A prospective multicentre phase II study of cisplatin and weekly docetaxel as first-line treatment for recurrent or metastatic nasopharyngeal cancer (KCSG HN07-01).

Abstract

BACKGROUND:

The purpose of this phase II study was to determine the efficacy and toxicity of cisplatin and weekly docetaxel combination chemotherapy as a first-line treatment in patients with recurrent or metastatic nasopharyngeal cancer.

PATIENTS AND METHODS:

Recurrent or metastatic nasopharyngeal cancer patients were enrolled and received a combination of weekly docetaxel (35 mg/m(2) on Day1 and Day8) and cisplatin (70 mg/m(2) D1) every 21 days, for up to a maximum of 6 cycles. The primary endpoint was objective response rate, and the secondary endpoints included toxicity of combination chemotherapy, progression-free survival, overall survival and 1-year survival rate.

RESULTS:

In total, 47 patients were enrolled and analysed, and 46 patients (97.9%) completed the planned protocol. In an intent-to-treat analysis, 6 patients (12.8%) achieved complete response (CR) and 27 patients (57.4%) showed partial response (PR), with an objective response rate of 70.2%. The median progression-free survival and overall survival were 9.6 months (95% C.I. 5.7-13.5 months) and 28.5 months (95% C.I. 16.9-40.1 months), respectively, and the 1-year survival rate was 89.9%. The common grade 3 adverse events were stomatitis (1.2%), neutropenia (0.8%), anaemia (0.8%), infection (0.8%) and diarrhoea (0.8%). Grade 4 adverse events were not observed in this study.

CONCLUSIONS:

The combination chemotherapy of cisplatin and weekly docetaxel is highly effective and shows favourable toxicity as a first-line chemotherapy in patients with recurrent or metastatic nasopharyngeal cancer.

• Authors: Jun Ho Ji, Korean Cancer Study Group (KCSG), Tak Yun, Sung-Bae Kim, Jung Hun Kang, Ji Chan Park, In Sung Cho, Chang Hak Sohn, Dae Seog Heo, Joung Soon Jang, Sang Won Shin, Deok Won Hwang, Jong-Mu Sun, Keunchil Park, Myung-Ju Ahn
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 48 Issue 17 Pg. 3198-204 (Nov 2012) ISSN: 1879-0852 [Electronic] England
• PMID: 22795584 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 Elsevier Ltd. All rights reserved.

Chemical References

• Taxoids
• Docetaxel
• Cisplatin

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Cisplatin (administration & dosage, adverse effects)
• Disease-Free Survival
• Docetaxel
• Female
• Humans
• Male
• Middle Aged
• Nasopharyngeal Neoplasms (drug therapy, mortality, pathology)
• Neoplasm Metastasis
• Neoplasm Recurrence, Local (drug therapy, mortality)
• Prospective Studies
• Taxoids (administration & dosage, adverse effects)