Abstract
Introduction: In advanced epithelial ovarian cancer patients, the standard of care is primary debulking surgery, followed by first-line chemotherapy often with bevacizumab addiction. In this context, some experiences have shown that a comprehensive treatment approach to surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) could improve the prognosis.Objective: This is a study aimed to explore the feasibility of primary debulking surgery and HIPEC upfront followed by first-line therapy with bevacizumab.Study Design: Phase II monocentric, open label, non-randomised and single-arm study. Forty patients affected by advanced ovarian cancer submitted to primary debulking surgery with HIPEC were enrolled in the study. After surgery, all patients underwent systemic chemotherapy with bevacizumab addiction.Results: Complete cytoreduction (RT = 0) was achieved in all cases. Treatment-related early complications were observed in 23 patients and in 15 cases were G1–G2. Major complications were reported in 8 patients. No postoperative death was recorded.Subsequent chemotherapy was administered in all cases. Median time between surgery and first cycle of chemotherapy was 42 days (range 30–76). Concomitant bevacizumab was administered in 34 patients (85%). Maintenance with bevacizumab was feasible in 33 patients (82.5%) and its withdrawal was necessary for 1 patient (2.5%) due to G3 hypertension.Conclusion: Our data suggest that HIPEC can be safely introduced in the upfront therapy of advanced ovarian cancer.
Highlights
In advanced epithelial ovarian cancer patients, the standard of care is primary debulking surgery, followed by first-line chemotherapy often with bevacizumab addiction
The addiction of the biological anti-angiogenic agent bevacizumab to standard chemotherapy resulted in a prolongation of progression-free survival (PFS), suggesting that the combination of carboplatin, paclitaxel and bevacizumab may become the new standard in the first-line treatment of advanced epithelial ovarian cancer (AEOC) [24]
hyperthermic intraperitoneal chemotherapy (HIPEC) has been proposed as a promising strategy based on several theoretical reasons: (i) i.p. chemotherapy is certainly effective in the management of AEOC, as reported in several randomized clinical trials [7]; (ii) hyperthermia has proved to enhance cytotoxicity of platinum compounds [25] and (iii) starting chemotherapy at surgery virtually avoids any delay in chemotherapy
Summary
In advanced epithelial ovarian cancer patients, the standard of care is primary debulking surgery, followed by first-line chemotherapy often with bevacizumab addiction. There is still a significant unmet need in the first-line therapy for ovarian cancer In this context, some experiences have shown that a comprehensive treatment approach of surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) could be able to improve the prognosis of AEOC as reported in few clinical studies [8,9,10,11,12,13,14,15,16,17]. The literature on HIPEC safety and efficacy in combination with bevacizumab is very less and needs to be better investigated Based on these considerations, we conducted a phase II monocentric, open label, non-randomized and single-arm study aimed to explore the feasibility of PDS and HIPEC upfront followed by first-line therapy with bevacizumab, as GOG-0218 schedule [7]
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