Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Intraoperative Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients with Locally Advanced Colon Cancer: A Prospective Parallel Phase II Study.

Version 1 : Received: 26 November 2020 / Approved: 27 November 2020 / Online: 27 November 2020 (08:49:39 CET)

How to cite: Macaione, I.; Mandalà, L.; Campisi, A.; Roz, E.; Mercadante, S.; Piazza, D.; Mezzatesta, P.; Gebbia, V. Intraoperative Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients with Locally Advanced Colon Cancer: A Prospective Parallel Phase II Study.. Preprints 2020, 2020110679 (doi: 10.20944/preprints202011.0679.v1). Macaione, I.; Mandalà, L.; Campisi, A.; Roz, E.; Mercadante, S.; Piazza, D.; Mezzatesta, P.; Gebbia, V. Intraoperative Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients with Locally Advanced Colon Cancer: A Prospective Parallel Phase II Study.. Preprints 2020, 2020110679 (doi: 10.20944/preprints202011.0679.v1).

Abstract

.Background: Prophylactic hyperthermic intraperitoneal chemotherapy (HIPEC) showed promising results in patients with colorectal carcinoma at high risk of recurrence but still without clinically and radiologically evident signs of peritoneal spread. This study aims to analyze the feasibility of this proactive, early phase, multimodality approach. Methods: A mono-institutional, prospective, parallel, two-stage phase II trial enrolled 49 patients to standard surgery or surgery plus intraoperative HIPEC. Before the procedure and during surgery, patients received intravenous fluorouracil (and leucovorin to potentiate oxaliplatin activity. Data analysis included length of hospital stay, surgery duration, type of surgery and chemotherapy-related complications risk score. Results: No significant difference was seen in the median time spent in the hospital with a median stay of 7 days in both groups (p=0.5720). The surgical procedure's median duration was longer in the HIPEC group than in the control one. Side-effects and surgical complications did not cross at any time the Pocock-type boundary for side/effect monitoring (p=0.80, N.S.). Conclusions: The present prospective study results demonstrate the feasibility and safety of the colorectal surgery plus HIPEC treatment in patients with colorectal cancer patients at high-risk for peritoneal invasion, although clinically and radiologically undetectable.

Subject Areas

Keywords. Colorectal cancer, peritoneal metastasis, HIPEC, surgery, feasibility.

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