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Cancer Chemother Pharmacol. 2008 Jan;61(1):33-8. Epub 2007 Mar 20.

Phase II clinical study of gemcitabine in the treatment of patients with advanced nasopharyngeal carcinoma after the failure of platinum-based chemotherapy.

Author information

1
Department of Medical Oncology, Cancer Center of Sun Yat-Sen University, 651# Dongfeng Road East, Guangzhou, 510060, People's Republic of China. zhangli6@mail.sysu.edu.cn

Abstract

PURPOSE:

This study was designed to evaluate the anti-tumor activity and toxicity profile of gemcitabine in the treatment of patients with advanced nasopharyngeal carcinoma (NPC) who had been pretreated with platinum-based chemotherapy.

METHOD:

This is an open label, single arm phase II trial. All patients were treated with single agent of gemcitabine. Gemcitabine was given in the dosage of 1.0 g/m(2) on days 1, 8, 15, each cycle repeated every 4 weeks. Gemcitabine was added to 100 ml normal saline infused over 30 min.

RESULT:

About 32 patients were enrolled in this trial. Thirty patients were assessable for response to treatment. Fourteen patients had a partial response (PR), giving an overall response rate of 43.8% (14/32); 9 patients had stable disease (28.1%) and 7 progressed disease (21.9%). The median time to progression was 5.1 months and median survival time was 16 months, 1 year survival rate was 67%, 2 year overall survival rate was 12%. A total of 11 patients (34.4%) experienced grade 3 and 4 toxicity and the main toxicity was myelosuppression. the non-hematology toxicity was minimal.

CONCLUSION:

The effectiveness of gemcitabine was higher and side effects were minimal in advanced NPC patients after platinum-based chemotherapy failed.

PMID:
17909810
DOI:
10.1007/s00280-007-0441-8
[Indexed for MEDLINE]

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