2016
Antitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort
Chow LQM, Haddad R, Gupta S, Mahipal A, Mehra R, Tahara M, Berger R, Eder JP, Burtness B, Lee SH, Keam B, Kang H, Muro K, Weiss J, Geva R, Lin CC, Chung HC, Meister A, Dolled-Filhart M, Pathiraja K, Cheng JD, Seiwert TY. Antitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort. Journal Of Clinical Oncology 2016, 34: 3838-3845. PMID: 27646946, PMCID: PMC6804896, DOI: 10.1200/jco.2016.68.1478.Peer-Reviewed Original ResearchConceptsOverall response rateNeck squamous cell carcinomaProgression-free survivalSquamous cell carcinomaMetastatic headExpansion cohortPD-L1Cell carcinomaAnti-programmed death-1 antibodySix-month progression-free survivalTreatment-related adverse eventsEnd pointDeath-1 antibodyDose of pembrolizumabAntitumor activityPrimary end pointSecondary end pointsHuman papillomavirus (HPV) statusPD-L1 expressionOverall survival rateDurable antitumor activityFrequent dosing scheduleAssociation of responseAdvanced HNSCCM HNSCC
2000
A phase I study of the antimetabolite (E)-2'-fluoromethylene-2'-deoxycytidine (MDL 101,731) administered as a twice-weekly infusion.
Burtness B, Belker M, Stoltz M, Peccerillo KM, Lamb LA, Chmael SE, McKeon A, Clark MB, Winship J, Marsh JC, Pizzorno G, DeVita VT. A phase I study of the antimetabolite (E)-2'-fluoromethylene-2'-deoxycytidine (MDL 101,731) administered as a twice-weekly infusion. The Cancer Journal 2000, 6: 309-15. PMID: 11079170.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityRest weekNovel antimetaboliteWeekly scheduleHuman tumor xenograft modelsWeeks of therapyLife-threatening toxicityPhase I trialFrequent dosing scheduleTumor xenograft modelIndicator lesionsNoninfectious feverPersistent neutropeniaStable diseaseWeekly infusionsDose escalationDosing schedulesI trialRectal cancerAdvanced cancerInitial doseMonths durationXenograft modelPatientsPreclinical tests