Clemens Tempfer1, Urs Giger-Pabst2, Ziad Hilal3, Askin Dogan3, Günther A Rezniczek3. 1. Department of Obstetrics and Gynecology, Marien Hospital Herne, Ruhr-Universität Bochum, Hölkeskampring 40, 44625, Herne, Germany. clemens.tempfer@rub.de. 2. Department of Surgery, Marien Hospital Herne, Ruhr-Universität Bochum, Herne, Germany. 3. Department of Obstetrics and Gynecology, Marien Hospital Herne, Ruhr-Universität Bochum, Hölkeskampring 40, 44625, Herne, Germany.
Abstract
BACKGROUND: Systemic chemotherapy is not effective in patients with peritoneal carcinomatosis (PC) and only a minority of affected patients is eligible for cytoreductive surgery. Intraperitoneal chemotherapy may provide a therapy alternative for these patients. METHODS: We performed a systematic review of clinical and experimental evidence on the safety and efficacy of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with PC and provide clinical recommendations based on the available evidence. RESULTS: Fifty-eight reports were identified, categorized as experimental (18 reports), clinical (28 reports), and other articles (14 reports). Experimental studies demonstrated improved tissue penetration and peritoneal coverage. The 28 clinical studies reported on 3515 procedures in 1547 patients with PC of various primary tumors with 16 of these studies reporting on patients with ovarian cancer. Toxicity was manageable. Based on 1197 patients in 22 studies, adverse events CTCAE grades 1, 2, 3, 4, and 5 were observed in 537 (45%), 167 (14%), 83 (7%), 10 (0.8%), and 19 (1.6%) cases, respectively. In a pooled analysis, the objective tumor response rate was 69% and the mean overall survival duration was 13.7 months. No significant hepatic, renal, or hematologic toxicity was described. PIPAC maintained and/or improved quality of life, as reported in 10 studies with 396 patients. CONCLUSIONS: Available evidence from controlled trials (phase I and phase II) and retrospective cohort studies in > 1500 patients unequivocally demonstrates that PIPAC is feasible, safe, and effective. PIPAC maintains quality of life in patients with recurrent cancer and PC. PIPAC is as evidence-based as any other treatment in women with ovarian cancer and PC beyond the third line of systemic chemotherapy and can be recommended in this indication.
BACKGROUND: Systemic chemotherapy is not effective in patients with peritoneal carcinomatosis (PC) and only a minority of affected patients is eligible for cytoreductive surgery. Intraperitoneal chemotherapy may provide a therapy alternative for these patients. METHODS: We performed a systematic review of clinical and experimental evidence on the safety and efficacy of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with PC and provide clinical recommendations based on the available evidence. RESULTS: Fifty-eight reports were identified, categorized as experimental (18 reports), clinical (28 reports), and other articles (14 reports). Experimental studies demonstrated improved tissue penetration and peritoneal coverage. The 28 clinical studies reported on 3515 procedures in 1547 patients with PC of various primary tumors with 16 of these studies reporting on patients with ovarian cancer. Toxicity was manageable. Based on 1197 patients in 22 studies, adverse events CTCAE grades 1, 2, 3, 4, and 5 were observed in 537 (45%), 167 (14%), 83 (7%), 10 (0.8%), and 19 (1.6%) cases, respectively. In a pooled analysis, the objective tumor response rate was 69% and the mean overall survival duration was 13.7 months. No significant hepatic, renal, or hematologic toxicity was described. PIPAC maintained and/or improved quality of life, as reported in 10 studies with 396 patients. CONCLUSIONS: Available evidence from controlled trials (phase I and phase II) and retrospective cohort studies in > 1500 patients unequivocally demonstrates that PIPAC is feasible, safe, and effective. PIPAC maintains quality of life in patients with recurrent cancer and PC. PIPAC is as evidence-based as any other treatment in women with ovarian cancer and PC beyond the third line of systemic chemotherapy and can be recommended in this indication.
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