*Division of Medical Oncology, "SG Moscati" Hospital, Avellino, Italy; †Department of Oncology, University of Turin, AOU San Luigi Orbassano, Turin, Italy; ‡Medical Oncology 1, "Fondazione IRCCS Istituto Nazionale dei Tumori", Milan, Italy; §Department of Oncology, San Paolo Hospital, Milan, Italy; ‖Second Medical Oncology Unit, "Istituto Oncologico Veneto", Padua, Italy; ¶European Institute of Oncology, Milan, Italy; #Department of Oncology, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola (FC), Italy; **Division of Medical Oncology, S. Maria della Misericordia Hospital, Perugia, Italy; ††Lung Cancer Unit, National Institute for Cancer Research, Genoa, Italy; ‡‡Medical Oncology Department, Santa Chiara Hospital, Trento, Italy; §§Medical Oncology Unit, San Vincenzo Hospital, Taormina, Catania, Italy; ‖‖Oncology Unit, Santa Maria delle Croci Hospital, Ravenna, Italy; ¶¶Medical Oncology Department, AUSL Bologna, Italy; ##Medical Oncology Unit, "Giovanni Paolo II" National Cancer Centre, Bari, Italy; ***Department of Oncology, Azienda Ospedaliera Treviglio, Treviglio (BG), Italy; †††Department of Oncology, University Hospital of Udine, Udine, Italy; ‡‡‡Department of Oncology, Ospedale Niguarda Ca' Granda, Milan, Italy; §§§AstraZeneca, Basiglio (MI), Italy; ‖‖‖LB Research, Cantù (CO), Italy; and ¶¶¶Medical Oncology, Second University of Naples, Naples, Italy.
J Thorac Oncol. 2014 May;9(5):733-7. doi: 10.1097/JTO.0000000000000120.
The aim of the present study was to evaluate the efficacy and tolerability of vandetanib plus gemcitabine (V/G) compared with gemcitabine alone in elderly patients with untreated advanced non-small-cell lung cancer.
This was a phase II, randomized, double-blind study. A total of 124 elderly patients (mean age, 75 yr; age range, 70-84 yr; 73% men) received V/G (n = 61) or placebo plus gemcitabine (n = 63). Progression-free survival (PFS) was the primary endpoint. Secondary endpoints were overall survival, objective response rate, duration of response, disease control rate, time to deterioration of performance status, and safety outcomes.
PFS was significantly prolonged with V/G (median, 183 days; 95% confidence interval, 116-214) compared with placebo plus gemcitabine (median, 169 days; 95% confidence interval, 95-194; p = 0.047). No statistically significant differences between arms were observed in all secondary endpoints, including overall survival. The addition of vandetanib to gemcitabine was well tolerated. The rate of patients with ≥1 treatment-related adverse event was comparable in the two arms, pyrexia, dyspnea, and neutropenia being the most common adverse events.
V/G combination was associated with a statistically significant prolongation of PFS compared with gemcitabine alone in untreated elderly patients with advanced non-small-cell lung cancer, with an acceptable safety profile.
本研究旨在评估凡德他尼联合吉西他滨（V/G）与吉西他滨单药相比在未经治疗的老年晚期非小细胞肺癌患者中的疗效和耐受性。
这是一项 II 期、随机、双盲研究。共纳入 124 例老年患者（平均年龄 75 岁；年龄范围 70-84 岁；73%为男性），分别接受 V/G（n=61）或安慰剂联合吉西他滨（n=63）治疗。无进展生存期（PFS）是主要终点。次要终点包括总生存期、客观缓解率、缓解持续时间、疾病控制率、体能状态恶化时间和安全性结局。
V/G 组 PFS 明显延长（中位 PFS：183 天；95%置信区间：116-214），安慰剂联合吉西他滨组中位 PFS 为 169 天（95%置信区间：95-194；p=0.047）。两组在所有次要终点（包括总生存期）均无统计学差异。V/G 联合吉西他滨治疗耐受性良好。两组治疗相关不良事件≥1 级的发生率相当，发热、呼吸困难和中性粒细胞减少症是最常见的不良事件。
与吉西他滨单药治疗相比，V/G 联合方案可显著延长未经治疗的老年晚期非小细胞肺癌患者的 PFS，且安全性可接受。
