A randomized phase III trial comparing induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as treatment of unresectable head and neck cancer
R Hitt, J J Grau, A López-Pousa, A Berrocal, C García-Girón, A Irigoyen, J Sastre, J Martínez-Trufero, J A Brandariz Castelo, E Verger, J J Cruz-Hernández, Spanish Head and Neck Cancer Cooperative Group (TTCC), C Almodóvar, H Cortés-Funes, Y Escobar, E Fonseca-Sánchez, J C Galcerán, M Guix, D Isla-Casado, C Jara-Sánchez, M R Leitão-Silva, J R Mel-Lorenzo, M Pastor-Borgoñón, P Pastor-Gaitán, A Rodríguez-Jaráiz, J M Millán, J Satrustegui-Galdona, M Moreno, E Estefanía, E Santiago, J J García, R Hitt, J J Grau, A López-Pousa, A Berrocal, C García-Girón, A Irigoyen, J Sastre, J Martínez-Trufero, J A Brandariz Castelo, E Verger, J J Cruz-Hernández, Spanish Head and Neck Cancer Cooperative Group (TTCC), C Almodóvar, H Cortés-Funes, Y Escobar, E Fonseca-Sánchez, J C Galcerán, M Guix, D Isla-Casado, C Jara-Sánchez, M R Leitão-Silva, J R Mel-Lorenzo, M Pastor-Borgoñón, P Pastor-Gaitán, A Rodríguez-Jaráiz, J M Millán, J Satrustegui-Galdona, M Moreno, E Estefanía, E Santiago, J J García
Abstract
Background: Concurrent 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 methods: Patients 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/m(2) 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).
Results: In 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.
Conclusion: Overall, this trial failed to show any advantage of ICT-CCRT over CCRT alone in patients with unresectable LASCCHN.
Trial registration: ClinicalTrials.gov NCT00261703.
Keywords: chemoradiotherapy; head and neck cancer; induction chemotherapy; unresectable.
Source: PubMed