Activity of docetaxel in platinum-treated non-small-cell lung cancer: Results of a phase II multicenter trial

被引:116
作者
Gandara, DR
Vokes, E
Green, M
Bonomi, P
Devore, R
Comis, R
Carbone, D
Karp, D
Belani, C
机构
[1] Univ Calif, Davis Canc Ctr, Sacramento, CA 95817 USA
[2] Univ Calif San Diego, San Diego, CA 92103 USA
[3] Univ Chicago, Chicago, IL 60637 USA
[4] Rush Univ, Chicago, IL 60612 USA
[5] Thomas Jefferson Univ, Philadelphia, PA 19107 USA
[6] Vanderbilt Univ, Nashville, TN USA
[7] Univ Pittsburgh, Pittsburgh, PA USA
[8] Univ Texas Dallas, Dallas, TX 75230 USA
[9] Tufts Univ New England Med Ctr, Boston, MA 02111 USA
关键词
D O I
10.1200/JCO.2000.18.1.131
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: Although several new chemotherapeutic agents are promising as primary therapy in non-small-cell lung cancer (NSCLC), few have demonstrated activity in platinum-refractory disease. Based on encouraging results reported in two single-institution studies of docetaxel in this setting, we performed a multicenter phase II trial evaluating this novel taxane in previously treated NSCLC patients prospectively categorized by platinum response status. Patients and Methods: Eighty patients with NSCLC previously treated with platinum-based chemotherapy received docetaxel at a dose of 100 mg/m(2) intravenously over 1 hour, repeated every 21 days, accompanied by dexamethasone 8 mg orally twice daily for 5 days. Forty-seven patients (59%) were defined as platinum-refractory based on response status to prior therapy. Results: The median number of cycles delivered per patient was four (range, one to 21 cycles). Partial response was observed in 13 (16%) of 80 of patients, with similar response rates in platinum-sensitive and platinum-refractory patients. The median survival time was 7 months, and the I-year survival rare wets 25%. Docetaxel was relatively well tolerated in this previously treated population. Grade IV neutropenia was common in patients (77%) but typically of brief duration. Febrile neutropenia was observed in 11 patients (14%), with no fatal infections. Severe fluid retention was rare (4% of patients). Conclusions: This multicenter phase II trial confirms antitumor activity and encouraging survival with docetaxel therapy in platinum-treated and platinum-refractory NSCLC. To validate these results, a phase III trial randomizing platinum-treated patients to docetaxel or best supportive care is underway. (C) 2000 by American Society of Clinical Oncology.
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页码:131 / 135
页数:5
相关论文
共 27 条
[1]   SURVIVAL DETERMINANTS IN EXTENSIVE-STAGE NON-SMALL-CELL LUNG-CANCER - THE SOUTHWEST-ONCOLOGY-GROUP EXPERIENCE [J].
ALBAIN, KS ;
CROWLEY, JJ ;
LEBLANC, M ;
LIVINGSTON, RB .
JOURNAL OF CLINICAL ONCOLOGY, 1991, 9 (09) :1618-1626
[2]  
ALBERTI W, 1995, BRIT MED J, V311, P899
[3]  
[Anonymous], 1994, OP CIT
[4]  
BLAGOSKLONNY MV, 1995, CANCER RES, V55, P4623
[5]  
Bonomi P, 1996, P AN M AM SOC CLIN, V15, P382
[6]  
BURRIS H, 1993, P AN M AM SOC CLIN, V12, pA1116
[7]  
Crinò L, 1998, SEMIN ONCOL, V25, P23
[8]  
DILLMAN RO, 1990, NEW ENGL J MED, V323, P904
[9]   Promising new agents in the treatment of non small cell lung cancer [J].
Edelman, MJ ;
Gandara, DR .
CANCER CHEMOTHERAPY AND PHARMACOLOGY, 1996, 37 (05) :385-393
[10]   PHASE-II STUDY OF DOCETAXEL FOR ADVANCED OR METASTATIC PLATINUM-REFRACTORY NON-SMALL-CELL LUNG-CANCER [J].
FOSSELLA, FV ;
LEE, JS ;
SHIN, DM ;
CALAYAG, M ;
HUBER, M ;
PEREZSOLER, R ;
MURPHY, WK ;
LIPPMAN, S ;
BENNER, S ;
GLISSON, B ;
CHASEN, M ;
HONG, WK ;
RABER, M .
JOURNAL OF CLINICAL ONCOLOGY, 1995, 13 (03) :645-651