顺铂/依托泊苷与拓扑替康序贯给药与交替给药作为广泛期小细胞肺癌一线治疗的比较：希腊肿瘤研究小组III期试验的初步结果

Sequential versus alternating administration of cisplatin/etoposide and topotecan as first-line treatment in extensive-stage small-cell lung cancer: preliminary results of a Phase III Trial of the Hellenic Oncology Research Group.

作者信息

Ignatiadis Michail, Mavroudis Dimitris, Veslemes Marinos, Boukovinas John, Syrigos Kostas, Agelidou Maria, Agelidou Athina, Gerogianni Aleka, Pavlakou Georgia, Tselepatiotis Evaggelos, Nikolakopoulos John, Georgoulias Vassilis

机构信息

Department of Medical Oncology, School of Medicine, University of Crete, Greece.

出版信息

Clin Lung Cancer. 2005 Nov;7(3):183-9. doi: 10.3816/CLC.2005.n.034.

DOI:10.3816/CLC.2005.n.034

PMID:16354313

Abstract

BACKGROUND

This trial was designed to compare the efficacy and toxicity of sequential versus alternating administration of cisplatin/etoposide and topotecan in patients with previously untreated extensive-stage small-cell lung cancer (SCLC).

PATIENTS AND METHODS

Two hundred eighty-four chemotherapy-naive patients were randomized between the sequential therapy arm (n=142; 4 cycles of cisplatin 75 mg/m2 intravenously [I.V.] on day 1 with etoposide 100 mg/m2 per day I.V. on days 1-3 followed by 4 cycles of topotecan 1.5 mg/m2 per day I.V. on days 1-5) and the alternating arm (n=142; same doses of cisplatin/etoposide on cycles 1, 3, 5, and 7 and topotecan on cycles 2, 4, 6, and 8). Treatment cycles for both regimens were administered every 3 weeks.

RESULTS

At this preliminary analysis, no statistically significant difference in the overall response rate, duration of response, time to disease progression, or median survival was observed between the 2 arms. A total of 756 cycles of the sequential therapy and 830 cycles of the alternating therapy were administered, with a median numbers of 6 and 7 cycles per patient, respectively. Topotecan was administered in 85 patients on the sequential arm and 132 patients on the alternating arm. Dose reductions for toxicity were similar in both arms. Grade 3/4 toxicities in the sequential and alternating arms, respectively, included neutropenia (51% and 52%; P=NS), anemia (12% and 11%; P=NS), febrile neutropenia (7% and 9%; P=NS), thrombocytopenia (19% and 20%; P=NS), and asthenia (8% and 2%; P=0.02). There were 4 toxicity-related deaths in the sequential arm versus 3 in the alternating arm.

CONCLUSION

Our preliminary conclusion is that the sequential and alternating regimens resulted in comparable activity and tolerability in previously untreated patients with extensive-stage SCLC.

摘要

背景

本试验旨在比较顺铂/依托泊苷与拓扑替康序贯给药和交替给药在先前未治疗的广泛期小细胞肺癌（SCLC）患者中的疗效和毒性。

患者与方法

284例未接受过化疗的患者被随机分为序贯治疗组（n = 142；第1天静脉注射顺铂75 mg/m²，第1 - 3天每天静脉注射依托泊苷100 mg/m²，共4个周期，随后第1 - 5天每天静脉注射拓扑替康1.5 mg/m²，共4个周期）和交替治疗组（n = 142；第1、3、5和7周期给予相同剂量的顺铂/依托泊苷，第2、4、6和8周期给予拓扑替康）。两种方案的治疗周期均每3周进行一次。

结果

在本次初步分析中，两组之间在总缓解率、缓解持续时间、疾病进展时间或中位生存期方面未观察到统计学上的显著差异。序贯治疗共进行了756个周期，交替治疗共进行了830个周期，每位患者的中位周期数分别为6个和7个。序贯治疗组8个患者、交替治疗组132个患者接受了拓扑替康治疗。两组因毒性而减少剂量的情况相似。序贯治疗组和交替治疗组3/4级毒性分别包括中性粒细胞减少（51%和52%；P = 无统计学意义）、贫血（12%和11%；P = 无统计学意义）、发热性中性粒细胞减少（7%和9%；P = 无统计学意义）、血小板减少（19%和20%；P = 无统计学意义）以及乏力（8%和2%；P = 0.02）。序贯治疗组有4例与毒性相关的死亡，交替治疗组有3例。