Cell-free and concentrated ascites reinfusion therapy (CART) for management of massive malignant ascites in gastric cancer patients with peritoneal metastasis treated with intravenous and intraperitoneal paclitaxel with oral S-1

2015 ◽  
Vol 41 (7) ◽  
pp. 875-880 ◽  
Author(s):  
H. Yamaguchi ◽  
J. Kitayama ◽  
S. Emoto ◽  
H. Ishigami ◽  
T. Ito ◽  
...  
2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4542-4542
Author(s):  
H. Ishigami ◽  
J. Kitayama ◽  
S. Kaisaki ◽  
A. Hidemura ◽  
M. Kato ◽  
...  

4542 Background: A phase II study to evaluate the efficacy and tolerability of weekly intravenous and intraperitoneal paclitaxel combined with S-1 was performed in gastric cancer patients with peritoneal metastasis. Methods: Gastric cancer patients with peritoneal dissemination and/or cancer cells on peritoneal cytology were enrolled. Paclitaxel was administered intravenously at 50 mg/m2 and intraperitoneally at 20 mg/m2 on days 1 and 8. S-1 was administered at 80 mg/m2/day for 14 consecutive days, followed by 7 days rest. The primary endpoint was the 1-year overall survival rate. Secondary endpoints were the response rate, efficacy against malignant ascites and safety. Results: Forty patients were enrolled, including 21 with primary tumors with peritoneal dissemination confirmed by staging laparoscopy, 13 with peritoneal recurrence, and 6 with positive peritoneal cytology only. The median number of courses administered was 7 (range 1–23). The 1-year overall survival rate was 78% (95% CI, 65–90%). The overall response rate was 56% (95% CI, 32–79%) in 18 patients with target lesions. Malignant ascites disappeared or decreased in 13 of 21 (62%) patients. The incidences of grade 3/4 hematological and non- hematological toxicities were 40% and 15%, respectively. The frequent grade 3/4 toxicities included neutropenia (38%), leukopenia (18%), anemia (10%), and nausea (8%). Catheter obstruction observed in one patient was the only complication related to the peritoneal access device or intraperitoneal infusion. There were no treatment-related deaths. Conclusions: Combination chemotherapy of intravenous and intraperitoneal paclitaxel with S-1 is well tolerated and active in gastric cancer patients with peritoneal metastasis. No significant financial relationships to disclose.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14530-e14530
Author(s):  
Hironori Yamaguchi ◽  
Hironori Ishigami ◽  
Shigenobu Emoto ◽  
Hiroharu Yamashita ◽  
Joji Kitayama

e14530 Background: This phase II study was performed to evaluate the efficacy and the tolerability of weekly intravenous and intraperitoneal paclitaxel (PTX) combined with oral S-1 in gastric cancer patients with macroscopic peritoneal metastasis. We previously reported a phase I and II study with the same regimen in gastric cancer patients with peritoneal metastasis, including patients with positive peritoneal washing cytology but negative macroscopic peritoneal metastasis. This trial was scrutinized and approved by a committee appointed by the Ministry of Health, Labour, and Welfare in Japan and performed under the special interim system for Advanced Medical Technology so as to generate an evidence for future approval of the treatment by the Ministry. Methods: Gastric cancer patients with primary tumors with macroscopic peritoneal metastasis confirmed by staging laparoscopy were enrolled. PTX was administered intravenously at 50 mg/m2, and intraperitoneally through a subcutaneous implanted access port at 20 mg/m2 on days 1 and 8. S-1 was administered orally twice daily at 80 mg/m2/day for 14 consecutive days followed by 7 days rest, repeated every 3 weeks. The primary endpoint was the one-year overall survival rate. Secondary endpoints were the response rate, efficacy against malignant ascites and safety. Results: In total, 35 patients were enrolled. All patients had several to numerous metastases to the distant peritoneum. The median number of administration course was 11 (range 2-29). The one-year overall survival rate was 77.1%. Massive malignant ascites decreased in 6 of 9 (66.7%) patients. Peritoneal washing cytology turned negative in 28 of 29 (96.7%) patients. The incidences of grade 3/4 hematological and non-hematological toxicities were 34% and 9%, respectively, all of which were reversible. Grade 3/4 toxicity was observed for neutropenia (34%), leukopenia (23%), anemia (9%). There were no treatment-related deaths. Conclusions: The combination chemotherapy regimen of weekly intravenous and intraperitoneal PTX combined with oral S-1 was well tolerated and active in gastric cancer patients with macroscopic peritoneal metastasis.


2013 ◽  
Vol 71 (3) ◽  
pp. 727-731 ◽  
Author(s):  
Hidenori Tamegai ◽  
Teruo Kaiga ◽  
Mitsugu Kochi ◽  
Masashi Fujii ◽  
Noriaki Kanamori ◽  
...  

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Lu Zhao ◽  
Ai-Guang Zhao ◽  
Gang Zhao ◽  
Yan Xu ◽  
Xiao-Hong Zhu ◽  
...  

Objective.We evaluated the efficiency of traditional Chinese herbal medicine (a compound herbal formula for invigorating spleen) as a complementary and alternative therapy for gastric cancer patients with peritoneal metastasis.Methods.Between 2001 and 2012, 93 gastric cancer patients with peritoneal metastasis were enrolled in this study. The effect of traditional Chinese herbal medicine on their long-term outcome was investigated. Kaplan-Meier method was used to assess the difference in survival time, and Cox proportional hazards regression analysis was performed to identify independent prognostic factors.Result.First-line palliative chemotherapy plus traditional Chinese herbal medicine was performed in 47 patients and the other 46 patients received chemotherapy alone. The overall survival was different between patients with and without traditional Chinese herbal medicine (12.0 versus 10.5 months;P=0.046). According to the Cox proportional hazard model, first-line chemotherapy cycle (hazards ratio [HR] = 0.527; 95% CI = 0.323~0.860) and TCHM (hazards ratio [HR] = 0.644; 95% CI = 0.481~0.992) were selected as independent prognostic factors for survival.Conclusion.The results suggest that traditional Chinese herbal medicine could improve the prognosis of the gastric cancer patients with peritoneal metastasis.


2011 ◽  
Vol 104 (5) ◽  
pp. 534-537 ◽  
Author(s):  
Hiroaki Saito ◽  
Kyoichi Kihara ◽  
Hirohiko Kuroda ◽  
Tomoyuki Matsunaga ◽  
Shigeru Tatebe ◽  
...  

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 139-139
Author(s):  
H. Ishigami ◽  
J. Kitayama ◽  
S. Kaisaki ◽  
H. Yamaguchi ◽  
H. Yamashita ◽  
...  

139 Background: Intraperitoneal (IP) chemotherapy is promising for the treatment of gastric cancer with peritoneal metastasis. We previously verified the safety and efficacy of IP paclitaxel (PTX) combined with S-1 and intravenous (IV) PTX in phase I and phase II studies (Oncology. 2009; Ann Oncol. 2010). Secondly, we developed a new IP-containing chemotherapy regimen, IV PTX plus IP cisplatin (CDDP) and PTX, for patients who have failed S-1-based chemotherapy. We performed a phase I study to determine the maximum-tolerated dose (MTD) and recommended dose (RD) in gastric cancer patients. Methods: A total of 9 gastric cancer patients were enrolled who had shown progression of peritoneal metastasis after S-1-based chemotherapy. PTX was administered intravenously at a dose of 100 mg/m2 and intraperitoneally over 1 hour with an initial dose of 20 mg/m2 (level 1), stepped up to 30 or 40 mg/m2 depending on observed toxicity. CDDP was subsequently administered intraperitoneally at a dose of 30 mg/m2 over 24 hours after PTX infusion. PTX and CDDP were administered on days 1 and 15 in 4-week cycles. Results: At dose level 1, dose-limiting toxicities (DLTs) were observed in 2 of 3 patients. One patient experienced grade 4 leukopenia, and the other grade 3 vomiting. Because of higher toxicities than anticipated, the initial dose-escalation schedule was abandoned, and the doses of IV PTX and IP CDDP were reduced to 80 mg/m2 and 25 mg/m2, respectively, while keeping the dose of IP PTX at 20 mg/m2 (level 0). At dose level 0, one of the first 3 patients experienced grade 3 nausea, and an additional 3 patients experienced no DLTs. Consequently, the MTD and RD were determined to be dose level 1 and dose level 0, respectively. No patients experienced complications related to the peritoneal access device or IP infusion. Conclusions: Combination chemotherapy of IV PTX plus IP CDDP and PTX was shown to be a safe regimen that should be further explored in clinical trials. No significant financial relationships to disclose.


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