Randomized phase III trial comparing cisplatin-etoposide to carboplatin-paclitaxel in advanced or metastatic non-small cell lung cancer.
Randomized phase III trial comparing cisplatin-etoposide to carboplatin-paclitaxel in advanced or metastatic non-small cell lung cancer.
复制标题
比较顺铂依托泊苷与卡铂紫杉醇治疗晚期或转移性非小细胞肺癌的随机 III 期试验。
作者：
C. Belani;Jangsoon Lee;M. Socinski;F. Robert;DM Waterhouse;K. Rowland;R. Ansari;R. Lilenbaum;R. Natale
背景
本研究旨在评估卡铂加紫杉醇方案（研究组）与顺铂加依托泊苷参考方案治疗晚期或转移性非小细胞肺癌的有效性和安全性。
患者和方法
共有 369 名患者入组，其中 A 组 179 名（顺铂 75 mg/m2 和依托泊苷 100 mg/m2），B 组 190 名（卡铂 AUC=6 mg/ml min 和紫杉醇 225 mg/m2），每 3 周重复一次周期。这些手臂在年龄、体能状态、体重减轻、疾病阶段和疾病可测量性方面都非常平衡。然而，被随机分到 A 组的女性明显多于 B 组（P=0.039）。
结果
A 组的客观缓解率 (ORR) 为 15%，而 B 组为 23%（P=0.061）。 A 组和 B 组的中位生存时间、进展时间和 1 年生存率分别为 274 天和 233 天（P=0.086）、111 天和 121 天（P=0.877）以及 37% 和 32%。最常见的毒性是中性粒细胞减少症和白细胞减少症，A 组的发生率高于 B 组。
结论
与顺铂-依托泊苷相比，卡铂-紫杉醇没有统计学上显着的生存优势。然而，卡铂-紫杉醇疗法总体上改善了生活质量。
BACKGROUND
The present study was designed to evaluate the efficacy and safety of the regimen of carboplatin plus paclitaxel (investigational arm) versus the reference regimen of cisplatin plus etoposide for the treatment of advanced or metastatic non-small-cell lung cancer.
PATIENTS AND METHODS
A total of 369 patients were enrolled, 179 on arm A (cisplatin 75 mg/m2 and etoposide 100 mg/m2) and 190 on arm B (carboplatin AUC=6 mg/ml min and paclitaxel 225 mg/m2), with cycles repeated every 3 weeks. The arms were well balanced with respect to age, performance status, weight loss, stage of disease and disease measurability. However, significantly more women were randomized to arm A than to arm B (P=0.039).
RESULTS
The objective response rate (ORR) was 15% on arm A compared with 23% on arm B (P=0.061). Median survival time, time to progression and 1-year survival rates for arms A and B were 274 days and 233 days (P=0.086), 111 days and 121 days (P=0.877), and 37% and 32%, respectively. The most prevalent toxicities were neutropenia and leukopenia and they occurred at a higher rate in arm A than in arm B.
CONCLUSION
There was no statistically significant survival advantage for carboplatin-paclitaxel compared with cisplatin-etoposide. However, there was an overall benefit in quality of life with the carboplatin-paclitaxel regimen.
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影响因子：
45.3
作者：
ALBAIN, KS;CROWLEY, JJ;LIVINGSTON, RB
通讯作者：
LIVINGSTON, RB
影响因子：
45.3
作者：
FINKELSTEIN, DM;ETTINGER, DS;RUCKDESCHEL, JC
通讯作者：
RUCKDESCHEL, JC
单独给予紫杉醇 3 小时输注以及与卡铂联用：剂量递增试验的初步结果。
DOI：
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发表时间：
1995
期刊：
Seminars in oncology.
影响因子：
--
作者：
Muggia,FM;Vafai,D;Natale,R;Israel,V;Zaretsky,S;McRae,A;Rogers,M;Jeffers,S
通讯作者：
Jeffers,S
影响因子：
45.3
作者：
CELLA, DF;TULSKY, DS;HARRIS, J
通讯作者：
HARRIS, J
影响因子：
45.3
作者：
Bonomi, P;Kim, KM;Johnson, D
通讯作者：
Johnson, D