Induction chemotherapy with docetaxel/cisplatin/5-fluorouracil followed by randomization to two cisplatin-based concomitant chemoradiotherapy schedules in patients with locally advanced head and neck cancer (CONDOR study) (Dutch Head and Neck Society 08-01): A randomized phase II study

Eur J Cancer. 2016 Jan:52:77-84. doi: 10.1016/j.ejca.2015.09.024. Epub 2015 Dec 1.

Abstract

Purpose: To study the feasibility of induction chemotherapy added to concomitant cisplatin-based chemoradiotherapy (CRT) in patients with locally advanced head and neck cancer (LAHNC).

Patients and methods: LAHNC patients were treated with 4 courses of docetaxel/cisplatin/5-fluorouracil (TPF) followed by randomization to either cisplatin 100 mg/m(2) with conventional radiotherapy (cis100 + RT) or cisplatin 40 mg/m(2) weekly with accelerated radiotherapy (cis40 + ART). Primary endpoint was feasibility, defined as receiving ≥ 90% of the scheduled total radiation dose. Based on power analysis 70 patients were needed.

Results: 65 patients were enrolled. The data safety monitoring board advised to prematurely terminate the study, because only 22% and 41% (32% in total) of the patients treated with cis100 + RT (n = 27) and cis40 + ART (n = 29) could receive the planned dose cisplatin during CRT, respectively, even though the primary endpoint was reached. Most common grade 3-4 toxicity was febrile neutropenia (18%) during TPF and dehydration (26% vs 14%), dysphagia (26% vs 24%) and mucositis (22% vs 57%) during cis100 + RT and cis40 + ART, respectively. For the patients treated with cis100 + RT and cis40 + ART, two years progression free survival and overall survival were 70% and 78% versus 72% and 79%, respectively.

Conclusion: After TPF induction chemotherapy, cisplatin-containing CRT is not feasible in LAHNC patients, because the total planned cisplatin dose could only be administered in 32% of the patients due to toxicity. However, all but 2 patients received more than 90% of the planned radiotherapy. Clinical Trials Information: NCT00774319.

Keywords: Chemoradiotherapy; Head and neck cancer; Induction chemotherapy; TPF.

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Chemoradiotherapy / adverse effects
  • Chemoradiotherapy / methods*
  • Chemoradiotherapy / mortality
  • Cisplatin / adverse effects
  • Cisplatin / therapeutic use*
  • Disease Progression
  • Disease-Free Survival
  • Docetaxel
  • Early Termination of Clinical Trials
  • Feasibility Studies
  • Female
  • Fluorouracil / adverse effects
  • Fluorouracil / therapeutic use*
  • Head and Neck Neoplasms / mortality
  • Head and Neck Neoplasms / pathology
  • Head and Neck Neoplasms / therapy*
  • Humans
  • Induction Chemotherapy
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Neoplasm Recurrence, Local
  • Netherlands
  • Radiotherapy Dosage
  • Risk Factors
  • Taxoids / adverse effects
  • Taxoids / therapeutic use*
  • Time Factors
  • Treatment Outcome

Substances

  • Taxoids
  • Docetaxel
  • Cisplatin
  • Fluorouracil

Associated data

  • ClinicalTrials.gov/NCT00774319