/ENGOT- ov20

Background The role of secondary cytoreductive surgery in recurrent ovarian cancer (ROC) has been under debate for decades. A recent trial in unselected patients (pts) failed to show an OS benefit.

Method Pts with ROC and 1st relapse after 6+ months (mos) platinum-free interval (TFIp) were eligible if they presented with a positive AGO-score (PS ECOG 0, ascites ≤500 ml, and complete resection at initial surgery) and were prospectively randomized to 2^nd-line chemotherapy alone vs. cytoreductive surgery followed by the same chemotherapy; platinum combination therapy was recommended. OS was primary endpoint in this superiority trial.

Results 407pts were randomized 2010-2014. The TFIp exceeded 12 mos in 75 % of pts. 206 pts were allocated to the surgery arm of whom finally 187 (91 %) were operated. A complete resection was achieved in 75 %; almost 90 % in both arms received a platinum-containing 2^nd-line chemo. 60 d mortality rates were 0 and 0.5 % in the surgery and no-surgery arm. Re-laparotomies were performed in 3.7 % of operated pts. Further grade 3/4 adverse events did not differ significantly between arms. Final results of the primary endpoint overall survival, progression-free-survival and time to first subsequent therapy will be presented. Further analysis will focus on subgroups depending on surgical outcome.

Conclusion The AGO DESKTOP III trial will provide a definitive answer on the highly relevant question of the role of surgery in patients with AGO score positive relapsed ovarian cancer.

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Artikel online veröffentlicht:
07. Oktober 2020