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)

BMC Cancer

Katrin Oertel³  Karin Spiegel³  Harald Schmalenberg⁶  Andreas Dietz⁵  Georg Maschmeyer²  Thomas Kuhnt⁴  Holger Sudhoff¹  Thomas G Wendt⁷  Orlando Guntinas-Lichius³ 

[1] Department of Otorhinolaryngology, Head and Neck Surgery, Klinikum Bielefeld, Bielefeld, Germany

[2] Department of Hematology, Oncology & Palliative Care, Klinikum Ernst von Bergmann, Potsdam, Germany

[3] Department of Otorhinolaryngology, Jena University Hospital, Lessingstrasse 2, Jena, D-07740, Germany

[4] Department of Radiation Oncology, University of Rostock, Rostock, Germany

[5] Department of Otorhinolaryngology/Plastic Surgery, University Hospital Leipzig, Leipzig, Germany

[6] Department of Medicine II, Jena University Hospital, Jena, Germany

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

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

Others  :  1080127
DOI  :  10.1186/1471-2407-12-483

 received in 2012-06-22, accepted in 2012-10-18,  发布年份 2012

【 摘 要 】

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)

【 授权许可】

   
2012 Oertel et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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