Phase III trial comparing paclitaxel poliglumex vs docetaxel in the second-line treatment of non-small-cell lung cancer.
Phase III trial comparing paclitaxel poliglumex vs docetaxel in the second-line treatment of non-small-cell lung cancer.
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在非小细胞肺癌的二线治疗中，比较了紫杉醇poliglumex vs多西他赛的第三阶段试验。
DOI：
10.1038/sj.bjc.6604372
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发表时间：
2008-05-20
影响因子：
8.8
通讯作者：
Bonomi, P.
中科院分区：
文献类型：
--
作者：
Paz-Ares, L.;Ross, H.;O'Brien, M.;Riviere, A.;Gatzemeier, U.;Von Pawel, J.;Kaukel, E.;Freitag, L.;Digel, W.;Bischoff, H.;Garcia-Campelo, R.;Iannotti, N.;Reiterer, P.;Bover, I.;Prendiville, J.;Eisenfeld, A. J.;Oldham, F. B.;Bandstra, B.;Singer, J. W.;Bonomi, P.
聚紫杉醇（PPX）是一种将紫杉醇与聚谷氨酸连接起来的高分子药物偶联物，可降低游离紫杉醇峰值浓度的全身暴露。既往接受过一次含铂化疗的非小细胞肺癌（NSCLC）患者接受175或210 mg m−2 PPX或75 mg m−2多西他赛。该研究入组了849例既往接受过治疗的晚期NSCLC患者。治疗组间的中位生存期（两组均为6.9个月，风险比=1.09，P=0.257）、1年生存期（PPX= 25%，多西他赛= 29%，P=0.134）和至疾病进展时间（PPX=2个月，多西他赛=2.6个月，P=0.075）相似。聚葡美紫杉醇与3级或4级中性粒细胞减少症（P<0.001）和发热性中性粒细胞减少症（P=0.006）显著相关。PPX组中3级或4级神经病变（P<0.001）更常见。接受PPX治疗的患者脱发较少，且未接受常规术前用药。与多西他赛组相比，PPX组因不良事件而停药的患者更多（34 vs 16%，P<0.001）。聚葡美紫杉醇和多西他赛产生相似的生存结果，但具有不同的毒性特征。与多西他赛相比，PPX的发热性中性粒细胞减少症和脱发较少，输液时间较短，并且消除了常规使用药物以预防超敏反应。与多西他赛相比，210 mg m−2剂量的聚葡美紫杉醇导致神经毒性增加。
Paclitaxel poliglumex (PPX), a macromolecule drug conjugate linking paclitaxel to polyglutamic acid, reduces systemic exposure to peak concentrations of free paclitaxel. Patients with non-small-cell lung cancer (NSCLC) who had received one prior platinum-based chemotherapy received 175 or 210 mg m−2 PPX or 75 mg m−2 docetaxel. The study enrolled 849 previously treated NSCLC patients with advanced disease. Median survival (6.9 months in both arms, hazard ratio=1.09, P=0.257), 1-year survival (PPX=25%, docetaxel=29%, P=0.134), and time to progression (PPX=2 months, docetaxel=2.6 months, P=0.075) were similar between treatment arms. Paclitaxel poliglumex was associated with significantly less grade 3 or 4 neutropenia (P<0.001) and febrile neutropenia (P=0.006). Grade 3 or 4 neuropathy (P<0.001) was more common in the PPX arm. Patients receiving PPX had less alopecia and did not receive routine premedications. More patients discontinued due to adverse events in the PPX arm compared to the docetaxel arm (34 vs 16%, P<0.001). Paclitaxel poliglumex and docetaxel produced similar survival results but had different toxicity profiles. Compared with docetaxel, PPX had less febrile neutropenia and less alopecia, shorter infusion times, and elimination of routine use of medications to prevent hypersensitivity reactions. Paclitaxel poliglumex at a dose of 210 mg m−2 resulted in increased neurotoxicity compared with docetaxel.
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DOI：
10.1042/bss0700263
发表时间：
2003-01-01
期刊：
PROTEASES AND THE REGULATION OF BIOLOGICAL PROCESSES
影响因子：
--
作者：
Podgorski, I;Sloane, BF
通讯作者：
Sloane, BF
影响因子：
3.6
作者：
Richards, Donald A.;Richards, Paul;Oldham, Fred
通讯作者：
Oldham, Fred
影响因子：
45.3
作者：
Shepherd, FA;Dancey, J;Berille, J
通讯作者：
Berille, J
影响因子：
158.5
作者：
Shepherd, FA;Pereira, JR;Seymour, L
通讯作者：
Seymour, L
影响因子：
3
作者：
Li, C;Newman, RA;Wallace, S
通讯作者：
Wallace, S