刘月娥, 任小沧, 陈雪霁. Dose escalation of lobaplatin combined with fixed docetaxel in second-line chemotherapy with solid tumors[J]. China Oncology, 2015, 25(3): 211-216.
刘月娥, 任小沧, 陈雪霁. Dose escalation of lobaplatin combined with fixed docetaxel in second-line chemotherapy with solid tumors[J]. China Oncology, 2015, 25(3): 211-216. DOI: 10.3969/j.issn.1007-3969.2015.03.009.
),完全缓解(complete response,CR)0例,部分缓解(partial response,PR)1例,疾病稳定(stable disease,SD)10例,疾病进展(progression disease,PD)3例;有效率(response rate,RR,CR+PR)为7.1%(1/14),疾病控制率(disease control rate,DCR,CR+PR+SD)为78.6%(11/14)。主要不良反应为白细胞下降,3例出现DLT,其中2例发生在洛铂40 mg/m
2
组。确定洛铂35 mg/m
2
组为MTD。结论:本组洛铂联合固定剂量多西紫杉醇的MTD为35 mg/m
2
,其不良反应可耐受。
Abstract
Background and purpose: Malignant tumors often relapsed or metastasized after first-line chemotherapy and needed second-line or above treatment. We conducted this study to define the maximum-tolerated dose (MTD) of lobaplatin with fixed docetaxel for Chinese patients in previously treated solid tumors. Methods: Escalating doses of lobaplatin with fixed docetaxel were administered in a modified Fibonacci sequence. The initial doses were lobaplatin 30 mg/m
2
and
docetaxel 60 mg/m
2
respectively. Escalating doses was 5 mg/m
2
. The regimen was repeated every 21 days. If no dose-limiting toxicity (DLT) was observed
the next dose level was applied. The procedures were repeated until DLT appeared. The MTD was declared to be one dose level below the level at which DLT appeared. Results: Seventeen patients received fifty-eight cycles chemotherapy at lobaplatin of level Ⅰ (30mg/m
2
)
level Ⅱ (35 mg/m
2
)and level Ⅲ(40 mg/m
2
). Cases of complete response (CR)
partial response (PR)
stable disease (SD) and progression disease (PD) for the whole group were 0
1
10 and 3
respectively. Response rate (RR
CR+PR) and disease control rate (DCR
CR+PR+SD) were 7.1% (1/14) and 78.6% (11/14)
respectively. The most common toxicity was leukopenia. Three DLTs occurred in 3 patients in the whole group
including 2 DLTs in dose level Ⅲ. We declared thus level Ⅱ was MTD. Conclusion: MTD of lobaplatin in our research was 35 mg/m
2
combined with fixed dose of docetaxel. This combination regimen was well tolerated.