A phase II Study of FOLFOX versus POF (paclitaxel plus FOLFOX) versus IP PAC (intraperitoneal paclitaxel) plus FOLFOX as a first-line treatment in advanced gastric cancer (AGC): A feasibility analysis.

Authors

null

Rongbo Lin

Fujian Provincial Cancer Hospital, Fuzhou, China

Rongbo Lin , Shen Zhao , Hui Li , Jie Liu , Nanfeng Fan

Organizations

Fujian Provincial Cancer Hospital, Fuzhou, China

Research Funding

Other

Background: Double regimens are commonly accepted for AGC in East Asia. However, triple regimens are recommended in west countries. POF regimen (a modified DCF reported in 2007, 2008, 2009, 2010 ASCO) appeared to be of good efficacy and was well tolerated in patients with AGC. Intraperitoneal paclitaxel showed high local concentration in abdominal cavity and low systemic toxicity. The aims of this study were to find out if the triplet POF was more effective with manageable side effects and IP PAC in combination with FOLFOX had higher local control rate and manageable systemic toxicity than doublet FOLFOX in AGC. Methods: The patients with AGC were randomized to three group. The FOLFOX regimen consisted of oxaliplatin 85 mg/m2, levoleucovorin 200 mg/m2, and 5-FU 400 mg/m2 bolus on day 1, then 5-FU 2400 mg/m2 continuous infusion over 46 hours. The POF regimen consisted of a 3-hour infusion of paclitaxel 135 mg/m2, followed by FOLFOX omitted 5-FU bolus. The IP PAC plus FOLFOX regimen consisted of paclitaxel 80 mg/m2 intraperitoneally plus FOLFOX. Every 14 days repeated for all three regimens. Up to 9 cycles of treatment were administered, followed by S-1 until disease progression Results: From 4th November 2015 to 10thJune 2016, 21 patients with ECOG PS 0-1 were assigned for the study. Grade ¾ toxicities, in the FOLFOX group (n = 7), neutropenia and nausea was one respectively; in the POF group (n = 9); neutropenia were two, stomatitis, nausea, vomiting, and fatigue was one respectively; in the IP PAC plus FOLFOX group (n = 5), neutropenia and fatigue was one respectively. No treatment-related death occurred. Median progression free survival and overall survival were 68 days and 194 days in FOLFOX group, 128 days and 282 days in POF group, 89 days and 178 days in IP PAC plus FOLFOX group. Conclusions: This pilot analysis showed three regimens including IP PAC plus FOLFOX had good safety profits. The POF group seemed to have better PFS and OS than the other two groups. This ongoing phase II study is feasible. Clinical trial information: NCT02845908

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2017 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Cancers of the Esophagus and Stomach

Track

Cancers of the Esophagus and Stomach

Sub Track

Translational Research

Clinical Trial Registration Number

NCT02845908

Citation

J Clin Oncol 35, 2017 (suppl 4S; abstract 56)

DOI

10.1200/JCO.2017.35.4_suppl.56

Abstract #

56

Poster Bd #

F12

Abstract Disclosures