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

Research Article

Georg Maschmeyer¹  Harald Schmalenberg²  Holger Sudhoff³  Katrin Oertel⁴  Karin Spiegel⁴  Orlando Guntinas-Lichius⁴  Andreas Dietz⁵  Thomas G Wendt⁶  Thomas Kuhnt⁷ 

[1] Department of Hematology, Oncology & Palliative Care, Klinikum Ernst von Bergmann, Potsdam, Germany;Department of Medicine II, Jena University Hospital, Jena, Germany;Department of Otorhinolaryngology, Head and Neck Surgery, Klinikum Bielefeld, Bielefeld, Germany;Department of Otorhinolaryngology, Jena University Hospital, Lessingstrasse 2, D-07740, Jena, Germany;Department of Otorhinolaryngology/Plastic Surgery, University Hospital Leipzig, Leipzig, Germany;Department of Radiation Oncology, Jena University Hospital, Jena, Germany;Department of Radiation Oncology, University of Rostock, Rostock, Germany;

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

DOI  :  10.1186/1471-2407-12-483

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

来源: Springer

【 摘 要 】

BackgroundInduction 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.MethodsPatients 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.ResultsEighteen 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.ConclusionsA 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 numberNCT01108042 (ClinicalTrials.gov Identifier)

【 授权许可】

Unknown   
© Oertel et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.