首页> 外文期刊>Lung cancer: Journal of the International Association for the Study of Lung Cancer >A phase II multicenter study of combined topotecan and gemcitabine as first line chemotherapy for advanced non-small cell lung cancer.
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A phase II multicenter study of combined topotecan and gemcitabine as first line chemotherapy for advanced non-small cell lung cancer.

机译:二期多中心研究topotecan相结合和吉西他滨作为一线化疗先进的非小细胞肺癌。

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摘要

This trial was designed to determine the 1-year survival rate, efficacy, and safety, produced by topotecan and gemcitabine as first line chemotherapy in advanced non-small cell lung cancer (ANSCLC). Fifty-three patients were enrolled; 51 received treatment. Topotecan 1 mg/m(2), days 1-5 and gemcitabine 1 g/m(2) days 1 and 15 were administered IV, each drug over 30 min; cycles consisted of 28 days. Treatment continued until progressive disease or intolerable toxicity. Nineteen patients (36%) had Eastern Cooperative Oncology Group criteria performance status (ECOG PS) = 0, 34 (64%) PS = 1. Median age was 64 years; 37 patients (70%) were male. Histology: adenocarcinoma (42%), squamous cell carcinoma (28%), large cell (19%), and unclassified (11%). Among 47 evaluable patients, eight (17%) had partial response, 11 (23%) had stable disease. One-year survival was 39% and median survival was 7.6 months (range, < 1-19.6). Grade 3 and 4 toxicities included neutropenia (53%), anemia (18%), thrombocytopenia (12%),asthenia (8%), and gastrointestinal disorders (8%); three patients (6%) experienced neutropenic fever. There were no treatment-related deaths. The combination topotecan/gemcitabine produced a 1-year survival similar to previous platinum-based regimens, when used as first line chemotherapy for ANSCLC. The toxicity profile was acceptable.
机译:这个试验的目的是确定1年存活率、功效和安全、生产的topotecan和吉西他滨作为第一行化疗在晚期非小细胞肺癌症(ANSCLC)。登记;1 - 5毫克/米(2),天,吉西他滨1 g / m(2)天1和15个管理第四,每个药物超过30最小值;一直持续到进步的疾病或无法忍受的毒性。东方合作肿瘤学集团标准性能状态(ECOG PS) = 0, 34 (64%) PS =1. 是男性。鳞状细胞癌(28%),大细胞(19%),和非保密(11%)。患者中,8例(17%)有部分反应,11(23%)有稳定的疾病。39%,平均生存7.6个月(范围,<1 - 19.6)。嗜中性白血球减少症(53%)、贫血(18%)、血小板减少症(12%)、无力(8%)、胃肠道障碍(8%);粒细胞减少性发热。治疗相关的死亡。topotecan /吉西他滨生产一年生存类似于以前的以铂为基础的方案,当用作ANSCLC第一线化疗。毒性是可以接受的。

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