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Randomized Controlled Trial
. 2012 Feb;15(2):84-9.
doi: 10.3779/j.issn.1009-3419.2012.02.04.

[A randomized clinical trial on the clinical efficacy and toxicities of single-agent paclitaxel liposome versus paclitaxel liposome plus oxaliplatin as first-line chemotherapy for advanced non-small cell lung cancer in elderly patients]

[Article in Chinese]
Xiaomei Zeng  1 , Zhixi Li, Mei Hou
Affiliations
Randomized Controlled Trial

[A randomized clinical trial on the clinical efficacy and toxicities of single-agent paclitaxel liposome versus paclitaxel liposome plus oxaliplatin as first-line chemotherapy for advanced non-small cell lung cancer in elderly patients]

[Article in Chinese]
Xiaomei Zeng et al. Zhongguo Fei Ai Za Zhi. 2012 Feb.

Abstract
in English, Chinese

Background and objective: The third generation single-agent drug has been recommended as a first-line chemotherapy for elderly patients with advanced non-small cell lung cancer (NSCLC). The aim of the current radomized trial is to compare the clinical efficacy and toxicities of single-agent paclitaxel liposome versus paclitaxel liposome plus oxaliplatin as a first-line chemotherapy for elderly patients.

Methods: Sixty-nine advanced NSCLC patients from July 2008 to August 2010, confirmed with pathology or cytology and had never received treatment, were randomly divided into two groups. The first group was given 135 mg/m² of single-agent paclitaxel liposome on day 1 of each cycle. The second group was given 135 mg/m² paclitaxel liposome plus 125 mg/m² oxaliplatin on day 1 of each cycle. One cycle is composed of 21 days. Efficacy and toxicities could be evaluated after two or more cycles.

Results: No statistical differences were observed between the two groups in terms of efficacy (22.9% vs 35.3%, P=0.297), disease control rate (60.0% vs 70.6%, P=0.450), and 1-year survival rate (28.6% vs 41.2%, P=0.724). However, the group treated with paclitaxel liposome plus oxaliplatin had longer progression free survival (PFS) (5.0 months vs 3.5 months, P=0.024). In addition, the toxicities that occurred in the two groups were similar including leukocytopenia (P=0.808), thrombocytopenia (P>0.999), anemia (P=0.477), and nausea/vomiting (P=0.777). The number of neurotoxicity that occurred in the two groups were 33 and 3 (97.1% vs 8.6%, P<0.001), respectively. However, all were grade I-II.

Conclusions: The clinical efficacy of paclitaxel liposome plus oxaliplatin as a first-line chemotherapy for elderly patients with advanced NSCLC is more better than that of the single-agent paclitaxel liposome. It prolongs PFS and is safe for clinical use.

背景与目的: 目前推荐第三代药物单药治疗老年晚期非小细胞肺癌（non-small cell lung cancer, NSCLC），本研究旨在比较紫杉醇脂质体与紫杉醇脂质体联合奥沙利铂一线治疗老年晚期NSCLC的临床疗效及毒副作用。

方法: 2008年7月-2010年8月未经过治疗的经病理学或细胞学确诊的老年晚期NSCLC患者69例随机分成紫杉醇脂质体单药组（35例）和紫杉醇脂质体联合奥沙利铂组（34例），单药组给予紫杉醇脂质体135 mg/m2 d1；联合组给予紫杉醇脂质体135 mg/m2 d1+奥沙利铂125 mg/m2 d1，每21天重复，至少治疗2个周期，评价疗效和不良反应。

结果: 单药组与联合组相比，治疗有效率（22.9% vs 35.3%, P=0.297）、疾病控制率（60.0% vs 70.6%, P=0.450）和1年生存率（28.6% vs 41.2%, P=0.724）差异均无统计学意义，联合组的无疾病进展生存期（progression free survival, PFS）较单药组延长1.5个月（5.0个月 vs 3.5个月，P=0.024）。在毒副作用方面，两组白细胞减少（P=0.808）、血小板减少（P＞0.999）、贫血（P=0.477）、恶心和呕吐的发生率（P=0.777）相当；两组发生神经毒性的患者分别为33例和3例（97.1% vs 8.6%, P＜0.001），但均为Ⅰ度-Ⅱ度。

结论: 紫杉醇脂质体联合奥沙利铂用于一线治疗老年晚期NSCLC疗效略优于紫杉醇脂质体单药，能延长患者的PFS，临床应用安全性好。

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Figures

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紫杉醇脂质体组与紫杉醇脂质体联合奥沙利铂组无疾病进展期比较 Comparison of progression free survival between paclitaxel liposome group and paclitaxel liposome plus oxaliplatin group
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