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.

Kim, Jin Young; Ryoo, Hun Mo; Bae, Sung Hwa; Kang, Byung Woog; Chae, Yee Soo; Yoon, Shinkyo; Baek, Jin Ho; Kim, Min Kyoung; Lee, Kyung Hee; Lee, Sun Ah; Song, Hong Suk; Kim, Jong Gwang
Anticancer research
2015Jun ; 35 ( 6 ) :3531-6.
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Kim, Jin Young - Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.
Ryoo, Hun Mo - Department of Oncology/Hematology, Daegu Catholic University Hospital, Daegu, Republic of Korea.
Bae, Sung Hwa - Department of Oncology/Hematology, Daegu Catholic University Hospital, Daegu, Republic of Korea.
Kang, Byung Woog - Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Daegu, Republic of Korea.
Chae, Yee Soo - Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Daegu, Republic of Korea.
Yoon, Shinkyo - Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Daegu, Republic of Korea.
Baek, Jin Ho - Department of Hematology/Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.
Kim, Min Kyoung - Department of Oncology/Hematology, Yeungnam University Medical Cener, Daegu, Republic of Korea.
Lee, Kyung Hee - Department of Oncology/Hematology, Yeungnam University Medical Cener, Daegu, Republic of Korea.
Lee, Sun Ah - Department of Hematology/Oncology, Daegu Fatima Hospital, Daegu, Republic of Korea.
Song, Hong Suk - Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea jkk21c@knu.ac.kr shs7436@dsmc.or.kr.
Kim, Jong Gwang - Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Daegu, Republic of Korea jkk21c@knu.ac.kr shs7436@dsmc.or.kr.
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. CI - Copyright??2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.
keyword
Docetaxel; chemotherapy; gastric cancer; oxaliplatin
MESH
Adenocarcinoma/*drug therapy/pathology, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse, Cisplatin/administration & dosage/adverse effects, Disease-Free Survival, Drug-Related Side Effects and Adverse Reactions/pathology, Female, Humans, Male, Middle Aged, Organoplatinum Compounds/*administration & dosage/adverse effects, Stomach Neoplasms/*drug therapy/pathology, Taxoids/*administration & dosage/adverse effects
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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).
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