PMID- 33876416 OWN - NLM STAT- MEDLINE DCOM- 20211130 LR - 20211130 IS - 1699-3055 (Electronic) IS - 1699-048X (Linking) VI - 23 IP - 8 DP - 2021 Aug TI - Sequential chemotherapy regimen of induction with panitumumab and paclitaxel followed by radiotherapy and panitumumab in patients with locally advanced head and neck cancer unfit for platinum derivatives. The phase II, PANTERA/TTCC-2010-06 study. PG - 1666-1677 LID - 10.1007/s12094-021-02567-z [doi] AB - 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 LA-SCCHN unfit for platinum. Patients received Px + Pb (9 weeks) as IT followed by Bio-RT + Pb. Primary endpoint: overall response rate (ORR) after IT, defined 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 profile. 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-specified boundary for considering the treatment active. Although Px + Pb as IT provides some benefit, the safety profile is worse than expected. To consider Pb + Px as IT as an alternative for platinum-unsuitable LA-SCCHN, further research/investigation would be needed. FAU - Martinez-Trufero, J AU - Martinez-Trufero J AUID- ORCID: 0000-0002-0997-2573 AD - Medical Oncology Department, University Hospital Miguel Servet, Av. Isabel la Catolica 1-3, 50009, Zaragoza, Spain. jmtrufero@seom.org. FAU - Lozano Borbalas, A AU - Lozano Borbalas A AD - Radiation Oncology Service, Institut Catala D'Oncologia (ICO) Hospitalet, Barcelona, Spain. FAU - Pajares Bernad, I AU - Pajares Bernad I AD - Medical Oncology Department, University Hospital Miguel Servet, Av. Isabel la Catolica 1-3, 50009, Zaragoza, Spain. FAU - Taberna Sanz, M AU - Taberna Sanz M AD - Medical Oncology Service, Institut Catala D'Oncologia (ICO) Hospitalet, Barcelona, Spain. FAU - Ortega Izquierdo, E AU - Ortega Izquierdo E AD - Medical Oncology Department, University Hospital Miguel Servet, Av. Isabel la Catolica 1-3, 50009, Zaragoza, Spain. FAU - Cirauqui Cirauqui, B AU - Cirauqui Cirauqui B AD - Medical Oncology Service, Institut Catala D'Oncologia (ICO) Badalona, Barcelona, Spain. FAU - Rubio-Casadevall, J AU - Rubio-Casadevall J AD - Medical Oncology Service, Institut Catala D'Oncologia (ICO) Girona, University Hospital Josep Trueta, Girona, Spain. FAU - Plana Serrahima, M AU - Plana Serrahima M AD - Medical Oncology Service, Institut Catala D'Oncologia (ICO) Hospitalet, Barcelona, Spain. FAU - Ponce Ortega, J M AU - Ponce Ortega JM AD - Radiation Oncology Service, University Hospital Miguel Servet, Zaragoza, Spain. FAU - Planas Toledano, I AU - Planas Toledano I AD - Radiation Oncology Service, Institut Catala D'Oncologia (ICO) Badalona, Barcelona, Spain. FAU - Caballero, J AU - Caballero J AD - Medical Oncology Service, University and Polytechnic Hospital La Fe, Valencia, Spain. FAU - Marruecos Querol, J AU - Marruecos Querol J AD - Radiation Oncology Service, Institut Catala D'Oncologia (ICO) Girona, University Hospital Josep Trueta, Girona, Spain. FAU - Iglesias Docampo, L AU - Iglesias Docampo L AD - Medical Oncology Service, University Hospital 12 de Octubre, Madrid, Spain. FAU - Lambea Sorrosal, J AU - Lambea Sorrosal J AD - Medical Oncology Service, University Hospital Lozano Blesa, Zaragoza, Spain. FAU - Adansa, J C AU - Adansa JC AD - Biomedical Research Institute of Salamanca, Salamanca, Spain. FAU - Mesia Nin, R AU - Mesia Nin R AD - Medical Oncology Service, Institut Catala D'Oncologia (ICO) Hospitalet, Barcelona, Spain. CN - Grupo Espanol de Tratamiento de Tumores de Cabeza y Cuello (TTCC) LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study DEP - 20210419 PL - Italy TA - Clin Transl Oncol JT - Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico JID - 101247119 RN - 6A901E312A (Panitumumab) RN - P88XT4IS4D (Paclitaxel) SB - IM MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - Cause of Death MH - Early Termination of Clinical Trials MH - Female MH - Head and Neck Neoplasms/*drug therapy/mortality/pathology/*radiotherapy MH - Humans MH - Induction Chemotherapy/methods MH - Male MH - Middle Aged MH - Organ Sparing Treatments MH - Paclitaxel/adverse effects/*therapeutic use MH - Panitumumab/adverse effects/*therapeutic use MH - Progression-Free Survival MH - Spain MH - Squamous Cell Carcinoma of Head and Neck/*drug therapy/mortality/pathology/*radiotherapy OTO - NOTNLM OT - Comorbidity OT - EGFR tyrosine kinase inhibitor OT - Head and neck neoplasms OT - Induction chemotherapy OT - Panitumumab OT - Squamous cell carcinoma EDAT- 2021/04/21 06:00 MHDA- 2021/12/01 06:00 CRDT- 2021/04/20 06:45 PHST- 2020/11/07 00:00 [received] PHST- 2021/02/02 00:00 [accepted] PHST- 2021/04/21 06:00 [pubmed] PHST- 2021/12/01 06:00 [medline] PHST- 2021/04/20 06:45 [entrez] AID - 10.1007/s12094-021-02567-z [pii] AID - 10.1007/s12094-021-02567-z [doi] PST - ppublish SO - Clin Transl Oncol. 2021 Aug;23(8):1666-1677. doi: 10.1007/s12094-021-02567-z. Epub 2021 Apr 19.