Phase II Study of Biweekly Pemetrexed and Gemcitabine in Patients with Previously Untreated Advanced Non-small Cell Lung Cancer

被引:11
作者
Spigel, David R. [1 ,2 ]
Hainsworth, John D. [1 ,2 ]
Barton, John H. [2 ]
Patton, Jeffrey F. [1 ,2 ]
Zubkus, John D. [2 ]
Simons, Lisa [1 ]
Griner, Paula [1 ]
Burris, Howard A., III [1 ,2 ]
Greco, F. Anthony [1 ,2 ]
机构
[1] Sarah Cannon Res Inst, Nashville, TN 37203 USA
[2] Tennessee Oncol PLLC, Nashville, TN USA
关键词
First-line; Non-small cell lung cancer; Pemetrexed; Gemcitabine; Phase II; CISPLATIN PLUS GEMCITABINE; DOSE-INTENSITY; CHEMOTHERAPY; TRIAL; REGIMENS; VINORELBINE; SCHEDULES; EFFICACY;
D O I
10.1097/JTO.0b013e3181d737e3
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Introduction: Pemetrexed and gemcitabine are safe and active non-small cell lung cancer (NSCLC) therapies when administered every 3 weeks. Biweekly scheduling was studied in this phase II trial. Methods: The primary objective was to assess the overall response rate in chemotherapy-naive patients with unresectable stage III/IV NSCLC. Patients received 500 mg/m(2) of pemetrexed intravenously and 1500 mg/m(2) of gemcitabine intravenously every 2 weeks for 8 to 12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy. Entry criteria included the following: all non-small cell histologies, measurable disease, Eastern Cooperative Oncology Group 0 to 2, and informed consent. Results: Seventy-two patients were enrolled. Baseline characteristics included the following: median age: 66 years (41-85 years); male/female: 65%/35%; Eastern Cooperative Oncology Group 0/1/2: 19%/67%/14%; and histology: adenocarcinoma (36%), large cell (18%), squamous (13%), and mixed or not specified (34%). The median number of cycles was 7 (range, 1-12). The most common (>= 5%) grade 3/4 toxicities were as follows: neutropenia (47%), leukopenia (31%), fatigue (25%), dyspnea (18%), pain (11%), and anemia (8%). Complete/partial responses for all patients: 1 patient/ 18 patients, respectively, for an overall response rate of 26% (95% confidence interval, 17-38%). Thirty-nine percentage of patients had stable disease, and 21% had disease progression (10 patients were not evaluable). Median progression-free survival was 6.2 months. One-year overall survival was 37.5%. Conclusion: Biweekly administration of pemetrexed and gemcitabine seems to be well tolerated with activity comparable with other first-line NSCLC regimens. Further study addressing whether biweekly scheduling could be an effective strategy to shorten overall treatment duration will require a randomized design.
引用
收藏
页码:841 / 845
页数:5
相关论文
共 21 条
[1]   Randomized phase II study of two gemcitabine schedules for patients with impaired performance status (Karnofsky performance status ≤ 70) and advanced non-small-cell lung cancer [J].
Baka, S ;
Ashcroft, L ;
Anderson, H ;
Lind, M ;
Burt, P ;
Stout, R ;
Dowd, I ;
Smith, D ;
Lorigan, P ;
Thatcher, N .
JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (10) :2136-2144
[2]   Chemotherapy in addition to supportive care improves survival in advanced non-small-cell lung cancer: A systematic review and meta-analysis of individual patient data from 16 randomized controlled trials - NSCLC meta-analyses collaborative group [J].
Burdett, S. ;
Stephens, R. ;
Stewart, L. ;
Tierney, J. ;
Auperin, A. ;
Le Chevalier, T. ;
Le Pechoux, C. ;
Pignon, J. P. ;
Arriagada, R. ;
Higgins, J. ;
Johnson, D. ;
van Meerbeeck, J. ;
Parmar, M. ;
Souhami, R. .
JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (28) :4617-4625
[3]   Gemcitabine as second-line treatment for advanced non-small-cell lung cancer:: A phase II trial [J].
Crinò, L ;
Mosconi, AM ;
Scagliotti, G ;
Selvaggi, G ;
Novello, S ;
Rinaldi, M ;
Della Giulia, M ;
Gridelli, C ;
Rossi, A ;
Calandri, C ;
De Marinis, F ;
Noseda, M ;
Tonato, M .
JOURNAL OF CLINICAL ONCOLOGY, 1999, 17 (07) :2081-2085
[4]  
Font A, 1999, CANCER-AM CANCER SOC, V85, P855, DOI 10.1002/(SICI)1097-0142(19990215)85:4<855::AID-CNCR12>3.0.CO
[5]  
2-R
[6]   Platinum-based and non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a randomised multicentre trial [J].
Georgoulias, V ;
Papadakis, E ;
Alexopoulos, A ;
Tsiafaki, X ;
Rapti, A ;
Veslemes, M ;
Palamidas, P ;
Vlachonikolis, I .
LANCET, 2001, 357 (9267) :1478-1484
[7]   Gemcitabine plus vinorelbine compared with cisplatin plus vinorelbine or cisplatin plus gemcitabine for advanced non-small-cell lung cancer: A phase III trial of the Italian GEMVIN Investigators and the National Cancer Institute of Canada Clinical Trials Group [J].
Gridelli, C ;
Gallo, C ;
Shepherd, FA ;
Illiano, A ;
Piantedosi, F ;
Robbiati, SF ;
Manzione, L ;
Barbera, S ;
Frontini, L ;
Veltri, E ;
Findlay, B ;
Cigolari, S ;
Myers, R ;
Ianniello, GP ;
Gebbia, V ;
Gasparini, G ;
Fava, S ;
Hirsh, V ;
Beziak, A ;
Seymour, L ;
Perrone, F .
JOURNAL OF CLINICAL ONCOLOGY, 2003, 21 (16) :3025-3034
[8]   Phase III Study by the Norwegian Lung Cancer Study Group: Pemetrexed Plus Carboplatin Compared With Gemcitabine Plus Carboplatin As First-Line Chemotherapy in Advanced Non-Small-Cell Lung Cancer [J].
Gronberg, Bjorn H. ;
Bremnes, Roy M. ;
Flotten, Oystein ;
Amundsen, Tore ;
Brunsvig, Paal Fr. ;
Hjelde, Harald H. ;
Kaasa, Stein ;
von Plessen, Christian ;
Stornes, Froydis ;
Tollali, Terje ;
Wammer, Finn ;
Aasebo, Ulf ;
Sundstrom, Stein .
JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (19) :3217-3224
[9]   Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy [J].
Hanna, N ;
Shepherd, FA ;
Fossella, FV ;
Pereira, JR ;
De Marinis, F ;
von Pawel, J ;
Gatzemeier, U ;
Tsao, TCY ;
Pless, M ;
Muller, T ;
Lim, HL ;
Desch, C ;
Szondy, K ;
Gervais, R ;
Shaharyar ;
Manegold, C ;
Paul, S ;
Paoletti, P ;
Einhorn, L ;
Bunn, PA .
JOURNAL OF CLINICAL ONCOLOGY, 2004, 22 (09) :1589-1597
[10]   NONPARAMETRIC-ESTIMATION FROM INCOMPLETE OBSERVATIONS [J].
KAPLAN, EL ;
MEIER, P .
JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION, 1958, 53 (282) :457-481