Combination of gemcitabine and cisplatin as first-line therapy in advanced non-small-cell lung cancer.
OBJECTIVE
The prognosis of patients with advanced non-small-cell lung cancer (NSCLC) is extremely poor. Many prospective randomized trials on patients with advanced NSCLC suggested systemic chemotherapy improves both the survival and quality of life. A phase II trial was conducted to evaluate the efficacy and safety profile of the combination chemotherapy of gemcitabine and cisplatin in advanced NSCLC.


METHODS
Forty-four patients with locally advanced or metastatic NSCLC were enrolled. The patients received a cisplatin, 75 mg/m(2), infusion over 30 minutes on days 1, followed by a gemcitabine, 1,250 mg/m(2), infusion over 30 minutes on days 1 and 8 every 3 weeks.


RESULTS
The median age of the patients was 64 years (range: 27 approximately 75). Forty-one patients were assessable for response and toxicity analyses. The overall response rate was 53.6%, but with no complete remissions. The median time to progression was 5.6 months (range: 1 approximately 15.4). The median survival was 14.2 months (95% confidence interval (CI), 13.8 approximately 22.5). A total of 179 cycles were administered, with a median of 4 cycles of chemotherapy, ranging from 2 to 9 cycles. The most common hematological toxicities were NCI grades 3/4 neutropenia (24%) and thrombocytopenia (7.8%). The most common non-hematological toxicity was fatigue (42.4%). There were no life-threatening toxicity or treatment related mortalities. The median duration of follow up was 9.4 months, ranging from 1.6 to 30.3 months.


CONCLUSIONS
In this trial, the combination of gemcitabine and cisplatin showed significant activity, with acceptable and manageable toxicities as a first-line regimen for patients with advanced NSCLC.
Lee
Nam-Su
NS
Department of Internal Medicine, Soon Chun Hyang University College of Medicine, Seoul, Korea.
Byun
Jae-Ho
JH
Bae
Sang-Byung
SB
Kim
Chan-Kyu
CK
Lee
Kyu-Taeg
KT
Park
Sung-Kyu
SK
Won
Jong-Ho
JH
Hong
Dae-Sik
DS
Park
Hee-Sook
HS
J Clin Oncol. 1993 Oct;11(10):1866-72
8410111
Semin Oncol. 1994 Jun;21(3 Suppl 6):49-59
8052874
Ann Oncol. 2000 Oct;11(10):1295-300
11106119
Lung Cancer. 2002 Jan;35(1):73-9
11750716
J Clin Oncol. 1997 Jan;15(1):297-303
8996156
Anticancer Res. 2002 Sep-Oct;22(5):3039-43
12530039
N Engl J Med. 2002 Jan 10;346(2):92-8
11784875
J Clin Oncol. 1997 Feb;15(2):744-9
9053500
J Clin Oncol. 2003 Nov 1;21(21):3909-17
14581415
Jpn J Clin Oncol. 2002 Feb;32(2):43-7
11948227
Anticancer Drugs. 1995 Dec;6 Suppl 6:19-25
8718421
Chest. 1991 Jun;99(6):1326-8
1645242
Clin Cancer Res. 1998 May;4(5):1087-100
9607565
Anticancer Res. 2002 Sep-Oct;22(5):3087-92
12530048
N Engl J Med. 1992 Nov 12;327(20):1434-41
1328881
Cancer Nurs. 1999 Apr;22(2):176-83
10217035
Eur J Cancer. 1996 Feb;32A(2):243-8
8664035
Chest. 1994 Sep;106(3):861-5
7521815
J Clin Oncol. 1999 Oct;17(10):3188-94
10506617
BMJ. 1995 Oct 7;311(7010):899-909
7580546