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

• J. Martínez Trufero ^[2] ; A. Lozano Borbalas ^[1] ; I. Pajares Bernad ^[2] ; M. Taberna Sanz ^[1] ; E. Ortega Izquierdo ^[2] ; B. Cirauqui Cirauqui ^[1] ; J. Rubió Casadevall ^[3] ; M. Plana Serrahima ^[1] ; J.M. Ponce Ortega ^[4] ; I. Planas Toledano ^[1] ; J. Caballero ^[5] ; J. Marruecos Querol ^[6] ; L. Iglesias Docampo ^[7] ; J. Lambea Sorrosal ^[8] ; J. C. Adansa ^[9] ; R. Mesía Nin ^[9]
  1. [1] Institute Catalá Oncología

     Institute Catalá Oncología

     Barcelona, España

     
  2. [2] Medical Oncology Department, University Hospital Miguel Servet, Av. Isabel la Católica 1-3, 50009 Zaragoza, Spain
  3. [3] Medical Oncology Service, Institut Català D’Oncologia (ICO) Girona, University Hospital Josep Trueta, Girona, Spain
  4. [4] Radiation Oncology Service, University Hospital Miguel Servet, Zaragoza, Spain
  5. [5] Medical Oncology Service, University and Polytechnic Hospital La Fe, Valencia, Spain
  6. [6] Radiation Oncology Service, Institut Català D’Oncologia (ICO) Girona, University Hospital Josep Trueta, Girona, Spain
  7. [7] Medical Oncology Service, University Hospital 12 de Octubre, Madrid, Spain
  8. [8] Medical Oncology Service, University Hospital Lozano Blesa, Zaragoza, Spain
  9. [9] Biomedical Research Institute of Salamanca, Salamanca, Spain

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• Localización: Clinical & translational oncology, ISSN 1699-048X, Vol. 23, Nº. 8, 2021, págs. 1666-1677
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • 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