Results of a phase II study of weekly paclitaxel plus carboplatin in patients with extensive small-cell lung cancer with eastern cooperative oncology group performance status of 2, or age ≥ 70 years
Results of a phase II study of weekly paclitaxel plus carboplatin in patients with extensive small-cell lung cancer with eastern cooperative oncology group performance status of 2, or age ≥ 70 years
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DOI：
10.1200/jco.2004.11.023
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发表时间：
2004-05-15
影响因子：
45.3
通讯作者：
Asmar, L
中科院分区：
文献类型：
--
作者：
Neubauer, M;Schwartz, J;Asmar, L
目的探讨紫杉醇加卡铂（PC）治疗广泛小细胞肺癌（ESCLC）患者的1年生存率、缓解率（RR）、进展时间（TTP）和安全性，这些患者的表现状态（PS）为2岁或大于等于70岁。患者和方法患者分别在每4周周期的第1天、第8天和第15天静脉输注PC（紫杉醇80 mg/m(2)和卡铂曲线下面积= 2），最多6个周期。结果2000年7月至2001年12月，入选77例符合条件的ESCLC患者（50.6%为男性，97.4%为白人，44.2% PS为2，中位年龄为74岁）。在66例可评估反应的患者中，25例对治疗有反应（1例完全缓解，24例部分缓解），客观RR为38%。病情稳定者8例（12.1%），进展者33例（50%）。中位生存期为7.2个月（范围< 1 ~ 24.4个月），估计1年生存率为30%。中位TTP为3.5个月（范围< 1至21.2个月），估计1年无进展生存率为8%。中位反应持续时间为4.5个月（范围1.6至17.5个月）。一例死亡（败血症）可能与研究药物有关。大于或等于5%的患者出现的3级和4级毒性包括中性粒细胞减少症（22.1%）、疲劳（8.6%）、贫血（5.2%）和恶心/呕吐（5.2%）。结论：该方案产生的毒性相对较少（66例可评估患者中只有2例因毒性而接受少于2个周期的治疗），中位生存期和1年生存期与其他方案相似。对于PS差或年龄大于或等于70岁的ESCLC患者，该方案可能是更好的治疗选择。(C) 2004年由美国临床肿瘤学会出版。
PurposeTo determine the 1-year survival, response rate (RR), time to progression (TTP), and safety of weekly paclitaxel plus carboplatin (PC) in patients with extensive small-cell lung cancer (ESCLC) with an Eastern Cooperative Performance Status performance status (PS) of 2 or an age greater than or equal to 70 years.Patients and MethodsPatients were treated with PC (paclitaxel 80 mg/m(2) and carboplatin area under the curve = 2) by intravenous infusion on days 1, 8, and 15 of every 4-week cycle for up to six cycles.ResultsBetween July 2000 and December 2001, 77 eligible patients (50.6% were male, 97.4% were white, 44.2% had PS of 2, with median age of 74 years) with ESCLC were enrolled. Among the 66 patients who were assessable for response, 25 responded to treatment (one complete response and 24 partial responses), for an objective RR of 38%. There were eight cases of stable disease (12.1%) and 33 cases of progressive disease (50%). The median survival was 7.2 months (range, < 1 to 24.4 months), and the estimated 1-year survival rate was 30%. The median TTP was 3.5 months (range, < 1 to 21.2 months), and the estimated 1-year progression-free survival rate was 8%. The median duration of response was 4.5 months (range, 1.6 to 17.5 months). One death (sepsis) was possibly related to the study drugs. Grades 3 and 4 toxicities experienced by greater than or equal to 5% of patients included neutropenia (22.1%), fatigue (8.6%), anemia (5.2%), and nausea/vomiting (5.2%).ConclusionThis regimen produced relatively few toxicities (only two of the 66 assessable patients received fewer than two cycles because of toxicity), and both the median and 1-year survival were similar to other regimens. This regimen may be a preferable treatment choice for patients with ESCLC who have a poor PS or who are aged greater than or equal to 70 years. (C) 2004 by American Society of Clinical Oncology.