Preclinical and clinical evaluation of four gemcitabine plus carboplatin schedules as front-line treatment for stage IV non-small-cell lung cancer

被引:15
|
作者
Bajetta, E
Stani, SC
De Candis, D
Zaffaroni, N
Zilembo, N
Cortinovis, D
Aglione, S
Mariani, L
Formisano, B
Bidoli, P
机构
[1] Ist Nazl Studio & Cura Tumori, Med Oncol Unit B, I-20133 Milan, Italy
[2] Ist Nazl Studio & Cura Tumori, Unit Expt Oncol C, I-20133 Milan, Italy
[3] Ist Nazl Studio & Cura Tumori, Unit Med Stat & Biometry, I-20133 Milan, Italy
关键词
carboplatin; gemcitabine; non-small-cell lung cancer;
D O I
10.1093/annonc/mdg060
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background: To explore the activity and tolerability of gemcitabine (GEM) and carboplatin (CBDCA) in non-small-cell lung cancer (NSCLC) we tested four administration sequences on H460 NSCLC cells, and at the same time performed a randomized phase II trial using analogous schedules. Patients and methods: GEM was given first in two in vitro sequences, and CBDCA first in the other two; interaction was quantified calculating a combination index. Eighty-eight chemotherapy-naive, stage IV NSCLC patients were randomly assigned to receive either: GEM (1000 mg/m(2)) on days 1 and 8 and CBDCA (AUC 5 mg.min/ml) on day 1, 4 h before GEM (arm A); same as arm A except CBDCA given 4 h after GEM (arm 13); GEM on days 1 and 8 and CBDCA on day 2 (arm Q; GEM on days 2 and 9 and CBDCA on day I (arm D). Courses were repeated every 21 days. Results: In the preclinical study, CBDCA given before GEM produced a synergistic cytotoxic effect. Two complete and 29 partial responses occurred in 86 of 88 treated patients (intention-to-treat analysis 35%; 95% confidence interval 25.5% to 46.8%). One- and 2-year survivals were 44% and 11%, respectively. Grade 3/4 thrombocytopenia occurred in 11%; grade 3/4 neutropenia in 17% and non-hematological toxicity was insignificant. Median survival was 11 months (range 7-18+), but better in patients receiving CBDCA first (arms A and D) (13 versus 9 months) than in patients receiving GEM first (arms B and Q. The response was greater (50% versus 31%) in arm A than in the other arms. Conclusions: The CBDCA/GEM combination is safe and active against stage IV NSCLC. Our preclinical and clinical findings suggest that administration of CBDCA before GEM gives the better outcome.
引用
收藏
页码:242 / 247
页数:6
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