A randomized phase III trial comparing induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as treatment of unresectable head and neck cancer
Por:
Hitt, R, Grau, JJ, Lopez-Pousa, A, Berrocal, A, Garcia-Giron, C, Irigoyen, A, Sastre, J, Martinez-Trufero, J, Castelo, JAB, Verger, E, Cruz-Hernandez, JJ
Publicada:
1 ene 2014
Resumen:
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 (ClinicalTrials.gov number, NCT00261703).
Filiaciones:
Hitt, R:
Hosp Univ 12 Octubre, Dept Med Oncol, Madrid, Spain
Grau, JJ:
Hosp Clin I Prov, Dept Med Oncol, Barcelona, Spain
Lopez-Pousa, A:
Hosp Santa Creu & Sant Pau, Dept Med Oncol, Barcelona, Spain
Berrocal, A:
Hosp Gen Univ, Dept Med Oncol, Valencia, Spain
Garcia-Giron, C:
Hosp Gen Yague, Dept Med Oncol, Burgos, Spain
Irigoyen, A:
Hosp Univ Virgen de las Nieves, Dept Med Oncol, Granada, Spain
Sastre, J:
Hosp Clin San Carlos, Dept Med Oncol, Madrid, Spain
Martinez-Trufero, J:
Hosp Univ Miguel Servet, Dept Med Oncol, Zaragoza, Spain
Castelo, JAB:
Univ Hosp, Dept Otorhinolaryngol, Madrid, Spain
Verger, E:
Hosp Clin I Prov, Dept Med Oncol, Barcelona, Spain
Cruz-Hernandez, JJ:
Hosp Clin Univ, Dept Med Oncol, Salamanca, Spain
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