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卡铂联合口服依托泊苷用于老年晚期非小细胞肺癌患者:一项II期研究

Carboplatin plus oral etoposide in elderly patients with advanced non small cell lung cancer. A phase II study.

作者信息

Gridelli C, Rossi A, Scognamiglio F, Guida C, Fiore F, Gatani T, Scoppa G, Pergola M

机构信息

Divisione di Oncologia Medica B, Istituto Nazionale Tumori, Napoli, Italy.

出版信息

Anticancer Res. 1997 Nov-Dec;17(6D):4755-8.

PMID:9494602
Abstract

More than 30% of lung cancers arise in patients over 70 years old. Elderly patients are not considered to tolerate chemotherapy, are generally excluded from clinical trials, and are not considered eligible for aggressive cisplatinbased chemotherapy in clinical practice. The aims of the present study were to test the activity and toxicity of a combination of carboplatin and oral etoposide in patients over 70 years old with advanced non small cell lung cancer. Carboplatin was given at a dose of 300 mg/m2, i.v., at day 1, and oral etoposide (50 mg capsules) at a total dose of 100 mg/die from day 1 to day 7, recycled every 4 weeks. Fourteen patients entered the study. Median age was 73 years (range 70-77), 42.9% of patients had at least one concomitant illness. The trial, according to the Gehan design, was terminated earlier because no objective response was observed among the first 14 patients. We reported, according to intent to treat analysis, 2 stable and 12 progressive diseases. Median time to progression was 2 months and median survival 6 months. Remarkable hematological toxicity was recorded. Finally, we do not recommend the combination of carboplatin and oral etoposide, at the doses and schedule used in the present study, in the treatment of elderly patients with advanced NSCLC. The combination might be reconsidered using a different etoposide schedule with chronic administration (21 days).

摘要

超过30%的肺癌发生在70岁以上的患者中。老年患者被认为不耐受化疗,通常被排除在临床试验之外,并且在临床实践中不被认为适合接受基于顺铂的积极化疗。本研究的目的是测试卡铂和口服依托泊苷联合用药对70岁以上晚期非小细胞肺癌患者的活性和毒性。卡铂剂量为300mg/m²,静脉注射,第1天给药;口服依托泊苷(50mg胶囊),从第1天至第7天,总剂量100mg/天,每4周重复一次。14名患者进入研究。中位年龄为73岁(范围70 - 77岁),42.9%的患者至少有一种伴随疾病。根据Gehan设计,该试验提前终止,因为在前14名患者中未观察到客观缓解。根据意向性分析,我们报告了2例病情稳定和12例病情进展的患者。中位疾病进展时间为2个月,中位生存期为6个月。记录到明显的血液学毒性。最后,我们不推荐本研究中使用的剂量和给药方案的卡铂和口服依托泊苷联合用药用于治疗老年晚期非小细胞肺癌患者。使用不同的依托泊苷慢性给药方案(21天)时,该联合用药方案可能需要重新考虑。

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