Phase II trial of gallium nitrate, amonafide and teniposide in metastatic non-small cell lung cancer. An Eastern Cooperative Oncology Group study (E2588).
Phase II trial of gallium nitrate, amonafide and teniposide in metastatic non-small cell lung cancer. An Eastern Cooperative Oncology Group study (E2588).
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硝酸镓、阿莫菲德和替尼泊苷治疗转移性非小细胞肺癌的 II 期试验。
DOI：
10.1007/bf00872862
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发表时间：
1995
影响因子：
3.4
通讯作者：
Blum,R
中科院分区：
文献类型：
--
作者：
Chang,AY;Tu,ZN;Smith,JL;Bonomi,P;Smith,TJ;Wiernik,PH;Blum,R
55 名转移性非小细胞肺癌 (NSCLC) 患者参与了这项 II 期随机研究，以评估三种新药：硝酸镓、阿莫菲德和替尼泊苷。患者的 ECOG 体能状态必须为 0 或 1，既往未接受化疗，且血液学、肝肾功能良好。 47 名患者符合条件且可评估。 14 名患者随机接受硝酸镓治疗，18 名患者接受阿莫菲德治疗，15 名患者接受替尼泊苷治疗。百分之七十四的符合条件的患者是男性。大多数患者 (89%) 的 ECOG 体力状态为 1。服用硝酸镓的患者出现 2 次 ECOG 4 级毒性，服用阿莫菲特的患者出现 7 次，服用替尼泊苷的患者出现 18 次。一名患者的死因（败血症）为阿莫那菲，两名患者的死因为替尼泊苷（感染和白细胞减少症）。所有参与的患者均未出现客观反应。总生存时间范围为 2 周至 156 周，中位生存时间为 23 周。三个治疗组之间没有生存差异。我们的结论是，硝酸镓、阿莫菲德和替尼泊苷在转移性非小细胞肺癌中没有活性，因此不需要对该疾病进行任何进一步的测试。
Fifty-five patients with metastatic non-small cell lung cancer (NSCLC) were entered into this phase II randomized study for evaluating three new agents: gallium nitrate, amonafide and teniposide. The patients had to have ECOG performance status 0 or 1, no prior chemotherapy, and adequate hematological, hepatic and renal functions. Forty-seven patients were eligible and evaluable. Fourteen were randomized to receive gallium nitrate, 18 to amonafide and 15 to teniposide. Seventy-four percent of eligible patients were male. The majority of patients (89%) had an ECOG performance status 1. ECOG grade 4 toxicity occurred twice in patients on gallium nitrate, seven times on amonafide and 18 times on teniposide. The cause of death was attributed to amonafide in one patient (from sepsis) and to teniposide in two patients (due to infection and leukopenia). There was no objective response in all the patients entered. The overall survival times ranged from 2 weeks to 156 weeks with a median of 23 weeks. There were no survival differences among the three treatment arms. We conclude that gallium nitrate, amonafide and teniposide are inactive in metastatic NSCLC and do not warrant any further testing in this disease.