A Phase II Trial of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Perfusion with Chemotherapy for Patients with Gastric Cancer and Carcinomatosis or Positive Cytology

Background Current national guidelines do not include hyperthermic intraperitoneal chemoperfusion (HIPEC) as treatment for gastric cancer, and there are no completed clinical trials of cytoreduction, gastrectomy, and HIPEC from the US. Methods Patients with gastric adenocarcinoma and positive perito...

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Published in:Annals of surgical oncology 2021, Vol.28 (1), p.258-264
Main Authors: Badgwell, Brian, Ikoma, Naruhiko, Murphy, Mariela Blum, Wang, Xuemei, Estrella, Jeannelyn, Roy-Chowdhuri, Sinchita, Das, Prajnan, Minsky, Bruce D., Lano, Elizabeth, Song, Shumei, Mansfield, Paul, Ajani, Jaffer
Format: Article
Language:English
Subjects:
Adenocarcinoma
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Cellular biology
Chemotherapy
Chemotherapy, Cancer, Regional Perfusion
Cisplatin
Clinical trials
Combined Modality Therapy
Cytology
Cytoreduction Surgical Procedures
Diagnosis
Gastrectomy
Gastric cancer
Humans
Hyperthermia, Induced
Laparoscopy
Medicine
Medicine & Public Health
Metastases
Metastasis
Mitomycin C
Morbidity
Oncology
Patients
Perfusion
Peritoneal diseases
Peritoneal Neoplasms - therapy
Peritoneal Surface Malignancy
Peritoneum
Stomach Neoplasms - drug therapy
Surgery
Surgical Oncology
Survival
Survival Rate
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Summary:Background Current national guidelines do not include hyperthermic intraperitoneal chemoperfusion (HIPEC) as treatment for gastric cancer, and there are no completed clinical trials of cytoreduction, gastrectomy, and HIPEC from the US. Methods Patients with gastric adenocarcinoma and positive peritoneal cytology or carcinomatosis who had completed systemic chemotherapy and laparoscopic HIPEC underwent cytoreduction, gastrectomy, and HIPEC with 30 mg mitomycin C and 200 mg cisplatin. The primary endpoint was overall survival (OS), with a secondary endpoint of postoperative complications (NCT02891447). Results We enrolled 20 patients from September 2016 to March 2019. Six patients had positive cytology only and 14 had carcinomatosis. All patients were treated with systemic chemotherapy with a median of eight cycles (range 5–11 cycles) and at least one laparoscopic HIPEC. The median peritoneal carcinomatosis index at cytoreduction/gastrectomy/HIPEC was 2 (range 0–13). After surgery, the 90-day morbidity and mortality rates were 70% and 0%, respectively. Median length of hospital stay was 13 days (range 7–23 days); median follow-up was 33.5 months; median OS from the date of diagnosis of metastatic disease was 24.2 months; and median OS from the date of cytoreduction, gastrectomy, and HIPEC was 16.1 months. 1-, 2-, and 3-year OS rates from the diagnosis of metastatic disease were 90%, 50%, and 28%, respectively. Conclusions Survival rates for patients with gastric adenocarcinoma and peritoneal disease treated with cytoreduction, gastrectomy, and HIPEC are encouraging; our early results are similar to those of recent prospective registry studies. Multi-institutional and cooperative group trials should be supported to confirm survival and safety outcomes.
ISSN:1068-9265
1534-4681
DOI:10.1245/s10434-020-08739-5