一项III期随机研究：比较顺铂和依托泊苷联合化疗与不含顺铂的依托泊苷方案治疗广泛期小细胞肺癌患者的疗效。
A Phase III Randomized Study Comparing a Chemotherapy with Cisplatin and Etoposide to a Etoposide Regimen without Cisplatin for Patients with Extensive Small-Cell Lung Cancer.
作者信息
Berghmans Thierry, Scherpereel Arnaud, Meert Anne-Pascale, Giner Vicente, Lecomte Jacques, Lafitte Jean-Jacques, Leclercq Nathalie, Paesmans Marianne, Sculier Jean-Paul
机构信息
Department of Intensive Care, Institut Jules Bordet, Centre des tumeurs, Université Libre de Bruxelles, Bruxelles, Belgium.
Department of Oncological Emergencies, Institut Jules Bordet, Centre des tumeurs, Université Libre de Bruxelles, Bruxelles, Belgium.
出版信息
Front Oncol. 2017 Sep 19;7:217. doi: 10.3389/fonc.2017.00217. eCollection 2017.
INTRODUCTION
In a literature meta-analysis, we showed survival benefits for regimens including cisplatin [hazard ratio (HR) 0.61; 95% confidence interval (CI), 0.57-0.66] and for those including etoposide (HR 0.65; 0.61-0.69). That benefit was mainly observed when etoposide alone or in combination with cisplatin was included in the chemotherapy regimens. Our objective was to determine if chemotherapy with both drugs improves survival in comparison to a non-platinum regimen with etoposide.
METHODS
Extensive small-cell lung cancer patients were randomized between cisplatin-etoposide (CE) and ifosfamide + etoposide + epirubicin regimen (IVE) between 2000 and 2013.
RESULTS
176 and 170 eligible patients were allocated to CE and IVE (315 deaths were required before analysis), respectively. Objective response rates were not significantly different: 60% with CE and 59% with IVE. No statistically significant difference in median survival and 1-year and 2-year was observed with rates of 9.6 months, 31 and 5% for CE and 10 months, 39 and 9% for IVE, respectively. HR was 0.84 (95% CI 0.68-1.05, = 0.16). Only two prognostic factors for survival were retained in multivariate analysis: sex with HR = 0.69 (95% CI 0.49-0.97, = 0.03) and performance status with HR = 0.53 (95% CI 0.49-0.97, < 0.0001). After adjustment for these prognostic factors, HR for survival was 0.83 (95% CI 0.65-1.08, = 0.17). There was more thrombopenia in the CE regimen and more leukopenia with IVE.
CONCLUSION
Combination of CE failed to improve survival in comparison to an etoposide-containing regimen without cisplatin.
CLINICAL TRIAL REGISTRATION
https://clinicaltrials.gov/ct2/show/NCT00658580?term=ELCWP+01994&rank=1, identifier NCT00658580.
引言
在一项文献荟萃分析中，我们发现含顺铂的治疗方案具有生存获益（风险比[HR] 0.61；95%置信区间[CI]，0.57 - 0.66），含依托泊苷的方案也有生存获益（HR 0.65；0.61 - 0.69）。这种获益主要在化疗方案中包含单独使用依托泊苷或其与顺铂联合使用时观察到。我们的目的是确定与含依托泊苷的非铂类方案相比，两种药物联合化疗是否能提高生存率。
方法
2000年至2013年期间，大量小细胞肺癌患者被随机分配接受顺铂 - 依托泊苷（CE）方案和异环磷酰胺 + 依托泊苷 + 表柔比星方案（IVE）。
结果
分别有176例和170例符合条件的患者被分配至CE组和IVE组（分析前需要315例死亡病例）。客观缓解率无显著差异：CE组为60%，IVE组为59%。中位生存期、1年和2年生存率在两组间无统计学显著差异，CE组分别为9.6个月、31%和5%，IVE组分别为10个月、39%和9%。HR为0.84（95% CI 0.68 - 1.05，P = 0.16）。多因素分析中仅保留了两个生存预后因素：性别，HR = 0.69（95% CI 0.49 - 0.97，P = 0.03）；体能状态，HR = 0.53（95% CI 0.49 - 0.97，P < 0.0001）。在对这些预后因素进行调整后，生存HR为0.83（95% CI 0.65 - 1.08，P = 0.17）。CE方案中血小板减少更多见，IVE方案中白细胞减少更多见。
结论
与不含顺铂的含依托泊苷方案相比，CE联合方案未能提高生存率。
临床试验注册
https://clinicaltrials.gov/ct2/show/NCT00658580?term=ELCWP+01994&rank=1，标识符NCT00658580 。
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