Fibrin-sealant-delivered cisplatin chemotherapy versus cisplatin hyperthermic intraperitoneal perfusion chemotherapy for locally advanced gastric cancer without peritoneal metastases: a randomized phase-II clinical trial with a 40-month follow-up.
A new intraoperative cisplatin administration method for patients with locally advanced gastric cancer (AGC) and without peritoneal metastasis, fibrin-sealant-delivered cisplatin chemotherapy, was reported, and its safety, pharmacokinetics, and efficacy were compared with cisplatin hyperthermic intraperitoneal perfusion chemotherapy. Forty-two AGC patients were randomly divided into 2 groups: fibrin-sealant-delivered cisplatin chemotherapy (FS) (n = 21) and cisplatin hyperthermic intraperitoneal perfusion chemotherapy (CHIC) (n = 21). Both groups received 120 mg cisplatin after complete cytoreductive surgery. At different time points, cisplatin concentrations in patients' sera and urine samples were measured to determine time-dependent maximal concentration (Cmax) and the area under the curve (AUC). The primary and secondary end-points were overall survival (OS) and safety profiling, respectively. Occurrence of grade-3 to grade-4 liver or kidney dysfunction was less frequent in the FS group than in the CHIC group (28.6 % vs 47.6 %). Cisplatin Cmax and AUC for the serum and urine of the FS patients were significantly lower than that of the CHIC patients. Elimination half-life of cisplatin in the FS group was significantly longer than in the CHIC group (24.1 h vs 14.2 h). After a median follow-up of 40 months, 1-, 2-, and 3-years OS were 90.5 %, 71.4 %, and 61.9 % in the FS group, and 61.9 %, 47.6 %, and 42.8 % in the CHIC group, respectively. The median OS was 35.9 months in the FS group and 29.1 months in the CHIC group. Fibrin-sealant-delivered cisplatin chemotherapy was as effective and had a favorable pharmacokinetic profile with similar survival outcomes as cisplatin hyperthermic intraperitoneal perfusion chemotherapy following complete cytoreductive surgery of locally advanced GC without peritoneal metastases.
Department of Surgery, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200025, China.
Ou
O
Huang
XiangHong
X
Lu
XiangDong
X
Xu
Yong
Y
Shi
D016461:Chemoembolization, Therapeutic / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage*; D003131:Combined Modality Therapy / Q000379:methods; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006490:Hemostatics / Q000008:administration & dosage; D006801:Humans; D006979:Hyperthermia, Induced / Q000379:methods*; D007263:Infusions, Parenteral / Q000379:methods; D008297:Male; D008875:Middle Aged; D010534:Peritoneal Neoplasms / Q000556:secondary / Q000628:therapy; D013274:Stomach Neoplasms / Q000473:pathology* / Q000628:therapy*; D016896:Treatment Outcome
D015718:Fibrin Tissue Adhesive; D006490:Hemostatics; D002945:Cisplatin