Dose determination for molecularly targeted therapies: Much Ado About Nothing

被引:0
作者
Tolcher, Anthony [1 ]
机构
[1] START, Clin Res, 4383 Med Dr,Suite 4021, San Antonio, TX 78229 USA
关键词
CELL LUNG-CANCER; PHASE-I; TRIAL; INHIBITOR; GEFITINIB; SAFETY; ZD1839;
D O I
10.1002/cncr.30584
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Literature reviews and meta-analyses of phase 1 studies are particularly difficult to perform and rarely draw useful conclusions due to the small size of individual studies and the varied populations. With the low rate of success in oncology drug development, the focus should turn to improving the efficiency of phase 1 studies. See also pages 1409-15.
引用
收藏
页码:1298 / 1300
页数:3
相关论文
共 10 条
  • [1] Albanell J, 2002, J CLIN ONCOL, V20, P110, DOI 10.1200/JCO.20.1.110
  • [2] Phase I safety, pharmacokinetic, and pharmacodynamic trial of ZD1839, a selective oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with five selected solid tumor types
    Baselga, J
    Rischin, D
    Ranson, M
    Calvert, H
    Raymond, E
    Kieback, DG
    Kaye, SB
    Gianni, L
    Harris, A
    Bjork, T
    Averbuch, SD
    Feyereislova, A
    Swaisland, H
    Rojo, F
    Albanell, J
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2002, 20 (21) : 4292 - 4302
  • [3] Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer
    Fukuoka, M
    Yano, S
    Giaccone, G
    Tamura, T
    Nakagawa, K
    Douillard, JY
    Nishiwaki, Y
    Vansteenkiste, J
    Kudoh, S
    Rischin, D
    Eek, R
    Horai, T
    Noda, K
    Takata, I
    Smit, E
    Averbuch, S
    Macleod, A
    Feyereislova, A
    Dong, RP
    Baselga, J
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2003, 21 (12) : 2237 - 2246
  • [4] Determinants of the recommended phase 2 dose of molecular targeted agents
    Hansen, Aaron R.
    Cook, Natalie
    Amir, Eitan
    Siu, Lillian L.
    Razak, Albiruni Ryan Abdul
    [J]. CANCER, 2017, 123 (08) : 1409 - 1415
  • [5] Phase I Oncology Studies: Evidence That in the Era of Targeted Therapies Patients on Lower Doses Do Not Fare Worse
    Jain, Rajul K.
    Lee, J. Jack
    Hong, David
    Markman, Maurie
    Gong, Jing
    Naing, Aung
    Wheler, Jennifer
    Kurzrock, Razelle
    [J]. CLINICAL CANCER RESEARCH, 2010, 16 (04) : 1289 - 1297
  • [6] Dynamic contrast-enhanced magnetic resonance imaging as a biomarker for the pharmacological response of PTK787/ZK 222584, an inhibitor of the vascular endothelial growth factor receptor tyrosine kinases, in patients with advanced colorectal cancer and liver metastases:: Results from two phase I studies
    Morgan, B
    Thomas, AL
    Drevs, J
    Hennig, J
    Buchert, M
    Jivan, A
    Horsfield, MA
    Mross, K
    Ball, HA
    Lee, L
    Mietlowski, W
    Fuxius, S
    Unger, C
    O'Byrne, K
    Henry, A
    Cherryman, GR
    Laurent, D
    Dugan, M
    Marmé, D
    Steward, WP
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2003, 21 (21) : 3955 - 3964
  • [7] Analysis of Impact of Post-Treatment Biopsies in Phase I Clinical Trials
    Sweis, Randy F.
    Drazer, Michael W.
    Ratain, Mark J.
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2016, 34 (04) : 369 - +
  • [8] Phase I study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PTK787/ZK 222584 administered twice daily in patients with advanced cancer
    Thomas, AL
    Morgan, B
    Horsfield, MA
    Higginson, A
    Kay, A
    Lee, L
    Masson, E
    Puccio-Pick, M
    Laurent, D
    Steward, WP
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (18) : 4162 - 4171
  • [9] Wang S., 2016, NY TIMES, pA23
  • [10] Gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804): a multicentre, double-blind randomised phase 3 trial
    Zhang, Li
    Ma, Shenglin
    Song, Xiangqun
    Han, Baohui
    Cheng, Ying
    Huang, Cheng
    Yang, Shujun
    Liu, Xiaoqing
    Liu, Yunpeng
    Lu, Shun
    Wang, Jie
    Zhang, Shucai
    Zhou, Caicun
    Zhang, Xiangwei
    Hayashi, Nobuya
    Wang, Mengzhao
    [J]. LANCET ONCOLOGY, 2012, 13 (05) : 466 - 475