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Randomized trial of induction chemotherapy with cisplatin and 5-fluorouracil with or without docetaxel for larynx preservation.
- Source :
-
Journal of the National Cancer Institute [J Natl Cancer Inst] 2009 Apr 01; Vol. 101 (7), pp. 498-506. Date of Electronic Publication: 2009 Mar 24. - Publication Year :
- 2009
-
Abstract
- 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.<br />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.<br />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).<br />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.
- Subjects :
- Adult
Aged
Antineoplastic Combined Chemotherapy Protocols adverse effects
Chemotherapy, Adjuvant adverse effects
Cisplatin administration & dosage
Docetaxel
Female
Fluorouracil administration & dosage
Humans
Karnofsky Performance Status
Male
Middle Aged
Radiotherapy, Adjuvant adverse effects
Remission Induction
Taxoids administration & dosage
Treatment Outcome
Young Adult
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Carcinoma, Squamous Cell drug therapy
Carcinoma, Squamous Cell surgery
Hypopharyngeal Neoplasms drug therapy
Hypopharyngeal Neoplasms surgery
Laryngeal Neoplasms drug therapy
Laryngeal Neoplasms surgery
Laryngectomy methods
Neoadjuvant Therapy methods
Subjects
Details
- Language :
- English
- ISSN :
- 1460-2105
- Volume :
- 101
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Journal of the National Cancer Institute
- Publication Type :
- Academic Journal
- Accession number :
- 19318632
- Full Text :
- https://doi.org/10.1093/jnci/djp007