The published studies suggest that for selected women with stage IIIC or IV epithelial ovarian cancer , neoadjuvant chemotherapy and interval cytoreduction are non-inferior to primary cytoreduction and adjuvant chemotherapy with respect to overall and progression-free survival and are associated with less perioperative morbidity and mortality .
PURPOSE To provide guidance to clinicians regarding the use of neoadjuvant chemotherapy and interval cytoreduction among women with stage IIIC or IV epithelial ovarian cancer .
Phase III randomised clinical trial comparing primary surgery versus neoadjuvant chemotherapy in advanced epithelial ovarian cancer with high tumour load (SCORPION trial): Final analysis of peri-operative outcome.
OBJECTIVE To establishing whether neoadjuvant chemotherapy ( NACT ) followed by interval debulking surgery ( IDS ) is superior primary debulking surgery ( PDS ) in terms of clinical outcome as well as peri-operative morbidity in advanced epithelial ovarian cancer ( AEOC ) endowed with high tumour load ( HTL ) . MATERIAL AND METHODS This is a single-Institution , superiority , r and omised phase III trial enrolling supposed AEOC women . Patients considered pre-operatively eligible were triaged to staging laparoscopy to assess the predictive index ( PI ) of tumour load . All AEOC women with PI≥8 or≤12 ( considered as HTL ) were included . They were r and omly assigned ( 1:1 ratio ) to undergo either PDS followed by systemic adjuvant chemotherapy ( arm A , st and ard ) , or NACT followed by IDS ( NACT/IDS ) ( arm B , experimental ) . Co- primary outcome measures were postoperative complications ( grade d according to the Memorial Sloan Kettering Cancer Center surgical secondary events grading system ) and progression free survival ( PFS ) ; secondary outcomes were overall survival , and quality of life ( QoL ) . QoL was assessed using the EORTC QoL question naires . A sample size of 110 patients was required for the analysis of the first co- primary end-point ( major peri-operative morbidity ) whereas recruitment is still on-going to achieve the statistical power on PFS . RESULTS Between October 2011 and November 2014 , we registered 280 AEOC . Of the 110 eligible women , 55 were assigned to arm A and 55 to arm B. Despite different extension of surgery , rates of complete residual disease ( residual tumour=0 cm ) were superimposable between the groups ( 45.5 % versus 57.7 % ; p=0.206 ) . Twenty-nine patients ( 52.7 % ) in arm A experienced early grade III-IV complications versus three patients ( 5.7 % ) in IDS ( p=0.0001 ) . The most common complication was grade III and consisted of symptomatic pleural effusion requiring thoracic drainage ( 17/55 women ( 30.9 % ) in arm A versus 1/52 ( 1.9 % ) in arm B , p=0.0001 ) . Three grade IV ( 5.4 % ) ( i.e. , two re-operations for postoperative haemorrhage and one septic multi-organ failure ) , and two grade V ( 3.6 % ) ( two deaths for acute cardiopulmonary failure ) early complications were observed in arm A only . Mean QoL scores of several scales/items were shown to ameliorate over time in both arms . Emotional functioning , cognitive functioning , nausea/vomiting , dyspnoea , insomnia and hair loss were statistically and clinical ly better in NACT/IDS compared to PDS arm . CONCLUSIONS Perioperative moderate/severe morbidity as well as QoL scores were shown to be more favourable in NACT/IDS arm than PDS in AEOC patients with very HTL . Completion of patient enrolment and analysis of survival data will clarify whether PDS with such a high rate of severe complications is an acceptable treatment in AEOC women with HTL
The published studies suggest that for selected women with stage IIIC or IV epithelial ovarian cancer , neoadjuvant chemotherapy and interval cytoreduction are non-inferior to primary cytoreduction and adjuvant chemotherapy with respect to overall and progression-free survival and are associated with less perioperative morbidity and mortality .
PURPOSE To provide guidance to clinicians regarding the use of neoadjuvant chemotherapy and interval cytoreduction among women with stage IIIC or IV epithelial ovarian cancer .