A prospective multicenter phase II trial of induction chemotherapy followed by bio-chemoradiotherapy for locally advanced recurrent nasopharyngeal carcinoma
Mené à Hong Kong auprès de 33 patients atteints d'un carcinome rhinopharyngé récidivant de stade localement avancé (durée médiane de suivi : 28,5 mois), cet essai multicentrique de phase II évalue l'efficacité, du point de vue notamment du taux de réponse complète, du contrôle régional de la maladie et des taux de survie, et la toxicité d'une chimiothérapie d'induction par docétaxel-cisplatine-fluorouracile suivie d'un traitement combinant de manière concomitante docétaxel, cétuximab et radiothérapie avec modulation d'intensité
Objectives : Re-irradiation is the preferred treatment modality as salvage for the majority of patients with advanced locally recurrent nasopharyngeal carcinoma (rNPC). This prospective phase II study evaluated if induction docetaxel, cisplatin and fluorouracil (TPF) followed by weekly docetaxel and cetuximab in concurrence with intensity modulated radiotherapy, can improve the treatment outcome for these patients. Materials/Methods : 33 patients with rNPC (T3 – T4, N0 – N1, M0) were recruited. 19 patients (57.6%) had stage rT3 recurrence and the rest had stage rT4. 8 patients also had rN1 at the time of relapse. Treatment outcomes and safety were evaluated. Results : Amongst these 33 patients, 1 died after one cycle of TPF, 5 patients withdrew from the study during the induction period due to ≥ grade 3 toxicities; 27 patients completed the whole course of treatment but one died before any assessment could be made. The median follow-up period was 28.5 months. The progression-free survival and overall survival at 3 years for the whole group were 35.7% and 63.8% respectively. Among the 26 patients who could be assessed after treatment, the complete response rate was 30.8% and the loco-regional control rate at 3 years was 49.2%. Temporal lobe necrosis (TLN) developed in 8 cases. The rates of ≥ grade 3 hearing loss, soft tissue necrosis, dysphagia and trismus were 30.8%, 15.4%, 11.5% and 19.2%, respectively. Overall, 5 patients died due to acute (1 after cycle 1 TPF & 1 after completion of bio-chemoradiotherapy) or late (2 epistaxis and 1 TLN) treatment-related complications. Conclusions : The proposed salvage treatment regimen for advanced locally recurrent NPC could achieve a better treatment outcome than previous studies. However, poor tolerability of induction TPF and high rate of TLN limit its applicability outside clinical trials.
http://www.redjournal.org/article/S0360-3016(17)34164-0/fulltext 2017