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 2nd-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 2nd-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.
