Email updates

Keep up to date with the latest news and content from BMC Cancer and BioMed Central.

Open Access Highly Accessed Research article

Phase I trial of split-dose induction docetaxel, cisplatin, and 5-fluorouracil (TPF) chemotherapy followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1)

Katrin Oertel1, Karin Spiegel1, Harald Schmalenberg2, Andreas Dietz3, Georg Maschmeyer4, Thomas Kuhnt5, Holger Sudhoff6, Thomas G Wendt7 and Orlando Guntinas-Lichius1*

Author affiliations

1 Department of Otorhinolaryngology, Jena University Hospital, Lessingstrasse 2, Jena, D-07740, Germany

2 Department of Medicine II, Jena University Hospital, Jena, Germany

3 Department of Otorhinolaryngology/Plastic Surgery, University Hospital Leipzig, Leipzig, Germany

4 Department of Hematology, Oncology & Palliative Care, Klinikum Ernst von Bergmann, Potsdam, Germany

5 Department of Radiation Oncology, University of Rostock, Rostock, Germany

6 Department of Otorhinolaryngology, Head and Neck Surgery, Klinikum Bielefeld, Bielefeld, Germany

7 Department of Radiation Oncology, Jena University Hospital, Jena, Germany

For all author emails, please log on.

Citation and License

BMC Cancer 2012, 12:483  doi:10.1186/1471-2407-12-483

Published: 20 October 2012

Abstract

Background

Induction chemotherapy (ICT) with docetaxel, cisplatin and fluorouracil (TPF) followed by radiotherapy is an effective treatment option for unresectable locally advanced head and neck cancer. This phase I study was designed to investigate the safety and tolerability of a split-dose TPF ICT regimen prior to surgery for locally advanced resectable oral and oropharyngeal cancer.

Methods

Patients received TPF split on two dosages on day 1 and 8 per cycle for one or three 3-week cycles prior to surgery and postoperative radiotherapy or radiochemotherapy. Docetaxel was escalated in two dose levels, 40 mg/m2 (DL 0) and 30 mg/m2 (DL −1), plus 40 mg/m2 cisplatin and 2000 mg/m2 fluorouracil per week using a 3 +3 dose escalation algorithm.

Results

Eighteen patients were enrolled and were eligible for toxicity and response. A maximum tolerated dose of 30 mg/m2 docetaxel per week was reached. The most common grade 3+ adverse event was neutropenia during ICT in 10 patients. Surgery reached R0 resection in all cases. Nine patients (50%) showed complete pathologic regression.

Conclusions

A split-dose regime of TPF prior to surgery is feasible, tolerated and merits additional investigation in a phase II study with a dose of 30 mg/m docetaxel per week.

Trial registration number

NCT01108042 (ClinicalTrials.gov Identifier)

Keywords:
Docetaxel; Cisplatin; 5-fluorouracil; Locally advanced oral cancer; Surgery; Radiotherapy