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首页> 外文期刊>The oncologist >Randomized Phase II Study of First-Line Biweekly Gemcitabine and Carboplatin Versus Biweekly Gemcitabine and Carboplatin plus Maintenance Gemcitabine in Elderly Patients with Untreated Non-Small Cell Lung Cancer: LOGIK0801
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Randomized Phase II Study of First-Line Biweekly Gemcitabine and Carboplatin Versus Biweekly Gemcitabine and Carboplatin plus Maintenance Gemcitabine in Elderly Patients with Untreated Non-Small Cell Lung Cancer: LOGIK0801

机译：一线双周吉西他滨和卡铂的随机期II研究与双周吉西他滨和卡铂加上老年人未经处理的非小细胞肺癌患者的吉西他滨：LOGIK0801

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Background. The primary objective of this randomized phase II study was to assess progression-free survival (PFS) in elderly patients with advanced non-small cell lung cancer (NSCLC) treated with gemcitabine (GEM) maintenance therapy versus best supportive care following first-line GEM plus carboplatin (CBDCA). Methods. Elderly chemotherapy-naive patients with stage IIIB or IV NSCLC were randomly assigned 1:1 to the control arm or the study arm. All patients received biweekly combination therapy with GEM and CBDCA (1,000 mg/m2 GEM and CBDCA at an area under the curve [AUC] of 3 on days 1 and 15, every 4 weeks). In the study arm, patients with objective response or stable disease following three or four cycles of initial chemotherapy received maintenance GEM. Results. Eighty-four patients were enrolled. The objective response rates (ORRs) were 17.5% in the control arm and 14.0% in the study arm. The most common toxicity was neutropenia (control arm: 47.5% and study arm: 69.8%). The median progression-free survivals were 4.99 months (control arm) and 4.44 months (study arm), and the median overall survivals (OSs) were 21.7 months (control arm) and 8.2 months (study arm). Conclusion. Our data do not support maintenance GEM after biweekly CBDCA+GEM in elderly patients with NSCLC.
机译：背景。该随机期II研究的主要目的是评估老年人患有先进的非小细胞肺癌（NSCLC）的患者的无进展生存期（PFS），并在一线宝石之后最佳支持性护理加上卡铂（CBDCA）。方法。年长化疗 - 尾痛患者IIIB或IV NSCLC随机分配1：1至控制臂或研究臂。所有患者均接受母猪和CBDCA的双周结合治疗（在第1天和第15天的曲线[AUC]的1,000mg / m2 gem和cbdca，每4周，每4周）。在研究臂中，患者患有客观反应或稳定的疾病，初始化疗的三个或四个循环接受维护宝石。结果。八十四名患者注册。目标反应率（ORR）在控制臂中为17.5％，研究臂中的14.0％。最常见的毒性是中性粒细胞减少（控制手臂：47.5％和研究臂：69.8％）。中位的无进展幸存者为4.99个月（控制手臂）和4.44个月（研究手臂），中位数幸存者（OSS）为21.7个月（控制手臂）和8.2个月（研究手臂）。结论。我们的数据在老年NSCLC患者中双周CBDCA + GEM之后不支持维护宝石。

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