演題抄録

FACO International Workshop

開催概要
開催回
第53回・2015年・京都
 

A randomized controlled trial to explore benefit of intraperitoneal paclitaxel for gastric cancer patients with high risk of peritoneal carcinomatosis: INPACT study

演題番号 : FWS7-2

[筆頭演者]
Kodera Yasuhiro:1 
[共同演者]
Takahashi Naoto:2、Yoshikawa Takaki:3、Takiguchi Nobuhiro:4、Fujitani Kazumasa:5、Itou Seiji:6、Miyamoto Katsufumi:7、Takayama Osamu:8、Imano Motohiro:9、Tsuburaya Akira:12、Kobayashi Daisuke:1、Miyashita Yumi:13、Morita Satoshi:10,13、Sakamoto Junichi:11

1:Department of Gastroenterological Surgery, Graduate School of Medicine, Nagoya University、2:Department of Surgery, Kashiwa Hospital, The Jikei University、3:Department of Gastrointestinal Surgery, Kanagawa Cancer Center、4:Department of Surgery, Chiba Cancer Center、5:Department of Surgery, Osaka General Medical Center、6:Department of Gastroenterological Surgery, Aichi Cancer Center Hospital、7:Department of Surgery, Hyogo Prefectural AWAJI Hospital、8:Department of Surgery, Itami City Hospital、9:Department of Surgery, Faculty of Medicine, Kinki University、10:Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University、11:Tokai Central Hospital、12:Department of Gastroenterological Center, Medical center, Yokohama City University、13:Data Center, Epidemiological and Clinical Research Information Network

 

Intraperitoneal administration (IP) of paclitaxel effectively controlled peritoneal disease from ovarian cancer, but its safety and feasibility in gastric cancer patients had not been well-explored. INPACT study (UMIN000002957) was designed to make a head to head comparison between paclitaxel delivered IP and DIV. Patients with histologically proven type 4 or large (>8 cm) type 3 gastric cancer or gastric cancer with resectable P1 or CY1 status were registered during surgery to be randomly allocated to either Group A (PTX 60 mg/m2 IP on the day of surgery and on days 14, 21, 28, 42, 49, and 56) or Group B (PTX 80 mg/m2 DIV by the identical schedule). Protocol treatments are to be followed after 2~3 weeks by further treatment with S-1 or S-1/CDDP. The primary endpoint was two-year survival rate. This preliminary report looks at safety and feasibility of the intraperitoneal paclitaxel. Of 177 preregistered patients, 83 were randomly allocated (39 with Group A and 44 with Group B). There was no difference in patient demographics between the two groups. There was no complication directly associated with IP with the exception of one case of catheter occlusion. Although the incidence of surgical complications was similar between the groups that 6 cases of bowel obstruction occurred exclusively in the Group A suggest possible association with catheter insertion or IP therapy. Postoperative hospital stay was 25.4 days for the Group A and 18.2 days for the Group B (p=0.0413). All 7 courses were delivered in 74.4% of the Group A and 72.7% of the Group B. The relative dose intensity of paclitaxel was 81.4% and 77.5%, respectively. There was one case of anaphylaxis that led to immediate termination of the protocol treatment in the Group B. To conclude, PTX can be safely delivered either IP or DIV from the day of surgery, and can be continued without overt toxicity.

キーワード

臓器別:胃・十二指腸

手法別:臨床試験

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