A PROSPECTIVE MULTICENTER PHASE II STUDY OF CISPLATIN AND WEEKLY DOCETAXEL AS FIRST-LINE TREATMENT OF RECURRENT OR METASTATIC NASOPHARYNGEAL CANCER (KCSG HN07-01)

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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.

Methods

Recurrent or metastatic nasopharyngeal cancer patients were enrolled and received a combination of weekly docetaxel (35 mg/m2 on days 1 and 8) and cisplatin (70 mg/m2 D1) every 21 days, for up to a maximum of six cycles. The primary end point was the objective response rate, and the secondary end points included the toxicity of combination chemotherapy, progression-free survival, overall survival and 1-year survival rate. The study is registered with ClinicalTrials.gov, number NCT01312311.

Results

In total, 47 patients were enrolled and analyzed and 46 patients (97.9%) completed the planned protocol. In an intent-to-treat analysis, 6 patients (12.8%) achieved complete response and 27 patients (57.4%) showed partial response, with an objective response rate of 70.2%. The median progression-free survival and overall survival were 9.6 months (95% CI: 5.7–13.5 months) and 28.5 months (95% CI: 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%), anemia (0.8%), infection (0.8%) and diarrhea (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 favorable toxicity as a first-line chemotherapy in patients with recurrent or metastatic nasopharyngeal cancer.

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