Journal of the National Cancer Institute Advance Access originally published online on March 24, 2009
JNCI Journal of the National Cancer Institute 2009 101(7):498-506; doi:10.1093/jnci/djp007
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© The Author 2009. Published by Oxford University Press.
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Randomized Trial of Induction Chemotherapy With Cisplatin and 5-Fluorouracil With or Without Docetaxel for Larynx Preservation
Affiliations of authors: Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique d’Oncologie et de Radiothérapie, Tours, France (YP, PG, SC, GC); Centre Hospitalier de Lorient, Lorient, France (CS); Centre Paul Papin, Angers, France (CT); Centre Jean Perrin, Clermond-Ferrand, France (JT); Institut Gustave Roussy, Villejuif, France (SF); Centre Hospitalier Universitaire Poitiers, Poitiers, France (SG); Clinique Sainte Catherine, Avignon, France (MA)
Correspondence to: Gilles Calais, Henry Kaplan Center, Clinique d’Oncologie et de Radiothérapie, Centre Hospitalier Régional et Universitaire de Tours, 2 Blvd Tonnellé, 37044 Tours, France (e-mail: calais{at}med.univ-tours.fr).
Background: Chemotherapy with cisplatin (P) and 5-fluorouracil (F) followed by radiotherapy in patients who respond to chemotherapy is an alternative to total laryngectomy for patients with locally advanced larynx and hypopharynx cancer. Data suggest that docetaxel (T) may add to the efficacy of PF. The objective of this trial was to determine whether adding T to PF could increase the larynx preservation rate.
Methods: Patients who had larynx and hypopharynx cancer that required total laryngectomy were randomly assigned to receive three cycles of TPF or PF. Patients who responded to chemotherapy received radiotherapy with or without additional chemotherapy. Patients who did not respond to chemotherapy underwent total laryngectomy followed by radiotherapy with or without additional chemotherapy. The primary endpoint was 3-year larynx preservation rate. Secondary endpoints included acute toxicities and overall response. All statistical tests were two-sided.
Results: Baseline patient and tumor characteristics were well balanced between the TPF (n = 110) and PF (n = 103) groups. With a median follow-up of 36 months, the 3-year actuarial larynx preservation rate was 70.3% with TPF vs 57.5% with PF (difference = 12.8%; P = .03). Patients in the TPF group had more grade 2 alopecia, grade 4 neutropenia, and febrile neutropenia, whereas patients in the PF group had more grade 3 and 4 stomatitis, thrombocytopenia, and grade 4 creatinine elevation. The overall response was 80.0% in the TPF group vs 59.2% in the PF group (difference = 20.8%; P = .002).
Conclusions: In patients with advanced larynx and hypopharynx carcinomas, TPF induction chemotherapy was superior to the PF regimen in terms of overall response rate. These results suggest that larynx preservation could be achieved for a higher proportion of patients.
| CONTEXT AND CAVEATS Prior knowledge Treatment with chemotherapy using cisplatin and 5-fluorouracil followed by radiation therapy for those who respond to chemotherapy is an alternative to total laryngectomy for patients with advanced cancer of the larynx and hypopharynx. Adding docetaxel may increase the efficacy of the chemotherapy regimen and the ability to preserve the larynx. Study design Randomized phase III trial of cisplatin plus 5-fluorouracil with or without docetaxel for patients with advanced cancer of the larynx and hypopharynx that required total laryngectomy. Outcomes were 3-year larynx preservation rate, acute toxicities, and overall response. Contributions The 3-year larynx preservation rate was 70.3% with the cisplatin, 5-fluorouracil, docetaxel combination and 57.5% without docetaxel. Patients who were treated with the regimen containing docetaxel had more severe infections but had better overall response than those who did not receive docetaxel (80% vs 59.2%). Implications The addition of docetaxel to cisplatin and 5-fluorouracil improved overall response and increased larynx preservation in patients with advanced cancers of the larynx and hypopharynx. Limitations The study was designed for advanced cancers of the larynx and hypopharynx; thus, the findings should not be generalized to all sites of advanced cancers of the head and neck. From the Editors
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Manuscript received August 7, 2008; revised December 12, 2008; accepted January 7, 2009.
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J Natl Cancer Inst 2009 101: 437.
J Natl Cancer Inst 2009 101: 437.
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  R. I. Haddad Re: Randomized Trial of Induction Chemotherapy With Cisplatin and 5-Fluorouracil With or Without Docetaxel for Larynx Preservation J Natl Cancer Inst, August 19, 2009; 101(16): 1157 - 1158. [Full Text] [PDF]
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