Objectives To present the postoperative outcomes in our ongoing clinical trial.
Methods Cross-sectional analysis of early data from our phase 2 trial – an open-label, multicenter, single-arm trial on the safety and efficacy of neoadjuvant chemotherapy (NACT) followed by fast-track cytoreductive surgery (CRS) plus short-course HIPEC in advanced ovarian cancer (ClinicalTrials.gov: NCT02249013).
Results Fifteen patients with stage IIIB (n=1) or IIIC (n=14) epithelial malignancies were enrolled until July, 2019. The median (range) age was 46 years (19–67), with preoperative serum CA125 levels of 737.7U/mL (161.6–6550). The median number of NACT cycles was 3 (2–4), resulting in PCI scores of 11 (3–18) at the time of CRS/HIPEC – developed after 29 days (26–43) from the last NACT cycle. Time to restarts i.v. chemotherapy was 39 days (31–74). Median operation time was 490 minutes (235–865), with 9 patients requiring major bowel resection as rectosigmoidectomy (n=8) or partial colectomy (n=1). Median length of hospital stay was 5 days (3–10), with ICU stay of 1 day (1–5). Four patients experienced no postoperative complications, whereas 5 suffered only minor G1/G2 complications, and 6 suffered major G3 complications, according to the NCI/CTCAE classification. The most common complications were electrolytes imbalance and anemia. Two patients experienced reoperation because of G3 postoperative hemorrhage or peritoneal infection, whereas no deaths were recorded.
Conclusions Our protocol seems to be feasible and safe, with manageable low rates of short- and middle-term complications. Recruitment to this pioneering clinical trial in Brazil is ongoing.
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