ORIGINAL ARTICLE – GASTROINTESTINAL ONCOLOGY Phase II Trial of Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion for Peritoneal Carcinomatosis or Positive Peritoneal Cytology in Patients with Gastric Adenocarcinoma Brian Badgwell, MD, MS 1 , Mariela Blum, MD 2 , Prajnan Das, MD 3 , Jeannelyn Estrella, MD 4 , Xuemei Wang, MS 5 , Linus Ho, MD 2 , Keith Fournier, MD 1 , Richard Royal, MD 1 , Paul Mansfield, MD 1 , and Jaffer Ajani, MD 2 1 Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; 2 Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; 3 Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; 4 Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX; 5 Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX ABSTRACT Purpose. The aim of this phase II study was to perform neoadjuvant hyperthermic intraperitoneal chemoperfusion (HIPEC) via a minimally invasive approach without cytoreduction for patients with gastric cancer and positive peritoneal cytology or low-volume peritoneal carcinomatosis. Methods. Patients with gastric or gastroesophageal ade- nocarcinoma and positive peritoneal cytology or radiologically occult peritoneal carcinomatosis after sys- temic chemotherapy received laparoscopic HIPEC with mitomycin C 30 mg and cisplatin 200 mg. Patients whose peritoneal disease resolved were offered gastrectomy. The primary endpoint was overall survival (OS), with sec- ondary endpoints of HIPEC complications and gastrectomy rate. Results. We enrolled 19 patients (6 with positive peri- toneal cytology only and 13 with peritoneal carcinomatosis) and treated them with 38 laparoscopic HIPEC procedures. Patients had received a median of 8 cycles (range 3–12) of systemic chemotherapy prior to enrollment. Fourteen patients were also treated with chemoradiotherapy before or between cycles of HIPEC. The complication rate for HIPEC was 11% (4 of 38 pro- cedures), the 30-day mortality rate was 0%, and the median length of hospital stay after HIPEC was 3 days (range 2–6). Five patients went on to receive gastrectomy. The median follow-up was 18.9 months, the median OS from the date of diagnosis of metastatic disease was 30.2 months, and the median OS from the first laparoscopic HIPEC was 20.3 months. Conclusions. Laparoscopic HIPEC was well tolerated, and an encouraging number of patients demonstrated an absence of peritoneal disease after HIPEC and were able to undergo gastrectomy. Comparative studies will be required to clarify survival benefits. Gastric cancer is the third leading cause of cancer-re- lated death worldwide, with the peritoneum representing the most common site of metastatic disease. 1,2 Although there have been advances in the multimodality treatment of localized gastric cancer, current National Comprehensive Cancer Network guidelines for patients with gastric cancer metastasis to the peritoneum recommend systemic chemotherapy or best supportive care. 3 The reported median survival durations for patients with peritoneal dis- ease are 6–15 months, and complications from bowel obstruction and malignant ascites are common. 4–7 There is increasing interest in and support for hyper- thermic intraperitoneal perfusion with chemotherapy (HIPEC) to treat gastric cancer metastasis limited to the peritoneum. 8 Studies in Asian populations of patients with locally advanced but resectable gastric adenocarcinoma This work was presented at the Society of Surgical Oncology Annual Cancer Symposium, Seattle, WA, USA, 17 March 2017. Ó Society of Surgical Oncology 2017 First Received: 14 June 2017 B. Badgwell, MD, MS e-mail: bbadgwell@mdanderson.org Ann Surg Oncol DOI 10.1245/s10434-017-6047-4