Phase II Trial of Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion for Peritoneal Carcinomatosis or Positive Peritoneal Cytology in Patients with Gastric Adenocarcinoma
- 907 Downloads
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.
Patients with gastric or gastroesophageal adenocarcinoma and positive peritoneal cytology or radiologically occult peritoneal carcinomatosis after systemic 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 secondary endpoints of HIPEC complications and gastrectomy rate.
We enrolled 19 patients (6 with positive peritoneal 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 procedures), 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.
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.
The authors thank Melissa Burkett of the Department of Scientific Publications for editorial assistance.
Brian Badgwell, Mariela Blum, Prajnan Das, Jeannelyn Estrella, Xuemei Wang, Linus Ho, Keith Fournier, Richard Royal, Paul Mansfield, and Jaffer Ajani have no conflicts of interest to declare.
- 1.World Health Organization, International Agency for Research on Cancer, GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide. http://globocan.iarc.fr. Accessed 6 Mar 2017.
- 3.National Comprehensive Cancer Network Guidelines Version 1.2017, Gastric Cancer. www.nccn.org. Accessed 1 May 2017.
- 24.Yang XJ, Huang CQ, Suo T, et al. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy improves survival of patients with peritoneal carcinomatosis from gastric cancer: final results of a phase III randomized clinical trial. Ann Surg Oncol. 2011;18(6):1575–81.CrossRefPubMedPubMedCentralGoogle Scholar
- 27.Rudloff U, Langan RC, Mullinax JE, et al. Impact of maximal cytoreductive surgery plus regional heated intraperitoneal chemotherapy (HIPEC) on outcome of patients with peritoneal carcinomatosis of gastric origin: results of the GYMSSA trial. J Surg Oncol. 2014;110(3):275–84.CrossRefPubMedGoogle Scholar
- 28.MD Anderson Cancer Center. Study of cytoreduction, gastrectomy, & hyperthermic intraperitoneal chemoperfusion (HIPEC) in gastric adenocarcinoma and carcinomatosis or positive cytology. https://clinicaltrials.gov/ct2/show/NCT02891447. Accessed 7 Mar 2017.
- 31.Leong T, Smithers BM, Haustermans K, et al. TOPGEAR: TOPGEAR: a randomized, phase III trial of perioperative ECF chemotherapy with or without preoperative chemoradiation for resectable gastric cancer: Interim Results from an International, Intergroup Trial of the AGITG, TROG, EORTC and CCTG. Ann Surg Oncol. 2017;24(8):2252–8.CrossRefPubMedGoogle Scholar