Phase II Study of Vinorelbine in Heavily Previously Treated Small Cell Lung Cancer
Phase II Study of Vinorelbine in Heavily Previously Treated Small Cell Lung Cancer
复制标题
长春瑞滨治疗既往接受过大量治疗的小细胞肺癌的 II 期研究
作者：
K. Furuse;K. Kubota;M. Kawahara;M. Takada;I. Kimura;M. Fujii;M. Ohta;K. Hasegawa;Kiyokazu Yoshida;S. Nakajima;T. Ogura;H. Niitani
24名先前接受治疗的难治性或复发小细胞肺癌(SCLC)患者进入了一项前瞻性的多中心II期研究。所有24名患者都接受了某种形式的以顺铂为基础的化疗。中位化疗时间为4.2个月(1.4~9.4个月)。患者每周接受25 mg/m2的长春瑞滨治疗。24名患者符合反应和毒性标准。在24名符合条件的患者中，有3人观察到部分缓解(12.5%；95%可信区间，2.7-32.4%)。所有3名有反应的患者都曾接受过包括长春新碱在内的化疗。最常见的不良反应是白细胞减少(91.7%，WHO 3-4级66.7%)和贫血(70.8%，20.8%，WHO 3级)。非血液学毒性为中度和轻度。这些结果支持对先前未接受治疗的患者进行两阶段序贯研究设计，以便在小细胞肺癌中进行进一步的II期研究。
Twenty-four previously treated patients with refractory or relapsed small cell lung cancer (SCLC) were entered into a prospective, multicenter phase II study. All 24 patients had been pretreated with some form of cisplatin-based chemotherapy. The median time of chemotherapy was 4.2 months (range 1.4–9.4 months). Patients were treated with a dose of 25 mg/m2 of vinorelbine weekly. Twenty-four patients were eligible for response and for toxicity. Partial response was observed in 3 out of 24 eligible patients (12.5%; 95% confidence interval, 2.7–32.4%). All 3 patients who responded had previous chemotherapy including vincristine. The most common toxicity was leukopenia (91.7%, 66.7% in WHO 3-4 grade) and anemia (70.8%, 20.8% in WHO 3 grade). Nonhematological toxicities were moderate and mild. These results support a two-stage sequential study design of previously untreated patients for further phase II study in SCLC.