Phase II Study of Patients With Peritoneal Carcinomatosis From Gastric Cancer Treated With Preoperative Systemic Chemotherapy Followed by Peritonectomy and Intraperitoneal Chemotherapy

Between January 2005 and March 2009, 18 consecutive patients with PC from gastric cancer were scheduled for neoadjuvant systemic chemotherapy followed by CRS+HIPEC+EPIC at Uppsala University Hospital, Uppsala, Sweden. The regional ethics committee approved the study and informed consent was obtained from each patient and the study was registered in ClinicalTrials.gov, with identifier NCT01379482. The eligibility requirements for treatment were: histologically confirmed diagnosis of primary gastric adenocarcinoma; histologically and radiologically confirmed PC diagnosis; no distant metastases; adequate renal, haematopoietic and liver functions, and Karnofsky performance status (KPS) of > 70. Table 1 summarises demographic and basic clinical patient data.

Patients Eighteen patients (eight female and ten male), with a median age of 57 years (range 38-74), were included in the study. Treatment began with three months' (range 2-4.5) neoadjuvant systemic chemotherapy. Four weeks after receiving the last course of chemotherapy, patients with no clinical and radiological signs of tumour progression underwent laparotomy in preparation for CRS+HIPEC followed by EPIC for five days. Patients with clinical and radiological signs of tumour progression during the neoadjuvant systemic chemotherapy did not undergo the planned loco-regional treatment but continued with palliative systemic chemotherapy at the discretion of the physician in charge of the patient.

Neoadjuvant chemotherapy The intention was to treat the patients with combination chemotherapy for three months. The choice of chemotherapy was individualised, but all patients received optimal drug combinations suitable for good performance patients with metastatic gastric cancer.

Routine clinical controls and blood sampling were done before every treatment cycle. In order to rule out patients with progressive disease and distant metastasis, abdominal and thoracic CT scan evaluations were performed prior to surgery.

Surgical treatment Depending on disease extent, CRS was performed as described by Sugarbaker. Immediately postoperatively, tumour load and completeness of cytoreduction for PC were recorded using the Peritoneal Cancer Index (PCI) [12] and Completeness of Cytoreduction scores (CC) respectively. The PCI (range 1-39) consists of lesion size scores in 13 different regions of the abdomen: 0=no tumour seen, 1=tumour up to 0.5 cm, 2=tumour up to 5 cm and 3=tumour>5 cm. The PCI score is calculated by adding together the lesion size scores for the 13 regions. The CC score is based upon the size of tumour left after cytoreduction: CC0=no peritoneal seeding visible, CC1=nodules up to 2.5 mm, CC2=nodules up to 2.5 cm and CC3=nodules>2.5 cm.