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Phase I/II docetaxel plus concurrent hyperfractionated radiotherapy in locally advanced unresectable head and neck cancer (TAX.ES1.102 study)

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Abstract

Introduction

Concurrent chemotherapy and radiotherapy is recommended for the treatment of locally advanced unresectable head and neck (H&N) cancer.

Objective

The primary purpose of the Phase I part of the study was to determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT) and recommended dose (RD) of docetaxel with hyperfractionation radiotherapy. The primary objective of the Phase II part was to determine the response rate to the RD of treatment and, secondarily, to assess the toxicity of the schedule, time to progression, duration of response and overall survival (OS).

Materials and methods

Patients (n=9 in Phase I; n=19 in Phase II) had unresectable H&N cancer. The starting docetaxel dose was 20 mg/m2 plus hyperfractionated radiotherapy. Ramping of docetaxel was 5 mg/m2 if MTD was not reached.

Results

MTD of docetaxel was 20 mg/m2. Limiting toxicities were grade 4 pneumonia and grade 4 mucositis. The RD was 15 mg/m2. Phase II initial response was 76% (CR=18%; PR=9%); updated response was 89% (CR=59%; PR=29%). The median progression-free survival was 7.8 months (95%CI: 0–22.3) and the median OS was 15.1 months (95%CI: 0–35.9). Grade 3–4 toxicities included mucositis (91%), pneumonia (27%) and fatigue (27%). There were 5 toxic deaths (2 from intestinal perforation, 3 from pneumonia).

Conclusions

Weekly docetaxel+hyperfractionation radiotherapy is active but with high toxicity rates and, hence, this treatment regimen would be difficult to justify.

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Authors and Affiliations

  1. Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, C/ Sant Antoni Maria Claret, 167, ES-08025, Barcelona, Spain

    Agustí Barnadas, Margarita Majem & Antonio López-Pousa

  2. Department of Medical Oncology Institut Català d’Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain

    Agustí Barnadas & Mireia Margelí

  3. Department of Medical Oncology Institut Català d’Oncologia Hospital Duran i Reynals, L’Hospitalet de Llobregat, Barcelona, Spain

    Ricard Mesía

  4. Department of Radiotherapy Oncology Institut Català d’Oncologia Hospital Duran i Reynals, L’Hospitalet de Llobregat, Barcelona, Spain

    Ramón Galiana

  5. Department of Radiotherapy Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

    José M. de Vega

  6. Department of Medical Oncology, Hospital Universitari Sant Joan de Reus, Reus, Tarragona, Spain

    Vicente Valentí

  7. Department of Radiotherapy Oncology, Hospital Universitari Sant Joan de Reus, Reus, Tarragona, Spain

    Lluís Anglada

  8. Medical Department, Sanofi-Aventis, Barcelona, Spain

    Ariadna Lloansí

  9. Department of Radiotherapy Oncology Institut Català d’Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain

    Antonio Arellano

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  1. Agustí Barnadas
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  2. Ricard Mesía
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  3. Margarita Majem
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Correspondence to Agustí Barnadas.

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Barnadas, A., Mesía, R., Majem, M. et al. Phase I/II docetaxel plus concurrent hyperfractionated radiotherapy in locally advanced unresectable head and neck cancer (TAX.ES1.102 study). Clin Transl Oncol 13, 254–260 (2011). https://doi.org/10.1007/s12094-011-0650-9

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  • DOI: https://doi.org/10.1007/s12094-011-0650-9

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