Pujol Jean-Louis, Milleron Bernard, Molinier Olivier, Quoix Elisabeth, Depierre Alain, Breton Jean-Luc, Gervais Radj, Debieuvre Didier, Hominal Stéphane, Namouni Fouad, Tonelli Dominique
Department of Thoracic Oncology, Montpellier Academic Hospital, Montpellier, France.
J Thorac Oncol. 2006 May;1(4):328-34.
We designed this phase II trial to evaluate the efficacy and safety of weekly paclitaxel in combination with monthly carboplatin as first-line treatment in elderly patients with advanced non-small cell lung cancer (NSCLC).
Main eligibility criteria were histologically or cytologically proven stage IIIB or IV NSCLC, age > or =70 years, Eastern Cooperative Oncology Group performance status 0-2, and measurable disease. The 4-week-based chemotherapy regimen consisted of carboplatin infusion (area under the concentration-time curve 6 mg/ml/min) on day 1 and paclitaxel 90 mg/m as a 1-hour infusion on days 1, 8, and 15. Tumor response was evaluated using Response Evaluation Criteria in Solid Tumors criteria, and symptoms were evaluated using the Lung Cancer Symptoms Scale. Analyses were performed on an intention-to-treat basis.
From February 2002 to August 2003, 51 patients (median age, 74 years) participated in the study. One complete and 21 partial responses were reported by the independent review committee, leading to an intention-to-treat objective response rate of 43% (95% confidence interval, 30-57%). The median progression-free and overall survivals were 7.5 (95% confidence interval, 6.2-9.4) and 13.6 (95% confidence interval, 7.5-17) months, respectively. Longitudinal evaluation of the Lung Cancer Symptoms Scale demonstrated lack of quality of life modification during the treatment period. Neurotoxicity was mild to moderate, with 6% of patients suffering from a grade 3 or 4 neuropathy. Myelosuppression was the main toxicity; 39% of patients experienced grade 3 or 4 neutropenia, 18% experienced grade 3 anemia, and 8% experienced grade 3 or 4 thrombocytopenia. There was no treatment-related death.
The combination of weekly paclitaxel 90 mg/m administered on days 1, 8, and 15 plus monthly carboplatin area under the curve 6 on day 1 of a 4-week cycle was feasible and active as a first-line treatment for elderly patients with NSCLC with a good safety profile. These results deserve further analysis to compare the standard care for these patients (monotherapies) with this doublet.
我们设计了这项II期试验，以评估每周一次的紫杉醇联合每月一次的卡铂作为老年晚期非小细胞肺癌（NSCLC）一线治疗的疗效和安全性。
主要入选标准为经组织学或细胞学证实的IIIB期或IV期NSCLC、年龄≥70岁、东部肿瘤协作组体能状态0 - 2且疾病可测量。基于4周的化疗方案包括第1天静脉输注卡铂（浓度 - 时间曲线下面积为6mg/ml/min），以及第1、8和15天静脉输注90mg/m²的紫杉醇，输注时间为1小时。使用实体瘤疗效评价标准评估肿瘤反应，使用肺癌症状量表评估症状。分析基于意向性治疗原则进行。
从2002年2月至2003年8月，51例患者（中位年龄74岁）参与了该研究。独立审查委员会报告了1例完全缓解和21例部分缓解，意向性治疗的客观缓解率为43%（95%置信区间，30 - 57%）。中位无进展生存期和总生存期分别为7.5个月（95%置信区间，6.2 - 9.4）和13.6个月（95%置信区间，7.5 - 17）。肺癌症状量表的纵向评估显示治疗期间生活质量无改善。神经毒性为轻度至中度，6%的患者出现3级或4级神经病变。骨髓抑制是主要毒性；39%的患者出现3级或4级中性粒细胞减少，18%的患者出现3级贫血，8%的患者出现3级或4级血小板减少。无治疗相关死亡。
在4周周期的第1天给予曲线下面积为6的每月一次卡铂，以及第1、8和15天给予每周一次90mg/m²的紫杉醇联合治疗，作为老年NSCLC患者的一线治疗是可行且有效的，安全性良好。这些结果值得进一步分析，以将这些患者的标准治疗（单药治疗）与这种双联疗法进行比较。
