Efficacy and safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in women with recurrent gynaecological cancer and peritoneal carcinomatosis.

Abstract

e16523 Background: Peritoneal carcinomatosis (PC) is common in ovarian (OC) and other gynaecological cancers. We have developed an innovative therapy, Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC), which improves local tumor drug uptake and can be combined with systemic chemotherapy. PIPAC achieves outstanding local biodisponibility with low systemic exposure. Liver and renal toxicity are minimal. The procedure is safe for health workers. We present first results obtained in end-stage PC from gynaecological origin. Methods: Since 1.12.2011 we have performed 18 PIPAC applications in 9 end-stage PC patients with OC (n = 4), papillary (n = 3), tuba (n = 1) and cervix (n = 1) cancer. Mean age was 64.6 ± 16 years. In 4 instances, PIPAC was combined with cytoreductive surgery. Patients were followed-up until Dec, 2012 or until death. Tumor response was assessed by macroscopy (PCI) and microscopy. Results: No intraoperative complication was noted. Mean operating time (PIPAC alone) was 97 ± 20 min. PIPAC could be repeated at 6-weeks intervals (4x: n = 1; 3x: n = 3: 1x: n = 5). In one case, adhesions prevented iterative PIPAC. No adverse event > 2 CTCAE was noted after PIPAC alone. Six patients are alive. Median survival has not been reached after a mean follow-up of 8 months, actuarial survival after one year is 58,3%. Four patients were eligible for response assessment after repeated PIPAC. One showed complete remission (CR), three partial remission (PR). Performance index (Karnofsky) increased from 62 ± 17 % to 82 ± 5 % after therapy. Conclusions: These first results are promising. PIPAC can induce a regression of PC in advanced, therapy-resistant gynaecological cancers. PIPAC is well tolerated and can improve patient’s performance. First survival data are encouraging. PIPAC will now be evaluated in a phase-II clinical trial with cisplatin and doxorubicine (EudraCT 2012-004397-26) in therapy-resistant, recurrent OC.