Medical Oncology Unit, University of Palermo, La Maddalena Clinic for Cancer, Palermo, Italy.
Lung Cancer. 2010 Aug;69(2):218-24. doi: 10.1016/j.lungcan.2009.10.008. Epub 2009 Nov 11.
Quality of life (QoL) has gained greater importance in the management of metastatic non-small-cell lung cancer due to the palliative nature of treatment. Docetaxel (DCT) and cisplatin (CDDP) doublet has been reported to be associated to a better QoL than the weekly vinorelbine (VNR) and CDDP regimen. Recently a newer more tolerated schedule of the VNR/CDDP regimen has been published and is widely employed in medical practice. The impact of these regimens on patients' QoL as well as symptoms control and type and grading chemo-related side-effects has been compared prospectically.
Patients received CDDP 75 mg/m(2) plus DCT 75 mg/m(2) on day 1 every weeks (arm A) or CDDP 80 mg/m(2) on day 1 plus VNR 30 mg/m(2) day 1 and 8 every 3 weeks (arm B). G-CSF and/or EPO were employed as needed. Health-related QoL was assessed at entry and after every cycle by the EORTC-QLQ-C30 and LC13 questionnaires, toxicity by the NCI-NCCN CTC vs 2, and intent-to-treat objective response by the Recist criteria.
The QoL questionnaires were completed by 37 pts (88%) in the DCT/CDDP arm and 39 pts (87%) in the VNR/CDDP one. Baseline mean scores and rates at which pts failed to complete QoL assessment were similar in the two arms. Global health status of the EORTC QLQ-C30 scale and specific symptoms control (LC13 module) improved during treatment without any statistically significant difference between the two arms. Emotional functioning remained stable in both groups during treatment, whereas physical and role improved slightly. In the DCT/CDDP arm 14 pts (33%; 95%CL 24-40%) had PR, and 10 (24%) SD for a 57% TGCR. In the VNR/CDDP arm 12 pts (27%) achieved PR, 18 (41%) SD a 68% TGCR. Differences were not statistically significant. Median time-to-progression was 4.2 months in the DCT/CDDP arm and 4.5 months in the VNR/CDDP one, and median overall survival was 12.1 (range 1-26+ months) and 12.5 months (range 1-28+ months) for DCT/CDDP and VNR/CDDP arms, respectively. Febrile neutropenia rate was higher in the VNR/CDDP arm (p=0.02) as well as G3-4 anemia (p=0.005) and G-CSF/EPO use (p=0.019).
Global and specific health-related QoL data similar in both treatment groups with no statistically significant difference. Efficacy measures, overall response rate, time-to-progression and overall survival were equivalent in both arms. However, severe anemia and febrile neutropenia are statistically more frequent in the VNR/CDDP arm than in the DCT/CDDP one. These data should be considered in treatment decision-making for pts with advanced non-small-cell lung cancer and for the design of future trials with chemotherapy plus biologics.
由于治疗的姑息性质，生活质量（QoL）在转移性非小细胞肺癌的管理中变得更加重要。已经报道多西紫杉醇（DCT）和顺铂（CDDP）联合方案比每周长春瑞滨（VNR）和顺铂方案与更好的 QoL 相关。最近发表了一种新的、更耐受的 VNR/CDDP 方案，并在医学实践中广泛应用。这些方案对患者 QoL 以及症状控制和类型和分级化疗相关副作用的影响已被前瞻性比较。
患者接受 CDDP 75 mg/m(2)加 DCT 75 mg/m(2)，第 1 天每 1 周（臂 A）或 CDDP 80 mg/m(2)加 VNR 30 mg/m(2)第 1 天和第 8 天每 3 周（臂 B）。根据需要使用 G-CSF 和/或 EPO。在进入和每个周期后，通过 EORTC-QLQ-C30 和 LC13 问卷评估健康相关的 QoL，通过 NCI-NCCN CTC vs 2 评估毒性，通过 Recist 标准评估意向治疗的客观反应。
DCT/CDDP 臂的 37 名患者（88%）和 VNR/CDDP 臂的 39 名患者（87%）完成了 QoL 问卷。在两个臂中，基线平均评分和未能完成 QoL 评估的患者比例相似。在治疗期间，EORTC QLQ-C30 量表的全球健康状况和特定症状控制（LC13 模块）得到改善，两个臂之间没有统计学上的显著差异。在治疗期间，情感功能在两组中保持稳定，而身体和角色功能略有改善。在 DCT/CDDP 臂中，14 名患者（33%；95%CL 24-40%）有 PR，10 名患者（24%）有 SD，总反应率为 57%。在 VNR/CDDP 臂中，12 名患者（27%）达到 PR，18 名患者（41%）有 SD，总反应率为 68%。差异无统计学意义。DCT/CDDP 臂的中位无进展生存期为 4.2 个月，VNR/CDDP 臂为 4.5 个月，中位总生存期分别为 12.1 个月（范围 1-26+个月）和 12.5 个月（范围 1-28+个月）用于 DCT/CDDP 和 VNR/CDDP 臂。VNR/CDDP 臂的发热性中性粒细胞减少发生率较高（p=0.02），贫血（p=0.005）和 G-CSF/EPO 使用（p=0.019）的 G3-4 也较高。
两组患者的全球和特定健康相关 QoL 数据相似，无统计学差异。疗效指标、总反应率、无进展生存期和总生存期在两组中均相同。然而，严重贫血和发热性中性粒细胞减少在 VNR/CDDP 臂比在 DCT/CDDP 臂更常见。这些数据应在晚期非小细胞肺癌患者的治疗决策中以及未来化疗加生物制剂的临床试验设计中加以考虑。
