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Clinical Trial
. 2012 Oct;23(10):2708-2714.
doi: 10.1093/annonc/mds065. Epub 2012 Apr 6.

Laryngeal preservation with induction chemotherapy for hypopharyngeal squamous cell carcinoma: 10-year results of EORTC trial 24891

J-L Lefebvre  1 , G Andry  2 , D Chevalier  3 , B Luboinski  4 , L Collette  5 , L Traissac  6 , D de Raucourt  7 , J A Langendijk  8 ; EORTC Head and Neck Cancer Group
Affiliations
Clinical Trial

Laryngeal preservation with induction chemotherapy for hypopharyngeal squamous cell carcinoma: 10-year results of EORTC trial 24891

J-L Lefebvre et al. Ann Oncol. 2012 Oct.

Abstract

Background: We report the 10-year results of the EORTC trial 24891 comparing a larynx-preservation approach to immediate surgery in hypopharynx and lateral epilarynx squamous cell carcinoma.

Material and methods: Two hundred and two patients were randomized to either the surgical approach (total laryngectomy with partial pharyngectomy and neck dissection, followed by irradiation) or to the chemotherapy arm up to three cycles of induction chemotherapy (cisplatin 100 mg/m(2) day 1 + 5-FU 1000 mg/m(2) day 1-5) followed for complete responders by irradiation and otherwise by conventional treatment. The end points were overall survival [OS, noninferiority: hazard ratio (preservation/surgery) ≤ 1.428, one-sided α = 0.05], progression-free survival (PFS) and survival with a functional larynx (SFL).

Results: At a median follow-up of 10.5 years on 194 eligible patients, disease evolution was seen in 54 and 49 patients in the surgery and chemotherapy arm, respectively, and 81 and 83 patients had died. The 10-year OS rate was 13.8% in the surgery arm and 13.1% in the chemotherapy arm. The 10-year PFS rates were 8.5% and 10.8%, respectively. In the chemotherapy arm, the 10-year SFL rate was 8.7%.

Conclusion: This strategy did not compromise disease control or survival (that remained poor) and allowed more than half of the survivors to retain their larynx.

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Figures

Figure 1.
Figure 1.
Study flowchart. o is the number of events; n is the number of patients. *Included in the primary analysis. CT, chemotherapy; RT, external beam radiotherapy; S, surgery.
Figure 2.
Figure 2.
Cumulative incidence of first progression. o is the number of events; n is the number of patients.
Figure 3.
Figure 3.
Overall survival. o is the number of events; n is the number of patients.
Figure 4.
Figure 4.
Progression-free survival (time to locoregional or distant recurrence, second cancer or death of any cause). o is the number of events; n is the number of patients.
Figure 5.
Figure 5.
Larynx preservation [survival with preserved larynx; i.e. without local evolution or tracheotomy or feeding tube (i.e. larynx function preservation and local control)]. o is the number of events; n is the number of patients.
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References

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