For decades, patients with recurrent ovarian cancer have undergone secondary cytoreductive surgery (SCS). “The prevailing opinion, based on retrospective series and included in the National Comprehensive Cancer Network guidelines, was that surgery should be considered in selected patients,” summarizes lead investigator Robert Coleman. The results of the prospective randomized controlled GOG-0213 trial now indicate that SCS followed by chemotherapy does not improve overall survival (OS) over chemotherapy alone.

“We designed GOG-0213 to answer two questions: does the addition of bevacizumab improve the effect of paclitaxel and carboplatin chemotherapy, and does secondary surgery improve survival outcomes,” explains Coleman. Women with platinum-sensitive recurrent epithelial ovarian cancer were randomly assigned to SCS followed by platinum-based chemotherapy (n = 240) or chemotherapy alone (n = 245).

At a median follow-up duration of 48.1 months, “the median OS with surgery borders on being almost harmful,” Coleman opines. Indeed, median OS durations were 50.6 months and 64.7 months with SCS and chemotherapy alone, respectively (HR 1.29, 95% CI 0.97–1.72; P = 0.08).

Compared with incomplete resection, complete gross resection was associated with longer median OS durations: 56.0 months versus 37.8 months (HR 0.61, 95% CI 0.40–0.93). Complete gross resection did not, however, result in an OS benefit compared with chemotherapy alone: 56.0 months versus 64.7 months (HR 1.03, 95% CI 0.74–1.46).

“We estimated OS durations of 22 months when we wrote the trial protocol in 2000! The difference with the currently reported OS durations is proof of impressive advances in overall care for these patients, including better chemotherapy regimens,” Coleman notes.

Patient-reported quality of life scores were significantly lower immediately after SCS than with chemotherapy alone, but no significant differences were reported at later time points. Three deaths (one in the SCS group and two in the chemotherapy alone group) were deemed to be treatment-related.

the median OS with surgery borders on being almost harmful

GOG-0213 provides prospective evidence that patients with recurrent ovarian cancer do not derive an additional OS benefit from SCS before receiving chemotherapy. The results of three randomized surgery trials in this disease setting (DESKTOP III, with OS as the primary end point, and SOC 1 and SOCceR, with progression-free survival as the primary end point) are eagerly awaited.