Jin Young Kim1, Hun Mo Ryoo2, Sung Hwa Bae2, Byung Woog Kang3, Yee Soo Chae3, Shinkyo Yoon3, Jin Ho Baek4, Min Kyoung Kim5, Kyung Hee Lee5, Sun Ah Lee6, Hong Suk Song7, Jong Gwang Kim8. 1. Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea. 2. Department of Oncology/Hematology, Daegu Catholic University Hospital, Daegu, Republic of Korea. 3. Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Daegu, Republic of Korea. 4. Department of Hematology/Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea. 5. Department of Oncology/Hematology, Yeungnam University Medical Cener, Daegu, Republic of Korea. 6. Department of Hematology/Oncology, Daegu Fatima Hospital, Daegu, Republic of Korea. 7. Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea jkk21c@knu.ac.kr shs7436@dsmc.or.kr. 8. 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 thedocetaxel/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
RCT Entities:
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
Authors: Emil Ter Veer; Nadia Haj Mohammad; Gert van Valkenhoef; Lok Lam Ngai; Rosa M A Mali; Martijn G H van Oijen; Hanneke W M van Laarhoven Journal: Cancer Metastasis Rev Date: 2016-09 Impact factor: 9.264