Randomized controlled phase III study evaluating the impact of secondary cytoreductive surgery in recurrent ovarian cancer: AGO DESKTOP III/ENGOT ov20.

Abstract

5501 Background: The role of secondary cytoreductive surgery in recurrent ovarian cancer (OC) has not been defined by level-1 evidence. Methods: Pts with OC and 1st relapse after 6+ mos platin-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. Chemo regimens were selected according to the institutional standard. We report here results of the predetermined interim analysis. Results: 407pts were randomized 2010-2014. The TFIp exceeded 12 mos in 75% and 76% pts in both arms. 8.9% of 203 pts were operated despite of randomization to the no-surgery arm, whereas 6.9% of 204 pts in the surgery arm did not undergo operation. Complete resection was achieved in 67% of pts; 87% and 88% 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=p<0.001). PFS-2 between 1st and 2nd relapse equaled or even exceeded PFS-1 before 1strelapse in 26% after surgery and only 16% without-surgery. Analysis of the primary endpoint OS is kept blinded due to immaturity and will be evaluated after extended follow-up (the observed pooled unblinded 2-YSR was 83% instead of the initially in the protocol assumed 55-66%). 60d mortality rates were 0 and 0.5% in the surgery and no-surgery arm. Re-laparatomies were performed in 7 pts (3.5%) in the surgery arm.With the exception of myelosuppression which occurred more frequently in the no-surgery arm no further significant differences were observed with respect to grade 3+ acute adverse events. Conclusions: 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. Clinical trial information: NCT01166737.

ESMO–ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease

“…However, monitoring for recurrence might become more important if surgery for recurrent ovarian cancer is shown to improve survival 247. There is no evidence supporting a different follow-up regimen according to histotype, although it is recognised that not all tumours are associated with raised levels of CA125 248.…”

New in High Grade Serous Ovarian Cancer Treatment

“…Предварительные данные III фазы исследования позволяют предположить, что операция может быть повторена с преимуществом в выживаемости без прогрессирования (ВБП) у отобранных пациенток с рецидивом, чувствительным к препаратам платины. В исследовании AGO DESKTOP III/ ENGOT ov20 повторные циторедуктивные операции ассоциировались с клинически значимым 5,6-месячным увеличением ВБП [13]. Доказательства роли гипертермической внутрибрюшинной химиотерапии (HIPEC) после интервальных циторедуктивных операций ограниченны.…”

Impact of Provider Imaging Practices on Survival Outcomes in Advanced Ovarian Cancer

“…Recent data suggest that among patients with a good prognosis for resectability, SCS portends a significant progressionfree survival benefit of several months, although final overall survival (OS) data are pending. 4 However, the potential disadvantages of surveillance imaging include excess costs, 3,5 intervention for inconsequential incidental findings, 6,7 and heightened patient anxiety. 8,9 Previous studies attempted to elucidate whether earlier detection of ovarian cancer recurrence and intervention ultimately impact patient survival.…”