Multi-center Randomized Phase II Study of Weekly Docetaxel Versus Weekly Docetaxel-plus-Oxaliplatin as a Second-line Chemotherapy for Patients with Advanced Gastric Cancer

Title
Multi-center Randomized Phase II Study of Weekly Docetaxel Versus Weekly Docetaxel-plus-Oxaliplatin as a Second-line Chemotherapy for Patients with Advanced Gastric Cancer
Author(s)
이경희김진영[김진영]이선안[이선안]김민경강병웅[강병웅]김종광[김종광]백진호 [백진호 ]배성하[배성하]류훈모[류훈모]송홍숙[송홍숙]
Keywords
SUPPORTIVE CARE; COMBINATION CHEMOTHERAPY; SALVAGE CHEMOTHERAPY; PLATINUM; TRIAL; THERAPY; FLUOROPYRIMIDINE; 5-FLUOROURACIL; ADENOCARCINOMA; FLUOROURACIL
Issue Date
201506
Publisher
INT INST ANTICANCER RESEARCH
Citation
ANTICANCER RESEARCH, v.35, no.6, pp.3531 - 3536
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/m(2), days 1 and 8) or docetaxel (36 mg/m(2), days 1 and 8) and oxaliplatin (80 mg/m(2), 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://hdl.handle.net/YU.REPOSITORY/32094
ISSN
0250-7005
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의과대학 > 내과학교실 > Articles
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