Increased therapeutic index of weekly doxorubicin in the therapy of non-small cell lung cancer: a prospective, randomized study.
Increased therapeutic index of weekly doxorubicin in the therapy of non-small cell lung cancer: a prospective, randomized study.
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增加每周阿霉素治疗非小细胞肺癌的治疗指数：一项前瞻性随机研究。
DOI：
10.1200/jco.1984.2.3.207
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发表时间：
1984
期刊：
影响因子：
--
通讯作者：
E. Freireich
中科院分区：
文献类型：
--
作者：
M. Valdivieso;M. Burgess;M. Ewer;B. Mackay;S. Wallace;R. Benjamin;M. Ali;G. Bodey;E. Freireich
100 名非小细胞肺癌患者接受了阿霉素联合 ftorafur、环磷酰胺和顺铂 (FACP) 两种方案的随机评估。阿霉素每周给药 20 mg/m2，或每三周（标准）给药 60 mg/m2。 52 名患者被随机分配至 FACP/每周阿霉素组，48 名患者被随机分配至 FACP/标准阿霉素组。 FACP/每周阿霉素方案与较高的完全缓解率和部分缓解率（31% 与 19%）、较长的缓解持续时间（中位 33 周与 21 周）以及较长的缓解者生存期（中位 58 周与 50 周）相关。这些差异并不显着。在 FACP/每周阿霉素组中观察到中性粒细胞减少症较少 (p = 0.01) 和感染发病率较低 (p = 0.05)。 28 名患者接受了 35 次心内膜心肌活检，以评估阿霉素引起的心脏毒性。在 FACP/每周阿霉素组中，对 12 名接受累积阿霉素剂量范围为 250 至 1,190 mg/m2 的患者进行了 16 次活检。在 FACP/标准阿霉素方案中接受累积阿霉素剂量范围为 250 至 540 mg/m2 的 16 名患者进行了 19 次活检。 FACP/每周阿霉素方案与显着较低的心脏毒性评分相关（p = 0.01）。这项研究表明，每周给药阿霉素与标准给药方案一样有效，且心脏毒性较小。
One hundred patients with non-small cell lung cancer were entered into a randomized evaluation of two schedules of doxorubicin combined with ftorafur, cyclophosphamide, and cisplatin (FACP). Doxorubicin was given either weekly at 20 mg/m2, or every three weeks (standard) at 60 mg/m2. Fifty-two patients were randomized to the FACP/weekly doxorubicin arm and 48 patients to the FACP/standard doxorubicin arm. The FACP/weekly doxorubicin regimen was associated with higher complete and partial remission rates (31% versus 19%), longer response duration (median, 33 versus 21 weeks), and longer survival duration for responders (median, 58 versus 50 weeks). These differences were not significant. Less neutropenia (p = 0.01) and less infectious morbidity (p = 0.05) were observed in the FACP/weekly doxorubicin arm. Twenty-eight patients underwent 35 endomyocardial biopsies to assess doxorubicin-induced cardiotoxicity. Sixteen biopsies were performed in 12 patients receiving cumulative doxorubicin doses ranging from 250 to 1,190 mg/m2 within the FACP/weekly doxorubicin arm. Nineteen biopsies were performed in 16 patients receiving cumulative doxorubicin doses ranging from 250 to 540 mg/m2 within the FACP/standard doxorubicin regimen. The FACP/weekly doxorubicin regimen was associated with significantly lower cardiotoxicity scores (p = 0.01). This study indicates that weekly administered doxorubicin is as effective and less cardiotoxic than the standard schedule.