Phase II study of paclitaxel with 3-h infusion in patients with advanced gastric cancer

被引：123

作者：

Yamaguchi K. ^{[1
]}

Tada M. ^{[1
]}

Horikoshi N. ^{[2
]}

Otani T. ^{[3
]}

Takiuchi H. ^{[4
]}

Saitoh S. ^{[5
]}

Kanamaru R. ^{[6
]}

Kasai Y. ^{[7
]}

Koizumi W. ^{[8
]}

Sakata Y. ^{[9
]}

Taguchi T. ^{[10
]}

机构：

[1] Department of Gastroenterology, Saitama Cancer Center Hospital, Ina-machi, Saitama 362-0806

[2] Department of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo

[3] Third Department of Gastroenterology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka

[4] Second Department of Internal Medicine, Osaka Medical College, Takatsuki

[5] Department of Gastroenterology, Aomori Prefectural Central Hospital, Aomori

[6] Department of Clinical Oncology, Tohoku University, Sendai

[7] Second Department of Surgery, Nagoya University, Nagoya

[8] Department of Gastroenterology/Medical Oncology, Kitasato University East Hospital, Sagamihara

[9] Misawa Municipal Hospital, Misawa, Aomori

[10] Society for Cancer Chemotherapy, Osaka

来源：

Gastric Cancer | 2002年 / 5卷 / 2期

关键词：

Advanced gastric cancer; Paclitaxel; Phase II study;

D O I：

10.1007/s101200200015

中图分类号：

学科分类号：

摘要：

Background. To increase the options for agents for gastric cancer chemotherapy, we performed a phase II clinical trial on the use of a 3-h infusion of paclitaxel to confirm its efficacy and the feasibility of its use in patients with advanced gastric cancer. Methods. Thirty-two (32) patients with measurable metastatic gastric cancer were enrolled in this study. Seventeen patients (53%) had received prior chemotherapy for metastatic disease, 4 patients (13%) had adjuvant chemotherapy alone, and 11 patients (34%) were chemotherapy-naive. Paclitaxel was intravenously infused for 3h, at a dose of 210 mg/m2, once every 3 weeks. To prevent hypersensitivity reactions, standard premedication was administered to all patients. Results. Nine (28%; 9/32) objective partial responses (PRs) were observed (95% confidence interval [CI], 14%-47%), and the remaining 23 patients showed stable (12 patients; 37.5%) and progressive disease (11 patients; 34.4%). The median time to response was 20 days (range, 14-38 days). The median response duration was 87 days (range, 50-103 days). The median survival of all patients was 234 days (range, 13-646+ days). The major adverse reactions were myelosuppression (grade 3/4 leukopenia and neutropenia were observed in 59% and 88% of the patients, respectively), alopecia, and peripheral neuropathy. Peripheral neuropathy was observed in 19 patients, however, most of the patients recovered after the completion of treatment. Conclusion. A 3-h infusion of paclitaxel is an effective therapy for advanced gastric cancer and is clinically well tolerated by the patients.

引用

页码：90 / 95

页数：5

共 24 条

[1]

Ajani J.A., Fairweather J., Dumas P., Patt Y.Z., Pazdur R., Mansfield P.F., Phase II study of taxol in patients with advanced gastric carcinoma, Cancer J Sci Am, 4, pp. 269-274, (1998)

[2]

Wani M.C., Taylor H.L., Wall M.E., Coggon P., McPhail A.T., Plant antitumor agents. VI. The isolation and structure of taxol, a novel antileukemic and antitumor agent from Taxus brevifolia, J Am Chem Soc, 93, pp. 2325-2327, (1971)

[3]

Holmes F.A., Walters R.S., Theriault R.L., Forman A.D., Newton L.K., Raber M.N., Et al., Phase II trial of taxol, an active drug in the treatment of metastatic breast cancer, J Natl Cancer Inst, 83, pp. 1797-1805, (1991)

[4]

Einzig A.I., Wiernik P.H., Sasloff J., Runowicz C.D., Goldberg G.L., Phase II study and long-term follow-up of patients treated with taxol for advanced ovarian adenocarcinoma, J Clin Oncol, 10, pp. 1748-1753, (1992)

[5]

Einzig A.I., Hochster H., Wiernik P.H., Trump D.L., Dutcher J.P., Garowski E., Et al., A phase II study of taxol in patients with malignant melanoma, Invest New Drug, 9, pp. 59-64, (1991)

[6]

Chang A.Y., Kim K., Glick J., Anderson T., Karp D., Johnson D., Phase II study of taxol, merbarone, and piroxantrone in stage IV non-small-cell lung cancer: The Eastern Cooperative Oncology Group Results, J Natl Cancer Inst, 85, pp. 388-394, (1993)

[7]

Matsuoka H., Yano K., Saito T., Seo Y., Tomoda H., Cytotoxicity of paclitaxel in comparison with other anticancer agents against neoplastic cells obtained from clinical gastrointestinal carcinoma tissue, Anticancer Res, 15, pp. 2001-2006, (1995)

[8]

Ohtsu A., Boku N., Tamura F., Muro K., Shimada Y., Saigenji K., Et al., An early phase II study of a 3-h infusion of paclitaxel for advanced gastric cancer, Am J Clin Oncol, 21, pp. 416-419, (1998)

[9]

Guidelines for the clinical evaluation of antineoplastic drugs, (1992)

[10]

Ohtsu A., Shirao K., Miyata Y., Hyodo I., Saito H., Taguchi T., A phase II study of 3-h infusional paclitaxel in patients with advanced gastric cancer, Proc Am Soc Clin Oncol, 19, (2000)

← 1 2 3 →