Paclitaxel as HIPEC-Drug after Surgical Cytoreduction for Ovarian Peritoneal Metastases: A Randomized Phase III Clinical Trial (HIPECOVA).

Multidisciplinary strategies have transformed the management of advanced ovarian cancer. We aimed to evaluate the effectiveness of paclitaxel in hyperthermic intraperitoneal chemotherapy (HIPEC) following surgical cytoreduction for ovarian peritoneal metastases in a randomized phase III trial conducted between August 2012 and December 2019. Seventy-six patients were randomized to either the HIPEC or no HIPEC group. Although median values for the primary endpoints (recurrence-free survival (RFS) and overall survival (OS)) revealed superior outcomes for the HIPEC (RFS: 23 months, OS: 48 months) over the control group (RFS: 19 months, OS: 46 months), these differences were not statistically significant (p = 0.22 and p = 0.579). Notably, the HIPEC group demonstrated significantly higher 5-year OS and 3-year RFS rates (47.2% and 47.5%) compared to patients without HIPEC (34.5% and 21.3%). Stratification according to Peritoneal Surface Disease Severity Score (PSDSS) showed improved OS and RFS for patients with lower PSDSS (I-II) in the HIPEC-treated group (p = 0.033 and p = 0.042, respectively). The Clavien-Dindo classification of adverse event grades revealed no significant differences between HIPEC and controls (p = 0.482). While overall results were not statistically significant, our long-term follow-up emphasized the potential benefit of HIPEC-associated cytoreduction with paclitaxel, particularly in selected ovarian cancer patients with lower PSDSS indices.

Evaluation of the peritoneal surface disease severity score (PSDSS) in ovarian cancer patients undergoing cytoreductive surgery and HIPEC: Two pathogenetic types based study.

BACKGROUND AND OBJECTIVES: Clinical experience suggests that cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) play an important role in the management of ovarian cancer. In order to improve patient selection, the peritoneal surface disease severity score (PSDSS) was previously introduced for use in colorectal cancer patients. However, almost no data exist regarding the utility of the PSDSS index in ovarian cancer patients. METHODS: A retrospective study of the effectiveness of CRS and HIPEC was carried out in 59 patients with ovarian cancer. The PSDSS was based on three criteria: symptoms, extent of peritoneal dissemination, and primary tumor structure as assessed by histology and biomarker expression. RESULTS: The overall survival time for patients with ovarian cancer in PSDSS Stage I was 48 ± 25.3 months. For PSDSS Stage II, the survival time was 26.5 ± 4.7 months. For PSDSS Stage III, it was 15.5 ± 4 months, and for PSDSS Stage IV, it was 6 ± 4.3 months. A multivariate analysis showed that the PSDSS stage was the only independent survival predictor. CONCLUSIONS: These data demonstrate that a PSDSS based on two pathogenetic types may be useful for predicting survival outcomes in ovarian cancer patients treated with CRS/HIPEC.

Peritoneal Surface Disease Severity Score as a predictor of resectability in the treatment of peritoneal surface malignancies.

BACKGROUND: We evaluated the clinical utility of the Peritoneal Surface Disease Severity Score (PSDSS) as a preoperative predictor of resectability in the treatment of peritoneal surface malignancies. METHODS: Forty-nine patients were selected for cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) and were stratified according to the PSDSS retrospectively. RESULTS: Of 52 cytoreductive surgeries performed in 49 patients, HIPEC was performed in 33 cases (63%). We analyzed 31 cases of appendiceal and colorectal cancer patients who underwent CRS and HIPEC and 12 who underwent CRS only. 68% of the patients in whom CRS and HIPEC was performed were classified as PSDSS stage I or II. Contrastingly, all patients in whom CRS and HIPEC was unachievable were scored as PSDSS stage III or IV. CONCLUSIONS: The outcomes of this study suggest that the PSDSS can be used as a preoperative assessment tool to predict disease resectability in the treatment of peritoneal surface malignancies.