Phase I trial of weekly docetaxel combined with cisplatin in patients with non-small cell lung cancer

被引:10
作者
Koizumi, T [1 ]
Tsunoda, T [1 ]
Fujimoto, K [1 ]
Nomura, H [1 ]
Hirai, K [1 ]
Koyama, S [1 ]
Okada, K [1 ]
Kubo, K [1 ]
机构
[1] Shinshu Univ, Sch Med, Dept Internal Med 1, Shinshu 3908621, Japan
关键词
weekly docetaxel cisplatin; non-small-cell lung cancer; neutropenia;
D O I
10.1016/S0169-5002(01)00229-X
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
The phase I study was conducted to evaluate the maximum tolerated dose (mTD) and toxicity of weekly administered docetaxel combined with cisplatin in patients with non-small-cell lung cancer (NSCLC). In a dose escalation study, 22 patients, under 75 years old, with unresectable and metastatic untreated NSCLC with performance status (0-1) were enrolled. Patients were treated with cisplatin (day 1) and weekly docetaxel (days 1, 8, 15). Dose escalation levels in mg/m(2) were for cisplatin and docetaxel; 70 and 15 (level 1), 80 and 15 (level 2), 80 and 20 (level 3), 80 and 25 (level 4), 80 and 30 (level 5), respectively. Chemotherapy was repeated for at least two cycles every 28 days. All patients were assessable for toxicities. Although grade 3 neutropenia occurred in one case in level 4, there were no significant modifications of chemotherapy schedule until level 4. Grade 3 neutropenia occurred in all cases receiving level 5. One patient developed an infection, and two had incomplete recovery of neutropenia by the 28th day after the first cycle of chemotherapy. Nonhematological toxicities, including nephrotoxicity, nausea/vomiting, alopecia and hypersensitivity reaction, were tolerable. However, one case developed severe hyponatremia. Among 21 patients evaluable for response, eight cases achieved partial response, thus the overall response was 39%. Weekly administration of docetaxel at 25 mg/m(2) (days 1, 8, 15) combined with cisplatin 80 mg/m(2) (day 1) is recommended for phase II studies. The responses observed in the present study suggest an identical high degree of activity against NSCLC with less hematotoxicities compared with a standard schedule of cisplatin and docetaxel. (C) 2001 Elsevier Science Ireland Ltd. All rights reserved.
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收藏
页码:125 / 131
页数:7
相关论文
共 20 条
[1]   Phase I trial of weekly paclitaxel in advanced lung cancer [J].
Akerley, W ;
Glantz, M ;
Choy, H ;
Rege, V ;
Sambandam, S ;
Joseph, P ;
Yee, L ;
Rodrigues, B ;
Wingate, P ;
Leone, L .
JOURNAL OF CLINICAL ONCOLOGY, 1998, 16 (01) :153-158
[2]  
EXTRA JM, 1993, CANCER RES, V53, P1037
[3]   PHASE-II STUDY OF DOCETAXEL FOR RECURRENT OR METASTATIC NON-SMALL-CELL LUNG-CANCER [J].
FOSSELLA, FV ;
LEE, JS ;
MURPHY, WK ;
LIPPMAN, SM ;
CALAYAG, M ;
PANG, A ;
CHASEN, M ;
SHIN, DM ;
GLISSON, B ;
BENNER, S ;
HUBER, M ;
PEREZSOLER, R ;
HONG, WK ;
RABER, M .
JOURNAL OF CLINICAL ONCOLOGY, 1994, 12 (06) :1238-1244
[4]   PHASE-II TRIAL OF DOCETAXEL IN PATIENTS WITH STAGE-III AND STAGE-IV NON-SMALL-CELL LUNG-CANCER [J].
FRANCIS, PA ;
RIGAS, JR ;
KRIS, MG ;
PISTERS, KMW ;
ORAZEM, JP ;
WOOLLEY, KJ ;
HEELAN, RT .
JOURNAL OF CLINICAL ONCOLOGY, 1994, 12 (06) :1232-1237
[5]   First-line treatment of advanced non-small-cell lung cancer with docetaxel and cisplatin: A multicenter phase II study [J].
Georgoulias, V ;
Androulakis, N ;
Dimopoulos, AM ;
Kourousis, C ;
Kakolyris, S ;
Papadakis, E ;
Apostolopoulou, F ;
Papadimitriou, C ;
Vossos, A ;
Agelidou, M ;
Heras, P ;
Tzannes, S ;
Vlachonicolis, J ;
Mavromanolakis, E ;
Hatzidaki, D .
ANNALS OF ONCOLOGY, 1998, 9 (03) :331-334
[6]   RELATIONSHIPS BETWEEN THE STRUCTURE OF TAXOL ANALOGS AND THEIR ANTIMITOTIC ACTIVITY [J].
GUERITTEVOEGELEIN, F ;
GUENARD, D ;
LAVELLE, F ;
LEGOFF, MT ;
MANGATAL, L ;
POTIER, P .
JOURNAL OF MEDICINAL CHEMISTRY, 1991, 34 (03) :992-998
[7]   Phase I trial of docetaxel administered by weekly infusion in patients with advanced refractory cancer [J].
Hainsworth, JD ;
Burris, HA ;
Erland, JB ;
Thomas, M ;
Greco, FA .
JOURNAL OF CLINICAL ONCOLOGY, 1998, 16 (06) :2164-2168
[8]   Peripheral neuropathy induced by combination chemotherapy of docetaxel and cisplatin [J].
Hilkens, PHE ;
Pronk, LC ;
Verweij, J ;
Vecht, CJ ;
vanPutten, WLJ ;
vandenBent, MJ .
BRITISH JOURNAL OF CANCER, 1997, 75 (03) :417-422
[9]   COMPARATIVE INVITRO CYTOTOXICITY OF TAXOL AND TAXOTERE AGAINST CISPLATIN-SENSITIVE AND CISPLATIN-RESISTANT HUMAN OVARIAN-CARCINOMA CELL-LINES [J].
KELLAND, LR ;
ABEL, G .
CANCER CHEMOTHERAPY AND PHARMACOLOGY, 1992, 30 (06) :444-450
[10]   Phase II trial of docetaxel in previously untreated advanced non-small-cell lung cancer: A Japanese cooperative study [J].
Kunitoh, H ;
Watanabe, K ;
Onoshi, T ;
Furuse, K ;
Niitani, H ;
Taguchi, T .
JOURNAL OF CLINICAL ONCOLOGY, 1996, 14 (05) :1649-1655