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

Cancer. 2013 Dec 1;119(23):4111-8. doi: 10.1002/cncr.28324. Epub 2013 Aug 27.

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.

Keywords: chemotherapy; concurrent chemoradiation; nasopharyngeal carcinoma; radiotherapy.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • 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
  • Nasopharyngeal Neoplasms / mortality
  • Nasopharyngeal Neoplasms / radiotherapy
  • Nasopharyngeal Neoplasms / therapy*
  • Neoadjuvant Therapy*
  • Prospective Studies
  • Radiotherapy, Conformal
  • Survival Rate
  • Taxoids / administration & dosage

Substances

  • Antineoplastic Agents
  • Taxoids
  • Docetaxel
  • Cisplatin
  • Fluorouracil