Karampeazis Athanasios, Vamvakas Lambros, Kotsakis Athanasios, Christophyllakis Charalambos, Kentepozidis Nikolaos, Chandrinos Vassilios, Agelidou Anna, Polyzos Aris, Tsiafaki Xanthi, Hatzidaki Dora, Georgoulias Vassilis
401 Army General Hospital, Athens, Greece; Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471.
Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), 55 Lomvardou Street, 11471.
J Geriatr Oncol. 2017 Jan;8(1):23-30. doi: 10.1016/j.jgo.2016.05.002. Epub 2016 Jun 2.
To compare first-line treatment with docetaxel plus gemcitabine (DG) versus gemcitabine (G) in elderly patients with advanced/metastatic non-small-cell lung cancer (NSCLC).
Chemotherapy-naïve patients with inoperable stage IIIB/IV NSCLC, ≥70years, with an ECOG performance status (PS) of 0-2 were enrolled. Patients were stratified by PS and disease stage and randomized to either DG (docetaxel 30mg/m plus gemcitabine 900mg/m i.v.) or G (gemcitabine 1200mg/m i.v.) on days 1 and 8, every 3weeks. The study's primary end-point was overall survival (OS).
In this prematurely closed study, 106 patients with a median age of 75years (range, 70-92) were enrolled (DG: n=54; G: n=52); 77 (73%) had stage IV disease and 18 (17%) a PS of 2. There was no difference in terms of median OS (14.6 vs 12.2months; p=0.121), progression-free survival (PFS) (3.4 vs 2.6months; p=0.757) and overall response rate (26.0% vs 15.4%; p=0.233) between DG and G arm, respectively. Patients with an Instrumental Activities of Daily Living (IADL) score<7 had significantly lower median OS (7.6 vs 15.4months; p=0.002) and median PFS (1.7 vs 4.4months; p=0.009) than patients with higher IADL score. The regimens were well tolerated with no significant difference in severe toxicity.
DG and G demonstrated comparable efficacy in elderly patients with NSCLC and high IADL score was correlated with superior clinical outcome.
比较多西他赛联合吉西他滨（DG）与吉西他滨（G）作为一线治疗方案用于老年晚期/转移性非小细胞肺癌（NSCLC）患者的疗效。
纳入年龄≥70岁、美国东部肿瘤协作组（ECOG）体能状态（PS）为0 - 2、未经化疗的不可切除的ⅢB/Ⅳ期NSCLC患者。患者按PS和疾病分期分层，随机分为DG组（多西他赛30mg/m²加吉西他滨900mg/m²静脉注射）或G组（吉西他滨1200mg/m²静脉注射），于第1天和第8天给药，每3周重复。研究的主要终点为总生存期（OS）。
在这项提前终止的研究中，共纳入106例患者，中位年龄75岁（范围70 - 92岁）（DG组：n = 54；G组：n = 52）；77例（73%）为Ⅳ期疾病，18例（17%）PS为2。DG组和G组之间的中位OS（14.6个月对12.2个月；p = 0.121）、无进展生存期（PFS）（3.4个月对2.6个月；p = 0.757）和总缓解率（26.0%对15.4%；p = 0.233）均无差异。日常生活工具性活动（IADL）评分<7的患者中位OS（7.6个月对15.4个月；p = 0.002）和中位PFS（1.7个月对4.4个月；p = 0.009）显著低于IADL评分较高的患者。两种方案耐受性良好，严重毒性无显著差异。
DG和G在老年NSCLC患者中疗效相当，IADL评分高与较好的临床结局相关。
