摘要
Objective:The aim of the study was to investigate the prospective study if treatment with arsenic trioxide(As2O3) could enhance disease-free survival as adjuvant post-operative chemotherapy for gastric cancer patients and protect bone marrow from the negative effects of chemotherapy.Methods:84 adults were randomized into two groups.Patients in treatment group were treated with As2O3 and FOLFOX regimen,the other were administered with FOLFOX regimen only.Results:Four patients were withdrawn in treatment group after 3-4 cycles and the reasons were headache and fidgety(n = 2),arrhythmia(n = 1) and AST/ALT elevation(n = 1),while 1 patient in control group after 4 cycles for neutropenia.In the treatment group,the median DFS was 28.34 months(95% CI,25-33 months).While in control group,the median DFS was 24.50 months(95% CI,20-30 months).This difference was not statistically significant(chi-square:2.8885;P value:0.0892).Patients in the same subgroup of node-positive was 29 in the treatment group and 32 in control group,respectively.The median DFS was 27.87 months(95% CI,25-31 months) in the treatment group and 24.18 months(95% CI,19-31 months) in the control group with promising statistical significance(HR 1.89;chi-square:4.78;P value:0.0287).The most common grades 3-4 toxicity was leucopenia(n = 11) in control group and the difference was significant(chi-square:3.9768,P value:0.046) compared with that in treatment group(n = 4).Conclusion:The combination of arsenic trioxide and FOLFOX regimen has a potential advantage of enhancing disease-free survival in patients with gastric cancer in nodal-positive status as post-operative chemotherapy,and protect bone marrow from the negative effects of chemotherapy.
Objective: The aim of the study was to investigate the prospective study if treatment with arsenic trioxide (AS2O3) could enhance disease-free survival as adjuvant post-operative chemotherapy for gastric cancer patients and protect bone marrow from the negative effects of chemotherapy. Methods: 84 adults were randomized into two groups. Patients in treament group were treated with As2O3 and FOLFOX regimen, the other were administered with FOLFOX regimen only. Results: Four patients were withdrawn in treatment group after 3-4 cycles and the reasons were headache and fidgety (n = 2), rhythmia (n = 1) and AST/ALT elevation (n = 1), while 1 patient in control group after 4 cycles for neutropenia. In the treatment group, the median DFS was 28.34 months (95% CI, 25-33 months). While in control group, the median DFS was 24.50 months (95% CI, 20-30 months). This difference was not statistically significant (chi-square: 2.8885; P value: 0.0892). Pa- tients in the same subgroup of node-positive was 29 in the treatment group and 32 in control group, respectively. The median DFS was 27.87 months (95% CI, 25-31 months) in the treatment group and 24.18 months (95% CI, 19-31 months) in the control group with promising statistical significance (HR 1.89; chi-square: 4.78; P value: 0.0287). The most common grades 3-4 toxicity was leucopenia (n = 11) in control group and the difference was significant (chi-square: 3.9768, P value: 0.046) compared with that in treatment group (n = 4). Conclusion: The combination of arsenic trioxide and FOLFOX regimen has a potential advantage of enhancing disease-free survival in patients with gastric cancer in nodal-positive status as post-operative chemotherapy, and protect bone marrow from the negative effects of chemotherapy.
基金
Supported by a grant from the Harbin Technologies R&D Program of China (No.2004AA9CS196-9)
关键词
三氧化二砷
治疗效果
骨髓
保护
胃癌
化疗
arsenic trioxide (As2O3)
gastric cancer
FOLFOX regimen
bone marrow