International Journal of Radiation Oncology * Biology * Physics
Volume 77, Issue 1 , Pages 9-15, 1 May 2010

Radiochemotherapy With Cetuximab, Cisplatin, and Amifostine for Locally Advanced Head and Neck Cancer: A Feasibility Study

  • Michael I. Koukourakis, M.D.

      Affiliations

    • Department of Radiotherapy/Oncology, Democritus University of Thrace, Alexandroupolis, Greece
    • Corresponding Author InformationReprint requests to: Michael I. Koukourakis, M.D., Department of Radiotherapy/Oncology, Democritus University of Thrace, PO Box 12, Alexandroupolis 68100, Greece. Tel: (25) 510-74622; Fax: (25) 510-30349
  • ,
  • Pelagia G. Tsoutsou, M.D.

      Affiliations

    • Department of Radiotherapy/Oncology, Democritus University of Thrace, Alexandroupolis, Greece
  • ,
  • Antonios Karpouzis, M.D.

      Affiliations

    • Department of Dermatology, Democritus University of Thrace, Alexandroupolis, Greece
  • ,
  • Maria Tsiarkatsi, M.Sc.

      Affiliations

    • Department of Dermatology, Democritus University of Thrace, Alexandroupolis, Greece
  • ,
  • Ilias Karapantzos, M.D.

      Affiliations

    • Department of ENT Clinic, Democritus University of Thrace, Alexandroupolis, Greece
  • ,
  • Vassilios Daniilidis, M.D.

      Affiliations

    • Department of ENT Clinic, Democritus University of Thrace, Alexandroupolis, Greece
  • ,
  • Constantinos Kouskoukis

      Affiliations

    • Department of ENT Clinic, Democritus University of Thrace, Alexandroupolis, Greece

Received 26 February 2009; received in revised form 21 March 2009; accepted 10 April 2009. published online 09 September 2009.

Purpose

Radiotherapy (RT) combined with cisplatin or cetuximab is the standard of care for patients with locally advanced head/neck cancer (LA-HNC). The feasibility of radiochemotherapy with cisplatin and cetuximab, supported with amifostine, was herein investigated.

Methods and Materials

Forty-three patients with LA-HNC were recruited. Conformal hypofractionated/accelerated RT with amifostine cytoprotection (2.7 Gy/fraction, 21 fractions in 4 weeks) was combined with cisplatin (30 mg/m2/week) and cetuximab (standard weekly regimen) therapy. The dose of amifostine was individualized according to tolerance.

Results

A high daily amifostine dose (750–1,000 mg) was tolerated by 41.8% of patients, and a standard dose (500 mg) was tolerated by 34.9% of patients. A high amifostine dose was linked to reduced RT delays (p = 0.0003). Grade 3 to 4 (3-4) mucositis occurred in 7/43 (16.2%) patients, and fungal infections occurred in 18/43 (41.8%) patients. Radiation dermatitis was not aggravated. Interruption of cetuximab due to acneiform rash was necessary in 23.3% of patients, while amifostine-related fever and rash were not observed. Severe late radiation sequelae consisted of laryngeal edema (9% laryngeal cases) and cervical strictures (33% of hypopharyngeal cases). Good salivary function was preserved in 6/11 (54.5%) nasopharyngeal cancer patients. The complete response rate was 68.5%, reaching 77.2% in patients with minor radiotherapy delays. The 24-month local control and survival rates were 72.3% and 91%, respectively (median follow-up was 13 months.).

Conclusions

In this feasibility study, weekly administration of cisplatin and cetuximab was safely combined with accelerated RT, supported with amifostine, at the cost of a high incidence of acneiform rash but a reduced incidence of amifostine-related fever/rash. A high daily dose of amifostine allows completion of therapy with minor delays.

Radiotherapy, Acceleration, Cetuximab, Cisplatin, Amifostine

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 Conflict of interest: none.

PII: S0360-3016(09)00659-2

doi:10.1016/j.ijrobp.2009.04.060

International Journal of Radiation Oncology * Biology * Physics
Volume 77, Issue 1 , Pages 9-15, 1 May 2010