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)

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 I...

Descripción completa

Detalles Bibliográficos
Autores principales: Oertel, Katrin, Spiegel, Karin, Schmalenberg, Harald, Dietz, Andreas, Maschmeyer, Georg, Kuhnt, Thomas, Sudhoff, Holger, Wendt, Thomas G, Guntinas-Lichius, Orlando
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3485626/
https://www.ncbi.nlm.nih.gov/pubmed/23083061
http://dx.doi.org/10.1186/1471-2407-12-483
Descripción
Sumario: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/m(2) (DL 0) and 30 mg/m(2) (DL −1), plus 40 mg/m(2) cisplatin and 2000 mg/m(2) 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/m(2) 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)