Phase III SCORPION trial (ID number: NCT01461850) in epithelial ovarian cancer patients with high tumor load receiving PDS versus NACT: An interim analysis on peri-operative outcome

Abstract

Objectives: The SCORPION trial compared perioperative and survival outcome of primary debulking surgery (PDS) versus neo-adjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) in high tumor load advanced epithelial ovarian cancer patients (AEOC). The aim of this study was to perform an interim analysis with respect to the safety (i.e. peri-operative morbidity and mortality) of the trial. Methods: Patients' eligibility criteria were: pathologically proven ovarian cancer, 18 to 75 years old, ECOG performance status ≤ 2, FIGO stage IIIC–IV, no history of other cancers, intra-operative high tumor load assessed by staging laparoscopy (i.e. Fagotti's score between 8 and 12). Exclusion criteria were: intra-operative mesenteral retraction and miliary carcinosis on the bowel. Women were randomly assigned to PDS or NACT–IDS arm. Surgical data were evaluated by univariate analysis. Intra- and post-operative complications were assessed using the MSKCC surgical secondary events grading system. Survival data were not shown because the events were too far to reach the medians in both arms at this time. Results: Between October 2011 and November 2014, 200 suspicious AEOC women were eligible for the study, but only 110 were intra-operatively randomized. There were no significant differences between the two groups in the pre-operative characteristics and intra-operative tumor dissemination. Upper abdominal procedures were performed in 100% and 61.1% of the patients in the PDS and NACT–IDS arms, respectively (P = 0.0001). The percentages of optimal residual tumor (RT ≤ 1 cm) at PDS and IDS were 91% and 90% respectively, with a rate of complete cytoreduction (RT = 0) of 45.0% and 60.0%, respectively (P = 0.158). Major postoperative complication rates (MSKCC score ≥ 3) of the PDS and NACT–IDS groups were 52.6% (29/55) and 6.0% (3/55), respectively (P = 0.0001). Postoperative mortality rate was 3.6% (2/55) and 0% (0/55) in the PDS and NACT–IDS groups, respectively (P = 0.154). Conclusions: PDS is associated with a statistically significant higher risk of severe peri-operative morbidity with respect to NACT–IDS in high tumor load AEOC patients. Hence, waiting for survival data, we should be very careful in choosing the primary approach in this specific setting of women outside of a clinical trial.TableOperative and post-operative details.VariablePDS Nr. (%)NACT–IDS Nr. (%)P valueAll cases5555n.a.Upper abdominal procedures (UAP) Yes033 (61.1)0.0001 No55 (100)21 (38.9)Surgical complexity score groups aAccording to Aletti et al. (1) 1029 (53.7)0.0001 2–355 (100)25 (46.3)Size of residual disease No gross25 (45.5)30 (60.0)0.158 0.1–1 cm25 (45.5)15 (30.0) >1 cm5 (9.0)5 (10.0)Major post-operative complications bAccording to Memorial Sloan-Kettering Cancer Center surgical secondary events grading system (2). 324 (43.6)3 (6.0)0.001 43 (5.4)0 52 (3.6)0Median operative time (min) (range)451 (230–720)275 (70–400)0.0001Median blood loss (ΔHb g/dl) (range)3.25 (0.02–5.10)1.40 (0.01–6.20)0.001Patients transfused15 (27.3)5 (9.3)0.015Median hospital stay (dys) (range)12 (3–80)6 (2–13)0.0001Median days to start to start CT (range)40 (17–120)20 (6–40)0.0001a According to Aletti et al. (1)b According to Memorial Sloan-Kettering Cancer Center surgical secondary events grading system (2). Open table in a new tab 1. Aletti GD, Eisenhauer EL, Santillan A, Axtell A, Aletti G, Holschneider C, Chi DS, et al. Identification of patient groups at highest risk from traditional approach to ovarian cancer treatment. Gynecol Oncol. 2011 Jan;120(1):23-8. 2. Chi DS, Franklin CC, Levine DA, Akselrod F, Sabbatini P, Jarnagin WR, DeMatteo R, et al. Improved optimal cytoreduction rates for stages IIIC and IV epithelial ovarian, fallopian tube, and primary peritoneal cancer: a change in surgical approach. Gynecol Oncol 2004;94:650–4.