Phase II Study of Paclitaxel, Cisplatin, and 5-Fluorouracil Combination Chemotherapy in Patients with Advanced Gastric Cancer.
10.3346/jkms.2008.23.4.586
- Author:
Junyl HWANG
1
;
Sang Hee CHO
;
Hyun Jeong SHIM
;
Se Ryeon LEE
;
Jae Sook AHN
;
Duk Hwan YANG
;
Yeo Kyeoung KIM
;
Je Jung LEE
;
Hyeoung Joon KIM
;
Ik Joo CHUNG
Author Information
1. Department of Internal Medicine, Division of Hemato/Oncology, Chonnam National University Medical School, Gwangju, Korea. ijchung@chonnam.ac.kr
- Publication Type:Original Article ; Clinical Trial, Phase II
- Keywords:
Stomach Neoplasms;
Paclitaxel;
Cisplatin;
Fluorouracil
- MeSH:
Adenocarcinoma/*drug therapy/mortality;
Adult;
Aged;
Antineoplastic Combined Chemotherapy Protocols/*therapeutic use;
Cisplatin/administration & dosage;
Disease-Free Survival;
Female;
Fluorouracil/administration & dosage;
Humans;
Male;
Middle Aged;
Paclitaxel/administration & dosage;
Stomach Neoplasms/*drug therapy/mortality
- From:Journal of Korean Medical Science
2008;23(4):586-591
- CountryRepublic of Korea
- Language:English
-
Abstract:
This phase II study evaluated the efficacy and safety of combination chemotherapy with paclitaxel, cisplatin, and 5-fluorouracil (5-FU) in advanced gastric cancer. Patients with histologically confirmed gastric adenocarcinoma were eligible for the study. Paclitaxel (175 mg/m(2)) and cisplatin (75 mg/m(2)) were given as a 1-hr intravenous infusion on day 1, followed by 5-FU (750 mg/m(2)) as a 24-hr continuous infusion for 5 days. This cycle was repeated every 3 weeks. Forty-five eligible patients (median age, 56 yr) were treated in this way. Of the 41 patients in whom efficacy was evaluable, an objective response rate (ORR) was seen in 51.2% (95% CI, 0.35-0.67), a complete response in two, and a partial response in 19 patients. The median progression free survival was 6.9 months (95% CI, 5.86-7.94 months), and the median overall survival was 12.7 months (95% CI, 9.9-15.5). The main hematological toxicity was neutropenia and greater than grade 3 neutropenia was observed in twelve patients (54%). Febrile neutropenia developed in three patients (6.8%). The major non-hematological toxicities were asthenia and peripheral neuropathy, but most of patients showed grade 1 or 2. In conclusion, combination chemotherapy with paclitaxel, cisplatin, and 5-FU is a promising regimen, and was well tolerated in patients with advanced gastric cancer.