Multicenter phase II study of amrubicin, 9-amino-anthracycline, in patients with advanced non-small-cell lung cancer (Study 1): West Japan Thoracic Oncology Group (WJTOG) trial
Multicenter phase II study of amrubicin, 9-amino-anthracycline, in patients with advanced non-small-cell lung cancer (Study 1): West Japan Thoracic Oncology Group (WJTOG) trial
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氨柔比星、9-氨基蒽环类药物治疗晚期非小细胞肺癌的多中心 II 期研究（研究 1）：西日本胸部肿瘤组 (WJTOG) 试验
DOI：
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发表时间：
2006
影响因子：
3.4
通讯作者：
Y. Ariyoshi
中科院分区：
文献类型：
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作者：
T. Sawa;T. Yana;M. Takada;T. Sugiura;S. Kudoh;T. Kamei;T. Isobe;Hidehiko Yamamoto;S. Yokota;N. Katakami;Y. Tohda;Akira Kawakami;Y. Nakanishi;Y. Ariyoshi
目的：氨柔比星是一种新的9-氨基蒽环类抗生素。这项多中心II期研究旨在评估氨柔比星在非小细胞肺癌（NSCLC）患者中的疗效和安全性。
患者和方法：61例既往未经治疗的III期或IV期NSCLC患者进入本研究。要求患者具有经细胞学或组织学证实的可测量NSCLC，东部肿瘤协作组（ECOG）体力状态评分为0-2，且器官功能良好。氨柔比星以45 mg/m2/d每日静脉注射给药，连续3天，每3周一次。每例患者至少接受3个周期的治疗。
结果：所有61例患者均符合本试验条件，并可进行疗效和毒性评估。其中17例患者获得客观缓解，包括1例完全缓解和16例部分缓解，总缓解率为27.9%（95%置信区间[CI]，17.1%至40.8%）。中位生存期为9.8个月（95%CI，7.7个月至14.9个月）。主要毒副反应为骨髓抑制。中性粒细胞减少症、白细胞减少症、贫血和血小板减少症的3级或4级毒性发生率分别为72.1%、52.5%、23.0%和14.8%。作为明显的毒性事件，在各1例患者中观察到一过性3级便秘和碱性磷酸酶升高。此外，3名患者在治疗前通过诊断性成像确定为无症状间质性肺炎，在氨柔比星治疗后加重，其中2人死亡。其他非血液学毒性相对较轻。
结论：氨柔比星治疗非小细胞肺癌疗效肯定，耐受性好。
SummaryPurpose: Amrubicin is a novel 9-aminoanthracycline. This multicenter phase II study was conducted to evaluate the efficacy and safety of amrubicin in patients with non-small-cell lung cancer (NSCLC).
Patients and methods: Sixty-one previously untreated patients with stage III or IV NSCLC were entered this study. The patients were required to have cytologically or histologically proven measurable NSCLC, an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, and adequate organ function. Amrubicin was administered by daily intravenous injection at 45 mg/m2/day for 3 consecutive days every 3 weeks. At least 3 cycles of treatment were administered to each patient.
Results: All 61 patients registered in this trial were eligible and assessable for efficacy and toxicity. Of them, 17 patients achieved objective responses, consisting of one complete response and 16 partial responses, and the overall response rate was 27.9% (95% confidence interval [CI], 17.1% to 40.8%). The median survival time was 9.8 months (95% CI, 7.7 months to 14.9 months). The major toxicity was myelosuppression. The incidences of grade 3 or 4 toxicity were 72.1% for neutropenia, 52.5% for leukopenia, 23.0% for anemia, and 14.8% for thrombocytopenia. As noticeable toxic events, grade 3 hypotention and alkaline phosphatase elevation were transiently observed in one patient each. In addition, three patients who had had asymptomatic interstitial pneumonitis, identified by diagnostic imaging before treatment, aggravated after amrubicin treatment; two of them died. Other non-hematologic toxicities were relatively mild.
Conclusion: Amrubicin was an active, well-tolerated agent in the treatment of NSCLC.
DOI：
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发表时间：
1998-05
期刊：
Clinical cancer research : an official journal of the American Association for Cancer Research
影响因子：
--
作者：
P. Bunn;K. Kelly
通讯作者：
P. Bunn;K. Kelly