2022
Phase 2 LEAP-009: Lenvatinib (Lenva) With or Without Pembrolizumab (Pembro) vs. Chemotherapy (Chemo) for Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That has Progressed on Platinum and Immunotherapy
Harrington K, Cohen E, Siu L, Rischin D, Licitra L, Vermorken J, Le Q, Tahara M, Machiels J, Hawk N, Ge J, Bidadi B, Swaby R, Burtness B. Phase 2 LEAP-009: Lenvatinib (Lenva) With or Without Pembrolizumab (Pembro) vs. Chemotherapy (Chemo) for Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That has Progressed on Platinum and Immunotherapy. International Journal Of Radiation Oncology • Biology • Physics 2022, 112: e43-e44. DOI: 10.1016/j.ijrobp.2021.12.101.Peer-Reviewed Original ResearchPD-1/PD-L1 inhibitorsECOG performance statusPD-L1 inhibitorsM HNSCCDisease progressionRECIST v1.1Monotherapy armPerformance statusPO QDPD-L1 tumor proportion scoreOptimal second-line regimenEnd pointNeck squamous cell carcinomaPrimary end pointSecond-line regimenSecondary end pointsFirst-line treatmentTumor proportion scoreKey eligibility criteriaSquamous cell carcinomaInterim futility analysisMeasurable diseaseSOC chemotherapyMetastatic headUnacceptable toxicity
2012
LUX head and neck 2: A randomized, double-blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected, clinically high-risk, head and neck cancer patients.
Burtness B, Bourhis J, Vermorken J, Dai L, Lind C, Ehrnrooth E, Cohen E. LUX head and neck 2: A randomized, double-blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected, clinically high-risk, head and neck cancer patients. Journal Of Clinical Oncology 2012, 30: tps5599-tps5599. DOI: 10.1200/jco.2012.30.15_suppl.tps5599.Peer-Reviewed Original ResearchDisease-free survivalNeck dissectionPO QDAdvanced squamous cell cancerIrreversible ErbB family blockerAdequate bone marrowErbB family blockerStudy of afatinibSubsequent neck dissectionCompletion of chemoradiationEvidence of diseaseHigh-risk patientsSecond primary tumorsHealth-related qualityBase of tongueSquamous cell cancerRisk of recurrenceNeck cancer patientsPlatinum-based chemoradiationSalivary gland cancerConcurrent cisplatinCurative intentDefinitive chemoradiationPrior therapyStudy medication