Vol 14: Rationale and design of LUX-Head and Neck 1: a randomised, Phase III trial of afatinib versus methotrexate in patients with recurrent and-or metastatic head and neck squamous cell carcinoma who progressed after platinum-Report as inadecuate



 Vol 14: Rationale and design of LUX-Head and Neck 1: a randomised, Phase III trial of afatinib versus methotrexate in patients with recurrent and-or metastatic head and neck squamous cell carcinoma who progressed after platinum-


Vol 14: Rationale and design of LUX-Head and Neck 1: a randomised, Phase III trial of afatinib versus methotrexate in patients with recurrent and-or metastatic head and neck squamous cell carcinoma who progressed after platinum- - Download this document for free, or read online. Document in PDF available to download.

Download or read this book online for free in PDF: Vol 14: Rationale and design of LUX-Head and Neck 1: a randomised, Phase III trial of afatinib versus methotrexate in patients with recurrent and-or metastatic head and neck squamous cell carcinoma who progressed after platinum-
This article is from BMC Cancer, volume 14.AbstractBackground: Patients with recurrent and-or metastatic R-M head and neck squamous cell carcinoma HNSCC receiving platinum-based chemotherapy as their first-line treatment have a dismal prognosis, with a median overall survival OS of ~7 months. Methotrexate is sometimes used following platinum failure or in patients not fit enough for platinum therapy, but this agent has not demonstrated any OS improvement. Targeted therapies are a novel approach, with the EGFR-targeting monoclonal antibody cetuximab plus platinum-based chemotherapy approved in the US and Europe in the first-line R-M setting, and as monotherapy following platinum failure in the US. However, there is still a high unmet medical need for new treatments that improve outcomes in the second-line R-M setting following failure on first-line platinum-containing regimens. Afatinib, an irreversible ErbB family blocker, was recently approved for the first-line treatment of EGFR mutation-positive metastatic non-small cell lung cancer. Afatinib has also shown clinical activity similar to cetuximab in a Phase II proof-of-concept HNSCC trial. Based on these observations, the Phase III, LUX-Head & Neck 1 study is evaluating afatinib versus methotrexate in R-M HNSCC patients following progression on platinum-based chemotherapy in the R-M setting. Methods-Design: Patients with progressive disease after one first-line platinum-based chemotherapy are randomised 2:1 to oral afatinib starting dose 40 mg once daily or IV methotrexate starting dose 40 mg-m2 once weekly administered as monotherapy with best supportive care until progression or intolerable adverse events. Efficacy of afatinib versus methotrexate will be assessed in terms of progression-free survival primary endpoint. Disease progression will be evaluated according to RECIST v1.1 by investigator and independent central review. Secondary endpoints include OS, tumour response and safety. Health-related quality of life and biomarker assessments will also be performed. Discussion: If the LUX-Head & Neck 1 trial meets its primary endpoint, it will demonstrate the ability of afatinib to elicit an improved treatment benefit versus a commonly used chemotherapy agent in the second-line treatment of R-M HNSCC patients who have failed on first-line platinum-based therapy, confirm the clinical efficacy of afatinib observed in the Phase II proof-of-concept study, and establish a new standard of care for this patient population.



Author: Machiels, Jean-Pascal H; Licitra, Lisa F; Haddad, Robert I; Tahara, Makoto; Cohen, Ezra EW

Source: https://archive.org/







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