Resumen de Sequential chemotherapy regimen of induction with panitumumab and paclitaxel followed by radiotherapy and panitumumab in patients with locally advanced head and neck cancer unft for platinum derivatives. The phase II, PANTERA/TTCC‑2010‑06 study

Javier Martínez Trufero, Alicia Lozano, Isabel Pajares Bernad, M. Taberna, Eugenia Ortega Izquierdo, Beatriz Cirauqui Cirauqui, J. Rubió Casadevall, M. Plana Serrahima, J.M. Ponce Ortega, Isabel Planas Toledano, Javier Caballero Daroqui, J. Marruecos, Lara Iglesias Docampo, Julio José Lambea Sorrosal, Juan Carlos Adansa Klain, Ricard Mesía Nin

• Background Sequential treatment of Panitumumab (Pb) plus Paclitaxel (Px) as induction treatment (IT) followed by concurrent bioradiotherapy (Bio–RT) with Pb may be an alternative for locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) in patients ineligible for high-dose cisplatin therapy.

  Methods Phase II, single-arm, multicentre study, with two-stage design, in patients≥18 years with stage III–IVa–b LASCCHN unft for platinum. Patients received Px+Pb (9 weeks) as IT followed by Bio–RT+Pb. Primary endpoint: overall response rate (ORR) after IT, defned as: more than 70% of patients achieving complete response (CR) or partial response (PR) to IT. Secondary end-points: progression-free survival, organ preservation rate, safety profle.

  Results Study ended prematurely (51 patients) due to slow recruitment. ORR: 66.7% (95% CI: 53.7–79.6), 8 (15.7%) CR and 26 (51.0%) PR. 39 patients (76%) completed radiotherapy (RT). Pb and/or Px-related adverse events (AEs) grade 3–4:

  56.9% during IT and 63.4% during the concomitant phase, of which most common were skin toxicity (33.3%). Five deaths occurred during treatment, two of them (3.9%) were Pb and/or Px-related.

  Conclusions Although underpowered, ORR was higher than the pre-specifed boundary for considering the treatment active.

  Although Px+Pb as IT provides some beneft, the safety profle is worse than expected. To consider Pb+Px as IT as an alternative for platinum-unsuitable LA-SCCHN, further research/investigation would be needed