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
| Autor: | Martínez-Trufero J, Lozano Borbalas A, Pajares Bernad I, Taberna Sanz M, Ortega Izquierdo E, Cirauqui Cirauqui B, Rubió-Casadevall J, Plana Serrahima M, Ponce Ortega JM, Planas Toledano I, Caballero J, Marruecos Querol J, Iglesias Docampo L, Lambea Sorrosal J, Adansa JC, Mesía Nin R |
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| Rok vydání: | 2020 |
| Předmět: |
Aged
80 and over Male Paclitaxel Squamous Cell Carcinoma of Head and Neck Panitumumab Comorbidity EGFR tyrosine kinase inhibitor Head and neck neoplasms Induction chemotherapy Panitumumab Squamous cell carcinoma Induction Chemotherapy Middle Aged Progression-Free Survival stomatognathic diseases Head and Neck Neoplasms Spain Cause of Death Antineoplastic Combined Chemotherapy Protocols Early Termination of Clinical Trials Humans Female Organ Sparing Treatments Aged |
| Zdroj: | CLINICAL & TRANSLATIONAL ONCOLOGY r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe instname |
| ISSN: | 1699-3055 1699-048X |
| Popis: | 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.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.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.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. |
| Databáze: | OpenAIRE |
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