Induction chemotherapy with docetaxel/cisplatin/5-fluorouracil followed by randomization to two cisplatin-based concomitant chemoradiotherapy schedules in patients with locally advanced head and neck cancer (CONDOR study) (Dutch Head and Neck Society 08-01): A randomized phase II study

• Published in: European journal of cancer (1990) Vol. 52; pp. 77 - 84
• Main Authors: Driessen, C.M.L, de Boer, J.P, Gelderblom, H, Rasch, C.R.N, de Jong, M.A, Verbist, B.M, Melchers, W.J.G, Tesselaar, M.E.T, van der Graaf, W.T.A, Kaanders, J.H.A.M, van Herpen, C.M.L
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.01.2016
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Chemoradiotherapy; Chemoradiotherapy - adverse effects; Chemoradiotherapy - methods; Chemoradiotherapy - mortality; Cisplatin - adverse effects; Cisplatin - therapeutic use; Disease Progression; Disease-Free Survival; Early Termination of Clinical Trials; Feasibility Studies; Female; Fluorouracil - adverse effects; Fluorouracil - therapeutic use; Head and neck cancer; Head and Neck Neoplasms - mortality; Head and Neck Neoplasms - pathology; Head and Neck Neoplasms - therapy; Hematology, Oncology and Palliative Medicine; Humans; Induction Chemotherapy; Kaplan-Meier Estimate; Male; Middle Aged; Neoplasm Metastasis; Neoplasm Recurrence, Local; Netherlands; Radiotherapy Dosage; Risk Factors; Taxoids - adverse effects; Taxoids - therapeutic use; Time Factors; TPF; Treatment Outcome; Netherlands; Head and neck cancer; Induction chemotherapy; TPF; Chemoradiotherapy
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2015.09.024

Abstract Purpose To study the feasibility of induction chemotherapy added to concomitant cisplatin-based chemoradiotherapy (CRT) in patients with locally advanced head and neck cancer (LAHNC). Patients and methods LAHNC patients were treated with 4 courses of docetaxel/cisplatin/5-fluorouracil (TPF) followed by randomization to either cisplatin 100 mg/m2 with conventional radiotherapy (cis100 + RT) or cisplatin 40 mg/m2 weekly with accelerated radiotherapy (cis40 + ART). Primary endpoint was feasibility, defined as receiving ≥90% of the scheduled total radiation dose. Based on power analysis 70 patients were needed. Results 65 patients were enrolled. The data safety monitoring board advised to prematurely terminate the study, because only 22% and 41% (32% in total) of the patients treated with cis100 + RT (n = 27) and cis40 + ART (n = 29) could receive the planned dose cisplatin during CRT, respectively, even though the primary endpoint was reached. Most common grade 3–4 toxicity was febrile neutropenia (18%) during TPF and dehydration (26% vs 14%), dysphagia (26% vs 24%) and mucositis (22% vs 57%) during cis100 + RT and cis40 + ART, respectively. For the patients treated with cis100 + RT and cis40 + ART, two years progression free survival and overall survival were 70% and 78% versus 72% and 79%, respectively. Conclusion After TPF induction chemotherapy, cisplatin-containing CRT is not feasible in LAHNC patients, because the total planned cisplatin dose could only be administered in 32% of the patients due to toxicity. However, all but 2 patients received more than 90% of the planned radiotherapy. Clinical Trials Information: NCT00774319.