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

Background:

The role of secondary cytoreductive surgery in recurrent ovarian cancer (OC) has not been defined by level-1 evidence.

Method:

Pts with OC and 1st relapse after 6+ 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 randomized to 2^nd-line chemotherapy alone vs. cytoreductive surgery followed by chemo. We report here results of the predetermined interim analysis.

Results:

407 pts were randomized 2010 – 2014. Complete resection was achieved in 72.5% of pts; 91.1% and 88.7% received a platinum-containing 2^nd-line therapy. Median PFS was 14 mos without and 19.6 mos with surgery (HR: 0.66, 95%CI 0.52 – 0.83, p < 0.001). Median time to start of first subsequent therapy (TFST) was 21 vs. 13.9 mos in favor of the surgery arm (HR 0.61, 95%CI 0.48 – 0.77, p < 0.001). 60 d mortality rates were0% and 0.5% in the surgery and no-surgery arm.

Conclusion:

Surgery in pts with 1st relapse of OC after a TFIp of 6+ mos and selected by a positive AGO-Score resulted in a clinically meaningful increase of PFS and TFST with acceptable treatment burden. Until final OS data will definitively define the role of secondary cytoreductive surgery it should at least be considered as valuable option in pts with a positive AGO-Score.