Phase I/II study of docetaxel and cisplatin with concurrent thoracic radiation therapy for locally advanced non-small-cell lung cancer

被引：56

作者：

Kiura, K

Ueoka, H

Segawa, Y

Tabata, M

Kamei, H

Takigawa, N

Hiraki, S

Watanabe, Y

Bessho, A

Eguchi, K

Okimoto, N

Harita, S

Takemoto, M

Hiraki, Y

Harada, M

Tanimoto, M

机构：

[1] Okayama Univ, Sch Med, Dept Internal Med 2, Okayama 7008558, Japan

[2] Okayama Univ, Sch Med, Dept Radiol, Okayama 700, Japan

[3] Okayama Red Cross Hosp, Dept Internal Med, Okayama, Japan

[4] Sumitomo Besshi Gen Hosp, Dept Internal Med, Niihama, Japan

[5] Kawasaki Hosp, Kawasaki Med Sch, Dept Med, Okayama, Japan

[6] Mutual Aid Assoc Publ Sch Teachers, Chugoku Chuoh Hosp, Dept Internal Med, Fukuyama, Hiroshima, Japan

[7] Natl Shikoku Canc Ctr Hosp, Dept Internal Med, Matsuyama, Ehime, Japan

来源：

BRITISH JOURNAL OF CANCER | 2003年 / 89卷 / 05期

关键词：

combination chemotherapy; concurrent chemoradiation; lung cancer; cisplatin; docetaxel;

D O I：

10.1038/sj.bjc.6601217

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Recent studies have suggested the superiority of concomitant over sequential administration of chemotherapy and radiotherapy. Docetaxel and cisplatin have demonstrated efficacy in advanced non-small-cell lung cancer (NSCLC). This study evaluated the safety, toxicity, and antitumour activity of docetaxel/cisplatin with concurrent thoracic radiotherapy for patients with locally advanced NSCLC. Patients with locally advanced NSCLC ( stage IIIA or IIIB), good performance status, age less than or equal to75 years, and adequate organ function were eligible. Both docetaxel and cisplatin were given on days 1, 8, 29, and 36. Doses of docetaxel/cisplatin (mg m(-2)) in the phase I study portion were escalated as follows: 20/30, 25/30, 30/30, 30/35, 30/40, 35/40, 40/40, and 45/40. Beginning on day 1 of chemotherapy, thoracic radiotherapy was given at a total dose of 60 Gy with 2Gy per fraction over 6 weeks. In the phase I portion, the maximum tolerated doses (MTD) among 33 patients were docetaxel 45 mg m(-2) and cisplatin 40 mg m(-2). The major dose-limiting toxicity (DLT) was radiation oesophagitis. The recommended doses (RDs) for the phase II study were docetaxel 40 mg m(-2) and cisplatin 40 mg m(-2). A total of 42 patients were entered in the phase II portion. Common toxicities were leukopenia, granulocytopenia, anaemia, and radiation oesophagitis, with frequencies of grade greater than or equal to3 toxicities of 71, 60, 24, and 19%, respectively. Toxicity was significant, but manageable according to the dose and schedule modifications. Dose intensities of docetaxel and cisplatin were 86 and 87%, respectively. Radiotherapy was completed without a delay in 67% of 42 patients. The overall response rate was 79% (95% confidence interval (CI), 66 - 91%). The median survival time was 23.4+ months with an overall survival rate of 76% at 1 year and 54% at 2 years. In conclusion, chemotherapy with cisplatin plus docetaxel given on days 1, 8, 29, and 36 and concurrent thoracic radiotherapy is efficacious and tolerated in patients with locally advanced NSCLC and should be evaluated in a phase III study.

引用

页码：795 / 802

页数：8

共 46 条

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