S Gueli Alletti1, M Petrillo2, G Vizzielli3, C Bottoni3, F Nardelli4, B Costantini3, L Quagliozzi3, V Gallotta3, G Scambia5, A Fagotti4. 1. "Policlinico A. Gemelli" Foundation, L.go "A. Gemelli" n°8 00168, Rome, Italy. Electronic address: gueliallettis@gmail.com. 2. Division of Gynecologic Oncology, "ARNAS Civico" Hospital, P.zza "N. Leotta" 4, 90127 Palermo, Italy; Catholic University of the Sacred Heart, L.go "F. Vito" 1, 00168 Rome, Italy. 3. "Policlinico A. Gemelli" Foundation, L.go "A. Gemelli" n°8 00168, Rome, Italy. 4. Catholic University of the Sacred Heart, L.go "F. Vito" 1, 00168 Rome, Italy. 5. "Policlinico A. Gemelli" Foundation, L.go "A. Gemelli" n°8 00168, Rome, Italy; Catholic University of the Sacred Heart, L.go "F. Vito" 1, 00168 Rome, Italy.
Abstract
OBJECTIVE: To further investigate the role of MIS comparing patients submitted to MI-IDS with a balanced population treated by standard laparotomy. METHODS: The investigational arm (Cases) includes 30 AEOC patients treated with MI-IDS. The Control arm included a consecutive series of 65 AEOC patients submitted to laparotomic IDS. Inclusion criteria were: age>18years, histologically proven EOC, clinical complete/partial response after NACT, and ECOG PS <2. Preoperative clinical data, perioperative and oncological outcomes were analyzed. General Well-Being Schedule (GWBS) was administered to evaluate quality of life before and after surgery. RESULTS: Both groups were well-balanced. A higher percentage of women among Cases received bevacizumab-containing NACT compared with Controls. No statistical differences were registered in terms of surgical procedures and residual tumor. A significantly longer median OT in Cases was counterbalanced by more favorable EBL and median length of stay and TTC. No statistically significant differences were registered in terms of postoperative complications. Cases showed a 6months longer PFS compared to Controls. However, in multivariate analysis only the administration of Bevacizumab and a shorter TTC were independently associated with a longer PFS. Regarding QoL, no statistically significant differences were registered in Cases between pre- and postoperative GWBS score. Differently from Controls where this difference was statistically significant and a more intense distress were recorded. CONCLUSIONS: Minimally invasive approach could represent an advantageous alternative surgical way to perform interval debulking surgery in this specific subset of patients, with no impact on PFS. Based on these findings a randomized clinical trial is now under evaluation in our Institution.
OBJECTIVE: To further investigate the role of MIS comparing patients submitted to MI-IDS with a balanced population treated by standard laparotomy. METHODS: The investigational arm (Cases) includes 30 AEOC patients treated with MI-IDS. The Control arm included a consecutive series of 65 AEOC patients submitted to laparotomic IDS. Inclusion criteria were: age>18years, histologically proven EOC, clinical complete/partial response after NACT, and ECOG PS <2. Preoperative clinical data, perioperative and oncological outcomes were analyzed. General Well-Being Schedule (GWBS) was administered to evaluate quality of life before and after surgery. RESULTS: Both groups were well-balanced. A higher percentage of women among Cases received bevacizumab-containing NACT compared with Controls. No statistical differences were registered in terms of surgical procedures and residual tumor. A significantly longer median OT in Cases was counterbalanced by more favorable EBL and median length of stay and TTC. No statistically significant differences were registered in terms of postoperative complications. Cases showed a 6months longer PFS compared to Controls. However, in multivariate analysis only the administration of Bevacizumab and a shorter TTC were independently associated with a longer PFS. Regarding QoL, no statistically significant differences were registered in Cases between pre- and postoperative GWBS score. Differently from Controls where this difference was statistically significant and a more intense distress were recorded. CONCLUSIONS: Minimally invasive approach could represent an advantageous alternative surgical way to perform interval debulking surgery in this specific subset of patients, with no impact on PFS. Based on these findings a randomized clinical trial is now under evaluation in our Institution.
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