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A randomized phase III trial comparing induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as treatment of unresectable head and neck cancer

2013; Elsevier BV; Volume: 25; Issue: 1 Linguagem: Inglês

10.1093/annonc/mdt461

1569-8041

Ricardo Hitt, Juan J. Grau, Antonio López‐Pousa, Alfonso Berrocal, Carlos García Girón, Antonio Irigoyen López, Javier Sastre, Javier Martínez‐Trufero, J.A. Brandariz Castelo, E. Verger, Juan Jesús Cruz, Carmen Ruiz de Almodóvar, H. Cortés-Funes, Yolanda Escobar, Emilio Fonseca‐Sánchez, Joan Carles, Marta Guix, D. Isla-Casado, Carlos Jara-Sánchez, M.R. Leitão-Silva, Jose Ramón Mel-Lorenzo, M. Pastor-Borgoñón, P. Pastor-Gaitán, A. Rodríguez-Jaráiz, José M. Millán, J. Satrustegui-Galdona, María Cruz Moreno, E. Estefanía, Enrique Santiago, Javier García,

Salivary Gland Tumors Diagnosis and Treatment

BackgroundConcurrent chemoradiotherapy (CCRT) is the standard treatment for patients with unresectable, nonmetastatic locoregionally advanced squamous-cell carcinoma of the head and neck (LASCCHN). This randomized, open-label, phase III clinical trial compared the efficacy between standard CCRT and two different induction chemotherapy (ICT) regimens followed by CCRT.Patients and methodsPatients with untreated LASCCHN were randomly assigned to ICT (three cycles), with either docetaxel (Taxotere), cisplatin and 5-fluorouracil (TPF arm) or cisplatin and 5-fluorouracil (PF arm), followed by CCRT [7 weeks of radiotherapy (RT) with cisplatin 100 mg/m2 on days 1, 22 and 43]; or 7 weeks of CCRT alone. The primary end points were progression-free survival (PFS) and time-to-treatment failure (TTF).ResultsIn the intention-to-treat (ITT) population (n = 439), the median PFS times were 14.6 (95% CI, 11.6–20.4), 14.3 (95% CI, 11.8–19.3) and 13.8 months (95% CI, 11.0–17.5) at TPF-CCRT, PF-CCRT and CCRT arms, respectively (log-rank P = 0.56). The median TTF were 7.9 (95% CI, 5.9–11.8), 7.9 (95% CI, 6.5–11.8) and 8.2 months (95% CI, 6.7–12.6) for TPF-CCRT, PF-CCRT and CCRT alone, respectively (log-rank P = 0.90). There were no statistically significant differences for overall survival (OS). Toxic effects from ICT-CCRT were manageable.ConclusionOverall, this trial failed to show any advantage of ICT-CCRT over CCRT alone in patients with unresectable LASCCHN (ClinicalTrials.gov number, NCT00261703).