Phase 1 trial of intraperitoneal paclitaxel in combination with intravenous cisplatin and oral capecitabine in patients with advanced gastric cancer and peritoneal metastases (IPGP study)

Author(s):  
Sina Vatandoust ◽  
Tim Bright ◽  
Amitesh Chandra Roy ◽  
Muhammad Nazim Abbas ◽  
David Ian Watson ◽  
...  
2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14134-14134
Author(s):  
K. Yokoi ◽  
K. Omura ◽  
M. Hirano ◽  
T. Hara ◽  
Y. Munemoto ◽  
...  

14134 Background: Paclitaxel is effective against gastric cancer with serosal involvement and/or peritoneal dissemination. Combination of cisplatin and 5-fluorouracil is also active against advanced gastric cancer. Therefore, we designed a phase I trial of a combination of paclitaxel, cisplatin and 5-fluorouracil (TCF) to explore potential synergistic effect. Methods: Eligible patients had metastatic or unresectable gastric cancer with up to 1 prior chemotherapy regimen. The fixed dose of cisplatin 25 mg/m2 and paclitaxel 80 mg/m2 with escalation dose of 5-fluorouracil from 300 mg/m2 to a maximum of 600 mg/m2 on days 1, 8 and 15 of a 28 day schedule were administered. MTD and anti-tumor activity were evaluated. Results: No grade 3 or 4 toxicities at least possibly related to the treatments resulting in DLT were observed on every dose level. The clinical effects were determined in 3 patients with measurable lesions out of 7 cases. There were 2 partial responses, and disease stabilization was seen in one patient. Conclusions: Combination of paclitaxel, cisplatin and 5-fluorouracil (TCF) is considered to be feasible, well tolerated and active in patients with advanced gastric cancer and warrants further examination in a phase II trial. No significant financial relationships to disclose.


Author(s):  
Mustafa Raoof ◽  
Gautam Malhotra ◽  
Adrian Kohut ◽  
Michael O’Leary ◽  
Paul Frankel ◽  
...  

2021 ◽  
Author(s):  
JUNGMIN LEE ◽  
Soo Ho Choi ◽  
Jin Ho Baek ◽  
Dong Won Baek ◽  
Jong Gwang Kim ◽  
...  

Abstract Although nivolumab shows survival benefits for patients with advanced gastric cancer (AGC), predictive biomarkers for nivolumab treatment in AGC remain unclear, especially in the case of peritoneal metastases. Therefore, this study investigated the clinical significance of the prognostic nutrition index (PNI), reflecting the host nutritional status and immunity, in AGC patients undergoing nivolumab monotherapy. This study retrospectively analyzed 53 AGC patients who received nivolumab between October 2017 and February 2021. Among them, 35 patients with peritoneal metastases were reviewed to investigate the relationship between the PNI and oncological outcomes. The PNI was calculated as 10 × serum albumin level (g/dl) + 0.005× total lymphocyte count (per mm3) at the first administration of nivolumab. With a median follow-up duration of 2.0 (0.3 − 13.5) months, the median overall survival (OS) was 2.0 months. The overall response and disease-control rates were 0.0% and 20.0%, respectively. Among the 35 patients, 13 patients were identified as a high-PNI group. In the univariate analysis, the high-PNI group showed a significantly longer PFS and OS than the low-PNI group. In the multivariate analysis, the high-PNI was independently associated with a longer PFS (p = 0.021) and OS (p = 0.022). The PNI can be useful for predicting PFS and OS in AGC patients with peritoneal metastases. However, further studies are required to validate these results in AGC and new strategies are needed to improve the outcome for AGC patients with peritoneal metastases.


2012 ◽  
Vol 106 (3) ◽  
pp. 294-298 ◽  
Author(s):  
Kentaro Kishi ◽  
Yoshiyuki Fujiwara ◽  
Masahiko Yano ◽  
Masahiro Inoue ◽  
Isao Miyashiro ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document