Neoadjuvant chemotherapy followed by concurrent chemoradiation for locoregionally advanced nasopharyngeal carcinoma: interim results from 2 prospective phase 2 clinical trials.

Abstract

BACKGROUND:

The authors studied the efficacy of neoadjuvant chemotherapy, consisting of a taxane, cisplatin, and 5-fluorouracil (5-FU) (the TPF regimen) followed by concurrent chemoradiation, in 2 separately designed and synchronously executed phase 2 trials for stage III and IVA/IVB nasopharyngeal cancer (NPC).

METHODS:

Patients with newly diagnosed NPC were accrued to 2 trials, 1 for patients with stage III disease and the other for patients with IVA/IVB disease. All patients received TPF (docetaxel 75 mg/m(2), cisplatin 75 mg/m(2), and 5-FU 2500 mg/m(2) every 3 weeks for 3 cycles) followed by cisplatin 40 mg/m(2) per week concurrently with either 3-dimensional conformal radiation therapy or intensity-modulated radiation therapy.

RESULTS:

From January 2007 to July 2011, 52 eligible patients with stage III NPC and 64 eligible patients with nonmetastatic stage IV NPC were accrued. With a median follow-up of 32.9 months, the 3-year overall survival rates were 94.8% (95% confidence interval [CI], 87.6%-100%) and 90.2% (95% CI, 81.8%-98.6%) for the stage III NPC group and the IVA/IVB NPC group, respectively. The 3-year progression-free survival, distant metastasis-free survival, and local progression-free survival rates were 78.2% (95% CI, 64.6%-91.8%), 90.5% (95% CI, 79.7%-100%), and 93.9%(87.1%-100%), respectively, for patients with stage III NPC and 85.1% (95% CI, 75.1%-95.1%), 88% (95% CI, 78.6%-97.4%), and 100%, respectively, for patients with stage IVA/IVB NPC. The most common severe (grade 3/4) hematologic and nonhematologic adverse events were neutropenia (64 patients; 55.2%) and nausea/vomiting (23 patients; 19.8%).

CONCLUSIONS:

Neoadjuvant TPF followed by concurrent chemoradiation was well tolerated and produced encouraging outcomes in patients with locally advanced NPC in this hypothesis-generating study. The authors concluded that randomized controlled trials are warranted to definitively confirm this aggressive and potentially efficacious strategy.

• Authors: Lin Kong, Chaosu Hu, Xiaoshuang Niu, Youwang Zhang, Ye Guo, Ivan W K Tham, Jiade Jay Lu
• Journal: Cancer (Cancer) Vol. 119 Issue 23 Pg. 4111-8 (Dec 01 2013) ISSN: 1097-0142 [Electronic] United States
• PMID: 24037893 (Publication Type: Clinical Trial, Phase II, Journal Article)
• Copyright: © 2013 American Cancer Society.

Chemical References

• Antineoplastic Agents
• Taxoids
• Docetaxel
• Cisplatin
• Fluorouracil

Topics

• Antineoplastic Agents (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Chemoradiotherapy
• Cisplatin (administration & dosage)
• Docetaxel
• Female
• Fluorouracil (administration & dosage)
• Follow-Up Studies
• Humans
• Lymph Nodes (pathology)
• Male
• Middle Aged
• Nasopharyngeal Neoplasms (drug therapy, mortality, radiotherapy, therapy)
• Neoadjuvant Therapy
• Prospective Studies
• Radiotherapy, Conformal
• Survival Rate
• Taxoids (administration & dosage)