Phase II study of weekly paclitaxel and cisplatin combination therapy for advanced or recurrent gastric cancer.
OBJECTIVE
This study was performed to assess the efficacy and safety of weekly paclitaxel and cisplatin combination chemotherapy in patients with advanced or recurrent gastric cancer.


METHODS
Patients with advanced or recurrent gastric cancer were required to have ECOG performance status of 0 to 2, to be over 20 years of age, and to have adequate organ function. Paclitaxel 80 mg/m2 was administered intravenous over 1.5 h, followed by cisplatin 25 mg/m2 on day 1, 8 and 15 every 4 weeks.


RESULTS
All of the 52 patients enrolled, 49 patients were eligible. One patient had complete response. Nineteen had partial response, 13 had stable disease, 8 had progressive disease and 8 had not been evaluated. The median progression-free survival time was 166.5 days and median survival time was 323 days. The most common grade 3 to 4 hematological toxicies were leucopenia (14.3%), neutropenia (32.7%), and anemia (16.3%). The most common grade 3 non-hematological toxicities included anorexia (6.1%), nausea (4.1%), vomiting (2.0%) and fatigue (2.0%). No grade 4 non-hematological toxicities were reported.


CONCLUSIONS
Combination chemotherapy of weekly paclitaxel and cisplatin was highly active and well tolerated in patients with advanced or recurrent gastric cancer.
Nagata
Naoki
N
Department of surgery 1, University of Occupational and Environmental Health, Iseigaoka, Yahatanishi-ku, Kitakyushu-shi, 807-8555, Japan. n-nagata@med.uoeh-u.ac.jp
Kimura
Masayuki
M
Hirabayashi
Naoki
N
Tuburaya
Akira
A
Murata
Teruo
T
Kondo
Ken
K
Fukuda
Yasuhiko
Y
Kobayashi
Michiya
M
Miyashita
Yumi
Y
Nakao
Akimasa
A
Sakamoto
Junichi
J
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000188:drug therapy*
D017239:Paclitaxel; D002945:Cisplatin