1. 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
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Kim JY, Ryoo HM, Bae SH, Kang BW, Chae YS, Yoon S, Baek JH, Kim MK, Lee KH, Lee SA, Song HS, and Kim JG
- Subjects
- Adenocarcinoma pathology, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Antineoplastic Combined Chemotherapy Protocols adverse effects, Cisplatin administration & dosage, Cisplatin adverse effects, Disease-Free Survival, Docetaxel, Drug-Related Side Effects and Adverse Reactions pathology, Female, Humans, Male, Middle Aged, Organoplatinum Compounds adverse effects, Oxaliplatin, Stomach Neoplasms pathology, Taxoids adverse effects, Adenocarcinoma drug therapy, Organoplatinum Compounds administration & dosage, Stomach Neoplasms drug therapy, Taxoids administration & dosage
- 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., (Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.)
- Published
- 2015