Abstract
Background
We performed a prospective phase II trial to investigate the safety and efficacy of radiotherapy combined with capecitabine in patients suffering from a recurrence of a squamous cell carcinoma of the head and neck (SCCHN) within a previously irradiated field.
Patients and methods
A total of 31 evaluable patients with recurrent SCCHN received re-irradiation with a total dose of 50 Gy (25 fractions over 5 weeks) up to a maximum of 60 Gy combined with 900 mg/m2/day capecitabine given on the days of radiotherapy.
Results
The median time to relapse after the first course of radiotherapy was 15 months. The overall response rate in our study was 68% including 6 patients with a complete response. The median overall survival was 8.4 months. Grade 3 or 4 mucositis occurred in 4 patients and 1 patient, respectively. No grade 4 hematological toxicities were observed; 1 patient had grade 3 anemia. The cumulative median lifetime dose was 116 Gy.
Conclusion
Capecitabine combined with re-irradiation is a well-tolerated treatment in patients with recurrent SCCHN. In light of its good tolerability, it appears to be a potential option for patients with a reduced performance status and may also serve as a basis for novel treatment concepts, such as in combination with targeted therapies.
Zusammenfassung
Hintergrund
Wir führten eine prospektive Phase-II-Studie durch, um die Sicherheit und Effektivität einer Strahlentherapie kombiniert mit Capecitabin bei Patienten mit Rezidiven eines Plattenepithelkarzinoms der Kopf-Hals-Region, die in einem vorbestrahlten Areal auftraten, zu ermitteln.
Patienten und Methode
Insgesamt 31 auswertbare Patienten mit einem rezidivierten Plattenepithelkarzinom der Kopf-Hals-Region erhielten eine Re-Irradiation mit einer Gesamtdosis von 50 Gy (25 Fraktionen in 5 Wochen) bis zu maximal 60 Gy in Kombination mit 900 mg/m2/Tag Capecitabin an Bestrahlungstagen.
Ergebnisse
Das mediane Intervall zwischen Erstbestrahlung und Rezidiv betrug 15 Monate. Die Gesamtansprechrate in unserer Studie betrug 68%, einschließlich 6 kompletten Remissionen. Das mediane Überleben betrug 8,4 Monate. Mukositis Grad 3 fand sich bei 4 Patienten, Mukositis Grad 4 bei 1 Patienten. Außer 1 Fall von Grad-3-Anämie traten keine hämatologischen Grad-3/4-Nebenwirkungen auf. Die kumulative mediane Gesamtlebensdosis betrug 116 Gy.
Schlussfolgerung
Capecitabin in Kombination mit Re-Irradiation ist gut verträglich bei Patienten mit rezidiviertem Plattenepithelkarzinom des Kopf-Hals-Bereichs. Die gute Verträglichkeit empfiehlt dieses Behandlungsregime für Patienten in reduziertem Allgemeinzustand und kann auch als Basis für neue Behandlungskonzepte dienen, wie z. B. in Kombination mit zielgerichteten Therapien.
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Vormittag, L., Lemaire, C., Radonjic, D. et al. Re-irradiation combined with capecitabine in locally recurrent squamous cell carcinoma of the head and neck. Strahlenther Onkol 188, 235–242 (2012). https://doi.org/10.1007/s00066-011-0040-9
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DOI: https://doi.org/10.1007/s00066-011-0040-9