长春瑞滨用于既往接受过大量治疗的小细胞肺癌的II期研究。日本肺癌长春瑞滨研究组。

Phase II study of vinorelbine in heavily previously treated small cell lung cancer. Japan Lung Cancer Vinorelbine Study Group.

作者信息

Furuse K, Kubota K, Kawahara M, Takada M, Kimura I, Fujii M, Ohta M, Hasegawa K, Yoshida K, Nakajima S, Ogura T, Niitani H

机构信息

Department of Internal Medicine, National Kinki Central Hospital for Chest Diseases, Osaka, Japan.

出版信息

Oncology. 1996 Mar-Apr;53(2):169-72. doi: 10.1159/000227555.

DOI:10.1159/000227555

PMID:8604245

Abstract

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-state sequential study design of previously untreated patients for further phase II study in SCLC.

摘要

24例既往接受过治疗的难治性或复发性小细胞肺癌（SCLC）患者进入一项前瞻性多中心II期研究。所有24例患者均曾接受过某种形式的含顺铂化疗。化疗的中位时间为4.2个月（范围1.4 - 9.4个月）。患者接受每周25 mg/m²长春瑞滨的治疗。24例患者符合疗效和毒性评估标准。24例符合条件的患者中有3例观察到部分缓解（12.5%；95%置信区间，2.7 - 32.4%）。所有3例有反应的患者既往均接受过包括长春新碱在内的化疗。最常见的毒性反应是白细胞减少（91.7%，WHO 3 - 4级为66.7%）和贫血（70.8%，WHO 3级为20.8%）。非血液学毒性为中度和轻度。这些结果支持对既往未治疗的患者采用两阶段序贯研究设计，用于SCLC的进一步II期研究。