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Platinum-based chemotherapy (CT) plus cetuximab in recurrent or metastatic squamous cell carcinoma of the head and neck cancer (R/M-SCCHN): 5-year follow-up data for the extreme trial.
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2014
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Neck CancerNeoadjuvant TherapyExtreme TrialCt ArmTreatment VerificationRadiation MedicineOncologyClinical TrialsNeck OncologyClinical Radiation OncologyRadiation OncologyCancer ResearchMolecular OncologyRadiologyHealth SciencesCancer TreatmentPlatinum-based ChemotherapyCetuximab MaintenanceHead And Neck CancerMedicineCancer Therapeutics
6021^ Background: The EXTREME trial demonstrated that patients with R/M-SCCHN benefit significantly from the addition of cetuximab to first-line platinum-based CT in relation to overall survival, progression-free survival (PFS) and response rate. We report the 5-year follow-up data. Methods: The intent-to-treat (ITT) population comprised patients (pts) randomized to receive either platinum-based CT plus cetuximab (n=222) or CT alone (n=220) for 18 weeks (6 x 3-week cycles). Results: A total of 100 pts in the cetuximab arm who had at least stable disease received cetuximab monotherapy until disease progression or unacceptable toxicity, with a median treatment duration of 29.9 weeks. For 77% of these pts, the relative dose intensity (RDI) of cetuximab was ≥90% during this maintenance period. Thirty-one (14%) pts in the cetuximab arm and 25 (11%) in the CT arm of the ITT population were deemed long-term survivors (>2 years). Of these, 6 (22%) and 5 (23%) pts were p16+ and 11 (35%) and 10 (40%) pts had oropharyngeal tumors, in both arms respectively. At 5-years, 6 pts treated with CT plus cetuximab and 2 pts treated with CT alone were still in the study and known to be alive. In pts in the cetuximab arm, the frequency of severe (grade 3-4) adverse events (AEs) decreased from 81% to 49% during the cetuximab maintenance period compared with the previous treatment period with CT plus cetuximab. Grade 3 skin toxicity decreased from 9% when combined with CT to 5% during cetuximab maintenance and no grade 4 skin toxicity was observed.Twelve pts (5%) in the cetuximab arm of the ITT population were long-term responders (PFS>12 months) compared with 3 pts (1%) in the CT arm, with a median treatment duration of 67.7 weeks. The RDI of cetuximab was ≥90% for all long-term responders. Conclusions: The addition of cetuximab to first-line platinum-based CT significantly improves outcome for patients with R/M-SCCHN. Although there are notable differences in long-term responders favoring cetuximab, the 5-year survival figures are still extremely low for both arms of the study. Cetuximab maintenance therapy proved to be feasible with manageable skin reactions. Clinical trial information: NCT00122460.