Multicenter randomized phase II study of weekly docetaxel versus weekly docetaxel plus oxaliplatin as a second-line chemotherapy for patients with advanced gastric cancer.

Authors
JIN YOUNG KIMHUN MO RYOOSUNG HWA BAEBYUNG WOOG KANGYEE SOO CHAESHINKYO YOONJIN HO BAEKMIN KYOUNG KIMKYUNG HEE LEESUN AH LEEHONG SUK SONGJONG GWANG KIM
Department
Dept. of Internal Medicine (내과학)
Issue Date
2015
Citation
Anticancer Research, Vol.35(6) : 3531-3536, 2015
ISSN
0250-7005
Abstract
Aim: The current phase II clinical study was conducted to evaluate the efficacy and safety of weekly docetaxel alone, and weekly docetaxel-plus-oxaliplatin, as a second-line chemotherapy in patients with cisplatin-refractory advanced gastric cancer. Patients and Methods: We enrolled patients with histologically confirmed gastric adenocarcinoma whose disease had progressed after cisplatin-based regimens. Patients were randomly assigned to receive docetaxel alone (36 mg/m2, days 1 and 8) or docetaxel (36 mg/m2, days 1 and 8) and oxaliplatin (80 mg/m2, day 1) combination therapy every three weeks. Results: This trial was terminated early due to poor patient accrual rate. From January 2009 to January 2012, a total of 52 patients were enrolled in the current study from six centers: 27 patients in the docetaxel monotherapy arm and 25 patients in the docetaxel/oxaliplatin combination arm. Fifty-two patients were assessable for efficacy, and response rates as follows (response rate: 14.8% in the monotherapy arm, 24.0% in the combination arm; disease control rate: 48.1% in the monotherapy arm, 76.0% in the combination arm. The median progression-free survival was 2.0 (95% confidence interval=1.2-2.9) months in the monotherapy arm and 4.9 (95% confidence interval=3.6-6.6) months in the combination arm (p=0.002). The most common grade 3 or 4 adverse event was neutropenia (14% for monotherapy versus 32% for combination). No treatment-related mortality was observed. Conclusion: Weekly docetaxel and weekly docetaxel-plus-oxalipaltin regimens were found to be well-tolerated and effective as a second-line chemotherapy for patients with advanced gastric cancer.
URI
http://kumel.medlib.dsmc.or.kr/handle/2015.oak/35057
Appears in Collections:
1. Journal Papers (연구논문) > 1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
Keimyung Author(s)
송홍석; 김진영
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