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Induction chemotherapy followed by concomitant radiotherapy and weekly cisplatin versus the same concomitant chemoradiotherapy in patients with nasopharyngeal carcinoma: a randomized phase II study conducted by the Hellenic Cooperative Oncology Group (HeCOG) with biomarker evaluation
Affiliation:1. Department ofMedical Oncology “Papageorgiou” Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece;2. Department ofRadiation Oncology, “Ion Chiricuta” Cancer Institute, Cluj, Romania;3. Laboratory of Molecular Oncology, Hellenic Foundation for Cancer Research, Aristotle University of Thessaloniki School of Medicine, Thessaloniki;4. Department of Radiology “AHEPA” Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki;5. Section of Biostatistics, Hellenic Cooperative Oncology Group, Data Office, Athens;6. Department of Pathology, Aristotle University of Thessaloniki School of Medicine, Thessaloniki;7. Department of Otorinolaryngology, “AHEPA” Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki;8. Department of Pathology, “Ion Chiricuta” Cancer Institute, Cluj, Romania;9. Third Department of Medical Oncology, “Agii Anargiri” Cancer Hospital, Athens;10. Department of Radiation Oncology, “Agii Anargiri” Cancer Hospital, Athens;11. Department of Radiation Oncology, “Papageorgiou” Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki;12. Second Department of Medical Oncology, “Metropolitan” Hospital, Piraeus, Greece;13. Department of Medical Oncology, “Ion Chiricuta” Cancer Institute, Cluj, Romania
Abstract:BackgroundConcomitant administration of radiation therapy (RT) and chemotherapy with cisplatin (CCRT) is considered standard treatment in patients with locally advanced nasopharyngeal cancer (LA-NPC). The role of induction chemotherapy (IC) when followed by CCRT in improving locoregional control remains controversial.Patients and methodsTotally, 141 eligible patients with LA-NPC were randomized to either three cycles of IC with cisplatin 75 mg/m2, epirubicin 75 mg/m2 and paclitaxel (Taxol) 175 mg/m2 (CEP) every 3 weeks followed by definitive RT (70 Gy) and concomitant weekly infusion of cisplatin 40 mg/m2 (investigational arm, 72 patients) or to the same CCRT regimen alone (control arm, 69 patients).ResultsSixty-two patients (86%) received three cycles of IC. No difference between the arms was observed in the number of patients who completed RT (61 versus 64, P = 018). Overall and complete response rates were very similar in the two arms and so were 3-year progression-free and overall survival rates. Grade III or IV toxic effects from IC were infrequent, apart of alopecia. Mucositis, weight loss and leukopenia were the most prominent side-effects from CCRT.ConclusionIC with three cycles of CEP when followed by CCRT did not significantly improve response rates and/or survival compared with that of CCRT alone.
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