CHICAGO – Delaying debulking until patients have had some chemotherapy is a safer strategy for women with advanced ovarian cancer, according to interim results of the randomized phase III SCORPION trial (Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm).
The odds of complications such as sepsis, organ failure, and death in the perioperative period were 19.3 times higher among women who underwent primary debulking than among counterparts who underwent neoadjuvant chemotherapy followed by interval debulking, Dr. Anna Fagotti reported at the annual meeting of the Society of Gynecologic Oncology.
“Primary debulking surgery is associated with a statistically significantly higher risk of major perioperative morbidity with respect to interval debulking surgery in high–tumor load advanced epithelial ovarian cancer patients,” she said.
“Most of these complications, however, are grade 3, with a higher incidence than reported from retrospective analyses in the literature. The reported mortality rate [with primary debulking] … is in line with the literature data,” added Dr. Fagotti of the University of Perugia, Terni, Italy. “Our survival data will definitely clarify whether such a severe complication rate is acceptable in terms of cost-effectiveness.”
The trial also offers a cautionary note about study methodology in this setting, she said. Specifically, “any neoadjuvant chemotherapy clinical study that is based on instrumental or clinical evaluation only, excluding staging laparoscopy, might include very heterogeneous populations, thus leading to substantial biases.”
Giving some background to the research, Dr. Fagotti noted that case series have shown a survival advantage for women with advanced ovarian cancer who undergo primary debulking with optimal or no residual tumor, albeit at the cost of more extensive surgery. But randomized trials have shown similar survival and fewer complications with the interval debulking approach.
“We know also that many limits can be ascribed to these studies, so, as a consequence, there are gray-zone patients in whom the best primary treatment option is not clear yet,” she commented.
The 110 patients studied in SCORPION had suspected advanced ovarian cancer with a FIGO (International Federation of Gynecology and Obstetrics) stage of IIIc or IV, and had an intraoperative staging laparoscopy score of 8-12. They were randomized evenly to primary debulking followed by adjuvant chemotherapy or to neoadjuvant chemotherapy followed by interval debulking.
Three patients in the latter arm had progression during their chemotherapy and were therefore unable to proceed to their planned surgery, Dr. Fagotti reported.
On average, women in the interval debulking group had less extensive surgery than peers in the primary debulking group. In particular, they were significantly less likely to undergo pelvic and/or abdominal peritonectomy (58% vs. 100%), bowel resection (19% vs. 100%), diaphragmatic peritonectomy or resection (38% vs. 100%), partial hepatectomy (0% vs. 18%), and splenectomy (4% vs. 53%). Overall, they were nearly half as likely to have any upper abdominal procedure (58% vs. 100%).
Ninety percent of all patients had optimal cytoreduction to residual disease of 1 cm or less, with no significant difference between groups, Dr. Fagotti said.
In terms of surgical measures, the interval debulking group had a median operative time that was about a third shorter and median blood loss and hospital stays about half those with primary debulking.
The interval debulking group was significantly less likely to experience any major postoperative complication (6% vs. 53%, P = .001). Notably, they had lower rates of pleural effusion (2% vs. 31%), sepsis (0% vs. 7%), pulmonary thromboembolism (0% vs. 6%), reoperation with organ resection (0% vs. 4%), multiorgan failure (0% vs. 2%), and surgery-related death (0% vs. 4%).