Single-arm, multi-centre phase II study of lobaplatin combined with docetaxel for recurrent and metastatic nasopharyngeal carcinoma patients.

Abstract

OBJECTIVES:

The primarily aim of this phase II study is to evaluate the response rate (RR) and disease control rate (DCR). The secondary aim of this study is to assess the progression-free survival and overall survival of recurrent or metastatic nasopharyngeal carcinoma (NPC) patients treated with lobaplatin in combination with docetaxel.

MATERIALS AND METHODS:

Patients with recurrent and metastatic NPC received docetaxel (75 mg/m(2) on day 1) and lobaplatin (30 mg/m(2) on day 2) every 3 weeks for two to six courses.

RESULTS:

From April 2011 to July 2013, 39 patients were enrolled. In total, 3 patients (7.7%) had complete response, 21 (53.8%) had partial response, 9 (23.1%) had stable disease and 4 (10.3%) had progressive disease. The overall RR was 61.5% (95% CI, 46.2-76.8%), and the DCR was 84.6% (95% CI, 73.3-95.9%). The median time to progression was 10 months (95% CI, 7.3-12.8 months) after the median follow-up duration of 10.3 months (1.5-28.9 months). The most common grade 3/4 toxicities included leucopaenia and neutropaenia (17.9%), anaemia (5.1%) and increased aminotransferase level (2.6%). Other toxicities were grade 1/2 and minimal.

CONCLUSION:

Lobaplatin in combination with docetaxel demonstrated clinical activity and an acceptable toxicity profile in recurrent and metastatic NPC patients. Lobaplatin may be effective for recurrent and metastatic NPC patients who previously received cisplatin-based chemotherapy.

• Authors: Guo Xian Long, Jing Wen Lin, Dong Bo Liu, Xiao Yi Zhou, Xiang Lin Yuan, Guang Yuan Hu, Qi Mei, Guo Qing Hu
• Journal: Oral oncology (Oral Oncol) Vol. 50 Issue 8 Pg. 717-20 (Aug 2014) ISSN: 1879-0593 [Electronic] England
• PMID: 24844985 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 Elsevier Ltd. All rights reserved.

Chemical References

• Cyclobutanes
• Organoplatinum Compounds
• Taxoids
• Docetaxel
• lobaplatin

Topics

• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, therapeutic use)
• Cyclobutanes (administration & dosage)
• Docetaxel
• Female
• Humans
• Male
• Middle Aged
• Nasopharyngeal Neoplasms (drug therapy, pathology)
• Neoplasm Metastasis
• Organoplatinum Compounds (administration & dosage)
• Recurrence
• Survival Rate
• Taxoids (administration & dosage)