The use of cisplatin plus doxorubicin or paclitaxel in hyperthermic intraperitoneal chemotherapy (HIPEC) for stage IIIC or IV epithelial ovarian cancer: a comparative study.

PURPOSE: Our main aim is to analyze the survival results in women operated on for advanced ovarian cancer with two different HIPEC regimens (cisplatin plus doxorubicin versus paclitaxel). PATIENTS AND METHODS: A prospective cohort of patients with stage IIIC or IV epithelial ovarian cancer operated on with cytoreductive surgery and HIPEC, from October-2008 to February-2016, was retrospectively analyzed. The two drugs used, cisplatin/doxorubicin (Group A) and paclitaxel (Group B), were compared. RESULTS: Forty-one patients were treated with cytoreductive surgery and HIPEC; 19 patients (46%) were in Group A and 22 (54%) were in Group B. The extent of peritoneal disease was comparable between groups (Peritoneal Cancer Index of 10 in Group A versus PCI of 12.5 in Group B). There were no differences in morbidity between groups, with a severe morbidity (Dindo-Clavien III or IV) of 36.8% versus 27.3%, respectively. There was no postoperative mortality. Median follow-up was 39 months. Median overall survival was 79 months. Overall survival at 3 years in Group A was 66% versus 82.9% in Group B (p = 0.248). Incomplete cytoreduction (macroscopic residual tumour after surgery) was identified as the only independent factor that influenced overall survival (HR 12.30, 95% CI 1.28-118.33, p = 0.03). The cytostatic used in HIPEC had no influence in overall survival. CONCLUSION: The cytostatic used in HIPEC did not have a negative effect in the prognosis of patients with advanced ovarian cancer.

HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma.

BACKGROUND: Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). METHODS/DESIGN: The aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42-43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. DISCUSSION: We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma. TRIAL REGISTRATION: NCT02614534 ( clinicaltrial.gov ) Nov-2015.