Phase II study of docetaxel and cisplatin in patients with previously untreated metastatic non-small-cell lung cancer

被引：15

作者：

Okamoto H. ^{[1
]}

Watanabe K. ^{[1
]}

Segawa Y. ^{[2
]}

Ichinose Y. ^{[3
]}

Yokoyama A. ^{[4
]}

Yoneda S. ^{[5
]}

Niitani H. ^{[6
]}

机构：

[1] Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Hodogaya-ku, Yokohama 240-8555

[2] Department of Internal Medicine, Shikoku Cancer Center Hospital, Matsuyama

[3] Department of Respiratory Medicine, National Kyushu Cancer Center, Fukuoka

[4] Department of Internal Medicine, Niigata Prefectural Cancer Center Hospital, Niigata

[5] Department of Pulmonary Medicine Clinic, Saitama Cancer Center Hospital, Saitama

[6] The Tokyo Cooperative Oncology Group, Tokyo

来源：

International Journal of Clinical Oncology | 2000年 / 5卷 / 5期

关键词：

Cisplatin; Docetaxel; Non-small-cell lung cancer (NSCLC);

D O I：

10.1007/PL00012056

中图分类号：

学科分类号：

摘要：

Background. This phase II study was designed to determine the toxicity and efficacy of a low dose of docetaxel plus a standard dose of cisplatin for patients with metastatic non-small-cell lung cancer (NSCLC). Methods. Eligibility criteria included metastatic disease (stage IV) of NSCLC and a performance status (PS) of 0-2. Cisplatin 80 mg/m2 was given i.v. on day 1 and docetaxel 60 mg/m2 was given i.v. on day 1. Treatment was repeated every 3 to 4 weeks. Results. Forty-five patients were enrolled in the study, and the median age was 63 years. Forty-two patients (93%) had a PS of 0-1 and 38 (84%) received two to four courses of chemotherapy. The principal toxicity was neutropenia, and grade 3/4 occurred in 36%/49%. Other hematologic toxicities were mild. Of the 45 patients, subsequent chemotherapy was delayed due to toxicities in only 5 patients (11%), and dose modifications were needed in only 3 patients (7%). There were no treatment-related deaths. Non-hematological toxicities were relatively mild. Allergy (2%), skin rash (11%), edema (9%), and neuropathy (9%) occurred infrequently, and all were grade 1 toxicity. Of the 45 patients, 19 showed partial response, giving a response rate of 42%. The median survival time was 43.3 weeks, and the 1-year survival rate of all patients was 38.7%. Conclusion. This cisplatin/docetaxel combination chemotherapy is an active and non-toxic regimen in patients with metastatic NSCLC, a result which suggests that the combination may be suitable for randomized controlled trials.

引用

页码：316 / 322

页数：6

共 34 条

[1]

Saijo N., New chemotherapeutic agents for the treatment of non-small cell lung cancer: The Japanese experience, Chest, 113, (1998)

[2]

Souquet P.J., Chauvin F., Boissel J.P., Et al., Polychemotherapy in advanced non-small cell lung cancer: A meta-analysis, Lancet, 342, pp. 19-21, (1993)

[3]

Grilli R., Oxman A.D., Julian J.A., Chemotherapy for advanced non-small-cell lung cancer: How much benefit is enough?, J Clin Oncol, 11, pp. 1866-1872, (1993)

[4]

Marino P., Pampallona S., Preatoni A., Et al., Chemotherapy vs supportive care in advanced non-small-cell lung cancer: Results of a meta-analysis of the literature, Chest, 106, pp. 861-865, (1994)

[5]

Chemotherapy in non-small-cell lung cancer: A meta-analysis using updated data on individual patients from 52 randomized clinical trials, BMJ, 311, pp. 899-909, (1995)

[6]

Gueritte-Voegelein F., Guenard D., Lavelle F., Et al., Relationships between the structure of Taxol analogues and their antimitotic activity, J Med Chem, 34, pp. 992-998, (1991)

[7]

Denis J.N., Correa A., Greene A.E., An improved synthesis of the Taxol side chain and of RP56976, J Org Chem, 55, pp. 1957-1959, (1990)

[8]

Ringel I., Horwitz S.B., Studies with RP 56976 (Taxotere): A semi-synthetic analog of Taxol, J Natl Cancer Inst, 83, pp. 288-291, (1991)

[9]

Seidman A.D., Hudis C., Crown J.P.A., Et al., Phase II evaluation of Taxotere (RP 56976, NSC 628503) as initial chemotherapy for metastatic breast cancer, Proc Am Soc Clin Oncol, 12, (1993)

[10]

Kunitoh H., Watanabe K., Onoshi T., Et al., Phase II trial of docetaxel in previously untreated advanced non-small-cell lung cancer: A Japanese cooperative study, J Clin Oncol, 14, pp. 1649-1655, (1996)

← 1 2 3 4 →