Pulmonary toxicity in patients treated with gemcitabine plus vinorelbine or docetaxel for advanced non-small cell lung cancer:: outcome data on a randomized phase II study

被引:13
作者
Esteban, Emilio [1 ]
Villanueva, Noemi [1 ]
Muniz, Isabel [1 ]
Fernandez, Yolanda [1 ]
Fra, Joaquin [1 ]
Luque, Maria [1 ]
Jimenez, Paula [1 ]
Llorente, Beatriz [1 ]
Capelan, Marta [1 ]
Vieitez, Jose M. [1 ]
Estrada, Enrique [1 ]
Buesa, Jose M. [1 ]
Jimenez-Lacave, Angel [1 ]
机构
[1] Hosp Cent Asturias, Med Oncol Serv, Asturias 33006, Spain
关键词
non-small-cell lung cancer; vinorelbine; gemcitabine; docetaxel; pulmonary toxicity;
D O I
10.1007/s10637-007-9073-4
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Studies with the gemcitabine/vinorelbine (GV) or the gemcitabine/docetaxel (GD) combinations have shown similar efficacy and less toxicity compared to platinum-based chemotherapies, in patients with advanced non-small-cell lung cancer (NSCLC). The present trial was designed to test the efficacy and safety of both, GV and GD, combinations. Chemotherapy-naive patients (n=39)<= 75 years of age, KPS >= 60% and adequate hematological, renal and hepatic function were randomly assigned to receive G 1,000 mg/m(2)+either V 25 mg/m(2) or D 35 mg/m(2) (all of which were administered i.v.) on days 1 and 8 every 21 days. Baseline characteristics were comparable in GV (n=20) and GD (n=19) groups. Results indicated objective response of 7 (35%) vs 6 (31%) patients and median time-to-treatment failure of 120 versus 90 days in the GV and GD arms, respectively. The most common non-hematological toxicities were (GV vs GD): grade 2-4 pulmonary toxicity in 1 (5%) vs 7 (37%); grade 2-3 diarrhea 0 versus 4 (21%) and edema 1 (5%) vs 3 (16%); grade 3-4 hematological toxicities occurred in 3 (15%) vs 1 (5%) patients. Our results indicate that the combination of gemcitabine/docetaxel does not have a favorable safety profile with this schedule of administration, particularly in terms of pulmonary toxicity.
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收藏
页码:67 / 74
页数:8
相关论文
共 51 条
[1]   EFFICACY AND SAFETY PROFILE OF GEMCITABINE IN NON-SMALL-CELL LUNG-CANCER - A PHASE-II STUDY [J].
ABRATT, RP ;
BEZWODA, WR ;
FALKSON, G ;
GOEDHALS, L ;
HACKING, D ;
RUGG, TA .
JOURNAL OF CLINICAL ONCOLOGY, 1994, 12 (08) :1535-1540
[2]   Cisplatin plus gemcitabine versus a cisplatin-based triplet versus nonplatinum sequential doublets in advanced non-small-cell lung cancer:: A Spanish lung cancer group phase III randomized trial [J].
Alberola, V ;
Camps, C ;
Provencio, M ;
Isla, D ;
Rosell, R ;
Vadell, C ;
Bover, I ;
Ruiz-Casado, A ;
Azagra, P ;
Jiménez, U ;
González-Larriba, JL ;
Diz, P ;
Cardenal, F ;
Artal, A ;
Carrato, A ;
Morales, S ;
Sánchez, JJ ;
de las Peñas, R ;
Felip, E ;
López-Vivanco, G .
JOURNAL OF CLINICAL ONCOLOGY, 2003, 21 (17) :3207-3213
[3]   SINGLE-AGENT ACTIVITY OF WEEKLY GEMCITABINE IN ADVANCED NON-SMALL-CELL LUNG-CANCER - A PHASE-II STUDY [J].
ANDERSON, H ;
LUND, B ;
BACH, F ;
THATCHER, N ;
WALLING, J ;
HANSEN, HH .
JOURNAL OF CLINICAL ONCOLOGY, 1994, 12 (09) :1821-1826
[4]   Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer - a randomized trial with quality of life as the primary outcome [J].
Anderson, H. ;
Hopwood, P. ;
Stephens, R. J. ;
Thatcher, N. ;
Cottier, B. ;
Nicholson, M. ;
Milroy, R. ;
Maughan, T. S. ;
Falk, S. J. ;
Bond, M. G. ;
Burt, P. A. ;
Connolly, C. K. ;
McIllmurray, M. B. ;
Carmichael, J. .
BRITISH JOURNAL OF CANCER, 2000, 83 (04) :447-453
[5]   Phase I and pharmacokinetic study of two sequences of gemcitabine and docetaxel administered weekly to patients with advanced cancer [J].
Bhargava, P ;
Marshall, JL ;
Fried, K ;
Williams, M ;
Lefebvre, P ;
Dahut, W ;
Hanfelt, J ;
Gehan, E ;
Figuera, M ;
Hawkins, MJ ;
Rizvi, NA .
CANCER CHEMOTHERAPY AND PHARMACOLOGY, 2001, 48 (02) :95-103
[6]   Randomized phase III study of gemcitabine-cisplatin versus etoposide-cisplatin in the treatment of locally advanced or metastatic non-small-cell lung cancer [J].
Cardenal, F ;
López-Cabrerizo, MP ;
Antón, A ;
Alberola, V ;
Massuti, B ;
Carrato, A ;
Barneto, I ;
Lomas, M ;
García, M ;
Lianes, P ;
Montalar, J ;
Vadell, C ;
González-Larriba, JL ;
Nguyen, B ;
Artal, A ;
Rosell, R .
JOURNAL OF CLINICAL ONCOLOGY, 1999, 17 (01) :12-18
[7]   DOCETAXEL (TAXOTERE(TM)) IS ACTIVE IN NON-SMALL-CELL LUNG-CANCER - A PHASE-II TRIAL OF THE EORTC EARLY CLINICAL-TRIALS GROUP (ECTG) [J].
CERNY, T ;
KAPLAN, S ;
PAVLIDIS, N ;
SCHOFFSKI, P ;
EPELBAUM, R ;
VANMEERBEEK, J ;
WANDERS, J ;
FRANKLIN, HR ;
KAYE, S .
BRITISH JOURNAL OF CANCER, 1994, 70 (02) :384-387
[8]   Gemcitabine and cisplatin versus mitomycin, ifosfamide, and cisplatin in advanced non-small-cell lung cancer:: A randomized phase III study of the Italian lung cancer project [J].
Crinò, L ;
Scagliotti, GV ;
Ricci, S ;
De Marinis, F ;
Rinaldi, M ;
Gridelli, C ;
Ceribelli, A ;
Bianco, R ;
Marangolo, M ;
Di Costanzo, F ;
Sassi, M ;
Barni, S ;
Ravaioli, A ;
Adamo, V ;
Portalone, L ;
Cruciani, G ;
Masotti, A ;
Ferrara, G ;
Gozzelino, F ;
Tonato, M .
JOURNAL OF CLINICAL ONCOLOGY, 1999, 17 (11) :3522-3530
[9]  
DADDARIO G, 2003, LUNG CANCER S4, V41, pS68
[10]   A PHASE-II STUDY OF NAVELBINE (VINORELBINE) IN THE TREATMENT OF NON SMALL-CELL LUNG-CANCER [J].
DEPIERRE, A ;
LEMARIE, E ;
DABOUIS, G ;
GARNIER, G ;
JACOULET, P ;
DALPHIN, JC .
AMERICAN JOURNAL OF CLINICAL ONCOLOGY-CANCER CLINICAL TRIALS, 1991, 14 (02) :115-119